U.S. approves H1N1 vaccine, says enough for everyone
Tue Sep 15, 2009 6:06pm EDT
By Susan Heavey
WASHINGTON (Reuters) - U.S. health officials have approved vaccines from four drugmakers to help prevent the H1N1 swine flu, ensuring there will be enough to inoculate Americans who want the protection, U.S. Health Secretary Kathleen Sebelius told lawmakers on Tuesday.
The U.S. Food and Drug Administration cleared vaccines from Sanofi-Aventis SA, CSL Ltd, Medimmune and Novartis AG for the H1N1 strain of influenza, she said.
"There will be vaccines for everyone," Sebelius said at a hearing of the U.S. House of Representatives Energy and Commerce Committee.
There are about 300 million potential users, she said, adding that not all Americans will opt for the shot. The first doses should be available within the next four weeks, according to the FDA.
Manufacturers and governments have been scrambling for vaccines to target the new H1N1 flu strain, which was declared a pandemic in June. The World Health Organization said it could infect as many as one-third of the world's population, or 2 billion people.
Sebelius said the government has already contracted to buy 195 million doses from a total of five manufacturers and that more purchases are likely depending on how many people decide to get vaccinated.
GlaxoSmithKline Plc is also working to develop a H1N1 vaccine and win FDA approval.
Some skeptics have questioned the safety of the vaccines, especially given the quick development. Clinical trials for most adults began in early August.
So far, preliminary data show most healthy adults have a good immune response eight to 10 days after receiving a single shot, the FDA said. Other studies are underway for children, and trials for pregnant women just began, Sebelius said.
"The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines," Dr. Jesse Goodman, FDA's acting chief scientist, said in a statement.
FREE VACCINES
U.S. officials are launching a large-scale vaccination effort in mid-October to inoculate the population, including those most at risk such as pregnant women and young people ages 6 months to 24 years.
H1N1 vaccines will be free, Sebelius said, but some healthcare providers may charge an administration fee. The federal government is planning to spend about $1.4 billion for states and hospitals to prepare for the virus, she added.
Flu season typically runs from October to May, but U.S. officials saw H1N1 cases throughout the summer with an uptick from summer camps and now schools.
Still, people won't be able to get the vaccine for weeks.
"The fact that vaccines won't begin distribution until October makes preventing the spread of flu even more critical," Sebelius said in her testimony.
Vaccine or lack of
Moderators: yankee-in-france, Fashionista
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Hope there's enough for the elderly and disabled.
by Eliza » Fri Sep 18, 2009 12:21 am
US to share 10 percent swine flu vaccine globally
(AP) – 9/17/09
WASHINGTON — President Barack Obama says the United States will share 10 percent of its swine flu vaccine supply with other nations.
The White House on Thursday announced that the move would help fight the global spread of swine flu, known among scientists as H1N1.
The White House says the flu vaccines would be available through the World Health Organization.
The White House says the virus does not recognize international borders and the United States is working with Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland, and the United Kingdom to share vaccines.
(AP) – 9/17/09
WASHINGTON — President Barack Obama says the United States will share 10 percent of its swine flu vaccine supply with other nations.
The White House on Thursday announced that the move would help fight the global spread of swine flu, known among scientists as H1N1.
The White House says the flu vaccines would be available through the World Health Organization.
The White House says the virus does not recognize international borders and the United States is working with Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland, and the United Kingdom to share vaccines.
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Fri Sep 18, 2009 12:23 am
UPDATE 1-Rich countries to share some swine flu vaccine
Thu Sep 17, 2009 6:45pm EDT
(Updates throughout with quotes, details)
WASHINGTON, Sept 17 (Reuters) - Nine rich countries agreed to share extra swine flu vaccine with less-developed countries on Thursday, just as companies prepared to deliver supplies.
The United States pledged 10 percent of its vaccine supply, joining Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland, and Britain.
The World Health Organization has been working to persuade countries to share their supplies of vaccine against the pandemic. "They own most of the vaccine out there," WHO's Dr. Keiji Fukuda told scientists at an Institute of Medicine pandemic influenza meeting this week.
"The single biggest (issue) we have to deal with is disparity."
Vaccine makers GlaxoSmithKline (GSK.L: Quote, Profile, Research, Stock Buzz) and Sanofi-Pasteur (SASY.PA: Quote, Profile, Research, Stock Buzz) previously pledged 120 million doses to WHO. Experts estimate that 80 percent of the world's nearly 7 billion people live in the developing world, with little hope of getting a vaccine.
WHO has been urging countries that pre-ordered vaccine from the 25 or so manufacturers to share some of it.
"Whatever is available to WHO will be made available first to least-developed countries, about 49 countries, with the intention of providing them to vaccinate their healthcare workers," Fukuda said.
The United States has ordered 195 million doses of H1N1 vaccine from five makers -- Glaxo, Sanofi, Australia's CSL (CSL.AX: Quote, Profile, Research, Stock Buzz), AstraZeneca's (AZN.L: Quote, Profile, Research, Stock Buzz) MedImmune unit and Novartis NOVN.AX.
This is not enough to cover 300 million people but the U.S. Centers for Disease Control and Prevention says almost every year influenza vaccines go unused and millions of doses are thrown away.
Countries all expect a bonus with the news that many of the vaccines being made will protect people with a single dose. Most had ordered vaccine with the expectation that two doses would be needed, so the many now have more than anticipated.
"We will have enough vaccine for every American who wants it," White House spokesman Reid Cherlin said.
The CDC has designated about 160 million people as high-risk, including pregnant women, people with heart disease, asthma or diabetes, healthcare workers and school-aged children.
"We continue to stress that it is most important for those in high-risk populations to receive the vaccine because they are the groups most likely to have the most severe reaction to the disease," Cherlin said.
European countries agreed to share vaccine this week under a European Commission plan. (Reporting by Patricia Zengerle and Maggie Fox; Editing by Cynthia Osterman)
Thu Sep 17, 2009 6:45pm EDT
(Updates throughout with quotes, details)
WASHINGTON, Sept 17 (Reuters) - Nine rich countries agreed to share extra swine flu vaccine with less-developed countries on Thursday, just as companies prepared to deliver supplies.
The United States pledged 10 percent of its vaccine supply, joining Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland, and Britain.
The World Health Organization has been working to persuade countries to share their supplies of vaccine against the pandemic. "They own most of the vaccine out there," WHO's Dr. Keiji Fukuda told scientists at an Institute of Medicine pandemic influenza meeting this week.
"The single biggest (issue) we have to deal with is disparity."
Vaccine makers GlaxoSmithKline (GSK.L: Quote, Profile, Research, Stock Buzz) and Sanofi-Pasteur (SASY.PA: Quote, Profile, Research, Stock Buzz) previously pledged 120 million doses to WHO. Experts estimate that 80 percent of the world's nearly 7 billion people live in the developing world, with little hope of getting a vaccine.
WHO has been urging countries that pre-ordered vaccine from the 25 or so manufacturers to share some of it.
"Whatever is available to WHO will be made available first to least-developed countries, about 49 countries, with the intention of providing them to vaccinate their healthcare workers," Fukuda said.
The United States has ordered 195 million doses of H1N1 vaccine from five makers -- Glaxo, Sanofi, Australia's CSL (CSL.AX: Quote, Profile, Research, Stock Buzz), AstraZeneca's (AZN.L: Quote, Profile, Research, Stock Buzz) MedImmune unit and Novartis NOVN.AX.
This is not enough to cover 300 million people but the U.S. Centers for Disease Control and Prevention says almost every year influenza vaccines go unused and millions of doses are thrown away.
Countries all expect a bonus with the news that many of the vaccines being made will protect people with a single dose. Most had ordered vaccine with the expectation that two doses would be needed, so the many now have more than anticipated.
"We will have enough vaccine for every American who wants it," White House spokesman Reid Cherlin said.
The CDC has designated about 160 million people as high-risk, including pregnant women, people with heart disease, asthma or diabetes, healthcare workers and school-aged children.
"We continue to stress that it is most important for those in high-risk populations to receive the vaccine because they are the groups most likely to have the most severe reaction to the disease," Cherlin said.
European countries agreed to share vaccine this week under a European Commission plan. (Reporting by Patricia Zengerle and Maggie Fox; Editing by Cynthia Osterman)
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Sat Sep 19, 2009 10:57 pm
Swine Flu Shots Safe for People With Weak Immune Systems: Experts
FRIDAY, Sept. 18 (HealthDay News) -- The H1N1 swine flu vaccines approved this week by the U.S. Food and Drug Administration can be safely used by people with compromised immune systems, according to new recommendations from the American Academy of Allergy, Asthma & Immunology.
These would include people whose immune responses are weakened by medical treatments (such as for cancer or organ transplant) and those infected with HIV, the experts said.
Influenza vaccines can be made from live -- but modified and weakened -- virus, or they can be made from the harmless byproducts of the virus (so-called "killed" virus vaccines). According to the experts at the American Academy of Allergy, Asthma & Immunology (AAAAI), all of the injected H1N1 vaccines so far approved by the FDA are of the "killed" variety.
"There's never any harm with giving killed influenza vaccine" to immuno-compromised individuals, said Dr. Kenneth Bromberg, director of the Vaccine Research Center at The Brooklyn Hospital Center in New York City.
There is one vaccine out there that those with weakened immune systems should avoid: the nasal spray form of the flu vaccine, FluMist. FluMist is already available as a seasonal flu vaccine, and 3.4 million doses of an H1N1 version of FluMist are expected to be distributed nationally the first week of October, CDC officials announced Friday.
FluMist is derived from live (but very weakened) virus, so it could pose a problem for people with poor immune systems. The recommendation to avoid FluMist extends to people living in close proximity to an immune-compromised person, such as family members, because they could pass on the live virus to that individual, the AAAAI said.
No such threat exists for average Americans with robust immune responses, the experts said.
One question for some people with compromised immune systems is whether the flu shot will actually help them, given their poor immune defenses.
People with so-called "primary" immune deficiency -- rare immune deficiencies inherited at birth -- can take the H1N1 vaccine, the academy said. "Although the antibody response may be poor or low [in these individuals], the cell-mediated response may be a helpful immune response to [fight] the virus," AAAAI President-elect Dr. Mark Ballow said in a news release issued Thursday.
But, depending on their level of immune cell function, certain HIV-infected individuals may not be able to mount enough of an immune response to make flu vaccination worthwhile, the experts said.
"The issue is whether the compromised immune response might result in insufficient protection, not whether the inactivated H1N1 or seasonal influenza vaccine is excessively harmful," said Dr. Paul Greenberger, president of AAAAI.
"The CDC (U.S. Centers for Disease Control and Prevention) notes that most HIV patients can receive the immunization, and from earlier studies with seasonal flu shots, [it appears] there may be a reduced response if the number of CD4+ lymphocytes is less than 100/mm3," Greenberger said. "Better responses occurred if patients had CD4+ lymphocyte counts of at least 400."
He added that "studies haven't been published yet of H1N1 vaccination in HIV patients."
In other swine flu news, a study published in the September issue of the journal Risk Analysis seeks to quantify the risk from various routes of transmission of the swine flu virus. Researchers from the University of California, Berkeley, and the University of Illinois used sophisticated modeling and pored over the available data on four key means of person-to-person H1N1 transmission.
They speculate that hand contact with a contaminated surface brings a 31 percent risk of actual infection; inhaling tiny particles laden with virus in a room brings a 17 percent likelihood of infection; close contact where coughs spray viral-laden droplets onto the eyes, nostrils or lips brings a 52 percent chance of infection. Inhaling relatively large particles carrying virus when three feet or nearer to an infected person carries only a 0.52 percent risk for infection, the research team said.
According to the researchers, the study strengthens current recommendations to cover the mouth when coughing and to disinfect commonly touched surfaces.
More information
There's more on H1N1 flu at the U.S. Centers for Disease Control and Prevention.
FRIDAY, Sept. 18 (HealthDay News) -- The H1N1 swine flu vaccines approved this week by the U.S. Food and Drug Administration can be safely used by people with compromised immune systems, according to new recommendations from the American Academy of Allergy, Asthma & Immunology.
These would include people whose immune responses are weakened by medical treatments (such as for cancer or organ transplant) and those infected with HIV, the experts said.
Influenza vaccines can be made from live -- but modified and weakened -- virus, or they can be made from the harmless byproducts of the virus (so-called "killed" virus vaccines). According to the experts at the American Academy of Allergy, Asthma & Immunology (AAAAI), all of the injected H1N1 vaccines so far approved by the FDA are of the "killed" variety.
"There's never any harm with giving killed influenza vaccine" to immuno-compromised individuals, said Dr. Kenneth Bromberg, director of the Vaccine Research Center at The Brooklyn Hospital Center in New York City.
There is one vaccine out there that those with weakened immune systems should avoid: the nasal spray form of the flu vaccine, FluMist. FluMist is already available as a seasonal flu vaccine, and 3.4 million doses of an H1N1 version of FluMist are expected to be distributed nationally the first week of October, CDC officials announced Friday.
FluMist is derived from live (but very weakened) virus, so it could pose a problem for people with poor immune systems. The recommendation to avoid FluMist extends to people living in close proximity to an immune-compromised person, such as family members, because they could pass on the live virus to that individual, the AAAAI said.
No such threat exists for average Americans with robust immune responses, the experts said.
One question for some people with compromised immune systems is whether the flu shot will actually help them, given their poor immune defenses.
People with so-called "primary" immune deficiency -- rare immune deficiencies inherited at birth -- can take the H1N1 vaccine, the academy said. "Although the antibody response may be poor or low [in these individuals], the cell-mediated response may be a helpful immune response to [fight] the virus," AAAAI President-elect Dr. Mark Ballow said in a news release issued Thursday.
But, depending on their level of immune cell function, certain HIV-infected individuals may not be able to mount enough of an immune response to make flu vaccination worthwhile, the experts said.
"The issue is whether the compromised immune response might result in insufficient protection, not whether the inactivated H1N1 or seasonal influenza vaccine is excessively harmful," said Dr. Paul Greenberger, president of AAAAI.
"The CDC (U.S. Centers for Disease Control and Prevention) notes that most HIV patients can receive the immunization, and from earlier studies with seasonal flu shots, [it appears] there may be a reduced response if the number of CD4+ lymphocytes is less than 100/mm3," Greenberger said. "Better responses occurred if patients had CD4+ lymphocyte counts of at least 400."
He added that "studies haven't been published yet of H1N1 vaccination in HIV patients."
In other swine flu news, a study published in the September issue of the journal Risk Analysis seeks to quantify the risk from various routes of transmission of the swine flu virus. Researchers from the University of California, Berkeley, and the University of Illinois used sophisticated modeling and pored over the available data on four key means of person-to-person H1N1 transmission.
They speculate that hand contact with a contaminated surface brings a 31 percent risk of actual infection; inhaling tiny particles laden with virus in a room brings a 17 percent likelihood of infection; close contact where coughs spray viral-laden droplets onto the eyes, nostrils or lips brings a 52 percent chance of infection. Inhaling relatively large particles carrying virus when three feet or nearer to an infected person carries only a 0.52 percent risk for infection, the research team said.
According to the researchers, the study strengthens current recommendations to cover the mouth when coughing and to disinfect commonly touched surfaces.
More information
There's more on H1N1 flu at the U.S. Centers for Disease Control and Prevention.
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Sat Sep 19, 2009 11:13 pm
Distribution Of Swine Flu Vaccine Will Begin in Oct.
By David Brown
Washington Post Staff Writer
Saturday, September 19, 2009
Vaccine for the H1N1 influenza pandemic will be distributed on a three-day turnaround time from four regional warehouses around the country next month. The vaccine deliveries, expected to equal 20 million doses a week by the end of October, will be distributed among 90,000 immunization "providers," including health departments, hospitals, clinics, doctors' offices and pharmacies.
Those were among the details unveiled Friday by the Centers for Disease Control and Prevention as part of the federal government's increasingly complex response to the pandemic of H1N1 influenza, also known as swine flu.
"This is a huge logistical process. There's not [going to be] a sudden appearance of vaccine in 90,000 refrigerators around the country," said Jay Butler, an epidemiologist who leads the CDC's task force on the vaccine.
About 3.4 million doses of nasal-spray flu vaccine -- which can be used only by people age 2 to 49 -- are expected to be available the first week of October. The form of the vaccine that can be injected, which will form the vast bulk of the 195 million doses the government has ordered, won't be available until later in October when many experts think the flu outbreak will be in full swing.
All of the H1N1 vaccine will be bought by the federal government. It will be divided among states and territories on the basis of population. Providers, including private companies such as pharmacies, will get it for free. They won't be permitted to charge people or health insurers for it, but they can charge an "administration fee" for giving the shots or sprays. In some settings, such as public health clinics, people will get the shots free.
As the vaccine arrives at the four distribution centers -- their location for the moment is secret -- the CDC will tell each state what its allocation will be. States will put in orders based on the need in their jurisdictions and the number of doses that hospitals, clinics and other providers say they can use in the immediate future.
Vaccine will then be sent directly to providers; the CDC expects to have 90,000 names and addresses on file. Orders will be filled in three business days and the vaccine shipped overnight, Butler told reporters in a teleconference Friday.
Government planners expect demand for vaccine will outstrip supply in the first weeks after it becomes available. During that time, states will have to decide which hospitals, clinics and offices are most apt to reach the priority populations and thus should get vaccine first.
The CDC won't police those decisions and expects that very quickly there will be enough vaccine to fill essentially all orders from states.
By David Brown
Washington Post Staff Writer
Saturday, September 19, 2009
Vaccine for the H1N1 influenza pandemic will be distributed on a three-day turnaround time from four regional warehouses around the country next month. The vaccine deliveries, expected to equal 20 million doses a week by the end of October, will be distributed among 90,000 immunization "providers," including health departments, hospitals, clinics, doctors' offices and pharmacies.
Those were among the details unveiled Friday by the Centers for Disease Control and Prevention as part of the federal government's increasingly complex response to the pandemic of H1N1 influenza, also known as swine flu.
"This is a huge logistical process. There's not [going to be] a sudden appearance of vaccine in 90,000 refrigerators around the country," said Jay Butler, an epidemiologist who leads the CDC's task force on the vaccine.
About 3.4 million doses of nasal-spray flu vaccine -- which can be used only by people age 2 to 49 -- are expected to be available the first week of October. The form of the vaccine that can be injected, which will form the vast bulk of the 195 million doses the government has ordered, won't be available until later in October when many experts think the flu outbreak will be in full swing.
All of the H1N1 vaccine will be bought by the federal government. It will be divided among states and territories on the basis of population. Providers, including private companies such as pharmacies, will get it for free. They won't be permitted to charge people or health insurers for it, but they can charge an "administration fee" for giving the shots or sprays. In some settings, such as public health clinics, people will get the shots free.
As the vaccine arrives at the four distribution centers -- their location for the moment is secret -- the CDC will tell each state what its allocation will be. States will put in orders based on the need in their jurisdictions and the number of doses that hospitals, clinics and other providers say they can use in the immediate future.
Vaccine will then be sent directly to providers; the CDC expects to have 90,000 names and addresses on file. Orders will be filled in three business days and the vaccine shipped overnight, Butler told reporters in a teleconference Friday.
Government planners expect demand for vaccine will outstrip supply in the first weeks after it becomes available. During that time, states will have to decide which hospitals, clinics and offices are most apt to reach the priority populations and thus should get vaccine first.
The CDC won't police those decisions and expects that very quickly there will be enough vaccine to fill essentially all orders from states.
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Sat Sep 19, 2009 11:18 pm
Global production of A/H1N1 vaccines far less than forecast, says WHO
www.chinaview.cn 2009-09-19 07:24:54 Print
GENEVA, Sept. 18 (Xinhua) -- The global production of vaccines for the A/H1N1 flu will be far less than the previous forecast maximum of 4.9 billion doses a year, the World Health Organization(WHO) said on Friday.
WHO spokesman Gregory Hartl told a news briefing in Geneva the previous forecast had been based on all drug makers producing the new vaccine with full capacity, but drug makers were still producing vaccines for seasonal flu.
The WHO has said that it's impossible for the world's 6.3 billion people to all be vaccinated against the A/H1N1 flu because of the limited production capacity for vaccines.
It also recommends other preventive and treatment measures, including anti-viral and other drugs, social distancing and personal hygiene.
www.chinaview.cn 2009-09-19 07:24:54 Print
GENEVA, Sept. 18 (Xinhua) -- The global production of vaccines for the A/H1N1 flu will be far less than the previous forecast maximum of 4.9 billion doses a year, the World Health Organization(WHO) said on Friday.
WHO spokesman Gregory Hartl told a news briefing in Geneva the previous forecast had been based on all drug makers producing the new vaccine with full capacity, but drug makers were still producing vaccines for seasonal flu.
The WHO has said that it's impossible for the world's 6.3 billion people to all be vaccinated against the A/H1N1 flu because of the limited production capacity for vaccines.
It also recommends other preventive and treatment measures, including anti-viral and other drugs, social distancing and personal hygiene.
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Mon Sep 21, 2009 7:42 pm
With seasonal flu shots plentiful and H1N1 vaccines expected soon, early vaccination is urged
Health officials want physicians to begin preparing by getting vaccinated.
By Susan J. Landers, AMNews staff. Posted Sept. 21, 2009.
Washington -- Federal health officials say there is plenty of vaccine for seasonal influenza this year, and are urging physicians and patients to use it.
Authorities expect a vaccine for influenza A(H1N1) to be ready by mid-October. On Sept. 15, the Food and Drug Administration approved applications from four manufacturers to make the vaccine.
Health officials say this is one of the most complicated influenza seasons in memory -- involving two flu viruses, one of which has sparked a pandemic. But their message is still simple -- get vaccinated.
"Flu is already the most unpredictable of all the infectious diseases. We know that this year we are in uncharted territory," said Centers for Disease Control and Prevention Director Thomas Frieden, MD, MPH.
Even as H1N1 grabs the headlines, it's important that physicians and the public not overlook the seasonal flu, health officials stressed. Each year 5% to 20% of the population contracts seasonal flu, about 200,000 are hospitalized with flu-related complications, and 36,000 die.
Only 1 dose of the H1N1 vaccine is required for healthy adults. About 115 million doses of seasonal flu vaccine are available, with about 40 million doses already shipped to physicians' offices and clinics.
"This is a serious disease," Health and Human Services Secretary Kathleen Sebelius said at a Sept. 10 news briefing. "Getting vaccinated for seasonal flu right now is good advice."
Sebelius said vaccination rates for health care professionals remain too low -- only about 40% are immunized for the flu each year. "We would like health care workers to go to the front of the line."
AMA Immediate Past President Nancy H. Nielsen, MD, PhD, is urging every physician to get a shot. "It's important for all physicians to be involved in helping patients make sure they are protected. And if we ourselves do not get vaccinated, we are not taking care of patients."
Last spring's arrival of the H1N1 virus caught everyone by surprise. Had that strain emerged earlier, it would have been addressed as a component of this year's seasonal flu shot, Sebelius said.
The H1N1 virus never disappeared during the summer -- as the seasonal flu virus typically does -- and is spreading. "We are seeing as much flu in early September as we would normally see at the height of flu season," Dr. Frieden said.
115 million doses of seasonal flu vaccine will be available in 2009. But health officials said they are optimistic about the nation's response to H1N1. The approval of four manufacturers to make H1N1 flu vaccine means state health departments should begin receiving shipments by Oct. 15 for distribution to doctors.
Promising results from clinical trials indicate that one dose of the new vaccine, rather than two, provides protection for most healthy adults. The trials also showed that the vaccine provoked a robust immune response just eight to 10 days after immunization, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, which is running some of the trials.
In addition, there were no safety concerns, Dr. Fauci said. The only side effects were normal swelling and redness at the injection site and a runny nose or nasal congestion from the nasal spray version of the vaccine.
Officials had predicted that full immunity might not occur until about a month after inoculation and then only after two injections. Sebelius said the trial findings have improved this scenario. "It shortens the window of worry, and more people can be protected much earlier."
The new data suggesting one dose of H1N1 vaccine will be effective mean the expected supply of about 195 million doses will go much further than originally thought. Immunization efforts being planned by state health departments also will be simplified if there is no need for everyone to get a second shot.
But young children, a priority group to receive vaccine, still may need two shots to provide immunity. Trials including children and pregnant women began later than trials in healthy adults. Results are not yet available.
Up to 20% of the population contract flu each season. Although vaccination is the first line of defense against both influenzas, the antivirals oseltamivir (Tamiflu) and zanamivir (Relenza) may be helpful in treating flu patients who are hospitalized, according to guidance released Sept. 8 by the CDC. The antivirals can reduce severity of symptoms when started within 48 hours of the onset of illness.
But the supply is not infinite. Federal officials are asking physicians to reserve the antivirals for the sickest patients and those at the highest risk for severe illness from either seasonal flu or H1N1. Most people who contract influenza-like illnesses this season will recover with rest and fluids and won't need an antiviral, said Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases.
Judicious use of antivirals also could help reduce the chances that the H1N1 virus will develop broad resistance to the drugs, the CDC said. Some cases of antiviral resistance to H1N1 already have been reported.
If patients are sick enough to need antivirals, physicians should not wait to confirm the viral strain, Dr. Schuchat said.
"Beginning treatment within the first 48 hours of symptoms can really help with the outcome."
The print version of this content appeared in the Sept. 28, 2009 issue of American Medical News.
Back to top
--------------------------------------------------------------------------------
ADDITIONAL INFORMATION:
Who should get which shot when
Although nearly everyone who wants a seasonal flu shot will likely be able to get one, certain groups are at a higher risk for serious complications. For HIN1, findings that one shot of the new vaccine will provide protection may allow more people to be vaccinated. However, the Centers for Disease Control and Prevention has established priority groups.
Seasonal influenza priority groups
Children and teens, age 6 months to 19 years
Pregnant women
Adults age 50 and older
Anyone with a chronic medical condition, such as diabetes, heart disease or asthma
Residents of nursing homes and other long-term-care facilities
People who live with or care for those at high risk for flu complications.
____________________________________________________________
Influenza A(H1N1) priority groups include
Pregnant women
People who live with or care for infants younger than 6 months
Health care professionals and emergency personnel
Children and young adults, age 6 months to 24 years
Adults age 25 to 64 who are at high risk for complications from the flu because of chronic health disorders or compromised immune systems
Source: Centers for Disease Control and Prevention
Health officials want physicians to begin preparing by getting vaccinated.
By Susan J. Landers, AMNews staff. Posted Sept. 21, 2009.
Washington -- Federal health officials say there is plenty of vaccine for seasonal influenza this year, and are urging physicians and patients to use it.
Authorities expect a vaccine for influenza A(H1N1) to be ready by mid-October. On Sept. 15, the Food and Drug Administration approved applications from four manufacturers to make the vaccine.
Health officials say this is one of the most complicated influenza seasons in memory -- involving two flu viruses, one of which has sparked a pandemic. But their message is still simple -- get vaccinated.
"Flu is already the most unpredictable of all the infectious diseases. We know that this year we are in uncharted territory," said Centers for Disease Control and Prevention Director Thomas Frieden, MD, MPH.
Even as H1N1 grabs the headlines, it's important that physicians and the public not overlook the seasonal flu, health officials stressed. Each year 5% to 20% of the population contracts seasonal flu, about 200,000 are hospitalized with flu-related complications, and 36,000 die.
Only 1 dose of the H1N1 vaccine is required for healthy adults. About 115 million doses of seasonal flu vaccine are available, with about 40 million doses already shipped to physicians' offices and clinics.
"This is a serious disease," Health and Human Services Secretary Kathleen Sebelius said at a Sept. 10 news briefing. "Getting vaccinated for seasonal flu right now is good advice."
Sebelius said vaccination rates for health care professionals remain too low -- only about 40% are immunized for the flu each year. "We would like health care workers to go to the front of the line."
AMA Immediate Past President Nancy H. Nielsen, MD, PhD, is urging every physician to get a shot. "It's important for all physicians to be involved in helping patients make sure they are protected. And if we ourselves do not get vaccinated, we are not taking care of patients."
Last spring's arrival of the H1N1 virus caught everyone by surprise. Had that strain emerged earlier, it would have been addressed as a component of this year's seasonal flu shot, Sebelius said.
The H1N1 virus never disappeared during the summer -- as the seasonal flu virus typically does -- and is spreading. "We are seeing as much flu in early September as we would normally see at the height of flu season," Dr. Frieden said.
115 million doses of seasonal flu vaccine will be available in 2009. But health officials said they are optimistic about the nation's response to H1N1. The approval of four manufacturers to make H1N1 flu vaccine means state health departments should begin receiving shipments by Oct. 15 for distribution to doctors.
Promising results from clinical trials indicate that one dose of the new vaccine, rather than two, provides protection for most healthy adults. The trials also showed that the vaccine provoked a robust immune response just eight to 10 days after immunization, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, which is running some of the trials.
In addition, there were no safety concerns, Dr. Fauci said. The only side effects were normal swelling and redness at the injection site and a runny nose or nasal congestion from the nasal spray version of the vaccine.
Officials had predicted that full immunity might not occur until about a month after inoculation and then only after two injections. Sebelius said the trial findings have improved this scenario. "It shortens the window of worry, and more people can be protected much earlier."
The new data suggesting one dose of H1N1 vaccine will be effective mean the expected supply of about 195 million doses will go much further than originally thought. Immunization efforts being planned by state health departments also will be simplified if there is no need for everyone to get a second shot.
But young children, a priority group to receive vaccine, still may need two shots to provide immunity. Trials including children and pregnant women began later than trials in healthy adults. Results are not yet available.
Up to 20% of the population contract flu each season. Although vaccination is the first line of defense against both influenzas, the antivirals oseltamivir (Tamiflu) and zanamivir (Relenza) may be helpful in treating flu patients who are hospitalized, according to guidance released Sept. 8 by the CDC. The antivirals can reduce severity of symptoms when started within 48 hours of the onset of illness.
But the supply is not infinite. Federal officials are asking physicians to reserve the antivirals for the sickest patients and those at the highest risk for severe illness from either seasonal flu or H1N1. Most people who contract influenza-like illnesses this season will recover with rest and fluids and won't need an antiviral, said Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases.
Judicious use of antivirals also could help reduce the chances that the H1N1 virus will develop broad resistance to the drugs, the CDC said. Some cases of antiviral resistance to H1N1 already have been reported.
If patients are sick enough to need antivirals, physicians should not wait to confirm the viral strain, Dr. Schuchat said.
"Beginning treatment within the first 48 hours of symptoms can really help with the outcome."
The print version of this content appeared in the Sept. 28, 2009 issue of American Medical News.
Back to top
--------------------------------------------------------------------------------
ADDITIONAL INFORMATION:
Who should get which shot when
Although nearly everyone who wants a seasonal flu shot will likely be able to get one, certain groups are at a higher risk for serious complications. For HIN1, findings that one shot of the new vaccine will provide protection may allow more people to be vaccinated. However, the Centers for Disease Control and Prevention has established priority groups.
Seasonal influenza priority groups
Children and teens, age 6 months to 19 years
Pregnant women
Adults age 50 and older
Anyone with a chronic medical condition, such as diabetes, heart disease or asthma
Residents of nursing homes and other long-term-care facilities
People who live with or care for those at high risk for flu complications.
____________________________________________________________
Influenza A(H1N1) priority groups include
Pregnant women
People who live with or care for infants younger than 6 months
Health care professionals and emergency personnel
Children and young adults, age 6 months to 24 years
Adults age 25 to 64 who are at high risk for complications from the flu because of chronic health disorders or compromised immune systems
Source: Centers for Disease Control and Prevention
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Mon Sep 21, 2009 7:56 pm
latimes.com
Sanofi-Aventis CEO says US deliveries of swine flu vaccine to begin in October
By Associated Press
10:35 AM PDT, September 21, 2009
PARIS (AP) — Sanofi-Aventis SA will begin delivering the first doses of its new swine flu vaccine in the United States by mid-October, the head of France's largest pharmaceutical company said Monday.
In an interview with French daily Le Figaro, Chris Viehbacher said Sanofi-Aventis will be able to produce at least 800 million doses of the vaccine per year.
Separately, the company's vaccines division announced in a statement Monday that it had received a new order from the U.S. Department of Health and Human Services to produce the equivalent of 27.3 million doses, bringing the total U.S. order to 75.3 million doses.
As for deliveries in France, Viehbacher told Le Figaro that they could begin by late November, after approval by European drug regulators.
Last week the U.S. Food and Drug Administration approved the new swine flu vaccine, a long-anticipated step as the U.S. government works to start mass vaccinations next month.
The vaccine is being made by CSL Ltd. of Australia, Switzerland's Novartis Vaccines, Maryland-based MedImmune LLC and Sanofi Pasteur of France — which produces flu shots at its Swiftwater, Pennsylvania, factory.
London-based GlaxoSmithKline also was expected to supply vaccine.
Typically fewer than 100 million Americans seek flu vaccine every year, and it's unclear whether swine flu — what scientists prefer to call the 2009 H1N1 strain — will prompt much more demand.
Sanofi-Aventis CEO says US deliveries of swine flu vaccine to begin in October
By Associated Press
10:35 AM PDT, September 21, 2009
PARIS (AP) — Sanofi-Aventis SA will begin delivering the first doses of its new swine flu vaccine in the United States by mid-October, the head of France's largest pharmaceutical company said Monday.
In an interview with French daily Le Figaro, Chris Viehbacher said Sanofi-Aventis will be able to produce at least 800 million doses of the vaccine per year.
Separately, the company's vaccines division announced in a statement Monday that it had received a new order from the U.S. Department of Health and Human Services to produce the equivalent of 27.3 million doses, bringing the total U.S. order to 75.3 million doses.
As for deliveries in France, Viehbacher told Le Figaro that they could begin by late November, after approval by European drug regulators.
Last week the U.S. Food and Drug Administration approved the new swine flu vaccine, a long-anticipated step as the U.S. government works to start mass vaccinations next month.
The vaccine is being made by CSL Ltd. of Australia, Switzerland's Novartis Vaccines, Maryland-based MedImmune LLC and Sanofi Pasteur of France — which produces flu shots at its Swiftwater, Pennsylvania, factory.
London-based GlaxoSmithKline also was expected to supply vaccine.
Typically fewer than 100 million Americans seek flu vaccine every year, and it's unclear whether swine flu — what scientists prefer to call the 2009 H1N1 strain — will prompt much more demand.
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Mon Sep 21, 2009 8:15 pm
Sanofi Pasteur Receives Additional Order from U.S. Government to Produce Influenza...
Mon Sep 21, 2009 12:13pm EDT
Sanofi Pasteur Receives Additional Order from U.S. Government to Produce Influenza A (H1N1) Vaccine
- Company has now committed to produce 75.3 million doses of vaccine for the
U.S. government -
LYON, France and SWIFTWATER, Pa., Sept. 21 /PRNewswire-FirstCall/ -- Sanofi
Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and
NYSE: SNY), announced today that the company has received an additional order
from the U.S. Department of Health and Human Services (HHS) to produce vaccine
to help protect against the Influenza A (H1N1) 2009 virus. The new order is
for the production of bulk antigen equivalent to 27.3 million doses based on
15 mcg of antigen per dose. Specifications for formulation and filling of this
new bulk order will be the subject of a separate order. To date, Sanofi
Pasteur has committed to the U.S. government a total of 75.3 million doses of
Influenza A (H1N1) 2009 Monovalent Vaccine.
"We are pleased to be able to support the U.S. government's pandemic response
efforts through the production of additional doses of A (H1N1) vaccine," said
Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "As the
only company manufacturing inactivated influenza vaccine in the U.S., we
recognize the important role Sanofi Pasteur serves in the country's pandemic
response plan and we have committed our resources to responding to our public
health needs."
Sanofi Pasteur began commercial production of the new influenza vaccine in
June using the novel virus strain to provide doses for clinical trials and to
respond to the initial order from HHS. Influenza A (H1N1) 2009 Monovalent
Vaccine was licensed by the U.S. Food and Drug Administration on September 15.
Sanofi Pasteur is testing the immunogenicity and safety of the Influenza A
(H1N1) 2009 Monovalent Vaccine produced in the U.S. through clinical trials,
which began in the U.S. on August 6. Final data from these clinical trials
will provide additional information to guide recommendations on the optimal
dosage, number of doses and schedule.
Sanofi Pasteur operates influenza vaccine production facilities in the U.S.
and in France. Production of the new A (H1N1) vaccine for HHS is being
performed at the company's U.S.-based production facility.
About Influenza A (H1N1) 2009 Monovalent Vaccine
The U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated
influenza virus vaccine indicated for active immunization of persons six
months of age and older against influenza disease caused by pandemic (H1N1)
2009 virus.
The Influenza A (H1N1) 2009 Monovalent Vaccine is manufactured by the same
process as Sanofi Pasteur's seasonal trivalent influenza virus vaccine
licensed in the U.S. Influenza A (H1N1) 2009 Monovalent Vaccine is formulated
to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1)
v-like virus. Influenza A (H1N1) 2009 Monovalent Vaccine is licensed for
single-dose presentations in syringes and vials and in multi-dose vials. There
is no preservative used in the singledose presentations. Multi-dose vials
contain a preservative.
Safety Information for Influenza A (H1N1) 2009 Monovalent Vaccine
Influenza vaccine should not be administered to anyone with a known severe
hypersensitivity to egg
proteins, any vaccine component or life-threatening reactions after previous
administration of any
influenza vaccine. Recurrence of Guillain-Barre syndrome (GBS) has been
temporally associated with the administration of influenza vaccine. The
decision to give Influenza A (H1N1) 2009 Monovalent Vaccine to individuals who
have a prior history of GBS should be based on careful consideration of the
potential benefits and risks. Vaccination with Influenza A (H1N1) 2009
Monovalent Vaccine may not protect all individuals.
Before administering Influenza A (H1N1) 2009 Monovalent Vaccine, please see
full U.S. Prescribing Information at www.vaccineplace.com/products.
About Influenza Vaccine Production at Sanofi Pasteur
Sanofi Pasteur operates influenza vaccine production facilities in Val de
Reuil, France and in Swiftwater, Pa. (U.S.). All Sanofi Pasteur influenza
vaccine facilities have been designed and built to be able to switch from
seasonal influenza vaccine production to pandemic influenza vaccine
production.
Sanofi Pasteur produces approximately 40 percent of the influenza vaccines
distributed worldwide and more than 45 percent of the influenza vaccines
distributed in the U.S. for the 2008-2009 influenza season. More information
about Sanofi Pasteur's pandemic preparedness efforts can be found at
www.pandemic.influenza.com.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops
and distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more
than 1.6 billion doses of vaccine in 2008, making it possible to immunize more
than 500 million people across the globe. A world leader in the vaccine
industry, Sanofi Pasteur offers the broadest range of vaccines protecting
against 20 infectious diseases. The company's heritage, to create vaccines
that protect life, dates back more than a century. Sanofi Pasteur is the
largest company entirely dedicated to vaccines. Every day, the company invests
more than EUR 1 million in research and development. For more information,
please visit: www.sanofipasteur.com or www.sanofipasteur.us.
Forward Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements
include financial projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations with
respect to future events, operations, products and services, and statements
regarding future performance. Forward-looking statements are generally
identified by the words "expects," "anticipates," "believes," "intends,"
"estimates," "plans" and similar expressions. Although sanofi-aventis'
management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties,
many of which are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include those discussed or identified in the public filings with the SEC and
the AMF made by sanofi-aventis, including those listed under "Risk Factors"
and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended December 31,
2008. Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking information
or statements.
Contacts
Global Media Relations US Media Relations
Pascal Barollier Donna Cary
T. +33-(0)4-37-37-50-38 T. +1-570-957-0717
pascal.barollier@sanofipasteur.com donna.cary@sanofipasteur.com
www.sanofipasteur.com www.sanofipasteur.us
SOURCE Sanofi Pasteur
Global Media Relations, Pascal Barollier, +33-0-4-37-37-50-38,
pascal.barollier@sanofipasteur.com, or US Media Relations, Donna Cary,
+1-570-957-0717, donna.cary@sanofipasteur.com
Mon Sep 21, 2009 12:13pm EDT
Sanofi Pasteur Receives Additional Order from U.S. Government to Produce Influenza A (H1N1) Vaccine
- Company has now committed to produce 75.3 million doses of vaccine for the
U.S. government -
LYON, France and SWIFTWATER, Pa., Sept. 21 /PRNewswire-FirstCall/ -- Sanofi
Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and
NYSE: SNY), announced today that the company has received an additional order
from the U.S. Department of Health and Human Services (HHS) to produce vaccine
to help protect against the Influenza A (H1N1) 2009 virus. The new order is
for the production of bulk antigen equivalent to 27.3 million doses based on
15 mcg of antigen per dose. Specifications for formulation and filling of this
new bulk order will be the subject of a separate order. To date, Sanofi
Pasteur has committed to the U.S. government a total of 75.3 million doses of
Influenza A (H1N1) 2009 Monovalent Vaccine.
"We are pleased to be able to support the U.S. government's pandemic response
efforts through the production of additional doses of A (H1N1) vaccine," said
Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "As the
only company manufacturing inactivated influenza vaccine in the U.S., we
recognize the important role Sanofi Pasteur serves in the country's pandemic
response plan and we have committed our resources to responding to our public
health needs."
Sanofi Pasteur began commercial production of the new influenza vaccine in
June using the novel virus strain to provide doses for clinical trials and to
respond to the initial order from HHS. Influenza A (H1N1) 2009 Monovalent
Vaccine was licensed by the U.S. Food and Drug Administration on September 15.
Sanofi Pasteur is testing the immunogenicity and safety of the Influenza A
(H1N1) 2009 Monovalent Vaccine produced in the U.S. through clinical trials,
which began in the U.S. on August 6. Final data from these clinical trials
will provide additional information to guide recommendations on the optimal
dosage, number of doses and schedule.
Sanofi Pasteur operates influenza vaccine production facilities in the U.S.
and in France. Production of the new A (H1N1) vaccine for HHS is being
performed at the company's U.S.-based production facility.
About Influenza A (H1N1) 2009 Monovalent Vaccine
The U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated
influenza virus vaccine indicated for active immunization of persons six
months of age and older against influenza disease caused by pandemic (H1N1)
2009 virus.
The Influenza A (H1N1) 2009 Monovalent Vaccine is manufactured by the same
process as Sanofi Pasteur's seasonal trivalent influenza virus vaccine
licensed in the U.S. Influenza A (H1N1) 2009 Monovalent Vaccine is formulated
to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1)
v-like virus. Influenza A (H1N1) 2009 Monovalent Vaccine is licensed for
single-dose presentations in syringes and vials and in multi-dose vials. There
is no preservative used in the singledose presentations. Multi-dose vials
contain a preservative.
Safety Information for Influenza A (H1N1) 2009 Monovalent Vaccine
Influenza vaccine should not be administered to anyone with a known severe
hypersensitivity to egg
proteins, any vaccine component or life-threatening reactions after previous
administration of any
influenza vaccine. Recurrence of Guillain-Barre syndrome (GBS) has been
temporally associated with the administration of influenza vaccine. The
decision to give Influenza A (H1N1) 2009 Monovalent Vaccine to individuals who
have a prior history of GBS should be based on careful consideration of the
potential benefits and risks. Vaccination with Influenza A (H1N1) 2009
Monovalent Vaccine may not protect all individuals.
Before administering Influenza A (H1N1) 2009 Monovalent Vaccine, please see
full U.S. Prescribing Information at www.vaccineplace.com/products.
About Influenza Vaccine Production at Sanofi Pasteur
Sanofi Pasteur operates influenza vaccine production facilities in Val de
Reuil, France and in Swiftwater, Pa. (U.S.). All Sanofi Pasteur influenza
vaccine facilities have been designed and built to be able to switch from
seasonal influenza vaccine production to pandemic influenza vaccine
production.
Sanofi Pasteur produces approximately 40 percent of the influenza vaccines
distributed worldwide and more than 45 percent of the influenza vaccines
distributed in the U.S. for the 2008-2009 influenza season. More information
about Sanofi Pasteur's pandemic preparedness efforts can be found at
www.pandemic.influenza.com.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops
and distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more
than 1.6 billion doses of vaccine in 2008, making it possible to immunize more
than 500 million people across the globe. A world leader in the vaccine
industry, Sanofi Pasteur offers the broadest range of vaccines protecting
against 20 infectious diseases. The company's heritage, to create vaccines
that protect life, dates back more than a century. Sanofi Pasteur is the
largest company entirely dedicated to vaccines. Every day, the company invests
more than EUR 1 million in research and development. For more information,
please visit: www.sanofipasteur.com or www.sanofipasteur.us.
Forward Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements
include financial projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations with
respect to future events, operations, products and services, and statements
regarding future performance. Forward-looking statements are generally
identified by the words "expects," "anticipates," "believes," "intends,"
"estimates," "plans" and similar expressions. Although sanofi-aventis'
management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties,
many of which are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include those discussed or identified in the public filings with the SEC and
the AMF made by sanofi-aventis, including those listed under "Risk Factors"
and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended December 31,
2008. Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking information
or statements.
Contacts
Global Media Relations US Media Relations
Pascal Barollier Donna Cary
T. +33-(0)4-37-37-50-38 T. +1-570-957-0717
pascal.barollier@sanofipasteur.com donna.cary@sanofipasteur.com
www.sanofipasteur.com www.sanofipasteur.us
SOURCE Sanofi Pasteur
Global Media Relations, Pascal Barollier, +33-0-4-37-37-50-38,
pascal.barollier@sanofipasteur.com, or US Media Relations, Donna Cary,
+1-570-957-0717, donna.cary@sanofipasteur.com
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Wed Sep 23, 2009 11:51 pm
Booster Shots
Oddities, musings and news from
the world of health
« Previous Post | Booster Shots Home | Next Post »
Injectable vaccine better than intranasal for seasonal flu in adultsSeptember 23, 2009 | 2:01 pm
Injectable vaccines containing inactivated viruses prevent about 50% more seasonal flu in healthy adults than the intranasal vaccine containing a weakened virus, according to a new report today in the New England Journal of Medicine.*
"We have two effective vaccines," said Dr. Arnold S. Monto of the University of Michigan, who led the study. "In children, I would prefer FluMist [intranasal vaccine] and in adults, injected, based on the data we have. However, an adult who does not want a shot should take FluMist." But he noted that it is not yet clear whether the same findings will hold for the pandemic H1N1 influenza virus, commonly known as swine flu.
FluMist will be the first vaccine available for swine flu, with at least 3.4 million doses arriving around the beginning of October. Overall, FluMist, manufactured by MedImmune Corp.of Gaithersburg, Md., will account for about 42 million of the roughly 270 million doses of swine flu vaccine ordered by the federal government.
Multiple studies have shown that the intranasal vaccine works better against seasonal flu in children. Three large head-to-head studies showed that those who received FluMist had 35% to 53% fewer cases of flu than those who received injectable vaccines. But the results in adults have been much more inconsistent, with some studies showing FluMist to be better and others showing injectables to be superior.
Researchers at the University of Michigan, where the inactivated-virus vaccine was originally developed by epidemiologist Hunein "John" Massaab, have been studying its efficacy for several years. Earlier results have suggested that the injectable vaccine was better, but the results have not been conclusive -- in part because the seasonal flu outbreaks of recent years have been mild.
For the current study, Monto and his colleagues enrolled 1,952 healthy adults in the fall of 2007. Healthy adults were chosen because they are the only group for which seasonal flu vaccine is not recommended and are thus the only group that could ethically be given placebo vaccines. Half were given either FluMist or an injectable vaccine produced by Sanofi-Pasteur, and half were given a placebo.
By the end of the January-April 2008 flu season, the injectable vaccine had protected 68% of recipients, while the intranasal vaccine had protected 36%. That's 50% fewer. Many people believe that even when the vaccine does not prevent infection, it minimizes symptoms of the virus. Monto said that they are now compiling data to determine whether that is the case but that "the differences are not striking."
Karen Lancaster, a spokesperson for MedImmune, noted that "other studies have indicated that FluMist works just as well as or, in some cases, better than the flu shot. As a result, in adults, the jury is still out."
The difference in response between adults and children may offer some hope for use of vaccines against swine flu, according to Monto. The intranasal vaccine must infect the nasal passages to produce a protective immune response. Adults who have been exposed to a variety of influenza viruses probably have more antibodies in their nasal passages than do children, who have been exposed to few viruses. Because the swine flu is so sharply different from the seasonal viruses of past years, even adults may have little resistance to it and the swine flu vaccine is likely to be more efficient than expected, he said.
-- Thomas H. Maugh II
Oddities, musings and news from
the world of health
« Previous Post | Booster Shots Home | Next Post »
Injectable vaccine better than intranasal for seasonal flu in adultsSeptember 23, 2009 | 2:01 pm
Injectable vaccines containing inactivated viruses prevent about 50% more seasonal flu in healthy adults than the intranasal vaccine containing a weakened virus, according to a new report today in the New England Journal of Medicine.*
"We have two effective vaccines," said Dr. Arnold S. Monto of the University of Michigan, who led the study. "In children, I would prefer FluMist [intranasal vaccine] and in adults, injected, based on the data we have. However, an adult who does not want a shot should take FluMist." But he noted that it is not yet clear whether the same findings will hold for the pandemic H1N1 influenza virus, commonly known as swine flu.
FluMist will be the first vaccine available for swine flu, with at least 3.4 million doses arriving around the beginning of October. Overall, FluMist, manufactured by MedImmune Corp.of Gaithersburg, Md., will account for about 42 million of the roughly 270 million doses of swine flu vaccine ordered by the federal government.
Multiple studies have shown that the intranasal vaccine works better against seasonal flu in children. Three large head-to-head studies showed that those who received FluMist had 35% to 53% fewer cases of flu than those who received injectable vaccines. But the results in adults have been much more inconsistent, with some studies showing FluMist to be better and others showing injectables to be superior.
Researchers at the University of Michigan, where the inactivated-virus vaccine was originally developed by epidemiologist Hunein "John" Massaab, have been studying its efficacy for several years. Earlier results have suggested that the injectable vaccine was better, but the results have not been conclusive -- in part because the seasonal flu outbreaks of recent years have been mild.
For the current study, Monto and his colleagues enrolled 1,952 healthy adults in the fall of 2007. Healthy adults were chosen because they are the only group for which seasonal flu vaccine is not recommended and are thus the only group that could ethically be given placebo vaccines. Half were given either FluMist or an injectable vaccine produced by Sanofi-Pasteur, and half were given a placebo.
By the end of the January-April 2008 flu season, the injectable vaccine had protected 68% of recipients, while the intranasal vaccine had protected 36%. That's 50% fewer. Many people believe that even when the vaccine does not prevent infection, it minimizes symptoms of the virus. Monto said that they are now compiling data to determine whether that is the case but that "the differences are not striking."
Karen Lancaster, a spokesperson for MedImmune, noted that "other studies have indicated that FluMist works just as well as or, in some cases, better than the flu shot. As a result, in adults, the jury is still out."
The difference in response between adults and children may offer some hope for use of vaccines against swine flu, according to Monto. The intranasal vaccine must infect the nasal passages to produce a protective immune response. Adults who have been exposed to a variety of influenza viruses probably have more antibodies in their nasal passages than do children, who have been exposed to few viruses. Because the swine flu is so sharply different from the seasonal viruses of past years, even adults may have little resistance to it and the swine flu vaccine is likely to be more efficient than expected, he said.
-- Thomas H. Maugh II
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
Great news.
by Eliza » Thu Sep 24, 2009 4:18 pm
U.S. doubles early supply of swine flu vaccine
Thu Sep 24, 2009 5:04pm EDT
By David Morgan
WASHINGTON (Reuters) - U.S. health officials said on Thursday more than 6 million doses of H1N1 swine flu vaccine will be available the first week of October, twice as many as they expected only a week ago.
But even as officials ramp up vaccine production, they say most Americans tend not to bother getting vaccinated -- especially the children and young adults most at risk of being infected by the new H1N1 virus.
"We really need to get the message out," U.S. Health and Human Services Secretary Kathleen Sebelius told reporters.
"Taking the risk and getting sick is probably not a wise roll of the dice," she said. "People can die, and the people who are going to be ill and die are much more likely to be children and young adults."
The U.S. government expects to have 6 million to 7 million doses of vaccine available the first week of October, up from an estimate of 3.4 million doses last week. Most of the early doses will be MedImmune's nose spray.
Another 40 million doses should be available in mid-October with production continuing at a rate of 10 million to 20 million doses per week to a total of more than 250 million by year end.
The United States has ordered vaccine from five companies -- MedImmune, a unit of AstraZeneca, Sanofi-Aventis, Australia's CSL, GlaxoSmithKline and Novartis.
Meanwhile, hopes dimmed for the world vaccine supply on Thursday. The World Health Organization reduced its estimate of vaccine production capacity from 5 billion doses a year to 3 billion, enough for only half the planet.
HEALTH RISK
The U.S. Centers for Disease Control and Prevention has designated certain people to be vaccinated first. They include school-aged children, pregnant women and people with underlying conditions such as heart disease, asthma or diabetes.
At least 46 U.S. children under 18 have died from H1N1 swine flu infection since April, when the disease was first detected in the United States. Usually, between April and October, no U.S. children die from influenza.
H1N1 became a pandemic in June and has infected millions of people in the United States, the CDC's Dr. Anne Schuchat said.
Sebelius said public reluctance to accept vaccination could itself pose a health risk.
She said that typically, fewer than 25 percent of children and pregnant women get vaccinated against seasonal flu, which kills about 250,000 to 500,000 people a year worldwide.
Vaccination rates are also below 30 percent for young adults and around 40 percent for healthcare workers.
An American Red Cross survey released last month showed that only 11 percent of Americans were very worried about the new swine flu while another 29 percent were somewhat worried. The rest -- 60 percent -- said they were not worried.
Swine flu is already widespread in 21 U.S. states. But the virus so far is proving to be milder than expected, with a death rate similar to that of seasonal flu.
Sebelius sought to emphasize the dangers swine flu poses for vulnerable groups by warning that many of the 36,000 deaths that occur in the United States during mild flu seasons could be children this time around.
"We are not making this up. This is serious," she said. "Parents need to understand."
So far, about 15 percent of children hospitalized for swine flu have required intensive care, Schuchat said.
Tests show the swine flu vaccine closely matches the H1N1 virus, which suggests it will protect people well. Children also respond to the vaccine just as they do the seasonal flu, meaning those over 10 need one shot while children 9 and under need two.
Thu Sep 24, 2009 5:04pm EDT
By David Morgan
WASHINGTON (Reuters) - U.S. health officials said on Thursday more than 6 million doses of H1N1 swine flu vaccine will be available the first week of October, twice as many as they expected only a week ago.
But even as officials ramp up vaccine production, they say most Americans tend not to bother getting vaccinated -- especially the children and young adults most at risk of being infected by the new H1N1 virus.
"We really need to get the message out," U.S. Health and Human Services Secretary Kathleen Sebelius told reporters.
"Taking the risk and getting sick is probably not a wise roll of the dice," she said. "People can die, and the people who are going to be ill and die are much more likely to be children and young adults."
The U.S. government expects to have 6 million to 7 million doses of vaccine available the first week of October, up from an estimate of 3.4 million doses last week. Most of the early doses will be MedImmune's nose spray.
Another 40 million doses should be available in mid-October with production continuing at a rate of 10 million to 20 million doses per week to a total of more than 250 million by year end.
The United States has ordered vaccine from five companies -- MedImmune, a unit of AstraZeneca, Sanofi-Aventis, Australia's CSL, GlaxoSmithKline and Novartis.
Meanwhile, hopes dimmed for the world vaccine supply on Thursday. The World Health Organization reduced its estimate of vaccine production capacity from 5 billion doses a year to 3 billion, enough for only half the planet.
HEALTH RISK
The U.S. Centers for Disease Control and Prevention has designated certain people to be vaccinated first. They include school-aged children, pregnant women and people with underlying conditions such as heart disease, asthma or diabetes.
At least 46 U.S. children under 18 have died from H1N1 swine flu infection since April, when the disease was first detected in the United States. Usually, between April and October, no U.S. children die from influenza.
H1N1 became a pandemic in June and has infected millions of people in the United States, the CDC's Dr. Anne Schuchat said.
Sebelius said public reluctance to accept vaccination could itself pose a health risk.
She said that typically, fewer than 25 percent of children and pregnant women get vaccinated against seasonal flu, which kills about 250,000 to 500,000 people a year worldwide.
Vaccination rates are also below 30 percent for young adults and around 40 percent for healthcare workers.
An American Red Cross survey released last month showed that only 11 percent of Americans were very worried about the new swine flu while another 29 percent were somewhat worried. The rest -- 60 percent -- said they were not worried.
Swine flu is already widespread in 21 U.S. states. But the virus so far is proving to be milder than expected, with a death rate similar to that of seasonal flu.
Sebelius sought to emphasize the dangers swine flu poses for vulnerable groups by warning that many of the 36,000 deaths that occur in the United States during mild flu seasons could be children this time around.
"We are not making this up. This is serious," she said. "Parents need to understand."
So far, about 15 percent of children hospitalized for swine flu have required intensive care, Schuchat said.
Tests show the swine flu vaccine closely matches the H1N1 virus, which suggests it will protect people well. Children also respond to the vaccine just as they do the seasonal flu, meaning those over 10 need one shot while children 9 and under need two.
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Eliza - Posts: 9704
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by Eliza » Fri Sep 25, 2009 5:11 pm
Seniors back of H1N1 vaccine line
When it comes to the H1N1 vaccine, according to the Pima County Health Department, seniors are at the back of the line.
That's causing some confusion because seniors are used to being the priority when it comes to getting the seasonal flu shot.
Dr. Michelle McDonald, chief medical officer with the Pima County Health Department, says the vaccine will be distributed next month but doctors are only supposed to be offering the the shot to high risk groups, which doesn't include seniors.
"It really does look seniors have some degree of immunity, particularly over 65 years of age but it may be down as low as 50 years of age having some degree of immunity due to a very strong similarity to circulating strains of H1N1 in the late 50's," Dr. McDonald said.
McDonald says less than 2 percent of their cases have been in individuals over 65 years of age.
She says high risk groups include health care workers, pregnant women, family members or care takers for children six months and younger, anyone six months old to 24 years of age and anyone with underlying health conditions like diabetes and lung disease.
McDonald says they just learned last week that anyone over ten years old will only need a single dose of the vaccine. Children younger than that would need two doses, three weeks apart. She says children younger than six months are too young for the vaccine.
When it comes to the H1N1 vaccine, according to the Pima County Health Department, seniors are at the back of the line.
That's causing some confusion because seniors are used to being the priority when it comes to getting the seasonal flu shot.
Dr. Michelle McDonald, chief medical officer with the Pima County Health Department, says the vaccine will be distributed next month but doctors are only supposed to be offering the the shot to high risk groups, which doesn't include seniors.
"It really does look seniors have some degree of immunity, particularly over 65 years of age but it may be down as low as 50 years of age having some degree of immunity due to a very strong similarity to circulating strains of H1N1 in the late 50's," Dr. McDonald said.
McDonald says less than 2 percent of their cases have been in individuals over 65 years of age.
She says high risk groups include health care workers, pregnant women, family members or care takers for children six months and younger, anyone six months old to 24 years of age and anyone with underlying health conditions like diabetes and lung disease.
McDonald says they just learned last week that anyone over ten years old will only need a single dose of the vaccine. Children younger than that would need two doses, three weeks apart. She says children younger than six months are too young for the vaccine.
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Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
At least they got the hand washing part right. :)
by Eliza » Sat Sep 26, 2009 10:40 pm
September 26, 2009
‘Bumpy’ Start Seen for Swine Flu Vaccine Plan
By DONALD G. McNEIL Jr.
The opening of the vaccination campaign for swine flu is “going to be a little bumpy,” the director of the Centers for Disease Control and Prevention predicted Friday as he gave new details about how the vaccine would be distributed.
The first doses should reach doctors by Oct. 6, said the director, Dr. Thomas R. Frieden, but almost all will be the FluMist nasal spray version, which has some limits on who may use it. By mid-October, 40 million doses of both the nasal spray and injectable versions should be out.
The FluMist version is not recommended for infants under 2, adults over 49, pregnant women or anyone with a range of underlying health problems. But it is easy to use, and some pediatricians prefer it because many children fear needles.
With vaccines going from 5 manufacturers to 90,000 distribution points, Dr. Frieden said he expected shortages in some places and oversupply in others. Distribution will be different from that of seasonal flu vaccine, which doctors buy on their own. All the swine flu vaccine has been ordered and paid for by the federal government, which is also paying for its distribution and providing syringes and other items with it.
In some states, the swine flu vaccine will be injected at public sites like schools and city clinics, as polio vaccine was doled out in the 1950s. The best-prepared school systems have already asked parents to sign consent forms and have discussed plans at parent-teacher association meetings, Dr. Frieden said. Doctors, pharmacies and companies may also dispense it; the government is urging them to keep fees minimal.
Dr. Frieden said that the virus had not mutated in any threatening way and that the vaccine was still a good match for it.
Flu activity, normally almost nonexistent in September, is now widespread in 26 states, up from 23 a week ago. Dr. Frieden said activity was “beginning to trend down in some areas,” including Georgia, the site of his agency. But, he added, that predicted little because in New York City, where he was health commissioner last spring, swine flu surged after being introduced at a school in Queens, quieted down briefly and then resumed until schools closed for summer.
Dr. Frieden also discounted news reports in Canada that some doctors there thought that having had a seasonal flu shot made a patient more likely to catch swine flu. No data from Canada supporting that has been published in medical journals, he said, and a review of data from New York City and the United States over all, as well as by Australian authorities of their recent winter flu season, showed no such effect.
Dr. Frieden said seasonal flu shots did not protect against swine flu but did not create a proclivity for it either.
‘Bumpy’ Start Seen for Swine Flu Vaccine Plan
By DONALD G. McNEIL Jr.
The opening of the vaccination campaign for swine flu is “going to be a little bumpy,” the director of the Centers for Disease Control and Prevention predicted Friday as he gave new details about how the vaccine would be distributed.
The first doses should reach doctors by Oct. 6, said the director, Dr. Thomas R. Frieden, but almost all will be the FluMist nasal spray version, which has some limits on who may use it. By mid-October, 40 million doses of both the nasal spray and injectable versions should be out.
The FluMist version is not recommended for infants under 2, adults over 49, pregnant women or anyone with a range of underlying health problems. But it is easy to use, and some pediatricians prefer it because many children fear needles.
With vaccines going from 5 manufacturers to 90,000 distribution points, Dr. Frieden said he expected shortages in some places and oversupply in others. Distribution will be different from that of seasonal flu vaccine, which doctors buy on their own. All the swine flu vaccine has been ordered and paid for by the federal government, which is also paying for its distribution and providing syringes and other items with it.
In some states, the swine flu vaccine will be injected at public sites like schools and city clinics, as polio vaccine was doled out in the 1950s. The best-prepared school systems have already asked parents to sign consent forms and have discussed plans at parent-teacher association meetings, Dr. Frieden said. Doctors, pharmacies and companies may also dispense it; the government is urging them to keep fees minimal.
Dr. Frieden said that the virus had not mutated in any threatening way and that the vaccine was still a good match for it.
Flu activity, normally almost nonexistent in September, is now widespread in 26 states, up from 23 a week ago. Dr. Frieden said activity was “beginning to trend down in some areas,” including Georgia, the site of his agency. But, he added, that predicted little because in New York City, where he was health commissioner last spring, swine flu surged after being introduced at a school in Queens, quieted down briefly and then resumed until schools closed for summer.
Dr. Frieden also discounted news reports in Canada that some doctors there thought that having had a seasonal flu shot made a patient more likely to catch swine flu. No data from Canada supporting that has been published in medical journals, he said, and a review of data from New York City and the United States over all, as well as by Australian authorities of their recent winter flu season, showed no such effect.
Dr. Frieden said seasonal flu shots did not protect against swine flu but did not create a proclivity for it either.
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Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Sun Sep 27, 2009 11:02 pm
Swine flu shot: Intense tracking for side effectsBy LAURAN NEERGAARD (AP)
AP-
WASHINGTON — More than 3,000 people a day have a heart attack. If you're one of them the day after your swine flu shot, will you worry the vaccine was to blame and not the more likely culprit, all those burgers and fries?
The government is starting an unprecedented system to track possible side effects as mass flu vaccinations begin next month. The idea is to detect any rare but real problems quickly, and explain the inevitable coincidences that are sure to cause some false alarms.
"Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone," said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services.
Health authorities hope to vaccinate well over half the population in just a few months against swine flu, which doctors call the 2009 H1N1 strain. That would be a feat. No more than 100 million Americans usually get vaccinated against regular winter flu, and never in such a short period.
How many will race for the vaccine depends partly on confidence in its safety. The last mass inoculations against a different swine flu, in 1976, were marred by reports of a rare paralyzing condition, Guillain-Barre syndrome.
"The recurring question is, 'How do we know it's safe?'" said Dr. Gregory Poland of the Mayo Clinic.
Enter the intense new monitoring. On top of routine vaccine tracking, there are these government-sponsored projects:
_Harvard Medical School scientists are linking large insurance databases that cover up to 50 million people with vaccination registries around the country for real-time checks of whether people see a doctor in the weeks after a flu shot and why. The huge numbers make it possible to quickly compare rates of complaints among the vaccinated and unvaccinated, said the project leader, Dr. Richard Platt, Harvard's population medicine chief.
_Johns Hopkins University will direct e-mails to at least 100,000 vaccine recipients to track how they're feeling, including the smaller complaints that wouldn't prompt a doctor visit. If anything seems connected, researchers can call to follow up with detailed questions.
_The Centers for Disease Control and Prevention is preparing take-home cards that tell vaccine recipients how to report any suspected side effects to the nation's Vaccine Adverse Event Reporting system.
"We don't have any reason to expect any unusual problems with this vaccine," said Dr. Neal Halsey, director of Hopkins' Institute for Vaccine Safety, who is directing the e-mail surveillance.
After all, the new H1N1 vaccine is a mere recipe change from the regular winter flu shot that's been used for decades in hundreds of millions of people without serious problems. Nor have there been any red flags in the few thousand people given test doses in studies to determine the right H1N1 dose. They've gotten the same sore arms and occasional headache or fever that's par for a winter flu shot.
But because this H1N1 flu targets the young more than the old, this may be the year that unprecedented numbers of children and pregnant women are vaccinated.
Then there's the glare of the Internet — where someone merely declaring on Facebook that he's sure the shot did harm could cause a wave of similar reports. Health authorities will have to tell quickly if there really do seem to be more cases of a particular health problem than usual.
So the CDC is racing to compile a list of what's normal: 25,000 heart attacks every week; 14,000 to 19,000 miscarriages every week; 300 severe allergic reactions called anaphylaxis every week.
Any spike would mean fast checking to see if the vaccine really seems to increase risk and by how much, so health officials could issue appropriate warnings.
Very rare side effects by definition could come to light only after large-scale inoculations begin — making this the year scientists may finally learn if flu vaccine truly is linked to Guillain-Barre, an often reversible but sometimes fatal paralysis. It's believed to strike between 1 and 2 of every 100,000 people. It often occurs right after another infection, such as food poisoning or even influenza.
But the vaccine concern stems from 1976, when 500 cases were reported among the 45 million people vaccinated against that year's swine flu. Scientists never could prove if the vaccine really caused the extra risk. The CDC maintains that if the regular winter flu vaccine is related, the risk is no more than a single case per million vaccinated.
So the question becomes, Is the risk of disease greater than that?
Mayo's Poland cites a study in Chicago that found the rate of preschoolers being hospitalized for the new H1N1 flu last spring was 2 1/2 times higher than that possible Guillain-Barre risk.
However the flu season turns out, the extra vaccine tracking promises a lasting impact.
"Part of what we hope is that it will teach us something about how to monitor the safety of all medical products quickly," said Harvard's Platt.
AP-
WASHINGTON — More than 3,000 people a day have a heart attack. If you're one of them the day after your swine flu shot, will you worry the vaccine was to blame and not the more likely culprit, all those burgers and fries?
The government is starting an unprecedented system to track possible side effects as mass flu vaccinations begin next month. The idea is to detect any rare but real problems quickly, and explain the inevitable coincidences that are sure to cause some false alarms.
"Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone," said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services.
Health authorities hope to vaccinate well over half the population in just a few months against swine flu, which doctors call the 2009 H1N1 strain. That would be a feat. No more than 100 million Americans usually get vaccinated against regular winter flu, and never in such a short period.
How many will race for the vaccine depends partly on confidence in its safety. The last mass inoculations against a different swine flu, in 1976, were marred by reports of a rare paralyzing condition, Guillain-Barre syndrome.
"The recurring question is, 'How do we know it's safe?'" said Dr. Gregory Poland of the Mayo Clinic.
Enter the intense new monitoring. On top of routine vaccine tracking, there are these government-sponsored projects:
_Harvard Medical School scientists are linking large insurance databases that cover up to 50 million people with vaccination registries around the country for real-time checks of whether people see a doctor in the weeks after a flu shot and why. The huge numbers make it possible to quickly compare rates of complaints among the vaccinated and unvaccinated, said the project leader, Dr. Richard Platt, Harvard's population medicine chief.
_Johns Hopkins University will direct e-mails to at least 100,000 vaccine recipients to track how they're feeling, including the smaller complaints that wouldn't prompt a doctor visit. If anything seems connected, researchers can call to follow up with detailed questions.
_The Centers for Disease Control and Prevention is preparing take-home cards that tell vaccine recipients how to report any suspected side effects to the nation's Vaccine Adverse Event Reporting system.
"We don't have any reason to expect any unusual problems with this vaccine," said Dr. Neal Halsey, director of Hopkins' Institute for Vaccine Safety, who is directing the e-mail surveillance.
After all, the new H1N1 vaccine is a mere recipe change from the regular winter flu shot that's been used for decades in hundreds of millions of people without serious problems. Nor have there been any red flags in the few thousand people given test doses in studies to determine the right H1N1 dose. They've gotten the same sore arms and occasional headache or fever that's par for a winter flu shot.
But because this H1N1 flu targets the young more than the old, this may be the year that unprecedented numbers of children and pregnant women are vaccinated.
Then there's the glare of the Internet — where someone merely declaring on Facebook that he's sure the shot did harm could cause a wave of similar reports. Health authorities will have to tell quickly if there really do seem to be more cases of a particular health problem than usual.
So the CDC is racing to compile a list of what's normal: 25,000 heart attacks every week; 14,000 to 19,000 miscarriages every week; 300 severe allergic reactions called anaphylaxis every week.
Any spike would mean fast checking to see if the vaccine really seems to increase risk and by how much, so health officials could issue appropriate warnings.
Very rare side effects by definition could come to light only after large-scale inoculations begin — making this the year scientists may finally learn if flu vaccine truly is linked to Guillain-Barre, an often reversible but sometimes fatal paralysis. It's believed to strike between 1 and 2 of every 100,000 people. It often occurs right after another infection, such as food poisoning or even influenza.
But the vaccine concern stems from 1976, when 500 cases were reported among the 45 million people vaccinated against that year's swine flu. Scientists never could prove if the vaccine really caused the extra risk. The CDC maintains that if the regular winter flu vaccine is related, the risk is no more than a single case per million vaccinated.
So the question becomes, Is the risk of disease greater than that?
Mayo's Poland cites a study in Chicago that found the rate of preschoolers being hospitalized for the new H1N1 flu last spring was 2 1/2 times higher than that possible Guillain-Barre risk.
However the flu season turns out, the extra vaccine tracking promises a lasting impact.
"Part of what we hope is that it will teach us something about how to monitor the safety of all medical products quickly," said Harvard's Platt.
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Tue Sep 29, 2009 11:51 pm
Sanofi-Aventis SA's (SNY) vaccines unit is to deliver its first shipment of swine-flu vaccine to the U.S. government Tuesday, ahead of schedule, a spokeswoman said.
The company cautioned that the shots may not become immediately available for administration because they will have to work their way through government distribution ...
The company cautioned that the shots may not become immediately available for administration because they will have to work their way through government distribution ...
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Eliza - Posts: 9704
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by Eliza » Wed Sep 30, 2009 12:26 am
Sanofi CEO says H1N1 vaccine en route early
Tue Sep 29, 2009 2:24pm EDT
NEW YORK (Reuters) - The chief executive officer of Sanofi-Aventis SA said on Tuesday his company has begun U.S. shipments of its H1N1 swine flu vaccine ahead of schedule.
"The first truck left today," Chris Viehbacher said in an interview. "So we're actually ahead of schedule, probably a couple of weeks."
Sanofi-Aventis, which has a contract to provide 75.3 million doses of its H1N1 vaccine to the U.S. government, is making all of its product at a new plant in Swiftwater, Pennsylvania.
Sanofi-Aventis said its first shipment is headed to a designated government distributor, but the Paris-based company declined to provide the location or other details.
The government hopes by the end of the year to acquire a total of 250 million doses from Sanofi and four other vaccine makers -- the MedImmune division of AstraZeneca Plc, Australia's CSL Ltd, GlaxoSmithKline Plc and Novartis AG.
Tue Sep 29, 2009 2:24pm EDT
NEW YORK (Reuters) - The chief executive officer of Sanofi-Aventis SA said on Tuesday his company has begun U.S. shipments of its H1N1 swine flu vaccine ahead of schedule.
"The first truck left today," Chris Viehbacher said in an interview. "So we're actually ahead of schedule, probably a couple of weeks."
Sanofi-Aventis, which has a contract to provide 75.3 million doses of its H1N1 vaccine to the U.S. government, is making all of its product at a new plant in Swiftwater, Pennsylvania.
Sanofi-Aventis said its first shipment is headed to a designated government distributor, but the Paris-based company declined to provide the location or other details.
The government hopes by the end of the year to acquire a total of 250 million doses from Sanofi and four other vaccine makers -- the MedImmune division of AstraZeneca Plc, Australia's CSL Ltd, GlaxoSmithKline Plc and Novartis AG.
-
Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Wed Sep 30, 2009 12:42 am
Military to get mandatory swine flu shots soon
By LOLITA C. BALDOR (AP) – 8 hours ago
WASHINGTON — A top U.S. military commander says troops will begin getting required swine flu shots in the next week to 10 days. Active duty forces deploying to war zones and other critical areas at the front of the vaccine line.
Air Force Gen. Gene Renuart also told The Associated Press that as many as 400 troops are ready to go to five regional headquarters around the country to assist federal health and emergency management officials if needed as the flu season heats up.
The Pentagon has bought 2.7 million vaccines, and 1.4 million of those will go to active duty military. National Guard troops on active duty are also required to receive the vaccine, as are civilian Defense Department employees who are in critical jobs.
By LOLITA C. BALDOR (AP) – 8 hours ago
WASHINGTON — A top U.S. military commander says troops will begin getting required swine flu shots in the next week to 10 days. Active duty forces deploying to war zones and other critical areas at the front of the vaccine line.
Air Force Gen. Gene Renuart also told The Associated Press that as many as 400 troops are ready to go to five regional headquarters around the country to assist federal health and emergency management officials if needed as the flu season heats up.
The Pentagon has bought 2.7 million vaccines, and 1.4 million of those will go to active duty military. National Guard troops on active duty are also required to receive the vaccine, as are civilian Defense Department employees who are in critical jobs.
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Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
by Eliza » Sun Oct 04, 2009 2:17 pm
OPINION: Don't force medical pros to get H1N1 vaccine
October 3, 2009 By GEORGE J. ANNAS
George J. Annas is a professor of health law, bioethics and human rights at Boston University School of Public Health, and author of "The Rights of Patients."
The New York State Health Commissioner's new mandate that all health care workers be vaccinated against both the seasonal and the swine flu this fall could qualify as the major public health blunder of the year, because it is likely to backfire.
Flu has been rightly characterized as a "slippery disease" that can mutate quickly and unpredictably, which means that planning for flu epidemics must be flexible and should be reviewed regularly as evidence of disease spread and severity accumulates.
We are already experiencing the beginning of a second wave of swine flu, the 2009 H1N1 influenza. Effective response will require cooperation of the public, and such cooperation (in actions such as getting vaccinated, social distancing and staying home when sick) will happen only if the public trusts its health officials.
Surveys have noted an erosion in public trust of government officials, but continued confidence in physicians and nurses. In this context, persuasion based on science, ethics and prudence, not on legal threats, should be the mandatory course of action for public health officials.
Physicians and nurses, educated and licensed professionals, dedicated to their patients' health and welfare, do have an ethical obligation to take all reasonable steps to protect their patients. During a threatened flu pandemic, like swine flu, this includes, I think, getting a swine flu vaccination.
So why not require vaccination if they refuse? There are at least four reasons.
The first is symbolic: The practice of medicine (and nursing) is a voluntary one based on informed choice - and will hopefully remain this way. Forcing physicians and nurses to become unconsenting patients - even for a flu shot - undermines the consensual nature of the health care relationship, and at least suggests that if health care professionals can be forced to take a vaccination for the good of others, perhaps everyone else can, too.
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The second reason is pragmatic. We are likely to get more physicians and nurses vaccinated in a well-planned and executed voluntary program (including providing the vaccinations at staff meetings, for example), than in a forced program that will draw and energize opposition.
Third, if enough physicians and nurses refuse vaccination, the mandate will be unenforceable, since no responsible public health official would try to close a hospital for failure to comply with the mandate in the midst of a flu epidemic.
Fourth, the requirement that physicians and nurses be vaccinated as a condition of practicing medicine and nursing in health care settings will predictably confuse the public when clarity is critical.
The public will reasonably ask, if physicians and nurses won't voluntarily take the swine flu vaccine, why should I? Do they know something I don't? Why do all other government officials, including President Barack Obama, the secretary of Health and Human Services and the head of the Centers for Disease Control, all recommend that swine flu vaccination be voluntary - at least outside the U.S. military, where troops live in close quarters and a flu epidemic among the troops would substantially limit their ability to perform?
Does anyone in authority really know what's going on? And if this new mandate is a response to the threatened swine flu epidemic, why does it apply to the seasonal flu as well - is there some new flu information that New York officials have that no one else has?
State Health Commissioner Dr. Richard Daines is right to note that seasonal flu vaccination rates among health care workers in New York have been too low in the past and need to improve. He is right to note the dedication of New York's health care workers in the context of great uncertainty and possible risk, including the early days of the HIV/AIDS epidemic and SARS.
But he is wrong to transform a reasonable professional ethics obligation into what looks like an arbitrary and unnecessary legal obligation. He is treating seasonal flu and swine flu vaccination the same - requiring them both - even though he thinks that H1N1 is the much more important vaccination to get.
Public health officials should work with medical and nursing organizations to persuade them to recommend that their members be vaccinated, and state licensing boards should, if they find it appropriate, make the same recommendation, if they also find it appropriate.
Medicine, nursing and public health are much stronger, and send a much more effective message to the public, when they work together than when they work at cross purposes.
And to the extent that the commissioner wants to protect health care workers themselves, the focus should not be entirely on vaccinations, but should include the health care institution environment, including hospital infection control procedures, adequate supplies of respiratory masks, and reasonable sick leave and worker compensation policies.
The ultimate measure of success or failure of a swine flu vaccination program will be in lives saved and lives lost. The most effective way to maximize the numbers of the public being vaccinated is to send the message that physicians and nurses believe this is the most reasonable approach to take to prevent wide-scale death and disease from the swine flu.
Legal threats and mandates undercut that public health message and will backfire.
October 3, 2009 By GEORGE J. ANNAS
George J. Annas is a professor of health law, bioethics and human rights at Boston University School of Public Health, and author of "The Rights of Patients."
The New York State Health Commissioner's new mandate that all health care workers be vaccinated against both the seasonal and the swine flu this fall could qualify as the major public health blunder of the year, because it is likely to backfire.
Flu has been rightly characterized as a "slippery disease" that can mutate quickly and unpredictably, which means that planning for flu epidemics must be flexible and should be reviewed regularly as evidence of disease spread and severity accumulates.
We are already experiencing the beginning of a second wave of swine flu, the 2009 H1N1 influenza. Effective response will require cooperation of the public, and such cooperation (in actions such as getting vaccinated, social distancing and staying home when sick) will happen only if the public trusts its health officials.
Surveys have noted an erosion in public trust of government officials, but continued confidence in physicians and nurses. In this context, persuasion based on science, ethics and prudence, not on legal threats, should be the mandatory course of action for public health officials.
Physicians and nurses, educated and licensed professionals, dedicated to their patients' health and welfare, do have an ethical obligation to take all reasonable steps to protect their patients. During a threatened flu pandemic, like swine flu, this includes, I think, getting a swine flu vaccination.
So why not require vaccination if they refuse? There are at least four reasons.
The first is symbolic: The practice of medicine (and nursing) is a voluntary one based on informed choice - and will hopefully remain this way. Forcing physicians and nurses to become unconsenting patients - even for a flu shot - undermines the consensual nature of the health care relationship, and at least suggests that if health care professionals can be forced to take a vaccination for the good of others, perhaps everyone else can, too.
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The second reason is pragmatic. We are likely to get more physicians and nurses vaccinated in a well-planned and executed voluntary program (including providing the vaccinations at staff meetings, for example), than in a forced program that will draw and energize opposition.
Third, if enough physicians and nurses refuse vaccination, the mandate will be unenforceable, since no responsible public health official would try to close a hospital for failure to comply with the mandate in the midst of a flu epidemic.
Fourth, the requirement that physicians and nurses be vaccinated as a condition of practicing medicine and nursing in health care settings will predictably confuse the public when clarity is critical.
The public will reasonably ask, if physicians and nurses won't voluntarily take the swine flu vaccine, why should I? Do they know something I don't? Why do all other government officials, including President Barack Obama, the secretary of Health and Human Services and the head of the Centers for Disease Control, all recommend that swine flu vaccination be voluntary - at least outside the U.S. military, where troops live in close quarters and a flu epidemic among the troops would substantially limit their ability to perform?
Does anyone in authority really know what's going on? And if this new mandate is a response to the threatened swine flu epidemic, why does it apply to the seasonal flu as well - is there some new flu information that New York officials have that no one else has?
State Health Commissioner Dr. Richard Daines is right to note that seasonal flu vaccination rates among health care workers in New York have been too low in the past and need to improve. He is right to note the dedication of New York's health care workers in the context of great uncertainty and possible risk, including the early days of the HIV/AIDS epidemic and SARS.
But he is wrong to transform a reasonable professional ethics obligation into what looks like an arbitrary and unnecessary legal obligation. He is treating seasonal flu and swine flu vaccination the same - requiring them both - even though he thinks that H1N1 is the much more important vaccination to get.
Public health officials should work with medical and nursing organizations to persuade them to recommend that their members be vaccinated, and state licensing boards should, if they find it appropriate, make the same recommendation, if they also find it appropriate.
Medicine, nursing and public health are much stronger, and send a much more effective message to the public, when they work together than when they work at cross purposes.
And to the extent that the commissioner wants to protect health care workers themselves, the focus should not be entirely on vaccinations, but should include the health care institution environment, including hospital infection control procedures, adequate supplies of respiratory masks, and reasonable sick leave and worker compensation policies.
The ultimate measure of success or failure of a swine flu vaccination program will be in lives saved and lives lost. The most effective way to maximize the numbers of the public being vaccinated is to send the message that physicians and nurses believe this is the most reasonable approach to take to prevent wide-scale death and disease from the swine flu.
Legal threats and mandates undercut that public health message and will backfire.
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Eliza - Posts: 9704
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by Eliza » Sun Oct 04, 2009 9:36 pm
October 5, 2009
Public Faces Long Wait To Get New Flu Vaccine
By BETSY MCKAY
The U.S. government is expecting delivery starting this week of enough doses of the new swine-flu vaccine for nearly every American who wants it, but state and local budget cuts coupled with limits on who can administer the vaccine could hamstring the campaign.
A second wave of the new flu, known as the 2009 H1N1 virus, is widespread across more than half of U.S. states, but it will be weeks before millions of people who want shots can get them. Manufacturers are still producing the 250 million doses the government has ordered, and state health officials must then determine where to distribute them.
Associated Press
Dr. Scott Nowlin fills out forms with Royanna Ayala, 3, in Austin, Texas last week. The state said vaccine should arrive in this week or next.
Government officials have said six million to seven million doses will be available this week.
A big question is how many people will actually want the vaccine amid concerns that it has been rushed to market and could produce side effects, as well as a sense among some that the disease isn't serious enough to warrant seeking a shot.
But health officials expect demand to rise as they unleash a media campaign to promote the vaccine and if the public hears more reports of deaths of otherwise healthy adults and children, such as the case of a 7-year-old girl in Dalton, Ga., last week.
The government set aside $1.5 billion to help fill in the blanks on a patchwork of public-health departments and private health providers and vendors to carry out what could be the country's largest-ever mass vaccination effort.
While a huge vaccine-distribution system has been built to get the H1N1 vaccine quickly to about 90,000 sites across the country, it is connected to a "rusty faucet," said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. "This system is already under great stress."
About 12,000 public-health positions were eliminated in 2008, and the pace of reductions has quickened this year, according to the Association of State and Territorial Health Officials, or Astho, a nonprofit organization that advocates for more public-health funding. There are about 102,000 public-health workers for states and territories, a number that doesn't include local health departments.
To meet potential demand for the vaccine, public-health officials are trying to attract volunteers and contract with private providers to administer shots in public clinics. "The cost of running a vaccine program has gone up dramatically," said Paul Jarris, Astho's executive director.
Adding to the problem: At least 30 states normally limit pharmacists from administering some vaccines to children of various ages, even though drugstores and large retailers dispense a growing percentage of seasonal flu shots. Children and young adults through age 24 are among those who will get top priority for H1N1 vaccine.
Some states are relaxing the rules or considering such a move to accommodate potentially huge demand for the H1N1 shot. Massachusetts expanded the authority of pharmacists, paramedics, dentists and third- and fourth-year medical students to administer seasonal and H1N1 shots to all those who want them. "We need all hands on deck," said Jennifer Manley, spokeswoman for the state's public-health department.
The first 600,000 doses are expected to be delivered by Tuesday, and state and local health officials are scrambling to figure out where to send them so they reach the people who need them most. While the virus makes most people only mildly ill, it has taken the lives of some children and young adults who were perfectly healthy until they were struck. One hundred pregnant women have been treated for H1N1 in intensive-care units, and 28 have died, according to the Centers for Disease Control and Prevention.
The initial doses are all in the form of a nasal spray not recommended for pregnant women or people with chronic health conditions. Both groups are among the 159 million people the government has said should get the H1N1 vaccine first. So officials are trying to steer the initial doses to other priority patients. Some states say this week's nasal-spray doses will be targeted at health-care workers. Pregnant women and people with chronic health conditions will be offered shots that could be delivered as early as later this week.
Government health officials have warned the effort will be bumpy at first. "What we're looking at is vaccinating as many people as want to be vaccinated in as short a period of time as possible, and there are enormous logistical challenges to that," Thomas Frieden, the CDC's director, acknowledged recently.
Each state has been allotted a total amount of vaccine based on the size of its population, and deliveries will be made every week, with the trickle increasing to a steady flow by midmonth. Because the vaccine comes in varying formulations, from the nasal spray that can be given only to healthy 2- to 49-year-olds, to pediatric doses in shot form, officials have to be careful to direct vaccine to outlets where those populations are found.
The uncertainty over supply is giving providers little time to prepare. "We're really going to have to be able to turn on a dime and be flexible," said Steve Pellito, director of wellness for Maxim Health Systems, a division of Maxim Healthcare Services that offers seasonal-flu clinics and hopes to offer H1N1 clinics, too.
As for efficacy, the circulating virus and the vaccine are very well matched, according to government health officials, which would make the vaccine effective.
The CDC is rolling out a media campaign to promote vaccination, with ads expected on buses in Chicago, Dallas and several other cities within the next two weeks. One will remind pregnant women that "flu can harm you and your baby" and urge them to get shots both against seasonal flu and the H1N1 influenza.
But the CDC doesn't plan an ad blitz yet because the shots aren't expected to be widely available for several weeks.
The agency also wants to be careful not to promote the shot too aggressively, said Kristine Sheedy, a CDC communications expert involved in the campaign. "We want to take an approach where we don't want people to feel coerced into making a decision," she said. "We're all prepared for the fact there will be several people we hope would choose vaccination but will not."
John Rouse, health director for Harnett County, N.C., said he is "sitting on pins and needles" for word of whether expected budget cuts in the state will force him to lay off any of his department's 104 staff. If that happens, "that's going to curtail our ability to be able to respond," he said.
The vaccination effort is "massive in scope, and it is complex," said Rhonda Medows, commissioner of Georgia's Department of Community Health. But approximately $38 million the state is receiving in federal funds to help carry out the H1N1 campaign and a reorganization that added staff to her department have helped, she said.
After learning only a week ago how many shots they could get in their first order, Maine health officials pored through a county-by-county list of about 500 health-care providers that had signed up to administer vaccine. Staff redeployed from other parts of the state's Center for Disease Control and Prevention spent all day Tuesday finding out how many doses each provider would need.
"This has been very labor intensive," said Dora Anne Mills, the state's public-health director.
Dr. Mills said she expects there to be enough vaccine for the general public, beyond the priority groups, in late November or early December, depending on demand. "We're going to go through a storm the next eight weeks," she said.
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Eliza - Posts: 9704
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by Eliza » Mon Oct 05, 2009 8:28 pm
Cuba calls for help obtaining swine flu vaccine
(AFP) – 8 hours ago
HAVANA — Cuba called Monday on the World Health Organization and the Pan American Health Organization to help it acquire doses of a vaccine against the A(H1N1) virus.
"The new vaccine against the A(H1N1) virus, which has begun being administered in more developed countries, is highly effective, but also very expensive," said Health Minister Luis Estruch.
"Our country is seeking the cooperation of the World Health Organization and the Pan American Health Organization in obtaining the vaccine so it can be administered to those people most vulnerable to the virus," he said.
Speaking to official daily newspaper Granma, Estruch said that Cuba has purchased stocks of the seasonal flu vaccine, which does not specifically protect against swine flu, and would vaccinate the population groups at greatest risk.
With 468 confirmed cases of infection and no deaths from the A(H1N1) virus, Cuba is taking various measures, including a strong media campaign, to prevent a second wave of infections in the autumn.
(AFP) – 8 hours ago
HAVANA — Cuba called Monday on the World Health Organization and the Pan American Health Organization to help it acquire doses of a vaccine against the A(H1N1) virus.
"The new vaccine against the A(H1N1) virus, which has begun being administered in more developed countries, is highly effective, but also very expensive," said Health Minister Luis Estruch.
"Our country is seeking the cooperation of the World Health Organization and the Pan American Health Organization in obtaining the vaccine so it can be administered to those people most vulnerable to the virus," he said.
Speaking to official daily newspaper Granma, Estruch said that Cuba has purchased stocks of the seasonal flu vaccine, which does not specifically protect against swine flu, and would vaccinate the population groups at greatest risk.
With 468 confirmed cases of infection and no deaths from the A(H1N1) virus, Cuba is taking various measures, including a strong media campaign, to prevent a second wave of infections in the autumn.
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Eliza - Posts: 9704
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by Eliza » Sat Oct 10, 2009 2:59 am
Health Workers Sue to Void FDA Approval of Swine Flu Vaccine
By Cary O’Reilly
Oct. 9 (Bloomberg) -- A group of New York doctors and health-care workers who are to be among the first inoculated against swine flu asked a federal judge to void U.S. approval of the vaccine until more safety tests are done.
Rima Laibow, a physician, nurse Suzanne Field and four other New York residents filed the suit in federal court in Washington today. They claim a state law requires them to get the vaccine, putting their health at risk from an unproven treatment and their livelihoods at risk if they refuse.
“This is an emergency action in a matter of significant public importance,” Leslie Fourton, an attorney for the health workers, said in the lawsuit. The Food and Drug Administration “has approved or licensed the vaccines without definitive prerequisite safety testing, in clear violation of federal law.”
The workers asked Judge Reggie Walton to issue an immediate order barring approvals of A/H1N1 vaccines until all legally required testing is conducted and an order preventing New York from firing them if they refuse to take it.
Doctors and hospital workers in Marion County, Indiana, and Le Bonheur Children’s Medical Center in Memphis, Tennessee, were among the first to receive AstraZeneca Plc’s nasal spray vaccine this week.
Swine flu, or H1N1, is spreading widely in most U.S. states. The first vaccines will be aimed at health-care workers, children, pregnant women and people with chronic conditions that put them at risk for complications. While the U.S. has ordered doses to cover all Americans, only half of U.S. adults plan to get the vaccine, according to a Harvard University poll.
Swine flu is responsible for more than 600 U.S. deaths since the virus was identified in April, according to the Centers for Disease Control and Prevention in Atlanta.
By Cary O’Reilly
Oct. 9 (Bloomberg) -- A group of New York doctors and health-care workers who are to be among the first inoculated against swine flu asked a federal judge to void U.S. approval of the vaccine until more safety tests are done.
Rima Laibow, a physician, nurse Suzanne Field and four other New York residents filed the suit in federal court in Washington today. They claim a state law requires them to get the vaccine, putting their health at risk from an unproven treatment and their livelihoods at risk if they refuse.
“This is an emergency action in a matter of significant public importance,” Leslie Fourton, an attorney for the health workers, said in the lawsuit. The Food and Drug Administration “has approved or licensed the vaccines without definitive prerequisite safety testing, in clear violation of federal law.”
The workers asked Judge Reggie Walton to issue an immediate order barring approvals of A/H1N1 vaccines until all legally required testing is conducted and an order preventing New York from firing them if they refuse to take it.
Doctors and hospital workers in Marion County, Indiana, and Le Bonheur Children’s Medical Center in Memphis, Tennessee, were among the first to receive AstraZeneca Plc’s nasal spray vaccine this week.
Swine flu, or H1N1, is spreading widely in most U.S. states. The first vaccines will be aimed at health-care workers, children, pregnant women and people with chronic conditions that put them at risk for complications. While the U.S. has ordered doses to cover all Americans, only half of U.S. adults plan to get the vaccine, according to a Harvard University poll.
Swine flu is responsible for more than 600 U.S. deaths since the virus was identified in April, according to the Centers for Disease Control and Prevention in Atlanta.
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Eliza - Posts: 9704
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by Eliza » Thu Oct 15, 2009 11:51 pm
'Stop the Shot' Campaign Against H1N1 Vaccine Hits Federal and State CourtsTresa Baldas
The National Law Journal
October 14, 2009
A "stop the shot" campaign has hit federal and state courts. This past Friday, a group of New York doctors and health care workers asked a federal judge in Washington, D.C., to order the federal government not to distribute the H1N1 vaccine. Specifically, they're challenging the legality of the licensing of the swine flu vaccine, alleging it was approved too quickly without appropriate testing for safety and effectiveness.
Furthermore, the plaintiffs, who filed their suit in the U.S. District Court in the District of Columbia, are seeking an immediate court order to halt mandated H1N1 flu shots in New York state. New York has ordered that all health care workers receive the H1N1 vaccine or risk losing their jobs.
That mandate is also facing a legal challenge in New York state trial court in Manhattan, where a lawsuit on behalf of 60,000 state health care workers has been filed against the state health commissioner to halt the required flu shots. The state has vowed a fight.
A similar lawsuit has been filed in the state of Washington, where the Washington State Nurses Association is suing a multifacility health care provider over a policy requiring nurses to get vaccinated for both the seasonal and swine flu.
"They don't want to be forced to take it. They know that it could be flawed," said Leslie Fourton, a New York solo practitioner who is one of several lawyers representing plaintiffs in the federal lawsuit in Washington.
Those plaintiffs include a medical doctor who believes the vaccine is harmful, a nurse who has had adverse reactions to prior flu vaccines, a pregnant nurse's aide who fears the vaccine could harm her unborn child, and a student who has classes in health care settings and is citing religious reasons for not taking the vaccine.
The plaintiffs also fear they'll be fired for not taking the vaccine, said Ralph Fucetola, a New Jersey lawyer working on the case. "They don't want to risk their jobs by not taking it. But these people literally are going to lose their livelihoods if they don't," he said.
The Washington regulatory law firm of Swankin & Turner is also advising the New York health care plaintiffs.
U.S. Food and Drug Administration officials declined comment on the pending litigation. But they did defend the agency's approval procedure for the H1N1 vaccine. "The FDA believes that this vaccine is safe and effective," said spokeswoman Pat El-Hinnawy. "The H1N1 vaccine is the same as the seasonal flu vaccine. It's just a strain of virus that's been changed ... and it's been given to hundreds of thousands -- if not hundreds of millions of people -- over the past 20 years."
The National Law Journal
October 14, 2009
A "stop the shot" campaign has hit federal and state courts. This past Friday, a group of New York doctors and health care workers asked a federal judge in Washington, D.C., to order the federal government not to distribute the H1N1 vaccine. Specifically, they're challenging the legality of the licensing of the swine flu vaccine, alleging it was approved too quickly without appropriate testing for safety and effectiveness.
Furthermore, the plaintiffs, who filed their suit in the U.S. District Court in the District of Columbia, are seeking an immediate court order to halt mandated H1N1 flu shots in New York state. New York has ordered that all health care workers receive the H1N1 vaccine or risk losing their jobs.
That mandate is also facing a legal challenge in New York state trial court in Manhattan, where a lawsuit on behalf of 60,000 state health care workers has been filed against the state health commissioner to halt the required flu shots. The state has vowed a fight.
A similar lawsuit has been filed in the state of Washington, where the Washington State Nurses Association is suing a multifacility health care provider over a policy requiring nurses to get vaccinated for both the seasonal and swine flu.
"They don't want to be forced to take it. They know that it could be flawed," said Leslie Fourton, a New York solo practitioner who is one of several lawyers representing plaintiffs in the federal lawsuit in Washington.
Those plaintiffs include a medical doctor who believes the vaccine is harmful, a nurse who has had adverse reactions to prior flu vaccines, a pregnant nurse's aide who fears the vaccine could harm her unborn child, and a student who has classes in health care settings and is citing religious reasons for not taking the vaccine.
The plaintiffs also fear they'll be fired for not taking the vaccine, said Ralph Fucetola, a New Jersey lawyer working on the case. "They don't want to risk their jobs by not taking it. But these people literally are going to lose their livelihoods if they don't," he said.
The Washington regulatory law firm of Swankin & Turner is also advising the New York health care plaintiffs.
U.S. Food and Drug Administration officials declined comment on the pending litigation. But they did defend the agency's approval procedure for the H1N1 vaccine. "The FDA believes that this vaccine is safe and effective," said spokeswoman Pat El-Hinnawy. "The H1N1 vaccine is the same as the seasonal flu vaccine. It's just a strain of virus that's been changed ... and it's been given to hundreds of thousands -- if not hundreds of millions of people -- over the past 20 years."
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Eliza - Posts: 9704
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They can't make up their minds.
by Eliza » Thu Oct 15, 2009 11:56 pm
Kids under 10 may need 2 swine flu vaccine doses
(AP) – 1 day ago
SWIFTWATER, Pa. — The vaccine maker Sanofi Pasteur says tests of its swine flu vaccine suggest that children under 10 may need two doses to be fully protected.
The U.S. Centers for Disease Control and Prevention says Wednesday's news is not surprising. This age group needs two doses of regular seasonal vaccine for full immunity to develop.
Federal officials have been hoping that one shot or squirt of nasal spray would do, so they can stretch the available supply of a vaccine much in demand.
(AP) – 1 day ago
SWIFTWATER, Pa. — The vaccine maker Sanofi Pasteur says tests of its swine flu vaccine suggest that children under 10 may need two doses to be fully protected.
The U.S. Centers for Disease Control and Prevention says Wednesday's news is not surprising. This age group needs two doses of regular seasonal vaccine for full immunity to develop.
Federal officials have been hoping that one shot or squirt of nasal spray would do, so they can stretch the available supply of a vaccine much in demand.
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Eliza - Posts: 9704
- Joined: Thu Feb 21, 2008 4:05 am
- Location: Deep in the hills with my rifle, bible, and pony
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