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Google uses their search data to estimate flu activity around the world: http://www.google.org/flutrends/us/#US.
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Get ready for the 2011 flu season today and order your flu shots in advance! Many vaccine suppliers run out of vaccine due to a rush in orders the closer we get to the flu season. By ordering your flu shots today we are able to secure your order for fall. To order, or request a quote, simply visit our quote request page or call 800-898-8211.
Joseph Brownstein on
ABC News Medical Unit
Departments Probe Medical Error at School
By JOSEPH BROWNSTEIN
ABC News Medical Unit
Jan. 20, 2010—
When staff members at a Wellesley, Mass., school went to the nurse last Friday, they expected to be injected with a vaccine for theH1N1 flu. What they received instead was a shot of insulin resulting in a bout with low blood sugar.
While the staffers seem to be suffering no long-term damage from mistakenly receiving the insulin injections, investigations are ongoing to determine what caused the medical error. Indications thus far have been that a school nurse was responsible. The nurse has been temporarily relieved of duty.
While ABC News contacted people at the departments of health for the town of Wellesley and the Commonwealth of Massachusetts, as well as the Wellesley School District, it remains unclear how the flu vaccine, which can be distributed in pre-filled syringes or vials, was mistaken for insulin, which is drawn from a vial because each dose needs to be calibrated when it is given.
Such errors have happened before. This past fall, a number of people in the neighboring town of Needham received a seasonal flu vaccine in place of the H1N1 vaccines they were supposed to receive. And in 2007, a teacher in the nearby town of Attleboro also received an injection of insulin instead of the intended flu shot.
“Mistakes can always be made,” said Lisa Lowery, a registered nurse and immunizations program manager for the Visiting Nurse Service in Indianapolis. While she is reluctant to blame the nurse, she said other steps can be taken to avoid such a problem.
The benefit of having a nurse specifically performing a vaccination clinic, according to Lowery, is that it allows the nurse to be more focused. “You’re in a habit of doing what you’re doing. You’re doing one vaccine and only one vaccine,” she said.
“In practices, you’re taught to take the bottle to another nurse and have her double-check what you’re about to give,” she said—a situation that isn’t possible when a school nurse alone is administering vaccine.
“That nurse is not used to injecting vaccines as a school nurse,” said Lowery. “It would have been her habit to pick up insulin. Having someone to back them up and check them out would have prevented some more errors. If you’re holding a vaccination clinic, use someone who’s used to doing that.”
Kay Renny, a registered nurse and manager of community programs for the Visiting Nurse Association of Southeast Michigan in Detroit said other steps are typically taken to avoid such a problem.
She said when her nurses are giving out both seasonal and swine flu vaccines, they do so in two separate lines with two separate forms, which do not look alike, so that nurses—who are only administering one shot—will notice. “This is the first year where we’re administering two flu vaccines at the same time,” she said, explaining it presented a new challenge.
When a mistake happens, “It doesn’t hurt them, but it doesn’t help them. What they want is what they’re there for,” said Renny. “You try to put steps in place to avoid that happening.”
She noted that the vials for insulin and flu vaccine are similar but the syringes are different, with those for insulin being smaller. “Whenever administering any kind of medication, you have to double check when you have multiple kinds of medication in front of you. You really need to double check your double check.”
While no one seems to be suffering long-term consequences from the medical error, adverse events are always possible with insulin being needlessly injected, since it drops the blood-sugar levels.
“It’s basically going to make them hypoglycemic,” said Dr. Sue Kirkman, senior vice president for medical affairs for the American Diabetes Association. “That might cause anything from just feeling shaky and jittery and hungry all the way down to making it difficult to think.”
Kirkman explained that a person can become unconscious if their blood-sugar drops too low, but noted that this type of error could be corrected by certain injections or “you can have the person eat carbohydrates to bring the blood sugar back up,” depending on the severity.
It remains unclear what, if any, impact this incident will have on public demand for flu vaccine.
Both nurses seemed to think, however, that the incident, while unfortunate, would likely improve safety in people still getting vaccinated without reducing the number of people willing to get the shot.
“When you have stories out there, then people are going to be asking the person administering—the nurse—what are you giving me?” said Renny. “What I think it does is help the administrator administer the right vaccine, because it’s forefront in their mind.”
“I do think people who are actively going to seek a shot are going to be proactive about asking the nurse, which is a good thing,” said Lowery. At the same time, she said, “We still need to encourage the public to get both their H1N1 vaccination,” noting that it remains unclear if H1N1 will return and the traditional peak of seasonal flu has not yet arrived.
“Don’t let an incident as isolated as this affect your choice,” she said. “Make sure you get vaccinated and prepare for the flu season.”
More Answers Needed
One complicating issue that has not been resolved yet is how the error was made, given that the H1N1 doses had come in prefilled syringes, while insulin doses are filled at the time from a vial.
Insulin “typically would not be in pre-filled syringes,” said Kirkman, adding that “there are some situations where a home health nurse, for example, might pre-fill syringes for someone who’s homebound. I think it’s just impossible to speculate.”
“It does seem odd,” said Lowery. “However, having been a school nurse, it involves more than giving out Band-Aids,” she said, noting that kids and teachers are coming in for a variety of ailments. “I can see, unfortunately, where it would be very easy to get flustered and confused.”
A woman answering the phone for the Wellesley superintendent’s office indicated that the investigation is ongoing and no answer could be provided for that particular question yet.
Copyright © 2010 ABC News Internet Ventures
Tests show the shots may not be potent enough to protect against virus
ATLANTA - Hundreds of thousands of swine flu shots for children have been recalled because tests indicate the vaccine doses lost some strength, government health officials said Tuesday.
The shots, made by Sanofi Pasteur, were distributed across the country last month and most have already been used, according to the Centers for Disease Control and Prevention. The 800,000 pre-filled syringes that were recalled are for young children, ages 6 months to nearly 3 years.
Dr. Anne Schuchat, a CDC flu expert, stressed that parents don’t need to do anything or to worry if their child got one — or even two — of the recalled shots. The vaccine is safe and effective, she said.
The issue is the vaccine’s strength. Tests done before the shots were shipped showed that the vaccines were strong enough. But tests done weeks later indicated the strength had fallen slightly below required levels.
Why the potency dropped isn’t clear. “That’s the $64,000 question,” said Len Lavenda, a Sanofi Pasteur spokesman.
Young children are supposed to get two doses, spaced about a month apart. Health officials don’t think children need to get vaccinated again, even if they got two doses from the recalled lots, said Schuchat.
Swine flu vaccine has been available since early October, and since then manufacturers have released about 95 million doses for distribution in the United States.
The recalled shots were made by Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group. The vaccine all tested fine when it was shipped out earlier this fall. But last week, testing of one lot showed that the potency had fallen about 12 percent below the government standard, Lavenda said.
The company found three other lots with diminished strength. It notified government health officials and did a voluntary recall, asking doctors to return any unused doses. The vaccine has been in high demand and the company doesn’t expect to see much come back, Lavenda added.
Officials with the Food and Drug Administration, the CDC and the company all said they believe the strength of the recalled doses is still high enough to protect children against the virus. No potency problem has been detected in the same vaccine packaged in other types of syringes or vials, Lavenda said.
Experts have a theory that the problem is specific to the children’s pre-filled syringes. For some reason, the antigen — the key vaccine ingredient — may be sticking to the walls of those syringes, said Dr. Jesse Goodman, the FDA’s deputy commissioner for science and public health.
Another manufacturer, Novartis, in February recalled five lots of seasonal flu vaccine packed in pre-filled syringes under similar circumstances.
Sanofi Pasteur bills itself as the No. 1 manufacturer of flu vaccines in the world. It makes flu vaccine at sites in France and in Pennsylvania.
Swine flu was first identified in April. During the first seven months of the pandemic, it has sickened about 50 million Americans and killed about 10,000, according to CDC estimates.
Kate Kelland on
LONDON (Reuters) - Criminal gangs are making millions of dollars out of the H1N1 flu pandemic by selling fake flu drugs over the internet, a web security firm said on Monday.
Sophos, a British security software firm said it had intercepted hundreds of millions of fake pharmaceutical spam adverts and websites this year, many of them trying to sell counterfeit antiviral drugs like Tamiflu to worried customers.
Tamiflu, an antiviral marketed by Switzerland’s Roche Holding and known generically as oseltamivir, is the frontline drug recommended by the World Health Organisation to treat and slow the progression of flu symptoms. GlaxoSmithKline makes another antiviral for flu, known as Relenza.
Sophos said many of the gangs behind the sites were based in Russia and the top five countries buying fake Tamiflu and other medicines on the internet were the United States, Germany, Britain, Canada and France.
Sophos spokesman Graham Cluley said a “worrying trend” towards stockpiling Tamiflu had already been seen in Britain—Europe’s worst-hit country in the H1N1 pandemic so far.
“As more and more cases of swine flu….come to light, it is essential that we all resist the panic-induced temptation to purchase Tamiflu online,” he said.
“The criminal gangs working behind the scenes at fake internet pharmacies are putting their customers’ health, personal information and credit card details at risk.”
The Geneva-based WHO, which declared H1N1 swine flu a pandemic in June, updated its guidance to doctors last week to say that antiviral drugs should be given even before tests conclude that an at-risk patient has the pandemic virus.
Sophos said criminal gangs were operating medicines websites branded as the “Canadian Pharmacy” to try to appear genuine.
It said its research showed that on one network operated out of Russia, called Glavmed, it was possible to earn an average of $16,000 a day promoting pharmaceutical websites.
“But the criminals can be members of more than one affiliate network, and some have boasted of earning more than $100,000 per day,” it said in a statement.
The pandemic H1N1 flu virus has now spread to 206 countries since it was first discovered in March. There have been more than 6,250 deaths to date, mostly in the Americas region, according to the latest WHO toll.
(Editing by David Cowell)
Fred Tasker on
You’d think Jonas Brothers tickets were going on sale the way people started waiting in line in the dark at 6 a.m. Wednesday. But, no, the attraction was swine flu vaccine.
By 9:30, half an hour before the mass vaccination clinic at the Miami-Dade Youth Fair pavilion in West Miami-Dade was supposed to open, 160 people were in line, so they let them in early. By 10 a.m., 400 awaited the vaccines.
Ana Borge, 42, of Miami, showed up at 6 a.m. to get vaccines for herself and her sons, 12-year-old Christopher, 11-year-old Jonathan and Anthony, who is 8.
``I think it’s very important,’’ she said. ``I’ve heard about people with complications, even people who have died.’‘
``I wanted to get here early because I knew there would be a line,’’ said Janet Pino, 33, of Miami, who also came at 6 a.m. with her parents, Felipe and Hilda Pino. ``I want my vaccination because I’m going to Barcelona for Christmas.’‘
On Wednesday, which is Veterans Day, the Miami-Dade Health Department was offering free H1N1 vaccinations until 6 p.m. at two sites: its downtown clinic at 1350 NW 14th St., and mass clinic at the Miami-Dade County Fair Expo Center Fuchs Pavilion, 10901 Coral Way.
By mid-day, the department announced it would not take additional clients at the Fair site, and estimated 2,500 people would be vaccinated at the site by the end of the day. The downtown clinic remains open until 6 p.m.
The department could offer shots at the mass clinic because H1N1 swine flu vaccine is beginning to flow more freely, with nearly half a million doses in Miami-Dade and Broward counties. Miami-Dade now has received 299,400 doses. Broward has received 195,000 doses.
Swine flu vaccine is in supply free at the five Miami-Dade County health clinics and 12 Federally Qualified Health Centers listed on the health department website at dadehealth.org. The other Miami-Dade clinics are closed for the holiday.
The Broward Health Department was closed Wednesday for Veterans Day, but it has opened a High Risk H1N1 Vaccination Clinic at its Northwest Health Center at 624 NW 15th Way, Fort Lauderdale, open 8 a.m. to 5 p.m. Mondays through Fridays.
Supplies are also arriving in the offices of 716 private Miami-Dade physicians who have registered with the Florida Shots program to give immunizations.
Vaccines go first to OB/GYNs and pediatricians and family practice doctors who serve patients at high priority to get the vaccines. That includes pregnant women, people who live with or care for children younger than 6 months of age, healthcare and emergency medical services personnel, people between 6 months and 24 years and people age 25 through 64 who have chronic health conditions such as asthma or diabetes.
On Wednesday, Walgreens pharmacies in Miami-Dade that have Take Care clinics had a few doses of H1N1 vaccine on sale for $18 a dose. By next week, vaccines also should be available at CVS pharmacies, Navarro, Publix and Winn-Dixie in Dade, she said.
University health clinics are receiving vaccines for use only among students and faculty.
Broward County has allocated 80,000 of its 195,000 doses to public and private schools, the rest to private doctors, universities, hospitals for their healthcare providers and emergency first-response personnel, in addition to its high-risk clinic. Commercial pharmacies and supermarkets do not yet have the vaccines, said Candy Sims, health department spokeswoman.
Mark Johnson and Laurel Walker on
Posted: Oct. 27, 2009
As doctors cope with shortages of swine flu vaccine and large numbers of people suffering influenza-like illness, the state and federal governments have shifted away from mass vaccination clinics toward targeting limited doses at those with greatest risk.
The Centers for Disease Control and Prevention lists those at greatest risk of serious illness from swine flu as: pregnant women; healthcare and emergency medical staff who have direct contact with patients; people who live with or provide care for children under 6 months old; children ages 6 months to 4 years; and children 5 to 18 with chronic medical conditions such as asthma and diseases of the heart and liver.
The recommended shift from mass clinics to targeted vaccinations forced the Milwaukee Health Department to re-evaluate plans for the 1,500 doses of vaccine left over from last week’s large clinics.
“It’s all needing to be reworked,” said Raquel Filmanowicz of the Milwaukee Health Department.
She said the city has received no new shipments of vaccine.
Meanwhile, the state and federal government held news conferences to announce that more vaccine has been allocated. Wisconsin has a cumulative allocation of 407,000 doses, although “probably not all of those have made it into the state yet,” said Stephanie Marquis, a spokeswoman for the state Department of Health Services.
The allocation is essentially the amount the CDC has said it’s going to give Wisconsin.
Thomas R. Frieden, director of the CDC, said the federal government has now received 22.4 million doses compared with about 14 million last Wednesday.
“We’ll be seeing in the coming week an increase in vaccine availability,” Frieden said. But he acknowledged that for now, the vaccine “is still too hard to get.”
Frieden said that eventually there will be enough vaccine for everyone who wants to receive it. He urged communities that have vaccine not to keep it in reserve but to use it as quickly as possible.
This week’s shift in strategy is made all the more confusing by the two forms of vaccine, the injectable form and the nasal mist, which have already been targeted to different populations.
Although both are considered safe and effective, the nasal mist is a live but much-weakened form of the H1N1 virus and is not recommended for people with a compromised immune system or underlying health conditions such as asthma. The injectable vaccine is made from dead virus. Based on the differences, the nasal mist has become known as a vaccine for generally healthy people ages 2 to 49.
The injectable vaccine has been reserved for those not considered healthy enough for the nasal mist. So far, the nasal mist has been plentiful, but the injectable vaccine has been in short supply.
At the Waukesha County Exposition Center on Tuesday, where county officials were holding their first clinic for targeted groups of the general public, a line started forming about 10:30 a.m.
By the 1 p.m. clinic opening, about 500 people patiently stood in a line snaking along a parking lot.
The clinic - among three planned Tuesday, Wednesday and Thursday from 1 to 7 p.m. each day at the Expo Forum Building - was targeted to healthy people between the ages of 2 and 49, caregivers of infants under 6 months of age, and health care workers and emergency responders. They expected to administer about 3,000 nasal doses over the course of the week, said spokeswoman Julianne Klimetz. About 250 emergency responders were vaccinated in three clinics over the last two weeks.
County officials are still awaiting the injectable H1N1 vaccine, which can be more widely administered.
Among the early arrivals Tuesday were Lynne Franz, her grandson Michael Vincent Franz, 4, and Michael’s mother, Jessica Franz. Neither grandmother, who is 58 and has MS, nor mother, who has asthma, was eligible for the nasal-administered vaccine. But they wanted to make sure Michael - who also got a regular flu shot several weeks ago - was protected.
“We heard the hype about it, and we wanted to make sure he was immunized,” said Lynne Franz of Brookfield.
Andrea Kolcott, 31, of the Town of Mukwonago was using her lunch hour to get immunized because she has a 4-month-old infant at home. Health officials say the best way to keep babies flu-free is to keep their caregivers healthy.
“I’m not normally a flu-paranoia person,” she said, but the whole family had gotten regular flu shots for the first time this year.
Public Health Director Nancy Healy-Haney said 14 people in Waukesha County have been hospitalized with the H1N1 flu since June and one woman with an underlying medical problem died in August. Officials also reported that Greenland Elementary School in Oconomowoc was closed Tuesday with nearly 40% of its 400 students out ill.
For the latest national updates on flu, go to the federal government’s Web portal: flu.gov
2009 Seasonal influenza vaccination: October 14, 2009
CDC has heard from some health care providers and other immunization providers who are frustrated because they are not currently able to obtain seasonal influenza vaccine.
Their concerns mirror some anecdotal media reports that this year demand for seasonal influenza vaccine appears to be substantially higher than last year.
Hard evidence of increased demand and its relationship to supply is not available. However, what we do know about vaccine supply and availability should help all of us get vaccine to people who need and want it.
The good news about vaccine supply is that current projections of the number of doses of seasonal influenza vaccine that will be available is very close (97%) to the planned number.
- Manufacturers now estimate that a total of 114 million doses will be brought to the U.S. market.
- In June, the 5 manufacturers estimated that they would produce 118 doses. (specific figures can be found at http://www.preventinfluenza.org/presentations_2009.asp)
- The difference between planned and the ultimate number of doses varies by manufacturer, but
there have been no major reductions in production. Other good news is that the seasonal flu vaccine has been made available earlier this season than ever before. As of the first week of October, 77 million doses have been distributed in the private and public sectors.
People have been responding to vaccine availability by getting immunized earlier this season.
• Two systems that look at vaccinations administered and billed show that many more individuals have been vaccinated this season than at the same time last year. However, this is most likely due to the early availability of vaccine.
If the anecdotal reports about increased demand turn out to be correct, the extra demand may not be fully met.
- Because the total number of doses that will be made this year is approximately the same as the number of doses that were actually administered last year, an increase in demand cannot be met this season.
- Manufacturers are not able to produce more seasonal influenza vaccine for this season.
Their facilities are currently being used for H1N1 vaccine production, which takes several months. Thus, these facilities would not be available for additional non‐H1N1 vaccine production in time for this influenza season.
- When the manufacturers made their estimates in June, related to the number of seasonal flu vaccine doses that they would bring to market, they were already planning to switch their facilities to the manufacturing of H1N1 monovalent vaccine
- Influenza vaccine takes several months to make. Early processes include making bulk vaccine; later processes include blending, filling, and packaging the vaccine.
- The manufacturing process is like a pipeline. To keep vaccine flowing through the system, bulk H1N1 vaccine needed to be started as soon as the bulk facilities became available, which was before all of the seasonal flu vaccine was filled and finished.
• The supply could still be reduced if the manufacturing steps after the bulk vaccine steps encounter problems. For example, a lot could fail FDA inspection.
We are working with manufacturers, states, and immunization providers to identify existing seasonal flu vaccine and get it to providers who can administer it to people who need and want it.
The situation is dynamic, and we expect it to continue to evolve as the influenza vaccine season continues.
• Some manufacturers fell short of their planned number of doses, and took orders that exceed the number of doses they now expect to make.
o This has caused their distributors to cancel or cut back on some vaccine orders
- In addition, some manufacturers have had a delay in the availability of vaccine, and this is resulting in orders that won’t be completed until November.
- Each year, some immunization providers order vaccine from more than one manufacturer or distributor, and then cancel other orders after the earliest vaccine is received. Because of this ordering pattern, some vaccine usually becomes available in October.
- However, we have not seen this so far this season. We are not seeing additional vaccine being released into the market as has been the case in past years.
- With orders and availability still being sorted out, CDC recommends that vaccine providers check the National Influenza Summit web site where available vaccine is listed by distributor: http://www.preventinfluenza.org/ in the link for healthcare professionals.
- Right now, this web site shows almost no vaccine available, but that all products are on order.
- We don’t know how much vaccine will become available, but it is unlikely that much more vaccine will enter the market.
- Providers, who have more vaccine than they anticipate using, are being encouraged to work with their local health department to identify other providers for the vaccine.
- One false rumor is that the federal government told the manufacturers to stop making seasonal vaccine earlier than they had planned to switch production to H1N1
- The reality is that the manufacturers are finishing their planned number of seasonal flu doses (to about 97%) and have moved on to their planned H1N1 production
- Another false rumor is that the manufacturers switched to H1N1 vaccine production because they will make more money on the new vaccine. There is no evidence to support this rumor.
You may have heard rumors related to the seasonal influenza vaccine supply.
Individuals should be encouraged to seek seasonal flu vaccine.
- There are many millions of doses yet to be distributed this season.
- Most will be able to obtain vaccine from their usual provider, but some will have to obtain the vaccine from an alternative provider
- People can find seasonal vaccine by checking the American Lung Association web site that identifies clinics that have influenza vaccine available: http://www.flucliniclocator.org/
- We are still early in flu season; there is still time for people to get vaccinated to protect them from becoming ill.
Richard Knox on
Millions of Americans already have been infected with swine flu. Forty-six states have widespread flu, and the president has declared a national emergency.
But only recently have U.S. health officials discovered why manufacturers can’t deliver as much swine flue vaccine as expected.
Officials at the Centers for Disease Control and Prevention say for months, the companies didn’t realize how far short their vaccine “yields” were falling. That’s because they didn’t have the chemicals — called reagents — that would have told them how much active ingredient they had in their vaccine production vats.
“To really understand how much product you have, you need to do potency tests,” says Dr. Anne Schuchat, chief of the CDC’s National Center for Immunization and Respiratory Diseases. She says reliable tests used to measure potency were delayed.
“When they were run, the manufacturers basically found out that the product they had was actually less than they thought they had,” Schuchat said in an interview with NPR. “That wasn’t something we knew a long time ago. That’s relatively recent.”
On top of that, there were glitches in new machines manufacturers installed to put vaccine in vials and package the vials. So there was an unexpected bottleneck in the so-called fill-and-finish part of getting vaccine out the door.
The CDC didn’t realize the combined effect of these problems until mid-October. That’s when it revised its projected swine flu vaccine delivery dates downward.
The problems have left local public health officials frustrated and bewildered.
“The vaccine situation is quite frustrating,” says Dr. Jonathan Fielding, the health commissioner for Los Angeles County.
“The numbers we were asked to anticipate and plan for have turned out to be gross overestimates of what has been supplied to us,” Fielding says. “I don’t understand what the issues are with the manufacturers, that from one week to the next they can’t give us more accurate estimates.”
Los Angeles County got its first delivery of vaccine against the new H1N1 flu last week. It got 300,000 doses for a city of 10 million, with no real idea of when to expect more. Two-thirds went to private health care providers, one-third to free public clinics.
Fielding says before now the county canceled dozens of vaccine clinics. When the first ones opened this past weekend, demand was brisk. People had to wait up to three hours to get a flu shot, and Fielding says he saw few people drop out of line.
Vaccine yield problems with swine flu are not new. Last July, vaccine manufacturers reported problems in growing the new H1N1 virus - or, rather, a hybrid of the swine flu virus and a standard vaccine virus strain - in chicken eggs. That’s a crucial step in the current technology for making flu vaccines.
However, CDC scientists thought those problems had been overcome. Unfortunately, not so. The Wall Street Journal reported on Saturday that some vaccine manufacturers have had only one-fifth the viral yield from chicken eggs that they expected.
Some manufacturers are reportedly working with a different “seed” strain of vaccine virus that gives better yields.
Meanwhile, the flu virus is spreading rapidly. No one knows when to expect the crest of this wave of the swine flu pandemic — the second wave since the new virus first appeared last April. Scientists at the University of Washington predict it will be sometime in November. Others decline to make projections.
Vaccine production won’t be able to catch up very soon. The CDC’s Schuchat says that raises an obvious question.
“People wonder whether, when the vaccine is available for you or those in your family, will it be too late for that vaccine to give you any benefit?” she acknowledges.
“It’s hard to make an argument that the vaccine is going to protect very many people at the rate it’s coming out,” says Dr. Marc Lipsitch of the Harvard School of Public Health, a CDC consultant. “Much of this wave will be over by the time most Americans have access to the vaccine.”
Schuchat disagrees. She says even when this wave of swine flu peaks, there will still be time for many people to get vaccinated.
“A key point is that when the peak occurs in any one area, half the people who are going to become infected haven’t yet become infected,” Schuchat says.
Fielding, the Los Angeles County health commissioner, thinks Schuchat is right.
“I don’t think it’s too little, too late,” Fielding says. “I think it’s too little. Obviously for people who get sick or who get very seriously ill, it’s too late. But for many others, I think it’s going to arrive in time to help prevent disease.”
Dr. Donald Burke, dean of the University of Pittsburgh’s School of Public Health, thinks swine flu vaccine will not come in time to protect most Americans against the current wave of infection. But he thinks there is a “very real possibility” of a third wave of swine flu in December or after the first of the year.
“So even if we see a peak now, I will stand with the recommendation to get vaccinated,” Burke says. Some think if enough children get vaccinated in November and December, that could prevent or blunt a third wave.
But CDC officials are currently chary of predicting when the vaccine will be available in quantities sufficient to protect the 159 million Americans who are considered at highest risk of the new H1N1 flu.
“Given how far off some of the projections have been from what we have now,” CDC director Thomas Frieden said ruefully last week, “I would prefer to just take it one day at a time, one week at a time.”
By Maggie Mertens on
The Centers for Disease Control is just as unhappy as the rest of us about the tight supply of swine flu vaccine, we heard today.
In an afternoon briefing today, CDC Director Dr. Thomas Frieden talked about the problems, saying the means of vaccine production aren’t exactly modern and are definitely not suited to responding to this pandemic. In short, manufacturers are having more trouble growing the virus for the vaccine than they originally expected. But, Frieden says, the method is the “tried and true” way that seasonal vaccines are produced, so at least we know it’s safe.
Another problem, Bloomberg reported today, is that some vaccine is held up by regulatory issues—not just manufacturing bottlenecks. GlaxoSmithKline still doesn’t have the US’s go-ahead for its H1N1 vaccine without an adjuvant, or immune-system booster, according to Bloomberg.
But Frieden focused on problems the vaccine makers are having in cultivating the virus. “Even if you yell at them, they don’t grow faster,” he said about the virus cultures.
More than 11 million doses of the vaccine have been shipped out for public use so far, bringing the total doses that have become available up to 16 million this week, the CDC said. That’s a far cry from the 195 million doses the CDC planned for by the end of the year and tensions are running high.
Frieden encourages people to get immunized when the vaccine becomes available, especially those at high risk, such as children and pregnant women.
As for the spread of the virus, swine flu is now widespread in 46 states. That’s on par with the top of the season for garden-variety flu, said Frieden, so it’s quite something in October. As for the new H1N1 virus, the CDC isn’t seeing any genetic changes in the virus.
Since the first outbreak of the virus in April in the US, 1,000 people have died and 20,000 have been hospitalized.
Frieden says he’s confident that everyone who wants to be vaccinated will have eventually be able to—just probably not as soon as they would like. For now, the CDC is steering clear of making any more projections and focusing on getting the vaccines to people as it becomes available.
Ridgely Ochs on
Citing shortages of flu vaccine, Gov. David A. Paterson has announced that the state Health Department was suspending a controversial mandate that all health care workers get vaccinated or lose their jobs.
“We need to be as resourceful as we can with the limited supplies of vaccine currently coming into the state,” Paterson said in a statement released late Thursday. He said the federal Centers for Disease Control and Prevention told the state this week that only about 23 percent - or 27.7 million doses - of its anticipated H1N1 vaccine supply would be available nationwide by the end of the month.
In August, the state health commissioner, Dr. Richard Daines, imposed the employee mandate for seasonal and swine flu shots, the first in the country, with a deadline of Nov. 30. At least four lawsuits were filed by health care workers who said the requirement violated their civil rights. Last week an Albany judge issued a temporary restraining order, suspending the mandate until Oct. 30.
Colleen Heinze, a nurse at Stony Brook University Medical Center who opposed the mandate, called the news “fantastic.”
“That means I get to keep my job,” she said.
Patricia Finn, a Rockland County lawyer who had filed a lawsuit on behalf of a Dutchess County nurse seeking to void the mandate, said she was pleased with the decision. “I’d like to think the commissioner heard the cries of the health care workers,” she said.
A health department spokeswoman, Claudia Hutton, said the lawsuits “had nothing to do with” the decision.
Daines said in the release vaccinating health care workers “continues to be an important patient safety measure” and urged hospitals to encourage employees to do so.
Nassau County Executive Thomas Suozzi said he had spoken with the governor and sent a letter Thursday calling on him to suspend the mandate because of too little vaccine. He called the decision “a wise move.”
Demand for H1N1 vaccine has exceeded supply in the state, including Nassau and Suffolk. The state Health Department opened a call-in center this week for doctors to place orders. So far this week, the CDC has allowed New York to order 146,300 doses of vaccine, while doctors have requested 1,482,822 doses, the state said.
Seasonal flu vaccine is also in short supply because many manufacturers switched over to make the H1N1 vaccine.
Suozzi called on the CDC to tell local officials how much H1N1 vaccine is available and who is getting it.
“I’m fed up with the CDC,” Suozzi said, adding he telephoned and sent a letter Thursday to Dr. Thomas Frieden, director of the agency.
Suozzi’s letter said local officials were unable “to provide accurate information on when or how vaccine will be distributed because we do not know what the CDC’s plan is.
“As a result, our residents are confused, our public health officials do not have accurate information,” he wrote.
The CDC acknowledged the problem. “We are experiencing a very fluid situation that is changing minute by minute,” said CDC spokesman Tom Skinner. “We understand that some officials are frustrated. “
Skinner said it would be the middle or end of November before there will be enough H1N1 vaccine. With Sid Cassese
Andrew Pollack on
Public health departments across the country have had to cancel vaccination clinics. Doctors have had to turn away patients. And consumers have had to make extra efforts to get immunized.
“We had patients scheduled; we had to cancel the patients,” said Dr. Ralph K. Messo Jr., who practices in Staten Island and Colts Neck, N.J.
Dr. Messo said he received only 150 of the 1,000 shots he ordered. “They keep giving us a shipment date, and then they don’t deliver,” he said.
Karyn O’Malley of New Canaan, Conn., said the town’s flu clinic, where her family had gone for the last two years, was canceled this year. The family’s pediatrician vaccinated Ms. O’Malley’s two daughters but then ran out of vaccine and placed her son on a waiting list. She received her own shot at Walgreens, but the drugstore did not have vaccine for children. And when her husband went to Walgreens a week later, it had run out of adult vaccine as well.
“It’s frustrating,” Ms. O’Malley said.
Public health officials and vaccine manufacturers say the shortfall was caused in part by the need to shift resources to the pandemic flu vaccine. There also appears to be an increase in demand probably because swine flu has raised public concern about flu in general.
They also say it is temporary. Ample vaccine should be available by November, leaving enough time to be inoculated before the seasonal flu arrives in force later in the winter. Virtually all the influenza virus circulating right now is the pandemic H1N1 strain, also known as swine flu.
“We just ask for people’s patience,” Dr. Anne Schuchat of the federal Centers for Disease Control and Prevention said Friday at a news conference.
Federal authorities are recommending that many people get vaccinated both against the seasonal flu and the new pandemic swine flu, though the priority groups for each vaccine differ somewhat. They say the seasonal vaccine will not protect against the pandemic strain.
Still, some doctors say the vaccine that arrives in November might go unused because consumers will have moved on. And because seasonal flu causes thousands of deaths each year, they say, the issue needs more attention.
“I was just horrified that no one was discussing it,” said Dr. Symra A. Cohn, a Manhattan internist.
Questions are also arising about how vaccine is allocated by the manufacturers and distributors. Some doctors and public health officials complain that big drugstore and grocery chains seem to have plenty of vaccine — and even advertise that — while they are left wanting.
“There certainly seems to be enough vaccine around if you’re willing to pay for it,” said Dr. Dora Anne Mills, the public health director for Maine, referring to the $25 or so that drugstores charge. “And yet I can’t get vaccine to public health clinics to serve the homeless and school kids, etc.”
To be sure, the shortage is nothing like the severe one in 2004, when some people waited in line for hours for a shot. Most years, millions of doses go unused.
Another reason for the temporary shortfall is that demand appears to be up sharply this year. Yet manufacturers cannot make extra vaccine to meet that demand because they have shifted to making pandemic vaccine.
Through Sept. 26, physicians had administered four times as many doses of seasonal vaccine as they had by the same point last year, according to SDI Health, which tracks insurance claims by physicians.
That probably reflects the fact that people are getting their seasonal vaccinations earlier this year, as well as true growth in demand. Health authorities have urged people to get seasonal flu inoculations earlier than usual in order to leave time for the pandemic flu vaccinations, which are now beginning.
Over all, the five flu vaccine manufacturers said in June that they hoped to deliver a combined 119 million doses this year, which is more than enough for a typical flu season.
But two makers will produce somewhat less than they hoped, so the total will end up at about 114 million doses, of which 77 million doses have been delivered.
Sanofi Pasteur, the largest supplier, has delivered only 30 million of its projected 50.5 million doses so far, in part because of production difficulties, a spokeswoman said. She said the rest should be delivered by the end of November.
Manufacturers say they try to be fair in allocating vaccines. But some customers end up with sharper cutbacks than others.
The Visiting Nurse Associations of America said Novartis cut its order by about 70 percent, even though the manufacturer’s overall production was down only 10 percent.
After Richard Blumenthal, the attorney general of Connecticut, intervened, Novartis increased its shipments to the association.
Andrin Oswald, the head of the vaccine business for Novartis, said the company took into account the uses of the vaccine and whether the customer had other suppliers.
Avani Chhaya on
As the first drops of novel H1N1 vaccine arrive in Illinois this week, Big Ten schools in other states are still striving to manage the outbreak of the virus.
Universities across the conference are offering safety kits and informational guidelines, cautioning students to stay home, wash hands, cover coughs and sneezes and get plenty of rest.
“Basically, what we’re doing is the common sense type of control that people do — stay hydrated, get plenty of rest, cough into your sleeves not your hands and wash your hands frequently,” said Susan Williams, spokeswoman at Indiana University.
Tom Moore, interim University of Iowa spokesman, said the number of novel H1N1, or swine flu, cases on campus is largely an estimate because the school is not testing to see if the cases of flu are H1N1.
“The general feeling is that we have 300 cases of influenza-like illnesses. The Centers for Disease Control and Prevention (CDC) doesn’t consider cases of influenza-like illness to be a reportable illness. We are dealing with estimates,” Moore said.
Moore said he does not know where the University of Iowa stands in comparison with other universities on the rate of swine flu cases.
As for the University, the total number of confirmed swine flu cases as of Oct. 6 is 781, said David Lawrance, medical director at McKinley Health Center, in an e-mail.
Kathy Edgren, director of health promotion and community relations at the University of Michigan, explained that the school had enacted an entire campaign to help cover coughs and wash hands all over campus.
The poster proposal depicts the “green hat guy” saying “getting sick sucks, coughs and sneezes spreads diseases,” Edgren said.
Michigan also offers kits in community centers, as well as prepared paper bags with a mask, thermometer and an informational sheet to tackle the effects of swine flu, she added.
Edgren said her mission is to get the message out to people in residence halls, fraternities, sororities and apartments.
“We’re getting ready to send a news release in anticipation of the H1N1 vaccine on campus,” Williams said.
Indiana is planning on sending that information out as soon as possible, she added.
Limiting the contact of the influenza virus helps prevent the spread of the disease to other students.
Being one of the eight universities in the country which conducts test trials of H1N1 , Iowa has suspended the requirement for students to receive a note from a physician to limit the exposure of the illness to others, Moore said.
He added that students with swine flu should download a report form and send it to their professors rather than travel across campus and possibly spread the disease.
“They seemed to be going down some. (Swine flu cases) seems to have peaked,” Edgren said. “At least this wave of it has, but we don’t know what’s going to happen down the road.”
Check out https://h1n1.cloudapp.net/Default.aspx, an online assessment you can take if you think you may have H1N1 (Swine Flu) developed by Microsoft and Emory University.
Mike Stobbe on
The Associated Press
About one in 13 U.S. swine flu deaths have been children and most of the kids have been of school age, the federal government said Thursday in its first study of the new flu’s youngest victims.
More than 40 U.S. children have died from the virus since it was first identified in this country in April. The report from the U.S. Centers for Disease Control and Prevention takes a comprehensive look at the first 36 deaths, and found some important differences in the pediatric death toll from swine flu as compared to seasonal flu:
—Normally, half or more of the children who die from flu are age 4 and younger. But more than 80 percent of the kids who died with swine flu were 5 or older.
—Almost two-thirds of the children who died with swine flu had epilepsy, cerebral palsy or other neurodevelopmental conditions. In a previous flu season, only a third of pediatric deaths had those conditions.
—Bacterial co-infections were a big danger, and were blamed in most of the deaths of otherwise healthy children. Co-infections usually occur when a patient, weakened by a virus, then gets hit by a bacterial bug.
The CDC released the report through one of its publications, Morbidity and Mortality Weekly Report.
Swine flu has caused more than 1 million illnesses in the United States, the CDC estimates. More than 550 deaths and 8,800 hospitalizations have been reported to date.
It’s hard to say whether children have accounted for a higher proportion of deaths from swine flu than they normally do from seasonal flu, though CDC officials say that seems to be true. The CDC doesn’t monitor seasonal flu deaths as closely as it does swine flu, and it has no comprehensive count of annual seasonal flu deaths to enable such a comparison.
The new report focuses on lab-confirmed swine flu deaths reported through Aug. 8. The CDC hasn’t been able to do as complete an analysis of cases that have come in since then, said Dr. Cynthia Moore, a CDC medical officer who was one of the study’s co-authors.
Through Aug. 8, there were 477 total swine flu deaths, including 36 in children.
Only about 20 percent of those children were age 4 or younger. That’s unusual: Often 50 percent or more of seasonal flu deaths are in infants and toddlers, who have less mature immune systems and smaller air passages and are generally in more danger from respiratory infections.
“There’s a lot of school-aged children” in the death count, said Dr. Beth Bell, a CDC epidemiologist who is a leader in the agency’s swine flu response efforts.
It’s not clear why such a large percentage of the swine flu pediatric deaths are in kids aged 5 and older. It simply may be because older children were more likely to encounter the virus—at schools, summer camps—than very young children who spend more time at home, Bell said.
The initial numbers in the report are small and the CDC will need to look at more reports to see if the trends hold up, CDC officials said.
Two-thirds of the children who died had high-risk medical conditions. Nearly all of them had an illness related to the nervous system, including mental retardation, cerebral palsy and epilepsy and other seizure disorders.
Years ago experts recognized that children with neurodevelopmental conditions are at higher risk of serious complications from the flu. But the proportion of swine flu victims with that kind of underlying condition was swine flu percentages are high compared to a previous flu season, CDC officials said.
It’s not clear how significant that finding is, because many of the children had other medical problems that had weakened their bodies, CDC officials said.
Of the children who were healthy before they got swine flu, many were probably killed by a one-two punch of swine flu working with a bacterial co-infection, CDC officials said.
Bacterial co-infections have been an increasingly noticed danger since the government started tracking pediatric flu deaths in 2004. So their occurrence with swine flu was not a surprise, but emphasized the needs for parents and doctors to be alert to the danger and give the child antibiotics when appropriate, CDC officials said.
Jessica Doyle and Karlie Pouliot on
For months we’ve have been waiting for the H1N1 vaccine to arrive in the U.S. – and now it looks like that wait is almost over. The new vaccine should be in some doctors’ offices as early as Monday, according to U.S. health officials.
But even though we’ve had weeks upon weeks to think about the new vaccine, many of us still have questions. So, FOXNews.com sought out the advice a few health experts to help us sort through all of this.
Q: Is the inhaled version of the vaccine, FluMist, coming first or will there also be shots available next week as well?
“States are ordering the nasal spray today,” Tom Skinner, a spokesman for the Centers for Disease Control and Prevention said. “We have several million doses of that available. We expect to have the injectable vaccine available for order shortly… states will receive nasal spray next week, followed by injectable vaccine.”
Q. What exactly is FluMist and who can get it?
“FluMist is a live modified H1N1 virus,” Dr. Peter Welch, an infectious disease doctor at Northern Westchester Hospital, Mount Kisco, N.Y., told FOXNews.com. “It’s sprayed into the nose and gives you a mild infection of the virus, which will prevent you from getting a more severe infection from the native virus.”
But FluMist is not for everyone.
“The nasal spray is for healthy individuals, ages 2 to 49,” Skinner said. “People with chronic underlying health conditions can’t get this vaccine.”
The good news is the injectable vaccine is on the heels of this nasal spray, Skinner said, so people with compromised immune systems will be able to get that as soon as it’s available – hopefully within the next few weeks. It’s been shown to be more effective than the nasal spray.
Q: Can you get the H1N1 shot and seasonal vaccine at the same time?
According to the CDC, the inactivated H1N1 vaccine can be administered at the same visit as any other vaccine, including pneumococcal polysaccharide vaccine. Live H1N1 vaccine can be administered at the same visit as any other live or inactivated vaccine EXCEPT seasonal live attenuated influenza vaccine.
Q: Who will need one shot and who will need two H1N1 shots?
“Children under the age of 10, who have never been vaccinated, need two shots of seasonal vaccine, and will likely need two H1N1 shots as well,” Skinner said. “Children older than 10, can receive one of each.”
Q: What are the side effects to either shot? Is it true the side effects for both shots are the same?
“Yes they both are the same,” Skinner said. “You may experience some tenderness at the site of the shot or swelling and maybe some redness. And if you have never been vaccinated before, you might get a low-grade fever – but you cannot get the flu from getting vaccine.”
Even though there’s no vaccine that is 100 percent safe, Welch said, it’s still imperative that people get these vaccines, especially those with compromised immune systems,.
“People need to get these vaccines because these illnesses are so much more severe than any side effects they will experience,” he added.
Q. What if I’m allergic to eggs?
“People who are severely allergic to eggs should not get either vaccine because the vaccines are made from embryonated eggs,” Welch said. “And there can be some egg proteins in the vaccine, which means a person allergic to eggs could potentially have a reaction.”
Flu vaccines have been made from embryonated eggs for a long time, Welch said, so if you’re allergic, talk to your doctor about whether they can get a vaccine that’s not made from eggs. If you can’t, you need to stay away from sick people, and if you do get sick, go see your doctor right away.
Q: Who’s first in line?
— Pregnant women who are considered 4-times more likely than the general population to experience complications from the H1N1 flu.
— People who live with and/or care for infants under the age of 6 months and children, i.e. parents, siblings, daycare providers, teachers.
— Health care and emergency medical providers.
— Children age 6 months to adults up to the age of 24. The attack rate for children between the ages of 5 and 14 is 14 times higher than that for adults over the age of 50.
— People age 25 to 64 years old with underlying health conditions that put them at high risk for influenza complications.
Q. Do people have any immunity to the H1N1 flu strain?
“People do not have immunity to H1N1 because it is a new strain of virus,” Welch said. This is why, in general, we expect a large number of cases of H1N1 because the population doesn’t have any immunity to it.”
On the other hand, Welch said many people in the population have some immunity to the seasonal flu because of they’ve had it in the past and have had the seasonal flu vaccine in the past.
“Most people who are exposed to H1N1 will probably get the disease due to no immunity,” he said. “That’s why it’s important get vaccinated.”
Q: How long will it take for either shot to provide protection?
Skinner said it will take about a week to 10 days for the shots to provide protection.
Q: How long does a flu vaccine last for?
People can be expected to be protected for the entire flu season, Skinner said, until March or April.
Tribune Wire Services
More swine flu vaccine will arrive the first week of October than officials previously thought - between 6 million and 7 million doses.
That’s roughly double earlier predictions, and most will be the nasal spray version called FluMist, Health and Human Services Secretary Kathleen Sebelius said Thursday.
Lots of flu shots will soon follow: About 40 million vaccine doses will arrive by mid-October, with between 10 million and 20 million more arriving each week, she said.
“There will be enough vaccine for every American,” Sebelius told reporters at the White House.
The first 6 million to 7 million doses of the H1N1 will be available the first week, mostly in the form of nasal sprays, with a small amount available in injections. They’ll be shipped from five manufacturers to providers such as doctors, pharmacies and schools identified by state governments.
The government wants people most at risk from swine flu - or the 2009 H1N1 strain - to be first in line for the initial doses. They include pregnant women, the young - from age 6 months to 24 years, and people younger than 64 who have flu-risky conditions such as asthma.
One caution: That first-arriving FluMist is only for healthy people ages 2 to 49, so many of the high-risk will need to watch for the shot version.
The vaccine itself will be free - the government bought it with taxpayer dollars. However, some providers may charge a fee to administer it; administration fees for regular flu vaccine often are in the $20 range.
But Sebelius said her office has been urging doctors and other vaccinators not to charge an administration fee. It’s another step to speed vaccinations especially of the poor and uninsured for whom even a modest fee could be a disincentive.
“We’re trying to lower the barriers as much as possible,” she said. “We can’t order them not to charge.”
While officials say there eventually will be enough vaccine for everyone, they urged that healthy adults wait, so targeted groups of people most at risk from the flu - totaling 159 million - can go first.
The five targeted groups most at risk are:
-Those who live with or care for children under the age of 6 months
-Health care and emergency service workers
-Those age 6 months to 24 years
-Anyone age 25 to 64 at higher risk due to chronic health disorders or compromised immune systems.
However, pregnant women and children under 2 shouldn’t get the nasal spray. It’s made with a live, weakened virus, while the injected vaccine is made from inactive virus.
For people age 65 and older, the risk of H1N1 infection is considered lower.
Sebelius said the vaccine will work better and faster than originally thought. It will immunize most people against the flu in eight to 10 days, she said, and people will need to get only one dose of the H1N1 vaccine. Earlier, the government had thought people would need two doses and that it would take up to three weeks to be immunized.
Federal officials told reporters they’re confident the vaccine is as safe as those for regular flu - with normal side effects possible, such as sore arms. “There is a high degree of confidence in the safety,” Sebelius said.
World Health Organization
Current phase of alert in the WHO global influenza preparedness plan
In the 2009 revision of the phase descriptions, WHO has retained the use of a six-phased approach for easy incorporation of new recommendations and approaches into existing national preparedness and response plans. The grouping and description of pandemic phases have been revised to make them easier to understand, more precise, and based upon observable phenomena. Phases 1–3 correlate with preparedness, including capacity development and response planning activities, while Phases 4–6 clearly signal the need for response and mitigation efforts. Furthermore, periods after the first pandemic wave are elaborated to facilitate post pandemic recovery activities.
The current WHO phase of pandemic alert is 6.
In nature, influenza viruses circulate continuously among animals, especially birds. Even though such viruses might theoretically develop into pandemic viruses, in Phase 1 no viruses circulating among animals have been reported to cause infections in humans.
In Phase 2 an animal influenza virus circulating among domesticated or wild animals is known to have caused infection in humans, and is therefore considered a potential pandemic threat.
In Phase 3, an animal or human-animal influenza reassortant virus has caused sporadic cases or small clusters of disease in people, but has not resulted in human-to-human transmission sufficient to sustain community-level outbreaks. Limited human-to-human transmission may occur under some circumstances, for example, when there is close contact between an infected person and an unprotected caregiver. However, limited transmission under such restricted circumstances does not indicate that the virus has gained the level of transmissibility among humans necessary to cause a pandemic.
Phase 4 is characterized by verified human-to-human transmission of an animal or human-animal influenza reassortant virus able to cause “community-level outbreaks.” The ability to cause sustained disease outbreaks in a community marks a significant upwards shift in the risk for a pandemic. Any country that suspects or has verified such an event should urgently consult with WHO so that the situation can be jointly assessed and a decision made by the affected country if implementation of a rapid pandemic containment operation is warranted. Phase 4 indicates a significant increase in risk of a pandemic but does not necessarily mean that a pandemic is a forgone conclusion.
Phase 5 is characterized by human-to-human spread of the virus into at least two countries in one WHO region. While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short.
Phase 6, the pandemic phase, is characterized by community level outbreaks in at least one other country in a different WHO region in addition to the criteria defined in Phase 5. Designation of this phase will indicate that a global pandemic is under way.
During the post-peak period, pandemic disease levels in most countries with adequate surveillance will have dropped below peak observed levels. The post-peak period signifies that pandemic activity appears to be decreasing; however, it is uncertain if additional waves will occur and countries will need to be prepared for a second wave.
Previous pandemics have been characterized by waves of activity spread over months. Once the level of disease activity drops, a critical communications task will be to balance this information with the possibility of another wave. Pandemic waves can be separated by months and an immediate “at-ease” signal may be premature.
In the post-pandemic period, influenza disease activity will have returned to levels normally seen for seasonal influenza. It is expected that the pandemic virus will behave as a seasonal influenza A virus. At this stage, it is important to maintain surveillance and update pandemic preparedness and response plans accordingly. An intensive phase of recovery and evaluation may be required.
This statistic came from a 2003 JAMA study by CDC scientists. The study used statistical modeling to estimate that during 9 influenza seasons from 1990-91 through 1998-99, an annual average of 36,000 flu-related deaths occurred among people whose underlying cause of death on their death certificate was listed as a respiratory or circulatory disease. A 2009 study that appeared in the journal Influenza and Other Respiratory Viruses made a similar estimate for the 10 influenza seasons from 1993 to 2003.
Michelle Fay Cortez on
Sept. 16 (Bloomberg)—The World Health Organization is in talks with the U.S. and other developed countries about using pandemic flu vaccine from their stockpiles for poorer nations after studies suggested only one shot is needed for protection.
Half a dozen trials released in the past week found a single injection of swine flu vaccine protected most healthy adults from the virus known formally as H1N1, with infection- fighting antibodies produced in as little as eight days. U.S. regulators approved shots from four manufacturers yesterday, clearing the way for immunizations to start within weeks.
“This is all contingent on these early reports” from the studies, said David Mercer, acting head of the communicable diseases unit of the WHO’s European region, which met in Copenhagen this week. “It may be possible that a single dose is protective, which would double the number of people that could be immunized.”
Public health officials expected it would take two doses to trigger immunity to the infection, a novel mix of swine, avian and human influenza. Countries including the U.S., U.K., France, Belgium, Finland, Sweden and Australia have already placed orders for the vaccine. Additional studies are needed to confirm the finding that only one shot is needed and can ensure protection for children and other high-risk groups.
“Some countries may have excessive stocks of vaccine and some won’t see the demand they have expected,” said Thomas Zeltner, director of Switzerland’s Federal Office of Public Health. “What is needed here is a good dialogue to ensure the reasonable use of vaccination.”
The U.S. is in “very active discussions” about donating some of its supply to countries that need it, said Nancy Cox, director for the flu division of the U.S. Centers for Disease Control and Prevention. The U.S. has about 600 million doses in advance purchase agreements from GlaxoSmithKline Plc, Novartis AG, CSL Ltd., AstraZeneca Plc and Sanofi-Aventis SA.
In a best-case scenario, the U.S. may need only half that amount, said Rebecca Martin, medical officer at the United Nations health agency’s European communicable diseases unit. It’s too soon to know if that will be the case, she said.
“We welcome the initial findings of some clinical trials,” WHO Director-General Margaret Chan said in a statement. “We cannot conclude now how many doses would be required for different groups.”
The U.K., which has ordered 132 million doses, is still planning two shots for each person and is monitoring the clinical trials, according to a Department of Health spokeswoman who declined to be named in line with government policy.
More data from the studies will be coming in mid-October about how effective the vaccine is in different age groups, Martin said in an interview.
“This is not just in the European region,” Martin said. “We’re all dipping into the same pool of vaccine.”
CSL, based in Melbourne, said it plans to donate the vaccine to developing nations in Asia and the South Pacific and is discussing a pilot program with the WHO to start by providing as many as 100,000 doses. Paris-based Sanofi, London-based Glaxo, and Basel, Switzerland-based Novartis are among the other companies making the vaccine.
As many as 2 billion people, or 30 percent of the world’s population, may become infected by the new virus as it spreads globally, according to the Geneva-based WHO. While fewer than 0.5 percent of sufferers may need hospitalization, those who do may require critical care for up to three weeks, overwhelming intensive-care units.
Concern that vaccine bought by governments might not get used by their people may make countries more inclined to share supplies with poorer nations, said Marie-Paule Kieny, director of the WHO’s Initiative for Vaccine Research.
“Some countries may take a more altruistic view now,” she said. “We will see this fear of not being able to use all of it and concern of public money being spent unwisely, and you may now start to see generosity mushrooming.”
It’s the day health officials have been waiting for. The Food and Drug Administration has approved the new swine flu vaccine. Officials hope the first limited supplies will be ready early next month. They say the bulk of the vaccine will start arriving October 15. Eventually there will be enough to go around for everyone.
But before that happens officials are urging certain people.. like children and those with underlying medical conditions to get the shot first. That vaccine is made by four companies including Monroe County based Sanofi Pasteur.
As health officials wait for that vaccine they say the H1N1 virus is spreading faster than anticipated. That is creating even more of an urgency for the vaccine. WFMZ’s Joscelyn Moes talked with a local doctor.
>> The symptoms are similar to those of season flu.. and doctors say.. so is prevention.
>> REPORTER: Now that the Food and Drug Administration has approved the swine flu vaccine.. the push to get it out to the public.. is approaching.
>> MOS: Are you planning on getting it? If my doctor suggests it I will get it.
>> MOS: Why take a chance.
>> DR. JEFFREY JAHRE: Those priority groups are anyone between the ages of 6 months and 24 years of age, anyone who’s a health care worker, anyone who has contact with a child that’s 6 months of age or less.
>> REPORTER: Federal health care officials say the H1N1 virus is spreading faster than previously thought. And while doctors *had* been advising swine flu patients to avoid contact for a day after the fever goes away.. a new study suggests patients need to be careful for as long as a week after the fever breaks.
>> DR. JEFFREY JAHRE: The one thing that we know about the swine flu is that it appears to be more transmissible that seasonal influenza.
>> REPORTER: If you’re experiencing symptoms doctors say it may be tempting to reach for something like Tamiflu but they advise against it because of possible side effects.
>> DR. JEFFREY JAHRE: We do not .. and I want to repeat we do not recommend that the average person who has no underlying health problems and who does not have a complicated form of swine influenza take any medication such as Tamiflu.
>> REPORTER: While swine flu continues to spread.. seasonal flu hasn’t even hit yet. Doctors say pretty soon we’ll be dealing with both.
>> Doctors suggest getting both the season flu and swine flu vaccines. They also say keep in mind common sense tips like washing your hands, covering your mouth or nose when you sneeze, and if you’re sick stay home.
MARILYNN MARCHIONE on
Fox 6 News
SAN FRANCISCO (AP) — Researchers delivered a double dose of good news Sunday in the fight against flu: successful tests of what could become the first new flu medicine in a decade, and the strongest evidence yet that such drugs save lives, not just shorten illness.
A single intravenous dose of the experimental drug, peramivir, cleared up flu symptoms as well as five days of Tamiflu pills did, a large study in Asia found. An IV treatment is badly needed because many sick people can’t swallow pills and because illness hinders the body’s ability to absorb oral medicines.
Several other studies showed the value of treatment with Tamiflu. In one study of hundreds of people stricken with bird flu around the world, half of those given Tamiflu survived, while nearly 90 percent of those not given flu medicines died. Other research showed Tamiflu improved survival from regular seasonal flu, too.
“There has been an accumulation of evidence over time that the antiviral drugs can save lives,” and the new studies confirm that hope, said Nancy Cox, flu chief at the U.S. Centers for Disease Control and Prevention.
Results were reported Sunday at an American Society for Microbiology conference in California. It is the first big meeting of infectious disease specialists since the new H1N1 swine flu emerged in April. Treatment options are getting huge attention because it will take a month or more for people to get swine flu vaccine and have time to develop immunity from the shot.
In the meantime, reports are streaming in that swine flu is causing havoc in children and young adults.
“After about a week of schools being back in, we’ve seen a tremendous rise in cases,” Dr. Jonathan McCullers, an infectious diseases specialist at St. Jude Children’s Research Hospital in Memphis, Tenn., said at the conference.
In recent weeks, at least 12 children and teens in his city have needed intensive care, including five with no previously known health problems. Some required breathing machines and other life support. One died, and another has developed resistance to Tamiflu, he said.
Swine flu now accounts for most flu cases in the United States. More than 1 million Americans have been infected and nearly 600 have died from it, the CDC estimates.
Treatment with Tamiflu or a similar drug, Relenza, is recommended for anyone hospitalized with flulike symptoms or at high risk of complications. The drugs should be started within two days of first symptoms, and they shorten illness by about a day. With the drugs in limited supply, and worries about resistance developing to them, new medicines are desperately needed.
Peramivir (purr-AM-uh-veer) was tested in nearly 1,100 people with seasonal flu last winter in Asia. They were given either Tamiflu pills for five days or a single infusion of 300 or 600 milligrams of peramivir.
Symptoms cleared in about 78 hours and 81 hours with lower and higher doses of peramivir, respectively, and in 82 hours with Tamiflu. Adverse drug reactions were less common with peramivir, said study leader Dr. Shigeru Kohno of Nagasaki University in Japan.
The fact peramivir is not a pill like Tamiflu or an inhaled drug like Relenza makes it less convenient yet “very promising” and valuable medically, Cox said.
“You can get it into the blood, into the lungs, where infection is occurring,” she explained.
Others were cautious.
“I’m very enthusiastic about peramivir for hospitalized patients,” but it was compared in a season when many flu cases were at least somewhat resistant to Tamiflu, said Dr. Frederick Hayden, a virus expert at the University of Virginia and a World Health Organization flu consultant.
BioCryst Pharmaceuticals Inc., of Birmingham, Ala., is developing peramivir with Japan-based Shionogi & Co. The U.S. government gave a major grant for its development, and officials have been discussing stockpiling the drug as part of flu pandemic preparedness plans.
Tamiflu, made by Swiss-based Roche Holding AG, and Relenza, made by British-based GlaxoSmithKline, came on the market in 1999. Most people who get swine flu don’t need them, but these drugs can help save the severely ill, studies sponsored by Tamiflu’s maker suggest.
The first results from a registry of 215 human cases of bird flu around the world show that nearly 90 percent of patients who did not receive Tamiflu or any other antiviral medicine died, compared with only half of those given Tamiflu treatment.
“The earlier it starts, the better,” said study leader Dr. Stephen Toovey, a Roche consultant and former employee now at Royal Free and University College of Medicine in London. “Even as far out as eight days after symptom onset, there is still benefit.”
Others looked at Tamiflu for ordinary seasonal flu:
— Researchers at six hospitals in Toronto monitored 238 intensive care patients during three recent flu seasons. Seventy percent were found to have flu, and one-fourth died within 15 days of diagnosis. Patients were nearly three times more likely to survive if treated with Tamiflu, even though very few of them got it soon after symptoms appeared, said Dr. Allison McGeer of Mount Sinai Hospital in Toronto.
— About half of 760 people with confirmed flu cases at two hospitals in Hong Kong in 2007 and 2008 were started on Tamiflu within two days. Only 4 percent of them died in the hospital versus 6 percent of those not given an antiviral drug, said Dr. Nelson Lee of the Chinese University of Hong Kong.
WASHINGTON (AP) — The nation’s first round of swine flu shots could begin sooner than expected, with some vaccine available as early as the first week of October, Health and Human Services Secretary Kathleen Sebelius said Sunday.
Sebelius said she is confident the vaccine will be available early enough to beat the peak of the expected flu season this fall and that early doses are intended for health care workers and other high-priority groups.
“We’re on track to have an ample supply rolling by the middle of October. But we may have some early vaccine as early as the first full week in October. We’ll get the vaccine out the door as fast as it rolls off the production line,” she told ABC’s “This Week.”
The possibility of early shots follows encouraging news from last week about the swine flu vaccine. Researchers have discovered that one dose instead of two could be enough for healthy adults, and protection could begin once vaccinated within 10 days instead of three weeks.
“That’s great, which means we’ll have a lot more vaccine,” she said. “We also have seen a robust immune response within 10 days, instead of three weeks as was feared.”
Sebelius said the vaccine doses will be distributed immediately to designated locations across the country once they are available.
“Every state has a plan saying these are the sites to get the vaccine as quickly as possible into people’s arms. That’s where the distribution will go,” she said.
“So, the first week in October, we expect some of the vaccine to begin to roll, and by mid-October, to have the kind of supplies we were talking about. But we may have some available earlier. And we’ll get it out to states as fast as it comes off the production lines,” Sebelius said.
One dose means tight supplies of H1N1 vaccine won’t be stretched so badly. Had it taken twice that dose, or two shots apiece, half as many people could have received the vaccine.
The winter flu vaccine is widely available now, and health authorities urged people last week to get shots now before swine flu shots start arriving.
In addition to concerns about swine flu, doctors also expect some garden-variety flu this fall as well, an illness that typically kills 36,000 Americans and hospitalizes 200,000 each year.
MATTHEW PERRONE on
Federal officials said Monday small business owners should be prepared to operate with fewer employees this fall as swine flu spreads across the country. The Department of Homeland Security is issuing guidelines on combating swine flu to small businesses, which employ about half the workers in the U.S. private sector. “They play a key role in protecting the health and safety of the country but also their own employees and also helping us limit impact of an H1N1 pandemic on our economy and our country,” Homeland Security chief Janet Napolitano told reporters. A guidebook released by the Department of Homeland Security recommends small businesses identify their essential operations and have plans for operating with reduced staffing. The government also says businesses should consider letting employees work from home if they get sick. Napolitano said small businesses could be particularly vulnerable to a pandemic because they often “have fewer resources, they work with leaner staffs and absenteeism can be a particular issue.” Monday’s announcement is the latest in a series of recommendations as the federal government braces for a potentially virulent outbreak this fall, which could hurt businesses by keeping workers at home. The swine flu virus has caused at least 3,205 deaths since it emerged in Mexico and the U.S. this year and became a global epidemic, according to the World Health Organization. Most deaths have been in the Western Hemisphere. About 45 million doses of swine flu vaccine from GlaxoSmithKline, Novartis and several other companies are expected to be available by mid-October. First in line to receive the vaccine are pregnant women, health care workers and younger adults with conditions such as asthma.
Federal officials said Monday small business owners should be prepared to operate with fewer employees this fall as swine flu spreads across the country.
The Department of Homeland Security is issuing guidelines on combating swine flu to small businesses, which employ about half the workers in the U.S. private sector.
“They play a key role in protecting the health and safety of the country but also their own employees and also helping us limit impact of an H1N1 pandemic on our economy and our country,” Homeland Security chief Janet Napolitano told reporters.
A guidebook released by the Department of Homeland Security recommends small businesses identify their essential operations and have plans for operating with reduced staffing. The government also says businesses should consider letting employees work from home if they get sick.
Napolitano said small businesses could be particularly vulnerable to a pandemic because they often “have fewer resources, they work with leaner staffs and absenteeism can be a particular issue.”
Monday’s announcement is the latest in a series of recommendations as the federal government braces for a potentially virulent outbreak this fall, which could hurt businesses by keeping workers at home.
The swine flu virus has caused at least 3,205 deaths since it emerged in Mexico and the U.S. this year and became a global epidemic, according to the World Health Organization. Most deaths have been in the Western Hemisphere.
About 45 million doses of swine flu vaccine from GlaxoSmithKline, Novartis and several other companies are expected to be available by mid-October. First in line to receive the vaccine are pregnant women, health care workers and younger adults with conditions such as asthma.
The Associated Press
Who needs vaccine against regular winter flu, and who should be first in line for the swine flu shot? There’s lots of overlap.
Regular flu vaccine is available now, and people who need it most include:
—Adults 50 and older.
—All children age 6 months to 18 years.
—People of any age with chronic health problems like asthma, heart disease or a weakened immune system.
—Caregivers to the high-risk, including babies younger than 6 months.
Don’t like shots? There’s a nasal spray version of the vaccine, called FluMist, available for people ages 2 to 49.
Once the swine flu vaccine starts arriving next month, the government says first in line will be:
—The young, from age 6 months up through age 24.
—Younger and middle-aged adults with those chronic health conditions.
Jeremy Ross on
Student is isolated, recovering
Marquette University identified its first case of swine flu (H1N1) on campus Tuesday. The student is isolated and is now recovering. Marquette isn’t disclosing many additional details about the infected co-ed.
The University admits prior to the student seeing medical professionals it’s possible the swine flu could have spread to others especially given the close quarters on campus.
A handful of students at Marquette have been tested for H1N1, and they’ve received one negative test while awaiting additional information.
The University says students who think they are sick with the flu should call the Student Health Service at 414-288-7184 for screening of symptoms. Students are also encouraged to call first before visiting the Student Health Service in person to limit exposure to other students.
Monitor FOX6Now.com and FOX6 News for updates on this developing story.
Mark Johnson and Kathleen Gallagher on
The Journal Sentinel
New technologies could speed up production
Posted: Sept. 5, 2009
In a contest that pits human against virus, the U.S. government is evaluating the safety and effectiveness of swine flu vaccine in hopes of having millions of doses ready for use before the next wave of the pandemic H1N1 sweeps across the nation.
This week the virus struck first, infecting a handful of students at the University of Wisconsin-Madison; an additional 25 to 30 are awaiting results of a swine flu test.
Across the United States, thousands of other students have reported influenza symptoms, though many have not been tested for swine flu, according to college officials and a survey by the American College Health Association.
“Well, I think it’s going to be a race,” said Douglas Reding, vice president of the Marshfield Clinic. “It could potentially be neck and neck depending on when the next outbreak occurs.”
At the Milwaukee Health Department, Medical Director Geoffrey Swain said: “I’ve got my fingers crossed. I’m hopeful that the swine flu outbreak will not have picked up a lot of steam before we get a lot of vaccine.”
The race comes at a time when the federal government is in the midst of a multibillion-dollar effort to boost America’s flu vaccine capacity and just as vaccine makers are moving into new technologies.
Toward the end of the bird flu scare about four years ago, the U.S. committed $5.6&enspbillion to boosting preparations to fight the next pandemic, including at least $2&enspbillion to develop new production methods for vaccine.
“We’re probably a couple of years away from the big transition,” said Mike Perdue, director of influenza and emerging disease for the federal Biomedical Advanced Research and Development Authority in Washington, D.C.
But Perdue stressed that the current vaccine production technology, which relies on millions of chicken eggs, is “tried and true” and from all indications should be an effective weapon against swine flu - unless the virus mutates.
Perdue said health officials still are not sure whether people will need one or two shots of the H1N1 vaccine, a question they hope to answer in the clinical trials under way.
Vaccines since 1945
Vaccines have been used to protect people against influenza since 1945.
The method blends science and educated guesswork. Each year, health officials around the globe pick the dominant strains of virus circulating in the most recent flu season and submit recommendations to the U.S. Food and Drug Administration, which chooses three and provides them to vaccine companies.
The selection takes place about eight months before the next flu season is expected to begin.
Companies grow each of the three flu strains separately, and then combine them to make one vaccine. The manufacturers rely on millions of specially prepared, fertilized chicken eggs to grow the virus strains. Each egg is injected with one strain, stimulating the production of virus-fighting antibodies.
Eggs are allowed to incubate for a few days until virus-ladened fluid can be removed. The virus is purified, then inactivated. Viral fragments from the three strains are combined to make the vaccine.
One company, MedImmune, uses a different system involving a live, but much weakened, virus. The end result is FluMist, a vaccine that is sprayed into patients’ nostrils rather than injected into muscle.
Much the same techniques used to make vaccines for seasonal flu are being employed to produce the vaccine for H1N1.
Although egg-based technology has worked well with flu for the most part, the influenza virus circulating the world can change while companies are still preparing their vaccines. That means by the time people receive the vaccine, it may match an old version of the virus rather than the version it is being called upon to fight. Also, people who are allergic to eggs cannot receive the vaccine.
Production can be slow
Perhaps most important in a year when a novel strain of influenza has grown into a pandemic, it is not so easy to quickly scale up vaccine production when using egg-based technology.
“The hens can only lay so fast,” said Ruth Karron, a professor at the Johns Hopkins School of Public Health who directs the university’s Center for Immunization Research.
And eggs present other disadvantages, as the vaccine marker Novartis has discovered this year in preparing swine flu vaccine.
“The virus is not growing as well in eggs as we had anticipated,” said Eric Althoff, global media relations director for the pharmaceutical giant.
Althoff said Novartis currently is producing only 30% of the amount of vaccine for swine flu that it would usually produce for a non-pandemic flu strain.
Other companies have had similar problems, and in August the U.S. Department of Health and Human Services announced that it had scaled back its estimate that 120 million doses would be ready by mid-October.
The department said about 45 million doses should be ready by then with another 20 million doses expected to arrive each week thereafter.
50 million doses
In addition, one company, MedImmune, has managed to produce more than 50 million doses of swine flu vaccine,much more than the 13 million the American government has contracted to buy, said Ben Machielse, executive vice president of operations. MedImmune is in negotiations with the U.S. to sell the additional doses.
For the other vaccine makers, the source of the problem was simple: They were getting fewer doses from each egg than anticipated.
“It’s this old, arcane procedure that’s been around and no one has changed it because there’s been no incentive to do it - and now we’re paying for it,” said Paul Radspinner, president and chief executive officer of FluGen Inc., a Madison start-up developing a technology many experts believe will join and perhaps even replace egg-based vaccine production.
FluGen expects to grow vaccine in mammalian cells.
Novartis already has developed a way to make vaccine from viruses grown in dog kidney cells. In 2007, the company was licensed to produce this vaccine in Europe.
So far, though, the technique has not been licensed in the U.S., and Novartis remains the only company marketing influenza vaccine grown in this manner.
Donna Cary, spokeswoman for Sanofi Pasteur, which makes about 45% of the world’s influenza vaccine, cautioned that flu vaccine plants take years to build and license, and she said no technique has proved that it can compete commercially with the egg-based system.
Cary said she believes the next advance will be the so-called universal influenza vaccine intended to provide protection against all known human strains of influenza A. In 2008, a British-American biotech company called Acambis reported preliminary success in Phase I trials of a universal influenza vaccine.
Shots for H1N1 protection
In the meantime, vaccine makers and health experts believe the influenza shots for H1N1 should provide strong protection. Although there remains time for H1N1 to undergo mutations, “We have not seen significant changes in the virus generally, which I think is important,” said Karron at Johns Hopkins.
In Milwaukee, Swain stressed that even if the vaccine does not prove to be a strong match for the H1N1 virus that infects people, it should offer important protection.
He compared the vaccine’s job to providing the body with a high-resolution photo of the virus so that the immune system knows what to look for. When the vaccine is not a strong match it simply provides the body with a fuzzier photo.
“It still has something to go on,” Swain said, “so it can start to do its work before you get sick enough to go to the hospital.”
The Associated Press
For more infomation, visit the CDC’s Website
WASHINGTON (AP) - Health and Human Services Secretary Kathleen Sebelius said Tuesday that a massive school closing wouldn’t stop the spread of the swine flu virus, saying vaccinations must be the defense against a menace that one report said could infect up to half of the population.
“What we know is that we have the virus right now traveling around the United States,” Sebelius said in a nationally broadcast interview. “And having children in a learning situation is beneficial ... What we learned last spring is that shutting a school down sort of pre-emptively doesn’t stop the virus from spreading.”
Sebelius appeared on NBC’s “Today” show one day after a special presidential advisory panel presented a grim report to the Obama White House, saying among other things that a “plausible scenario” for the United States later this year is wide-scale infections, possibly 30,000 to 90,000 deaths, mostly among young children and young adults, and perhaps as many as 300,000 sick enough to require intensive care unit treatment at hospitals.
Asked in the interview what people should do while awaiting the arrival of a vaccine, with first supplies likely by October but most not until the Thanksgiving season, Sebelius said: “I think it’s important that people begin to anticipate that we will have a vaccine. We think it’s likely that we’re going to need two shots for the vaccine.”
She said people should plan ahead for this, particularly those with pre-existing medical conditions, pregnant women and health care industry workers. Sebelius said federal health authorities also are recommending that people should immediately get their regular “seasonal” flu vaccine to bolster their health for the scenario yet to play out later this year regarding the swine flu virus.
“Seasonal flu vaccine is ready at the beginning of September,” she said. “We want the population that is most at risk to begin their seasonal flu vaccine now.”
A report by the President’s Council of Advisors on Science and Technology, delivered Monday, said that while the impact of H1N1 was impossible to predict, a “plausible scenario” is that the epidemic could “produce infection of 30-50 percent of the U.S. population this fall and winter, with symptoms in approximately 20-40 percent of the population (60-120 million people), more than half of whom would seek medical attention.”
Swine flu could lead to as many as lead to as many as 1.8 million U.S. hospital admissions during the epidemic, with up to 300,000 patients requiring care in intensive care units. In fact, those very ill patients could occupy 50-100 percent of all ICU beds in affected regions of the country at the peak of the epidemic and place “enormous stress” on ICU units.
Seasonal flue typically causes 30,000-40,000 annual deaths, mainly among people over 65.
People with certain pre-existing conditions, including pregnant women and patients with neurological disorders or respiratory impairment, diabetes, or severe obesity are at high risk, along with certain populations, such as Native Americans, the report said.
The fall resurgence in swine flu could occur as early as September, with the beginning of the school term, and the peak infection may occur in mid-October.
The report emphasized that this was a planning scenario, not a prediction. But, it added, “the scenario illustrates that an H1N1 resurgence could cause serious disruption of social and medical capacities in our country in the coming months.”
(Copyright 2009 by The Associated Press. All Rights Reserved.)
Steve Sternberg on
Nicholas Sarakas says his mother urged him not to take part in pandemic vaccine trials. “She was worried about me. She didn’t want them guinea-pigging me,” he says. “She made me promise never to be in another clinical trial.”
Sarakas, 25, decided to volunteer anyway. A college student without health insurance at the University of Missouri in St. Louis, he reasoned that he’d rather take his chances with the vaccine, and its risks, than pandemic flu.
“There are people my age that are dying from this,” he says.
Early Monday, Sarakas rolled up his sleeves for an injection in each arm, becoming one of dozens of adults enrolling in an unprecedented flurry of fast-track flu vaccine trials that will grow to include 11,131 adults and 5,740 children, with more trials planned.
The vaccine is designed to blunt the effect of a virus that, starting this fall, could infect 100 million people in the USA and cause 30,000 to 90,000 deaths based on scenarios drawn from past pandemics, says Arnold Monto of the University of Michigan, an adviser to the Centers for Disease Control and Prevention and the World Health Organization. About 36,000 people in the USA die each year of flu.
The virus, a new type of H1N1 strain also known as swine flu, has been linked to 6,506 hospitalizations and 436 deaths in the USA — up from 353 a week ago — since it emerged in Mexico in April.
Too many volunteers to count
The U.S. government has ordered roughly 195 million doses of pandemic flu vaccine, in addition to the 120 million doses of seasonal flu vaccine expected to be available by the end of September.
“Vaccine is a huge component of the public health response to influenza,” says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which is sponsoring the trial that enrolled Sarakas at Saint Louis University and four other trials at eight federally funded vaccine research centers across the country.
The flurry of swine flu vaccine trials, some sponsored by the U.S. government and others by five vaccine manufacturers, began late last week. Now people are clamoring to take part.
“We’ve had over 1,000 people call wanting to participate,” says Sharon Frey, lead investigator of the St. Louis study. “We’ve stopped counting.”
Frey says she expects to meet her quota of 200 volunteers by next week, thanks to widespread publicity.
Side effects, dosages unknown
“I feel really lucky that I get to participate,” says Karla Payne, 54, of Westchester, Ohio, who got her shots Monday in a study at Cincinnati Children’s Hospital Medical Center. “I used to work in the public schools. So many students didn’t have money for health care. When I saw in the paper that they would start using schools to vaccinate kids, I thought, gosh, this would be a good thing to do, because they need to get vaccine out there.”
The studies are necessary because so little is known about the pandemic vaccine, though many researchers believe it is likely to act much like seasonal vaccines, says Bruce Gellin, director of the Department of Health and Human Services National Vaccine Program Office.
Flu vaccines historically have few side effects beyond redness and soreness at the infection site. Studies of several thousand volunteers aren’t big enough to detect more subtle side effects such as Guillain-Barré syndrome, a rare nerve ailment that crops up in one of every million flu vaccine recipients. Federal health agencies have ramped up surveillance efforts to detect any severe side effects that might occur.
There are other uncertainties as well. For instance, vaccine makers don’t know how big a dose to give, how many doses will be needed per person for protection and whether it will be necessary to add an immune-booster called an adjuvant.
Each one of those factors may affect how many people can be vaccinated. For instance, if the usual 15-microgram dose has to be doubled, the number of people who could be vaccinated would fall to 98 million. If two shots are required at double the dose, the number of people who could be vaccinated would drop further, to 50 million.
Sources: Company data, Food and Drug Administration and the National Institutes of Health
We are currently seaking out Medical Doctors, Registered Nurses and Medical Assistants to help us administrer flu shots around The United States this fall. Contact us today if you are interested in making additional income as one of our many contracted affiliates in your area! For more information, feel free to call our office at (800)898-8211. We look forward to hearing from you!
Maggie Fox, Health and Science Editor on
WASHINGTON, July 24 (Reuters) - U.S. health officials strengthened their recommendations for seasonal flu vaccines on Friday, saying all children aged 6 months to 18 years should be immunized—especially because of the H1N1 flu pandemic.
The seasonal vaccine provides little or no protection against H1N1 swine flu, but immunization will help prevent people from being infected with both at once and can help minimize the effects of the pandemic on schools, workplaces and the economy in general, health experts say.
“Vaccination against seasonal influenza should begin as soon as vaccine is available and continue throughout the influenza season,” Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention told reporters in a telephone briefing.
“At this point, 83 percent of the population is recommended to get an annual flu vaccine,” she said. “Unfortunately, only about 40 percent of the U.S. population received the flu vaccine last year.”
Last year the CDC “encouraged” all children to be vaccinated. Now it “recommends” this—advice that does not have the force of law but that can affect what states and insurers do.
On Thursday U.S. Food and Drug Administration officials said they would work with companies and the National Institutes of Health to quickly test experimental H1N1 vaccines, with the aim of getting a vaccination plan underway as soon as possible.
Schuchat said H1N1 was still circulating.
“We are continuing to see transmission here in the United States in places like summer camps, some military academies and similar settings where people from different parts of the country come together,” she said.
“I think this is very unusual to have this much transmission of influenza during the (summer) and I think it’s a testament to how susceptible people are to this virus.”
TIP OF THE ICEBERG
The CDC said 43,771 cases of H1N1 influenza had been officially confirmed, with 302 deaths.
“But ... that’s really just the tip of the iceberg,” Schuchat said. “We believe there have been well over 1 million cases of the new H1N1 virus so far in the United States.”
She said the CDC would no longer report cases and was working on better ways to estimate how many people had been infected.
The pandemic spread globally in less than two months and has infected people in 160 countries, killing 800 people, the World Health Organization said. The WHO numbers do not include the latest CDC count.
Schuchat said there is no indication the virus is any worse in one country than another.
“There are differences in reporting. In some places, we’re hearing about only the severe cases. In other places, we’re hearing about illness that’s in the community,” she said.
She declined to call the pandemic “mild” and noted that people had died and many others had spent weeks in hospitals, sometimes on ventilators.
She said the CDC was also watching for more cases of seizures. The agency reported on Thursday on four children who suffered seizures from H1N1 infection but who recovered.
“At this point we’re strongly recommending them for treatment rather than for prevention,” she said.
To prevent flu, the drugs should be reserved for people at high risk of complications who have been in close contact with a known case, she said. (Editing by Xavier Briand)
Simeon Bennet on
July 22 (Bloomberg)—Nurse Luiza Duszynski flicks her syringe, squeezes a few drops of clear liquid from the needle and pushes it into Tara Seaton’s arm. With that, she became one of the world’s first recipients of a vaccine for swine flu.
Seaton is among the 240 healthy adult volunteers in Australia who CSL Ltd. began injecting today with its experimental vaccine against H1N1, the new virus strain that sparked the first influenza pandemic in 41 years.
“It was fine, I didn’t even feel it,” Seaton, a 28-year- old post-office assistant, said from the Royal Adelaide Hospital, where she received the shot.
CSL is testing the vaccine over the next seven weeks as it prepares to fill orders from Australia, the U.S. and Singapore. The World Health Organization and Melbourne-based CSL’s larger rivals such as Sanofi-Aventis SA will be watching the test to help determine whether one or two shots are needed to protect people and how many doses can be produced.
“The fundamental data that we and others around the world are interested in are the immune response to the first and second dose,” Andrew Cuthbertson, CSL’s chief scientific officer, told reporters in Adelaide. The test results will also show the effects of different doses, he said.
Volunteers are required to keep a diary for six months and record any signs and symptoms, including nausea, increased temperature and swelling around the injection area, Seaton said.
Swine flu has killed more than 700 people globally and sickened so many the WHO has stopped issuing a daily tally.
Novartis AG expects to start trials of its shot this month, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today, without giving a date. Sanofi plans to start tests of its shot in August, Albert Garcia, a spokesman for the Paris-based company’s vaccines unit, said in a phone interview.
“It is reasonable to say that, if all goes well, we will start delivering the vaccine by November or December,” Garcia said late yesterday. “This is the most reasonable time frame.”
David Outhwaite, a spokesman for GlaxoSmithKline Plc, declined to answer questions about the London-based drugmaker’s plans to test its shot. Deerfield, Illinois-based Baxter International Inc. will produce a vaccine by early August, after which it will perform clinical tests, spokesman Chris Bona said.
The Atlanta-based U.S. Centers for Disease Control and Prevention has said it expects a vaccine ready for widespread distribution in October.
Vaxine Pty, a South Australian biotechnology company, said it started tests on 300 volunteers in Adelaide on July 22 using a vaccine that’s boosted with a novel sugar-based compound. The company, based in Adelaide’s Flinders Medical Centre, has no orders yet for its experimental shot, Research Director Nikolai Petrovsky said in a telephone interview today.
There isn’t any commercial advantage to being the first maker to start human trials, as most manufacturers already have orders to supply vaccines to governments, said David Low, a health-care analyst at Deutsche Bank AG in Sydney.
“Being first is probably more of a PR coup,” Low said in a telephone interview on July 16.
CSL may record sales of A$300 million ($244 million) this year for its swine-flu vaccine, said Alexander Smith, a health- care analyst at JPMorgan Chase & Co. in Sydney.
“That sounds reasonable,” said Rachel David, a CSL spokeswoman.
Two shots of vaccine will probably be needed to protect people against the pandemic virus, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy, at the University of Minnesota in Minneapolis.
CSL has a contract to supply 21 million doses to the Australian government and an order from the U.S. for $180 million of antigen, enough for 20 million to 40 million doses, David said. The company also has an order from Singapore, she said, declining to give details.
The company is producing the CSL425 vaccine at capacity with the current customer base, David said.
The vaccine maker will give volunteers aged 18 to 64 years two shots, three weeks apart, to determine how many doses are needed to get the right level of protection, David said.
CSL is also testing the pandemic vaccine, known as Panvax (H1N1 A/California) in Australia, in a regular and double dose to see which is more effective, she said.
Volunteer Seaton said she had no fears about the injection and any possible side effects. The A$400 she received for participating in the trial was a bonus.
“I thought, worst-case scenario, if everyone gets swine flu then I’ll be vaccinated against it,” she said.
Mary Shedden on
The deaths of three Bay area men from swine flu Thursday and Friday prompted health officials to warn that the number of cases are on the rise and will only continue to increase.
Summer traditionally is the slowest season for flu, so slow that public health researchers usually stop their influenza surveillance program. But this year the increasing presence of swine flu - including an above-average number of summer cases in Hillsborough County - is keeping it going.
County health departments already are girding for a more severe fall and winter flu season, when hot, humid weather isn’t around to help slow transmission of the illness, said Warren McDougle, Hillsborough County epidemiology program manager.
“If it’s able to be passed this time of year, what will it be like when it starts to cool off and ‘flu season’ begins again,” he said.
World health officials are closely watching the winter flu season taking place south of the equator. In Australia, swine flu numbers are up over last year, according to the Atlanta-based Centers for Disease Control and Prevention.
That’s a warning for us, McDougle said.
People are being told flu prevention behavior must be taken seriously regardless of the time of year. That includes frequent hand-washing, covering one’s mouth when coughing or sneezing, and staying home when sick. Swine flu symptoms include sore throat, fatigue and a fever of 100 degrees or higher. Health experts suggest staying home for at least 24 hours after those symptoms are gone.
Although nearly 80 percent of the nation’s swine flu deaths have involved people with pre-existing health problems, a 22-year-old Sarasota man who died Thursday had no known medical issues. And he did not put off seeking treatment.
Influenza is always a public health concern, but swine flu spreads quickly and targets people traditionally not at risk for serious illness. A second man who died Thursday was a 31-year-old Polk County resident. On Friday, a 47-year-old Sarasota County man died.
“This seems to be targeting a younger population than usual for flu,” said Susan Smith, a Florida Department of Health spokeswoman.
When the first wave of cases hit in May, the average age of an afflicted Floridian was 16, McDougle said.
Scientists speculate that people exposed to swine flu in the 1970s are immune to the current strain, he said. People born in the 1980s and since have never been exposed and may not see themselves as at risk.
“They’re the healthy, active ones who do a lot of things in groups,” McDougle said.
Hillsborough health officials are watching summer-camp programs with particular concern. While none have shut down, a camp graduation program in Sarasota on Thursday at the Ringling College of Art and Design was canceled because seven teenage campers were being tested for the virus.
The CDC reported nationwide deaths of 263 people from swine flu as of Friday, and the diagnosis of 40,000 cases. In Florida, almost 2,200 cases have resulted in 16 deaths.
Other strains of flu kill 36,000 people in the United States each year.
Hillsborough, Pinellas, Manatee and Sarasota counties are tracking about 200 active cases, according to the respective health agencies.
Jacob Goldstein on
The Wall Street Journal
A few notable developments in the swine flu (aka H1N1 flu) pandemic:
The U.S. is planning a vaccination campaign that could start in October, with school-age children among the first to be offered a shot, Dow Jones Newswires reports. The new vaccine still has to be developed and tested. But if it works, the government will purchase much of the vaccine. Unlike seasonal flu, which disproportionately affects the elderly, the swine flu has hit particularly hard among school children.
Officials have documented three cases of Tamiflu-resistant swine flu, but they appear to be isolated cases and not evidence of widespread resistance, the WHO said. In one case, testing revealed that a teenage girl who flew from San Francisco to Hong Kong was infected with a Tamiflu-reistant strain, despite the fact that she hadn’t been treated with Tamiflu — suggesting a resistant strain that has the ability to spread from person to person, the New York Times reports. There is no evidence that the resistant strain is widespread, and Tamiflu-resistant flu is susceptible to Relenza, another drug.
The French government is planning to spend nearly $1 billion to buy 100 million doses of vaccine from Sanofi-Aventis, GlaxoSmithKline, Novartis and Baxter, reports the French newspaper Le Parisien. (The U.S. has already appropriated $1 billion for vaccine ingredients and up to $7.5 billion more for rolling out the vaccine if initial testing goes well, the NYT notes.)
Image of a flu-virus particle via CDC
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Florida’s surgeon general says the state is preparing for massive swine flu immunizations, starting with schoolchildren, as the Obama administration urges states to prepare for the likelihood that the virus might worsen in the fall.
‘‘We may end up averting a crisis. That’s our hope,’’ said President Barack Obama, who took time away from the G-8 summit in Italy to telephone another summit back home—the 500 state and local health officials meeting to prepare for swine flu’s fall threat.
‘‘We want to make sure we aren’t promoting panic, but we are promoting vigilance and preparation,’’ Obama said.
Kathleen Sebelius, Health and Human Services chief, told the flu summit some H1N1 vaccine should be ready by mid-October.
‘‘Scientists and public health experts forecast that the impact of H1N1 may well worsen in the fall, when the regular flu season hits or even earlier, when schools start to open, which is only five or six weeks away,’’ she said.
Florida already is planning for such vaccinations, said Dr. Ana M. Viamonte Ros, Florida surgeon general, as she emerged from the summit.
‘‘We’re already meeting with local schools and day-care centers on how we would do this,’’ she said. “By mid-October we won’t have doses for everyone. The vaccines will have to be directed toward individuals at high risk.’‘
Complicating the issue is the need to vaccinate against regular seasonal flu and the swine flu with different vaccines at the same time, Viamonte Ros said. Priorities would have to be different, because regular flu hits older people harder while swine flu is most widespread among the young.
No final decision has been made on whether to vaccinate Americans, Sibelius said. That depends on studies with experimental batches that are to start in August. But if all goes well, the federal government will buy vaccine from manufacturers and share it free among the states.
Confusion could arise as doctors, clinics and even pharmacies are in the midst of dispensing 100 million doses of regular winter flu vaccine at the same time schools are vaccinating against swine flu, Sibelius said.
She announced $350 million in federal grants to help states prepare.
Local officials also worry about the prospect of closing schools if the flu gets worse in the fall. School closures last spring created havoc for working parents without day care, until health officials reversed the policy and reopened schools even if they had swine flu cases.
Miami-Dade schools already are preparing for widespread vaccinations and also planning in case some schools have to close in the fall, said Wilma Steiner, Miami-Dade schools’ director of health services.
If Florida schools have to close again, they must be ready to use distant learning techniques to cope, she said.
‘‘We’re already using a lot of these things—teachers posting assignments, holding study sessions online so when schools reopen the kids won’t have fallen behind,’’ Viamonte Ros said.
Following Obama’s lead, Broward and Miami-Dade health leaders said Thursday that they already have extensive plans in place in case of serious swine flu pandemic this fall and winter. But they have much work to do.
‘‘We’re working really hard to be prepared,’’ said Lillian Rivera, director of the Miami-Dade Health Department. “But we’ve never experienced a pandemic before.’‘
A major concern is having enough qualified personnel available for big vaccination programs, she said.
‘‘We’ve had a mass vaccination plan in place for some time, working with law enforcement, emergency management services and healthcare providers,’’ said Dr. Paula Thaqi, director of the Broward County Health Department. “We’re making sure we’re ready with supplies, locations and staffing.’‘
U.S. health officials say the H1N1 virus has been relatively mild so far, and has shown no evidence of mutating into a more virulent strain.
Of 170 deaths so far in the United States, 75 percent involved people with underlying health conditions such as asthma or heart problems.
On Thursday, Baptist Hospital confirmed a swine flu death, putting total deaths in Miami-Dade County at four. It did not reveal details of the death.
The state health department Thursday also reported two other swine flu deaths—a 55-year-old man in Duval County and a 25-year-old woman in Palm Beach County—raising the number of lab-confirmed deaths in Florida to eight.
This report was supplemented with material from The Associated Press.
BETHESDA, Maryland (CNN)—Health and Human Services Secretary Kathleen Sebelius told government leaders at a swine flu preparedness summit Thursday that a vaccine to fight the H1N1 virus should be ready for distribution in mid-October.
But Sebelius also advised 500 government, health and education leaders to plan for the worst-case scenario of the virus reappearing with renewed strength this fall.
“What we need to assume is that it will come back in a much more severe form,” she said at the conference at the National Institutes of Health in Bethesda, Maryland, outside Washington.
Commonly called swine flu, the virus is also known as influenza A(H1N1). The World Health Organization declared the virus a global pandemic last month.
Sebelius said that extensive planning to combat the spread of the virus always could be scaled back later but that officials could not delay starting work on those preparations.
“We can step back from our planning. What we can’t do is wait until October,” she said.
The fight against H1N1 will be federally funded, the secretary said. She said the government will announce $350 million in preparedness grants on Friday, with $260 million for state health departments and $90 million for hospitals preparing for a possible surge of patients.
President Obama requested the summit, and he spoke to the group via video link from Italy, where he is attending the Group of Eight meeting of industrialized nations.
“We want to make sure we aren’t promoting panic, but we are promoting vigilance and preparation,” Obama said.
Obama urged state and local officials, including school districts, to prepare for a vaccination campaign in the fall and to anticipate that the virus could significantly affect schools.
Health care workers hope to evaluate a candidate vaccine against H1N1 in August, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who also spoke at the meeting.
Sebelius said medical experts are testing virus strains, preparing the production lines and beginning clinical trials.
She said the initial target group for the vaccine will be pregnant women, children ages 5 to 17, health care workers, the elderly and anyone with chronic health conditions such as asthma.
A new Web site has been set up for H1N1, http://www.flu.gov/, which has information on the virus and helpful tips.
A school nurse was one of three education workers invited to talk about their experiences in the spring during the wave of swine flu cases.
Mary Pappas of St. Francis Prep High School in Fresh Meadows, New York, said she was called on to take charge when students began showing up in her office with fevers.
Pappas said that she told the kids to pull out their cell phones and call their parents to come get them. That Thursday, she sent 102 students home; on Friday, another 80 sick students left school.
At one point, she said, there were so many sick teens that she asked a security guard to take their temperatures, write the number on a Post-it note and attach it to their chests.
The private school was closed during the following week.
According to the New York City Health Department, at least 69 cases of the H1N1 virus were confirmed at the school, and the number likely increased after the agency stopped counting.
A health department survey showed that one-third of the students, or 659 teens, reported flulike symptoms during April.
Belinda Lee Pustka, a school superintendent in Schertz, Texas, a suburb of San Antonio, said parks and churches closed when the swine flu hit.
Parents wanted to know the impact of the virus on their family and community, said Pustka, who oversees the Schertz-Cibolo-Universal City Independent School District.
Good communication was the key, she said. The district held daily news conferences and opened a Twitter account that some people used to ask questions during briefings.
“It was a very positive experience, but it was a very hard experience for the community,” Pustka added.
Swine flu continues to circulate in the United States and more than 120 other countries—especially in the Southern Hemisphere, where flu season is under way. The virus could hit the U.S. as children return to school, which is only weeks away, Sebelius told CNN earlier Thursday.
Thursday’s symposium offers an opportunity to look ahead and begin to put things in place, Sebelius said on CNN’s “American Morning.”
There are more than 33,900 confirmed and probable cases of the H1N1 virus in the United States, with 170 deaths, according to the Centers for Disease Control and Prevention. More than 98,000 cases have been documented worldwide, with 440 deaths, according to the WHO.
The virus has bucked traditional flu outbreak patterns. Influenza is typically more active during winter and then slows when the weather turns hot.
“Now, in the UK, as in many of the North American countries—Canada, Mexico and the United States—there has been quite widespread activity, or a lot of activity of this pandemic influenza virus. And right now, it is at a typical point of the year where the activity should be pretty low, but the activity is quite high because it is a pandemic situation for these countries,” Keiji Fukuda, WHO assistant director-general, said this week.
Regular seasonal flu kills about 36,000 Americans annually. Sebelius said the vaccine for seasonal flu is ready for use.
With the flu season just around the corner, it’s no wonder more and more companies are turning to corporate flu shot vendors such as Flu Shots For You. Do you have a large group of employees to vaccinate this fall? Uncertain of where you should start? We can help. With top-notch customer service, group discounts and a variety of appointment options to chose from, Flu Shots For You has what you are looking for. What are you waiting for? Call us today! Make (800)898-8211 the last number you dial for flu shots, period.
As if Swine flu, most commonly known as the H1N1 virus wasn’t creating enough trouble and scare for us all. Now, a new drug resistant strain has been discovered of this dangerously life-threatening virus. The new strain is completely invulnerable to the only known drug that can counter swine flu, Tamiflu. This new swine flu variant was observed in a Danish patient, who has now recovered.
Experts believe that, this new strain was created inside the patient himself, as he was previously taking Tamiflu dosages to prevent contracting swine flu. However, according to the U.S Center for Disease Control, this new strain has so far been found in only one patient. As the Danish citizen is now fully recovered, therefore, the chances of spreading of this new variant are virtually nil. CDC’s Bridges expressed his relief upon the recovery of the Danish patient, stating that, in case he had not taken Tamiflu in advance, it would have been a completely different scenario. If the patient had been infected by the new drug resistant strain, that could have been in circulation among the populace, then it would have created a very serious situation.
Since the onset of the swine flu, scientists have been immensely worried that the swine flu virus might fuse itself with variants of common seasonal flu and might mutate into an all new drug-resistant strain, that would be extremely hard to treat. However, a Switzerland based pharmaceutical firm has assured that, the newly discovered strain isn’t mutated in any form.
As of now the only known vaccines for the treatment of swine flu are Tamiflu and Relenza. The swine flu has so far claimed over 127 lives, with more than 3.000 patients in the hospitals and in the United States alone, the reported cases have risen to 28,000.
According to Terry Hurley (Spokesperson, Roche),
“It is possible to see occasional reports of resistance while a drug remains largely effective.”
As the Danish incident is an isolated case, therefore, CDC and the World Health Organization (WHO) are still recommending Tamiflu and Relenza as the most effective treatment for swine flu.
DONALD G. McNEIL Jr. on
Virtually all the dominant strain of flu in the United States this season is resistant to the leading antiviral drug Tamiflu, and scientists and health officials are trying to figure out why.
The problem is not yet a public health crisis because this has been a below-average flu season so far, and because the Tamiflu-resistant strain, one of three circulating, is still susceptible to other drugs. But infectious disease specialists are worried nonetheless.
Last winter, about 11 percent of the throat swabs from patients with the most common type of flu that were sent to the Centers for Disease Control and Prevention for genetic typing showed a Tamiflu-resistant strain. This season, 99 percent do.
“It’s quite shocking,” said Dr. Kent A. Sepkowitz, director of infection control at Memorial Sloan-Kettering Cancer Center in New York. “We’ve never lost an antimicrobial this fast. It blew me away.”
The single mutation that creates Tamiflu resistance appears to be spontaneous, and not a reaction to overuse of the drug. It may have occurred in Asia, and it was widespread in Europe last year. In response, the disease control agency issued new guidelines two weeks ago. They urged doctors to test suspected flu cases as quickly as possible to see if they are influenza A or influenza B, and if they are A, whether they are H1 or H3 viruses.
The only Tamiflu-resistant strain is an H1N1. Its resistance mutation could fade out, an agency scientist said, or a different flu strain could overtake H1N1 in importance, but right now it causes almost all flu cases in the country, except in a few mountain states, where H3N2 is prevalent.
Complicating the problem, antiviral drugs work only if taken within the first 48 hours of infection. A patient with severe flu could be given the wrong drug and die of pneumonia before test results come in. So the new guidelines suggest that doctors check with their state health departments to see which strains are most common locally and treat for them.
“We’re a fancy hospital, and we can’t even do the A versus B test in a timely fashion,” Dr. Sepkowitz said. “I have no idea what a doctor in an unfancy office without that lab backup can do.”
If a Tamiflu-resistant strain is suspected, the disease control agency suggests using a similar drug, Relenza. But Relenza is harder to take; it is a powder that must be inhaled and can cause lung spasms, and it is not recommended for children under 7.
Relenza, made by GlaxoSmithKline, is known generically as zanamivir. Tamiflu, made by Roche, is known generically as oseltamivir.
Alternatively, patients who have trouble inhaling Relenza can take a mixture of Tamiflu and rimantadine, an older generic drug that the agency stopped recommending two years ago because so many flu strains were resistant to it. By chance, the new Tamiflu-resistant H1N1 strain is not.
“The bottom line is that we should have more antiviral drugs,” said Dr. Arnold S. Monto, a flu expert at the University of Michigan’s School of Public Health. “And we should be looking into multidrug combinations.”
New York City had tested only two flu samples as of Jan. 6, and both were Tamiflu-resistant, said Dr. Annie Fine, an epidemiologist at the city’s health department. Flu cases in the city are only “here and there,” Dr. Fine said, and there have been no outbreaks in nursing homes. Elderly patients and those with the AIDS virus or on cancer therapy are most at risk.
But, she added, because of the resistance problem, the city is speeding its laboratory procedures so it can do both crucial tests in one day.
“And we strongly suggest that people get a flu shot,” Dr. Fine said. “There’s plenty of time and plenty of vaccine.”
Exactly how the Tamiflu-resistant strain emerged is a mystery, several experts said.
Resistance appeared several years ago in Japan, which uses more Tamiflu than any other country, and experts feared it would spread.
But the Japanese strains were found only in patients already treated with Tamiflu, and they were “weak” — that is, they did not transmit to other people.
“This looks like a spontaneous development of resistance in the most unlikely places — possibly in Norway, which doesn’t use antivirals at all,” Dr. Monto said.
Dr. Henry L. Niman, a biochemist in Pittsburgh who runs recombinomics.com, a Web site that tracks the genetics of flu cases worldwide, has been warning for months that Tamiflu resistance in H1N1 was spreading.
Dr. Niman argues that it started in China, where Tamiflu use is rare, was seen last year in Norway, France and Russia, then moved to South Africa (where winter is June to September), and back to the Northern Hemisphere in November.
The mutation conferring resistance to Tamiflu, known in the shorthand of genetics as H274Y on the N gene, was actually, Dr. Niman said, “just a passenger, totally unrelated to Tamiflu usage, but hitchhiking on another change.”
The other mutation, he said, known as A193T on the H gene, made the virus better at infecting people.
Furthermore, Dr. Niman blamed mismatched flu vaccines for helping the A193T mutation spread. Flu vaccines typically protect against three flu strains, but none have contained protections against the A193T mutation.
Dr. Joseph S. Bresee, chief of flu prevention at the disease control agency, said he thought Dr. Niman was “probably right” about the resistance having innocently piggy-backed on a mutation on the H gene — which creates the spike on the outside of the virus that lets it break into human cells. But Dr. Bresee said he doubted that last year’s flu vaccine was to blame, since the H1 strain in it protected “not perfectly, but relatively well” against H1N1 infection.
Dr. Niman said he was worried about two aspects of the new resistance to Tamiflu. Preliminary data out of Norway, he said, suggested that the new strain was more likely to cause pneumonia.
The flu typically kills about 36,000 Americans a year, the C.D.C. estimates, most of them the elderly or the very young, or people with problems like asthma or heart disease; pneumonia is usually the fatal complication.
And while seasonal flu is relatively mild, the Tamiflu resistance could transfer onto the H5N1 bird flu circulating in Asia and Egypt, which has killed millions of birds and about 250 people since 2003. Although H5N1 has not turned into a pandemic strain, as many experts recently feared it would, it still could — and Tamiflu resistance in that case would be a disaster.
As many as 500,000 New Yorkers may have been infected with the H1N1 virus that causes swine flu, federal officials said yesterday, far more than initially estimated by the city’s Department of Health.
The new data is based on a community survey that found 6.9 percent of New Yorkers experienced a flu-like illness during a three-week period in May when the illness was at its most active. Researchers used a new type of modeling to extrapolate an estimate of how many city residents were likely infected with the new virus but didn’t seek treatment.
“About half a million New Yorkers may have been infected,” said Dr. Anne Schuchat, director of National Center for Immunization and Respiratory Diseases at the CDC.
Nationwide, Schuchat said, there’s probably been 50 times more cases of swine flu than have been officially reported.
“There have been at least a million cases of the new H1N1 virus so far this year,” Schuchat said. “Reported cases are really just the tip of the iceberg.”
New York has recorded 804 swine flu hospitalizations and 32 deaths related to the disease. Earlier this month the city Health Department said new infections of the N1N1 virus appeared to be on the decline.
A 9-year-old Buffalo girl died of swine flu today— the second Buffalo School District student to die of the disease in a week.
Maya Harden, who died just after 9:30 a.m. Saturday in Women and Children’s Hospital, had been on life support. She was a fourth-grader at the Charles Drew Science Magnet School 59.
The girl’s death comes one week after 15-year-old Matthew Davis, an eighth-grader at Buffalo’s Harvey Austin School 97, Sycamore Street, died from swine flu complications.
“They tried everything to get her lungs circulating,” Maya’s mother, Akea Hollingsworth, said later in the day.
Because of confidentiality reasons, Buffalo School District officials did not identify the student.
Dr. James A. Williams, district superintendent, issued a statement.
“It is with a heavy heart and deep sadness that ... we mourn the loss of another student. “Please keep the family in your thoughts and prayers during this difficult time while they struggle with this terrible loss.”
Williams also pointed to the seriousness of the disease.
“... We ask parents again to remain vigilant in stopping the spread of H1N1. Please have your child wash and sanitize their hands as often as possible. The best way to remain disease free is to maintain proper hygiene and wash your hands on a regular basis.”
There’s still no reason to panic.
WITH CASES numbering more than 59,000 across 110 countries, Margaret Chan of the World Health Organization has declared a swine flu pandemic. “The world is moving into the early days of its first influenza pandemic in the 21st century,” Dr. Chan said from Geneva, where she is the WHO’s director general. “The virus is now unstoppable.” Chilling words, but no cause for panic.
Here are some things to keep in mind. The WHO Phase 6 designation, the highest alert for the global organization, is a recognition of the spread of the H1N1 virus, not the severity of the pandemic. Dr. Chan described the danger posed by swine flu as “moderate.” The U.S. Department of Health and Human Services has characterized the flu cases in this country as “less severe” than thought. So far, there have been 263 deaths worldwide, including 87 in the United States.
According to the WHO, seasonal flu kills 250,000 to 500,000 people globally. In the United States, there are about 36,000 deaths a year. The 1968 Hong Kong flu pandemic killed 1 million people worldwide.
The Obama administration has taken the proper approach from the outset. It has urged Americans to take precautions (stay home if you’re sick, cover your sneezes, wash your hands) while preparing for the possibility that this new form of swine flu could mutate into something more virulent. Antiviral medication has been moved from federal stockpiles to the states. Vaccine development has begun. There are discussions with state and local authorities to plan for an immunization campaign should the need arise.
Pandemics are serious, and there’s no telling how this new strain of swine flu might change. All eyes are on the Southern Hemisphere, where it’s winter and flu season is just beginning. Health authorities should remain vigilant and continue to keep the public informed. But the pandemic declaration is no reason to raid the drugstore for Tamiflu.
Are you convinced the flu shot gives you the flu? Do you think you’re not at risk? Do you believe the shot is ineffective? Consumer Reports says stop with your namby-pamby flimsy excuses. Here’s why:
1. Excuse: It’s better to build your own natural immunities (67 percent).
Reality: The body’s innate immune response against the flu virus is short-lived, usually just a few months. Moreover, the virus that causes the flu often changes from year to year. So any protection your body develops during one flu season is usually gone by the next. (That also explains why, unlike most other vaccines, you need a fresh flu shot each year.)
2. Excuse: You don’t get sick (45 percent).
Reality. Just because you haven’t had the flu in the past doesn’t mean you won’t get it this year. And just one bout of the disease may have you running for the flu shot next year. Indeed, the Centers for Disease Control and Prevention estimates that each year the flu sends some 225,000 people to the hospital, and causes the death of 35,000.
3. Excuse: You or someone you know has gotten sick from the vaccine (41 percent).
Reality: The nasal-spay version of the vaccine (FluMist) is made from a weakened virus, so you can develop at least mild symptoms from it. In fact, the government doesn’t recommend the nasal spray for people under 2 or over 49, and we recommend against the nasal spray unless you have a good reason for avoiding the injection. The shot, in contrast, is made from an inactivated virus, so it’s impossible to get the disease from it. If you do develop the flu after getting the shot, you were just one of the unlucky ones who were not protected by the vaccination (see question 8 below).
4. Excuse: You are worried about the side effects (35 percent).
Reality: Side effects are uncommon and usually mild, including soreness or redness at the injection site, aches, and mild fever. A small number of people do have a more serious allergic reaction to the shot. And research suggests that roughly 1 out of every 1 million people vaccinated might develop Guillain-Barre syndrome, a neurological disorder. But the shot’s protection against illness, hospitalization, and death far outweighs the risk. Still, if you’ve had Guillain-Barre syndrome, avoid the spray vaccine and discuss with your doctor whether to get a shot. Finally, there is no convincing evidence linking the mercury-containing preservative thimerosal with autism or other health problems. However, if you’re concerned, ask for a preservative-free vaccine, such as Fluzone.
5. Excuse: You’re not part of an at-risk population (29 percent).
Reality: The flu shot is especially important for certain groups of people—including pregnant women, those over age 50, and anyone with weakened immunity or chronic illness. But if you’ve been in a movie theater, or a crowded elevator, or a shopping mall, you’re at risk too.
6. Excuse: Medicine is now available for treating the flu (28 percent).
Reality: For the antiviral drugs oseltamivir (Tamiflu) and zanamivir (Relenza) to work, you have to start taking them within two days of the onset of symptoms. Even then, the drugs typically shorten the duration by only a day or so.
7. Excuse: You don’t like getting shots (27 percent).
Reality. Many people find that lying down for their shots helps them relax. And rising up slowly afterward helps prevent fainting, a problem that occurs in a small percentage of people who get the shot. Or, if necessary, talk with your doctor about getting the nasal spray.
8. Excuse: It’s ineffective (26 percent).
Reality: The shot generally prevents the flu in about 60 percent of healthy people in their 60s, though that varies depending on how well the vaccine matches the virus that actually emerges. And it has been shown to reduce hospitalizations from pneumonia or other complications by 27 to 70 percent, and deaths by up to 80 percent. Younger adults and children typically benefit even more from the shots, though for maximum protection children under the age of 9 who have not been previously vaccinated should receive two shots over the course of the season. People of any age who are frail or suffer from a chronic disease typically get somewhat less protection from the shot—though the benefits for them still vastly outweigh the risks.
9: Excuse: You don’t like going to the doctor (23 percent).
Reality: You don’t have to. Nearly a quarter of the people in our survey got the shot at work. Seven percent got the shot at a pharmacy. Health fairs run by insurance companies, colleges, or public-health clinics also often offer the vaccine.
10. Excuse: It costs too much (11 percent).
Reality: Nearly two-thirds of the people in our survey had no out-of-pocket expenses, and 90 percent of those who did had to pay less than $30.
11. Excuse: You don’t have the time (16 percent).
Reality: It usually takes just a few minutes, especially if you get it done at work, a pharmacy, or a health fair.
12. Excuse: You would rather get sick than go to work (5 percent).
Reality: Time to look for a new job.
Amin Mawani on
Wall Street Journal
Few companies have made preparing for a potential influenza pandemic a top priority. Perhaps more of them should.
The World Economic Forum earlier this year put the adverse economic impact of an influenza pandemic at around $500 billion. That was before the recent outbreak of swine flu sickened more than 28,000 people world-wide, leading the World Health Organization on June 11 to declare its first pandemic in 41 years. While WHO officials emphasized that most of the people infected so far have experienced mild symptoms and recovered quickly, they say the outbreak could become more serious.
Much of the cost associated with a pandemic involving a more virulent strain of flu would stem from employee absenteeism. It is estimated that 15% to 30% of employees would stay home during such a pandemic due to illness, family-care responsibilities and fear of being infected at work. The result would be to cripple operations and disrupt global supply chains. As in the credit crisis, the fallout likely would spread rapidly because of how connected the world’s economies are.
The good news is that employee absenteeism—and its financial toll on employers—may be controlled to a large extent with adequate planning and stockpiling of antiviral medication, masks and gowns.
The bad news is that few companies have taken steps to protect themselves. A 2007 survey reported at a Harvard Business School conference on pandemic planning found that while 88% of companies seemed prepared to deal with a power disruption and 70% with a technological failure, only 13% were prepared for the kind of labor-force disruption that would come with a pandemic.
There are many benefits associated with pandemic preparedness.
The companies that can prevent absenteeism during a pandemic will be well-positioned to take market share from those that can’t—a situation that may be hard to reverse once the panic subsides. They also may enjoy higher stock prices and cheaper credit because financial markets tend to reward firms with steady profits and cash flows.
Even if a pandemic never occurs, suppliers with a reputation for being prepared may have a competitive edge. Customers care about reliability and will value a supplier with a plan for weathering an economic shock.
Being unprepared carries potential risks, even legal ones. The Sarbanes-Oxley Act requires managers and directors to manage identified risks as part of adequate corporate governance of public corporations. To the extent that identifying and assessing pandemic risk becomes a generally accepted practice within the corporate community, those who are unprepared may be found to be negligent, and therefore liable to stakeholders, in the event a pandemic occurs.
Managers can make a case for pandemic preparedness using cost-benefit analysis and such performance measures as net present value, internal rate of return and payback, or the number of years within which an investment can be recouped from net annual cash-flow savings.
Doing the Math
The benefit of pandemic preparedness is simply the earnings before interest, taxes, depreciation and amortization, or Ebitda, that are preserved because employees aren’t absent. To figure this, managers must establish the contribution employees make to profits. Some of these calculations can get complex (because costs and benefits may occur in different years), but they are relatively manageable and should be evaluated by senior management.
If the probability of a pandemic is significant and the adverse impact can be alleviated, why aren’t more companies racing to prepare?
To some, pandemic preparedness may seem like an overwhelming exercise, with legal, regulatory, ethical, logistical and economic issues in ordering, storing and dispensing prescription medication. Other firms may be experiencing a liquidity crunch because of the credit crisis, while still others may have a shortage of employees with the know-how to come up with a plan for weathering a health crisis.
Some companies may think the entire industry will suffer equally when a pandemic strikes. That’s a risky assumption, given that some businesses are known to have contingency plans in place already.
Senior managers can’t afford to ignore the issue of pandemic preparedness. Considering that employees are the key profit drivers in most companies, managers must take leadership on issues related to disruptions of labor supply.
The Associated Press
EMPIRE, Colorado - A western Colorado summer camp scheduled this weekend for children with muscular dystrophy has been canceled over swine flu fears.
The national Muscular Dystrophy Association says 53 children were expected at the camp Sunday in Empire, about 40 miles west of Denver. Association officials say they canceled the camp along with others across the country because children with muscular dystrophy have weakened respiratory muscles that make them more vulnerable to swine flu.
Officials announced the cancellation Monday. MDA officials say 47 camps across the country that were expecting about 2,500 children were also called off after suspected swine flu cases in Utah and Pennsylvania.
This week, seven children and three adults at a Minnesota camp contracted swine flu.
Information from: KMGH-TV, http://www.thedenverchannel.com
NBC News on
Florida’s Broward County Health Department is issuing a reminder for summer camps to use precaution and watch for flu symptoms after a confirmed case of swine flu at a church camp. Some believe those who run the church camp tried to keep it quiet, an allegation the church denies. Information packets on swine flu were handed out to parents as they picked up their campers on Thursday, along with a letter notifying them of the confirmed case. Gia Mote, the mother of the child who contracted swine flu, says she told the church camp the previous week at least two kids had Inlfuenza A, and told the camp Wednesday morning her child had swine flu. Christ Church Camp waited a day and a half to notify parents. Some of them now feel the camp did so only after calls from reporters and several angry parents. County health inspectors visited the church on Friday. Church staff sterilized the facility. Camp administrators wouldn’t speak on camera. The director of the camp, Lauren Buschmann, said in the letter to parents “The safety and well-being of children entrusted to our care is of highest priority…If you have any concern about your child’s health being compromised through participation in summer camp or vacation bible study school, please feel free to remove them from participation.“ What happened at the Florida camp is not an isolated incident. Boy Scouts from Palm Beach County were among the 19 who got sent home from Camp Daniel Boone in Asheville, North Carolina after showing swine flu symptoms, and a camp in Georgia delayed its start by a day because of swine flu outbreak.
Florida’s Broward County Health Department is issuing a reminder for summer camps to use precaution and watch for flu symptoms after a confirmed case of swine flu at a church camp.
Some believe those who run the church camp tried to keep it quiet, an allegation the church denies.
Information packets on swine flu were handed out to parents as they picked up their campers on Thursday, along with a letter notifying them of the confirmed case.
Gia Mote, the mother of the child who contracted swine flu, says she told the church camp the previous week at least two kids had Inlfuenza A, and told the camp Wednesday morning her child had swine flu.
Christ Church Camp waited a day and a half to notify parents.
Some of them now feel the camp did so only after calls from reporters and several angry parents.
County health inspectors visited the church on Friday.
Church staff sterilized the facility.
Camp administrators wouldn’t speak on camera.
The director of the camp, Lauren Buschmann, said in the letter to parents “The safety and well-being of children entrusted to our care is of highest priority…If you have any concern about your child’s health being compromised through participation in summer camp or vacation bible study school, please feel free to remove them from participation.“
What happened at the Florida camp is not an isolated incident.
Boy Scouts from Palm Beach County were among the 19 who got sent home from Camp Daniel Boone in Asheville, North Carolina after showing swine flu symptoms, and a camp in Georgia delayed its start by a day because of swine flu outbreak.
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The Detroit News
Cop, 2 others in Metro area latest victims; Oakland leads in cases statewide
Lansing—Three new Michigan swine flu deaths were confirmed Thursday as health officials identified Oakland County as having more than half of the state’s cases.
Oakland County has 306 probable and confirmed swine flu cases. That’s nearly half of the state’s 655 instances and state health officials aren’t sure why the county has experienced the uptick.
“When we first started reporting these numbers, Kent County was in the lead,” said James McCurtis, spokesman for the Michigan Department of Community Health. “Now it’s Oakland County. Maybe it’s because of the amount of people. It doesn’t matter if you travel or not at this point. The flu is being transferred person-to-person now.”
Oakland County has 1.2 million people and 605,200 live in Kent County, according to the U.S. Census Bureau.
Health officials in Oakland County attribute the large number to area doctors actively testing for the swine flu, also known as the H1N1 virus.
Meanwhile, state health officials reported Thursday that five swine flu-related deaths have occurred in Michigan, including the 28-year-old Madison Heights police officer who died last week.
The three new confirmed cases include Officer Ryan Settlemoir of Macomb Township, who died June 12; a 63-year-old Macomb County woman who died Wednesday; and a 44-year-old Oakland County man who died Monday, according to the state health department. The identities of the victims were withheld by state and local health officials.
State health officials said details of underlying health conditions of the victims were not available.
The deaths follow those of Reva Miller, 53, of Warren, who died June 1 and was the first Michigan fatality of the swine flu, and a 58-year-old Roscommon man who died earlier this month.
And, they say, the death toll will likely rise.
“Unfortunately, people die from seasonal flu and so seeing a number of deaths for H1N1 in Michigan is not anything out of the ordinary,” McCurtis said.
“I’m sure more will occur because of the history of seasonal flu and what’s going on across the country.”
The World Health Organization last week declared a swine flu pandemic, the first global flu epidemic in 41 years, as infections climbed to nearly 30,000.
Nationwide, there have been 17,855 confirmed and probable cases in all 50 states, the District of Columbia and Puerto Rico. There have been 44 deaths nationwide, according to the Centers for Disease Control and Prevention Web site.
In Michigan, 655 confirmed and probable cases of the swine flu have been found, including 36 cases in Wayne, 26 in Macomb and 16 in Livingston counties, according to the MDCH Web site.
“It is not a time to panic,” said Kathy Forzley, manager of the Oakland County Health Division.
“It’s a time to consider that this is an influenza that’s here in our community and we all need to be practicing good prevention.”
Forzley urged people to wash their hands frequently and cover their noses and mouths when coughing and sneezing.
Meanwhile, community residents gathered Tuesday at Antioch Baptist Church in Warren to mourn the loss of Settlemoir, who became ill last month with 22 other officers in his department. The others have recovered and are back on the job.
Settlemoir had other underlying health conditions, according to the health department.
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DONALD G. McNEIL Jr. on
Although it is fading in much of the nation as warmer weather comes on, swine flu is causing outbreaks in summer camps just as it has in schools, federal officials said Thursday.
The illness has hospitalized 1,600 Americans, most of them young, and is blamed in 44 deaths, the officials said. It is most persistent in the Northeast, and nearly 90 percent of the flu cases that are tested nationally are the new swine H1N1, not seasonal flu.
The advice to camp administrators and parents is basically the same as for schools, said Dr. Daniel B. Jernigan, deputy director of the flu division of the Centers for Disease Control and Prevention: Camps should be on the alert for sick children, who should be kept home for a week or until 24 hours after symptoms have finished. (Not all camps offer refunds, the American Camp Association noted.) Parents should be prepared to take sick children home on short notice.
Religious camps in Clayton, Ga.; Santa Rosa, Calif.; and Cleveland, Ga., and a Boy Scout camp near Asheville, N.C., all reported probable swine flu cases in local newspapers this week. The C.D.C. also said that many hospitals and clinics were not doing enough to prevent the spread of flu within their walls.
Preliminary analysis of 26 cases of swine flu among health care workers in April and May showed that too few hospital staff members wore masks and other protection, and that patients with the flu were not being identified quickly enough.
“Infectious patients should be identified at the front door,” said Dr. Michael Bell, chief of infection control for the agency. “Identifying them up front is essential.”
When that is done correctly, Dr. Bell said, hospitals act appropriately by putting infectious patients in single rooms, covering their mouth and nose with masks, alerting staff members to wear protection and wash their hands, and doing some procedures in rooms pressurized to make sure no air escapes into corridors.
As if to emphasize the potential risks in hospitals, The Associated Press reported Thursday that 33 premature infants in a hospital in Greensboro, N.C., were getting precautionary flu treatment because a respiratory therapist had worked in the neonatal intensive-care unit after treating an older patient who later tested positive for the virus. None of the children had flu symptoms, a hospital administrator said.
WISN 12 News
MILWAUKEE—H1N1 flu has an explosive effect in certain age groups, according to an infectious disease specialist who 12 News spoke to Wednesday at Children’s Hospital of Wisconsin.For those with mild cases, some need antiviral medication; most go home and get better.“The flu itself we are seeing is milder,” said Dr. Michael Chusid of Children’s Hospital, “But there is a small group of individuals - mostly healthy people - who seem to react violently to it.“While the seasonal flu targets the very young and very old, this strain of flu has been striking a notably different age range.“When we look the positive tests we get the vast majority of individuals who are five to 18 years of age,” said Chusid.Contrary to more typical outbreaks, the H1N1 flu has experts exploring why it is more difficult for the healthier victims with stronger immune systems to fight the virus.“Their immune system is robust and when they get this relatively mild infection, at least mild for many people,” Chusid said. “They over react and the inflammation and this inflammation over reacts and produces causes a tremendous pneumonia and this is what is making them so sick.“The concern is about what currently is happening with this flu strain and what could happen next.“With the really big ones, there has been a small wave maybe like this—six months to two years—before the big tsunami of lots of infection,” said Chusid.He said it is also possible people who got flu strains back in the 1950s and 1960s have built up antibodies protecting them from this strain. Copyright 2009 by WISN.com. All rights reserved.
A(H1N1) Influenza Vaccine Production Process
(From Sanofi Pasteur)
A novel A(H1N1) influenza virus strain emerged in April 2009, with cases first reported in Mexico and the U.S. Human-to-human spread of the virus soon reached additional countries while world health officials expressed concern for a potential pandemic. As the world’s leading supplier of influenza vaccine, sanofi pasteur immediately activated its pandemic response plan and began assessing its capabilities to support public health efforts and produce a vaccine against the new strain.
Steven Reinberg on
New Swine Flu Strain Found in Brazil: Report
But it’s not clear if it’s any more dangerous than initial strain
By Steven Reinberg
WEDNESDAY, June 17 (HealthDay News)—Scientists in Brazil say they’ve discovered a new strain of the swine flu virus, according to published reports. But it’s not yet clear if the strain is any more dangerous than the previously-undiscovered strain that first surfaced in Mexico in April and has since swept the globe, causing relatively mild infections in most people.
The scientists discovered the new strain in a patient who had been hospitalized in Sao Paulo in April. The 26-year-old, who came down with flu symptoms after returning from Mexico, has made a full recovery, Fox News reported.
Health officials are closely monitoring the H1N1 swine flu virus as it migrates from the Northern Hemisphere to the Southern Hemisphere, where the flu season is now under way. While the swine flu doesn’t yet seem any more lethal than the regular flu that each winter kills 36,000 people in the United States alone, scientists fear it could mutate as it circulates around the globe, becoming more virulent and posing a greater health threat.
Nearly 36,000 people in 76 countries have been infected with the H1N1 virus, according to the latest figures from the World Health Organization, causing 163 deaths. The WHO last week formally declared a pandemic, triggered by the rapid spread of the H1N1 virus across North America, Australia, South America, Europe and regions beyond.
What makes the H1N1 strain different from the typical seasonal flu is that about half of the people killed worldwide were young and previously healthy. In contrast, regular forms of the seasonal flu typically prove most lethal to the very young and the elderly.
Given that trend, school children in the United States could be among the first to receive a swine flu vaccine this fall, if federal health officials decide to pursue a widespread inoculation program. Health and Human Services Secretary Kathleen Sebelius said Tuesday that she was urging school superintendents around the country to prepare for that possibility, the Associated Press reported.
“If you think about vaccinating kids, schools are the logical place,” Sebelius told the news service.
Schools do sometimes work in tandem with local health officials for special flu vaccination clinics, but it’s not common.
Sebelius said she’d soon call the nation’s governors to be sure “these months between now and the fall aren’t used as vacation months,” but to prepare for potential risks posed by the H1N1 virus, the AP said. “We can always sort of back off” if the new flu fades away, she said, “but we can’t wait till October hits and say, ‘Oh my heavens, what are we going to do?’ “
Last week, European drug maker Novartis AG announced that it had successfully produced the first batch of H1N1 swine flu vaccine, weeks earlier than had been expected. The shortened production schedule was made possible because the vaccine was produced in cells, rather than the egg-based method typically used for vaccines, the company said.
According to the AP, Novartis said it was using this first batch for evaluation and testing, prior to its use in people, and it was also being considered for use in clinical trials. Millions of doses of the vaccine might be produced weekly, the company said. The U.S. Department of Health and Human Services had already placed a $289 million order for swine flu vaccine with Novartis in May, the AP said.
The WHO said Monday that 76 countries have now reported 35,928 cases of H1N1 swine flue infection, including 163 deaths. The vast majority of those deaths—108—have occurred in Mexico, the source of the outbreak. The United States has reported 45 deaths, according to the agency.
According to WHO statistics, the last pandemic—the Hong Kong flu of 1968—killed about 1 million people. By comparison, ordinary flu kills about 250,000 to 500,000 people worldwide each year.
Since the outbreak started in April, health officials in the United States have said that infections have been mild for the most part, and most people recover fairly quickly. Testing has found that the H1N1 virus remains susceptible to two common antiviral drugs, Tamiflu and Relenza.
For more on swine flu, visit the U.S. Centers for Disease Control and Prevention.
SOURCES: Fox News; June 11, 2009, teleconference with Thomas R. Frieden, M.D., director, U.S. Centers for Disease Control and Prevention, and Anne Schuchat, M.D., director, CDC National Center for Immunization and Respiratory Disease; June 11, 2009, statements, U.S. Department of Health and Human Services and U.S. Department of Homeland Security; Associated Press
Last Updated: June 17, 2009
Copyright © 2009 ScoutNews, LLC. All rights reserved.
WISN 12 News
3 Milwaukeeans Have Died From Virus
MILWAUKEE —WISN 12 News has learned that the adolescent who died from the H1N1 virus this week was a 14-year-old girl. According to the medical examiner’s report, Tiara Mosely died Monday night. This was the third H1N1 death in the city of Milwaukee. The girl apparently had no other medical conditions that could have led to death, the Milwaukee Health Department said. “In the past, everybody would get the flu, but we would only worry about older individual or those with chronic disease actually dying from influenza,” Richard Olds, infectious disease doctor. “We have to now be much more focused on anyone who has influenza symptoms.“Two others adults have also died recently.The three cases are the only deaths from the H1N1 virus in Wisconsin.Wisconsin is one of nine states reporting multiple deaths.As of Tuesday, there were 2,000 confirmed cases of H1N1 virus in Milwaukee. The Milwaukee Health Department said it expects that number to increase in coming weeks.
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LONDON (Reuters) - Swiss drugs company Novartis will not give free vaccines against H1N1 flu to poor countries, though it will consider discounts, the Financial Times reported on Sunday.
“If you want to make production sustainable, you have to create financial incentives,” the FT quoted Novartis Chief Executive Daniel Vasella as saying in an early edition of Monday’s paper.
The director-general of the World Health Organization, Margaret Chan, has called for drugs companies to show solidarity with poor countries as they develop vaccines against the pandemic H1N1 virus, commonly known as swine flu.
As well as Novartis, U.S. company Baxter International and Europe’s Sanofi-Aventis, GlaxoSmithKline and Solvay are working on vaccines.
H1N1 has infected around 30,000 people globally, mostly in North America, though there have been few deaths outside Mexico and the United States. Europe suffered its first death on Sunday after a patient with pre-existing health problems died in Scotland.
General Business and Workplace Guidance for the Prevention of Novel Influenza A (H1N1) Flu in Worker
The CDC on
- Symptoms of Novel Influenza A (H1N1) Flu
- Prevention of Illness in Well Employees
- Management of Employee Exposure in the Workplace after a Confirmed Case
- How Businesses Can Respond to the Impact on their Operations and Employees
This guidance is to help employers with employees in OSHA's Lower Risk (Caution) Zone*: those employees who have minimal occupational contact with the general public and other coworkers (for example, office employees).
A novel influenza A (H1N1) virus has infected humans in the United States as well as multiple other countries, and the spread of this virus continues. Businesses and employers, in general, play a key role in protecting employees' health and safety, as well as in limiting the negative impact of the outbreak on the individual, the community, and the nation's economy. This interim guidance is meant to inform and educate management, unions, and employees about appropriate precautions and work practices to minimize the risk of potential employee exposure, illness, and the spread of novel influenza A (H1N1) flu in the workplace through general prevention and preparedness strategies and in the event that a worker becomes ill.
The guidance in this document may change as additional information about novel influenza A (H1N1) becomes known. Please check the website periodically for updated guidance.
Symptoms of Novel Influenza A (H1N1) Flu
The symptoms of this novel influenza A (H1N1) flu virus in people are similar to the symptoms of seasonal flu and include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills and fatigue. A significant number of people who have been infected with this virus also have reported diarrhea and vomiting. Also, as with seasonal flu, severe illnesses and death have occurred as a result of illness associated with this virus.
Prevention of Illness in Well Employees
Spread of this novel influenza A (H1N1) virus is thought to be happening in the same way that seasonal flu spreads. Flu viruses are spread mainly from person to person through coughing or sneezing by people with influenza. Sometimes people may become infected by touching something with flu viruses on it and then touching their eyes, mouth, or nose.
What can employers do to protect employees?
- Encourage sick workers to stay home and away from the workplace, and provide flexible leave policies.
- Encourage infection control practices in the workplace by displaying posters that address and remind workers about proper handwashing, respiratory hygiene, and cough etiquette. These posters can be found on the Germ Stopper: Posters and Other Materials page.
- Provide written guidance (email, etc.) on novel influenza A (H1N1) flu appropriate for the language and literacy levels of everyone in the workplace. Employers should work closely with local and state public health officials to ensure they are providing the most appropriate and up-to-date information (e.g., the CDC H1N1 Flu website).
- Provide sufficient facilities for hand washing and alcohol-based (at least 60%) hand sanitizers (or wipes) in common workplace areas such as lobbies, corridors, and restrooms.
- Provide tissues, disinfectants, and disposable towels for employees to clean their work surfaces, as well as appropriate disposal receptacles for use by employees.
- One study showed that influenza virus can survive on environmental surfaces and can infect a person for up to 2-8 hours after being deposited on the surface.To reduce the chance of spread of the novel influenza A (H1N1) virus, disinfect commonly touched hard surfaces in the workplace, such as work stations, counter tops, door knobs, and bathroom surfaces by wiping them down with a household disinfectant according to directions on the product label.
What can employees do to reduce the spread of novel influenza A (H1N1) flu in the workplace?
- Stay home if you are sick. If you have influenza-like illness symptoms, stay home for 7 days after symptoms begin or until you have been symptom-free for 24 hours, whichever is longer. Following these recommendations will help keep you from infecting others and spreading the virus.
- Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
- Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hand cleaners can be used if soap and water are not available.
- Avoid touching your eyes, nose, or mouth. Germs spread this way.
- Avoid close contact with sick people.
Management of Employee Exposure in the Workplace after a Confirmed Case of Novel Influenza A (H1N1) Flu
What to do when an employee comes to work with influenza-like illness symptoms in a community where novel influenza A (H1N1) virus is circulating
- Notify appropriate health center or first aid personnel.
- Place the employee in a room by him- or herself.
- If the employee needs to go into a common area, he or she should cover coughs/sneezes with a tissue or wear a facemask if available and tolerable.
- Notify the employee's supervisor or employer.
- Send the employee home as soon as possible.
- Call for emergency medical services if the ill person develops any of the emergency warning signs. See What to Do If You Get Flu-Like Symptoms to review emergency warning signs and for more information on what employees should do if they become sick.
- Ensure the ill employee stays home for 7 days after symptom onset or until symptom-free for 24 hours, whichever is longer.
- For recommendations on facemask and respirator use for the person assisting the ill employee see Interim Recommendations for Facemask and Respirator Use to Reduce Novel Influenza A (H1N1) Virus Transmission.
What to do for co-workers of an employee who is a suspected or confirmed case of novel influenza A (H1N1) flu
- Inform the employees of their exposure to a co-worker with confirmed, probable, or suspected novel H1N1 flu during the ill person's infectious period.
- Have the employees monitor for symptoms.
- Advise employees to check with their health care provider about any special care they might need if they are pregnant or have a chronic health condition such as diabetes, heart disease, asthma, or emphysema.
What to do for an employee with confirmed novel influenza A (H1N1) flu while he or she is on travel status
- Notify his or her supervisor or employer if an employee becomes ill on travel or temporary assignment.
- If outside the U.S., contact medical consultants or overseas medical assistance companies to assist in finding an appropriate medical provider in that country, if needed. A U.S. consular officer can help locate medical services. Take note that U.S. embassies, consulates, and military facilities do not have the legal authority, capability, and resources to evacuate or to give medications, vaccines, or medical care to private U.S. citizens overseas.
- See Novel H1N1 Flu and Travel for more information for travelers.
Considerations for Pregnant Employees with Suspected Novel Influenza A (H1N1) Flu
Pregnant women are known to be at higher risk for seasonal influenza complications. They might also be at higher risk for novel H1N1 influenza complications. Pregnant women with flu symptoms should contact their health care provider. For more information, please visit What Pregnant Women Should Know About H1N1 Virus.
How Businesses Can Respond to the Impact that Novel Influenza A (H1N1) Flu May Have on their Operations and Employees
What businesses can do to anticipate and respond to the impact of novel influenza A (H1N1) flu on operations
- Identify a workplace coordinator who will be responsible for dealing with novel influenza A (H1N1) flu issues and impact at the workplace, including contacting local health department and health care providers in advance and developing and implementing protocols for response to ill individuals.
- Determine who will be responsible for responding to ill individuals in the workplace, either through an established health clinic or as a first aid duty.
- Share your plans with employees and clearly communicate expectations.
- Review interim recommendations for facemask and respirator use in non-health care settings.
- Identify essential employees, essential business functions, and other critical inputs (e.g. raw materials, suppliers, subcontractor services/products, and logistics) required to maintain business operations by location and function should there be disruption during the novel influenza A (H1N1) flu outbreak.
- Implement business continuity plans if there is significant absenteeism in the workplace during this outbreak.
- Review your plan with regard to increases or decreases in demand for your products and/or services during the outbreak (e.g., the need for hygiene supplies).
- Review the CDC travel-related websites for up-to-date information and communicate these recommendations to employees who may have upcoming business-related travel.
- Establish an emergency communications plan. This plan includes identification of key contacts (with back-ups), chain of communications (including suppliers and customers), and processes for tracking and communicating business and employee status.
- Develop platforms (e.g., hotlines, dedicated websites) for communicating novel influenza A (H1N1) flu status and actions to employees, vendors, suppliers, and customers inside and outside the worksite in a consistent and timely way, including redundancies in the emergency contact system.
What businesses can do to anticipate and respond to the impact of novel influenza A (H1N1) on employees
- Examine policies for leave and employee compensation and review with managers, supervisors, and employees so they are up-to-date on sick leave policies, leave donation, and employee assistance services that are covered under the different employee sponsored health plans. Leave policies should be flexible and non-punitive.
- Plan for the possibility of unscheduled leave that encourages employees who are sick to stay at home to care for themselves and others who are ill with the flu or children dismissed from school.
- Establish policies for flexible worksite (e.g., telecommuting) and flexible work hours (e.g., staggered shifts), if needed.
- Communicate policies for employee access to and availability of health care, mental health, and social services including corporate and community resources.
*See the Risk Pyramid on page 11 of the OSHA Guidance on Preparing Workplaces for an Influenza Pandemic (PDF, 615 KB, 46 pages)
Occupational Safety and Health Administration
The World Health Organization (WHO) has declared a global flu pandemic after holding an emergency meeting.
It means the swine flu virus is spreading in at least two regions of the world with rising cases being seen in the UK, Australia, Japan and Chile.
WHO chief Dr Margaret Chan said the move does not mean the virus is causing more severe illness or more deaths.
The swine flu (H1N1) virus first emerged in Mexico in April and has since spread to 74 countries.
Dr Margaret Chan, WHO director-general
Official reports say there have been nearly 30,000 cases globally and 141 deaths with figures rising daily.
Hong Kong said it was closing all its nurseries and primary schools for two weeks following 12 school cases.
It is the first flu pandemic in 40 years - the last in 1968 killed about one million people.
However, the current pandemic seems to be moderate and causing mild illness in most people.
Most cases are occurring in young working age adults and a third to a half of complications are presenting in otherwise healthy people.
Dr Chan said: "We have evidence to suggest we are seeing the first pandemic of the 21st century.
"Moving to pandemic phase six does not imply we will see increased in deaths or serious cases."
She added it was important to get the right balance between complacency and vigilance and that pandemic strategies would vary between countries depending on their specific situation.
Professor John Oxford, flu expert
And the WHO do do not recommend closure of borders or any restrictions on the movement of people, goods or services.
But the picture could change very quickly.
Geneva - Swiss pharmaceutical giant Novartis said Friday it was making faster than expected progress on the production of a vaccine against swine flu.
The announcement came after the World Health Organisation (WHO) said Thursday that swine flu had now become a 'pandemic', the first in 41 years.
Novartis said 30 governments had already requested vaccine ingredient against the virus.
'Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations,' the company said in a statement, referring to the virus by its technical name.
WHO Director General Margaret Chan declared a pandemic based on the rapid global spread of the A(H1N1) virus but noted that for most people affected the disease was mild and they made a full recovery.
The WHO expected a vaccine against swine flu to be ready in September.
Novartis used a cell-based manufacturing technology at its plant in Marburg, Germany, which 'cut weeks off the time required to begin vaccine production.' The technology would also allow for faster full-scale production of the vaccine for the markets, once it was ready.
The first batch would be used for pre-clinical evaluation and testing and was also being considered for use in clinical trials, Novartis said.
The Basel, Switzerland-based company received a seed of the virus from the United States` Center for Disease Control.
It plans to start clinical trials in July and said it expected licencing in the autumn of 2009.
Novartis said a US Department of Health and Human Service's $289 million order in May 2009 remained 'the largest of the US government's commitments to influenza A(H1N1) vaccine ingredients.
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