Sunday, August 23, 2009
Influenza A (H1N1) 2009 Monovalent Vaccine Safety Monitoring: CDC Planning Recommendations for State, Local, Tribal, and Territorial Health Officials
Influenza A (H1N1) 2009 Monovalent Vaccine Safety Monitoring: CDC Planning Recommendations for State, Local, Tribal, and Territorial Health Officials: "Vaccines to protect against the pandemic H1N1 2009 influenza virus are being developed. These influenza A (H1N1) 2009 monovalent vaccines (2009 H1N1 monovalent vaccines) and are anticipated to become available in the fall of 2009. The Advisory Committee on Immunization Practices (ACIP) has made recommendations regarding who should receive the 2009 H1N1 monovalent vaccine when it becomes available, including priorities for use of initial doses of vaccine."
WHO Guidelines for Pharmacological Management of Pandemic (H1N1) 2009 Influenza and other Influenza Viruses
WHO Guidelines for Pharmacological Management of Pandemic (H1N1) 2009 Influenza and other Influenza Viruses: "The purpose of this document is to provide a basis for advice to clinicians on the use of the currently available antivirals for patients presenting with illness due to influenza virus infection as well the potential use of the medicines for chemoprophylaxis."
US Launching Massive Swine Flu Campaign
US Launching Massive Swine Flu Campaign
Sunday, 23 August 2009 07:52 Added by PT Editor Sarah Price
Washington, August 23, 2009, (Pal Telegraph) - Government health officials are mobilizing to launch a massive swine flu vaccination campaign this fall that is unprecedented in its scope -- and in the potential for complications.
The campaign aims to vaccinate at least half the country's population within months. Although more people have been inoculated against diseases such as smallpox and polio over a period of years, the United States has never tried to immunize so many so quickly.
But even as scientists rush to test the vaccine to ensure it is safe and effective, the campaign is lagging. Officials say only about a third as much vaccine as they had been expecting by mid-October is likely to arrive by then, when a new wave of infections could be peaking.
Among the unknowns: how many shots people will need, what the correct dosage should be, and how to avoid confusing the public with an overlapping effort to combat the regular seasonal flu.
To prepare, more than 2,800 local health departments have begun recruiting pediatricians, obstetricians, nurses, pharmacists, paramedics and even dentists, along with a small army of volunteers from churches and other groups. They are devising strategies to reach children, teenagers, pregnant women and young and middle-aged adults in inner cities, suburban enclaves and the countryside.
"This is potentially the largest mass-vaccination program in human history," said Howard Markel, a professor of medical history at the University of Michigan who is advising the Centers for Disease Control and Prevention as it spearheads the effort.Public health officials describe the effort as crucial to defend against the second wave of the Northern Hemisphere's first influenza pandemic in 41 years.
As schools reopen, the number of cases could jump sharply within weeks, sparking a second wave potentially far larger than the outbreak last spring. Although the swine flu appears no more dangerous than the typical seasonal flu, the new virus -- known as H1N1 -- is likely to infect many more people because most have no immunity against it.
The vaccine effort carries political risks for the Obama administration. "If the outbreak fizzles, they will be susceptible to being criticized for spending billions of dollars," said Harvey V. Fineberg, president of the National Academy of Sciences' Institute of Medicine, which advises Congress about medical issues. "On the other hand, if this outbreak is early and severe and there isn't enough vaccine, they'll be criticized for under-preparation."
Officials stress that they are proceeding cautiously. A final decision to move forward will not be made until they get the results of clinical trials -- testing to determine safety and dosing -- and assess the virus's threat. But officials are confident the vaccine will pass muster and expect a campaign will be launched as soon as manufacturers deliver the first vials.
"There's little doubt we're going to vaccinate people," said Anthony S. Fauci of the National Institute of Allergy and Infectious Diseases, who is leading the government's testing of the vaccine. "Who and when and exactly how -- we have to figure out."
The campaign is haunted by memories of the government's ill-fated 1976 effort to vaccinate against swine flu. The epidemic fizzled, but the vaccine was given to 40 million people and blamed for causing a rare paralyzing disorder known as Guillain-Barré Syndrome.Another wild card will be whether the vaccine will be delivered with an "adjuvant" to boost its effectiveness or stretch limited supplies into more doses. Adjuvants have been used in Europe, but the Food and Drug Administration has not authorized their use in the United States.
"This is an overreaction," said Barbara Loe Fisher of the National Vaccine Information Center, which opposes many vaccine policies. "There is no national security threat here. Why are we operating like this? This is not polio. This is not smallpox." Fears and misinformation about the vaccine are circulating, including inaccurate claims that it will be mandatory.
"I'm very concerned about the dangers of vaccines," said Janice Smith, 58, of Misawaka, Ind., who attended a public hearing Aug. 15, one of a series of meetings the CDC has sponsored to gauge public sentiment about the vaccine. Authorities are adamant that vaccination will be voluntary, and they say there is no reason to think the vaccine will be any less safe than the usual flu vaccine. An adjuvant will be used only if necessary and proven safe, they say.
To address concerns of pregnant women and parents with young children, some vaccine is being produced without a mercury additive. And because the short-term studies can identify only common, immediate side effects, the CDC will step up monitoring for rarer, serious complications such as Guillain-Barré. "We're putting into place systems that are as good as we can have to identify problems quickly if they do occur," CDC Director Thomas R. Frieden said.
On Friday, officials reported that no "red flags regarding safety" had emerged in the clinical trials. "We are continuing oversight on the quality and safety of the vaccine being produced, and the production process itself," said Jesse Goodman of the FDA. "That's going well so far, but our oversight is continuing." In the meantime, local officials are drafting plans tailored to their communities. The shots in the arms and squirts up the nose will happen in schools, medical offices, hospitals, public health clinics, workplaces, drug stores and at mass vaccination events, possibly including drive-through clinics in parking lots where people would stick their arms out their car windows for a stab.
"It is clearly what we would call an all hands on deck," said James Blumenstock of the Association of State and Territorial Health Officials. "We're not starting from scratch, but we also don't have everything on the shelf that we can just pull off and put in place. It's a full-court press in moving forward to have everything in place when we're ready to go."
In Maryland, officials estimate that 2.9 million people fall into the priority groups for the vaccine; Virginia estimates the number at 2.5 million and the District at 225,000. The national total is about 159 million people.
Public health departments "have suffered from decades of neglect and are now facing a fiscal crisis in many places where they have had to lay staff off, or furlough staff or freeze hiring," Frieden said. "So H1N1 has not come at a particularly good time." Setting priorities for delivering the vaccines will bring other complications. The elderly, usually first in line for flu shots, will not be this time because they seem more resistant to the virus. But they remain a top priority for the seasonal shots. Schools considering giving shots to children are making plans to get permission from parents and have to determine how best to line up anxious, rambunctious students.
Everyone who gets a swine flu shot may need a booster several weeks later, potentially causing mix-ups about who got which shot when. But Frieden and other outside observers expressed confidence that the program would be safe and successful. The federal government has spent close to $2 billion to buy up to 195 million doses of vaccine and adjuvant, including the standard shots and the newer FluMist nasal spray vaccine made by MedImmune of Gaithersburg.
The government is prepared to buy enough to vaccinate every person -- 600 million doses all together -- if the pandemic or demand warrants it. That could increase the cost to $5 billion for the vaccine alone. It would cost at least $9 billion to administer the vaccine to the entire population, according to the Association of State and Territorial Health Officials.
Although five companies are racing to produce as much vaccine as possible, the first batches are not expected for two months, in part because the virus grew at about half the projected rate. Production appears to be increasing, but the first 45 million to 52 million doses -- about a third of what officials were anticipating -- won't be ready until mid-October, with about 20 million doses a week expected after that to continue the campaign through the winter. Experts are uncertain whether they will face a shortage of vaccine because of high demand or will have plenty of vaccine but little interest.
"People's enthusiasm will depend largely on what they see happening around them," Fauci said. "If we get into the fall season and we don't see an explosion of cases, people will be less enthusiastic. If they see a lot of young people and kids getting sick, people will be very enthusiastic about getting vaccinated."
The CDC is formulating a $4.8 million multimedia campaign to encourage people to get vaccinated and help alleviate concerns and confusion, including radio and television public service announcements, print ads, and messages delivered via Twitter, RSS feeds and video podcasts on YouTube. Although the vaccine will be free, providers could charge about $15 to administer it -- a fee that will be covered by Medicare and many health insurance plans.
Experts also worry the swine flu will divert attention from the seasonal flu, which can cause serious illness. Officials will launch the seasonal flu vaccine campaign Sept. 10 -- about a month early in the hopes of vaccinating as many people as possible before the swine flu campaign. The more people who get both vaccines, the less likely the swine flu virus will mingle with one of the others to produce a more dangerous mutant. "We really don't want those ugly viruses mixing together," said Kim Elliott of the Trust for America's Health, a private nonprofit research and advocacy group.
- The Washington Post
Sunday, 23 August 2009 07:52 Added by PT Editor Sarah Price
Washington, August 23, 2009, (Pal Telegraph) - Government health officials are mobilizing to launch a massive swine flu vaccination campaign this fall that is unprecedented in its scope -- and in the potential for complications.
The campaign aims to vaccinate at least half the country's population within months. Although more people have been inoculated against diseases such as smallpox and polio over a period of years, the United States has never tried to immunize so many so quickly.
But even as scientists rush to test the vaccine to ensure it is safe and effective, the campaign is lagging. Officials say only about a third as much vaccine as they had been expecting by mid-October is likely to arrive by then, when a new wave of infections could be peaking.
Among the unknowns: how many shots people will need, what the correct dosage should be, and how to avoid confusing the public with an overlapping effort to combat the regular seasonal flu.
To prepare, more than 2,800 local health departments have begun recruiting pediatricians, obstetricians, nurses, pharmacists, paramedics and even dentists, along with a small army of volunteers from churches and other groups. They are devising strategies to reach children, teenagers, pregnant women and young and middle-aged adults in inner cities, suburban enclaves and the countryside.
"This is potentially the largest mass-vaccination program in human history," said Howard Markel, a professor of medical history at the University of Michigan who is advising the Centers for Disease Control and Prevention as it spearheads the effort.Public health officials describe the effort as crucial to defend against the second wave of the Northern Hemisphere's first influenza pandemic in 41 years.
As schools reopen, the number of cases could jump sharply within weeks, sparking a second wave potentially far larger than the outbreak last spring. Although the swine flu appears no more dangerous than the typical seasonal flu, the new virus -- known as H1N1 -- is likely to infect many more people because most have no immunity against it.
The vaccine effort carries political risks for the Obama administration. "If the outbreak fizzles, they will be susceptible to being criticized for spending billions of dollars," said Harvey V. Fineberg, president of the National Academy of Sciences' Institute of Medicine, which advises Congress about medical issues. "On the other hand, if this outbreak is early and severe and there isn't enough vaccine, they'll be criticized for under-preparation."
Officials stress that they are proceeding cautiously. A final decision to move forward will not be made until they get the results of clinical trials -- testing to determine safety and dosing -- and assess the virus's threat. But officials are confident the vaccine will pass muster and expect a campaign will be launched as soon as manufacturers deliver the first vials.
"There's little doubt we're going to vaccinate people," said Anthony S. Fauci of the National Institute of Allergy and Infectious Diseases, who is leading the government's testing of the vaccine. "Who and when and exactly how -- we have to figure out."
The campaign is haunted by memories of the government's ill-fated 1976 effort to vaccinate against swine flu. The epidemic fizzled, but the vaccine was given to 40 million people and blamed for causing a rare paralyzing disorder known as Guillain-Barré Syndrome.Another wild card will be whether the vaccine will be delivered with an "adjuvant" to boost its effectiveness or stretch limited supplies into more doses. Adjuvants have been used in Europe, but the Food and Drug Administration has not authorized their use in the United States.
"This is an overreaction," said Barbara Loe Fisher of the National Vaccine Information Center, which opposes many vaccine policies. "There is no national security threat here. Why are we operating like this? This is not polio. This is not smallpox." Fears and misinformation about the vaccine are circulating, including inaccurate claims that it will be mandatory.
"I'm very concerned about the dangers of vaccines," said Janice Smith, 58, of Misawaka, Ind., who attended a public hearing Aug. 15, one of a series of meetings the CDC has sponsored to gauge public sentiment about the vaccine. Authorities are adamant that vaccination will be voluntary, and they say there is no reason to think the vaccine will be any less safe than the usual flu vaccine. An adjuvant will be used only if necessary and proven safe, they say.
To address concerns of pregnant women and parents with young children, some vaccine is being produced without a mercury additive. And because the short-term studies can identify only common, immediate side effects, the CDC will step up monitoring for rarer, serious complications such as Guillain-Barré. "We're putting into place systems that are as good as we can have to identify problems quickly if they do occur," CDC Director Thomas R. Frieden said.
On Friday, officials reported that no "red flags regarding safety" had emerged in the clinical trials. "We are continuing oversight on the quality and safety of the vaccine being produced, and the production process itself," said Jesse Goodman of the FDA. "That's going well so far, but our oversight is continuing." In the meantime, local officials are drafting plans tailored to their communities. The shots in the arms and squirts up the nose will happen in schools, medical offices, hospitals, public health clinics, workplaces, drug stores and at mass vaccination events, possibly including drive-through clinics in parking lots where people would stick their arms out their car windows for a stab.
"It is clearly what we would call an all hands on deck," said James Blumenstock of the Association of State and Territorial Health Officials. "We're not starting from scratch, but we also don't have everything on the shelf that we can just pull off and put in place. It's a full-court press in moving forward to have everything in place when we're ready to go."
In Maryland, officials estimate that 2.9 million people fall into the priority groups for the vaccine; Virginia estimates the number at 2.5 million and the District at 225,000. The national total is about 159 million people.
Public health departments "have suffered from decades of neglect and are now facing a fiscal crisis in many places where they have had to lay staff off, or furlough staff or freeze hiring," Frieden said. "So H1N1 has not come at a particularly good time." Setting priorities for delivering the vaccines will bring other complications. The elderly, usually first in line for flu shots, will not be this time because they seem more resistant to the virus. But they remain a top priority for the seasonal shots. Schools considering giving shots to children are making plans to get permission from parents and have to determine how best to line up anxious, rambunctious students.
Everyone who gets a swine flu shot may need a booster several weeks later, potentially causing mix-ups about who got which shot when. But Frieden and other outside observers expressed confidence that the program would be safe and successful. The federal government has spent close to $2 billion to buy up to 195 million doses of vaccine and adjuvant, including the standard shots and the newer FluMist nasal spray vaccine made by MedImmune of Gaithersburg.
The government is prepared to buy enough to vaccinate every person -- 600 million doses all together -- if the pandemic or demand warrants it. That could increase the cost to $5 billion for the vaccine alone. It would cost at least $9 billion to administer the vaccine to the entire population, according to the Association of State and Territorial Health Officials.
Although five companies are racing to produce as much vaccine as possible, the first batches are not expected for two months, in part because the virus grew at about half the projected rate. Production appears to be increasing, but the first 45 million to 52 million doses -- about a third of what officials were anticipating -- won't be ready until mid-October, with about 20 million doses a week expected after that to continue the campaign through the winter. Experts are uncertain whether they will face a shortage of vaccine because of high demand or will have plenty of vaccine but little interest.
"People's enthusiasm will depend largely on what they see happening around them," Fauci said. "If we get into the fall season and we don't see an explosion of cases, people will be less enthusiastic. If they see a lot of young people and kids getting sick, people will be very enthusiastic about getting vaccinated."
The CDC is formulating a $4.8 million multimedia campaign to encourage people to get vaccinated and help alleviate concerns and confusion, including radio and television public service announcements, print ads, and messages delivered via Twitter, RSS feeds and video podcasts on YouTube. Although the vaccine will be free, providers could charge about $15 to administer it -- a fee that will be covered by Medicare and many health insurance plans.
Experts also worry the swine flu will divert attention from the seasonal flu, which can cause serious illness. Officials will launch the seasonal flu vaccine campaign Sept. 10 -- about a month early in the hopes of vaccinating as many people as possible before the swine flu campaign. The more people who get both vaccines, the less likely the swine flu virus will mingle with one of the others to produce a more dangerous mutant. "We really don't want those ugly viruses mixing together," said Kim Elliott of the Trust for America's Health, a private nonprofit research and advocacy group.
- The Washington Post
WHO warns of swine flu pandemic's second wave
WHO warns of swine flu pandemic's second wave
PTI 23 August 2009, 08:00am IST
GENEVA: The World Health Organisation is urging the planet to brace for a second wave of the swine flu pandemic as the heavily populated northern hemisphere edges towards the cooler season when flu thrives.
"The WHO is still mobilised and worried," spokesman Gregory Hartl said as the global health watchdog kept an anxious eye on some "mysterious" patterns of illness associated with the new A (H1N1) virus that appeared in April.
Influenza traditionally surges to its peak during the northern autumn and winter. WHO Director General Margaret Chan warned on Friday that there had been second and third waves in previous pandemics. "We cannot say for certain whether the worst is over or the worst is yet to come," Chan said in a videotaped address to a symposium on flu in the Asia-Pacific region. "We need to be prepared for whatever surprises this capricious new virus delivers next," she added.
Some 1,799 people have died since the A(H1N1) was uncovered in Mexico and the United States nearly six months ago, according to the UN health agency. By comparison, an estimated 250,000 to 500,000 people die around the world every year from seasonal flu, and overall the symptoms of the new pandemic virus have proved to be mild in the great majority of known cases. However, it has spread swiftly into 177 countries, proving to be more infectious than seasonal flu and more durable through warmer months.
Through a full season in the southern hemisphere, the pandemic strain gradually became dominant. WHO monitoring showed that it was now on the decline there, except in South Africa, and in some later affected areas of Argentina, Australia and Chile.
Some 182,000 people worldwide are known to have caught swine flu based on laboratory confirmed cases, but the WHO has long advised countries to give up counting; the true number may in the millions, according to some experts. It is also striking those in a more physically fragile phase of life, such as pregnant women or the chronically ill, as well as those who are obese and younger age groups than usual. Many of the most severe cases are among 30 to 50 year -olds.
WHO officials are also mystified at the "most worrying" characteristic of this flu virus, Hartl explained. About 40 percent of the most severe or fatal cases occur in people who are in perfect health, he said. However, he was unable to say how many severe cases had occurred, although they are generally regarded as a small proportion of the outbreak so far.
PTI 23 August 2009, 08:00am IST
GENEVA: The World Health Organisation is urging the planet to brace for a second wave of the swine flu pandemic as the heavily populated northern hemisphere edges towards the cooler season when flu thrives.
"The WHO is still mobilised and worried," spokesman Gregory Hartl said as the global health watchdog kept an anxious eye on some "mysterious" patterns of illness associated with the new A (H1N1) virus that appeared in April.
Influenza traditionally surges to its peak during the northern autumn and winter. WHO Director General Margaret Chan warned on Friday that there had been second and third waves in previous pandemics. "We cannot say for certain whether the worst is over or the worst is yet to come," Chan said in a videotaped address to a symposium on flu in the Asia-Pacific region. "We need to be prepared for whatever surprises this capricious new virus delivers next," she added.
Some 1,799 people have died since the A(H1N1) was uncovered in Mexico and the United States nearly six months ago, according to the UN health agency. By comparison, an estimated 250,000 to 500,000 people die around the world every year from seasonal flu, and overall the symptoms of the new pandemic virus have proved to be mild in the great majority of known cases. However, it has spread swiftly into 177 countries, proving to be more infectious than seasonal flu and more durable through warmer months.
Through a full season in the southern hemisphere, the pandemic strain gradually became dominant. WHO monitoring showed that it was now on the decline there, except in South Africa, and in some later affected areas of Argentina, Australia and Chile.
Some 182,000 people worldwide are known to have caught swine flu based on laboratory confirmed cases, but the WHO has long advised countries to give up counting; the true number may in the millions, according to some experts. It is also striking those in a more physically fragile phase of life, such as pregnant women or the chronically ill, as well as those who are obese and younger age groups than usual. Many of the most severe cases are among 30 to 50 year -olds.
WHO officials are also mystified at the "most worrying" characteristic of this flu virus, Hartl explained. About 40 percent of the most severe or fatal cases occur in people who are in perfect health, he said. However, he was unable to say how many severe cases had occurred, although they are generally regarded as a small proportion of the outbreak so far.
How to fight flu spread
FACTBOX: How to fight flu spread
(Reuters) - The World Health Organization issued the following guidelines on Saturday about ways to prevent and fight flu, especially in poor areas where medical facilities may lack staff, beds and drugs:
SOCIAL DISTANCING
-- "Social distancing, respiratory etiquette, hand hygiene, and household ventilation, are at present the most feasible measures available to reduce or delay disease (morbidity) caused by pandemic influenza."
-- This includes keeping at least an arm's length distance from other people, minimizing public gatherings, and covering coughs and sneezes.
-- Once pandemic flu becomes widespread in a community, however, the WHO said that "interventions to isolate patients and quarantine contacts would probably be ineffective, not a good use of limited health resources, and socially disruptive."
-- "Routine mask use in public places should be permitted but is not expected to have an impact on disease prevention."
MILD CASES TREATED AT HOME
-- "During a pandemic, very high numbers of patients presenting to the health-care facility will necessitate home treatment," the WHO said.
-- "In the case of mild illness, patients should be provided with supportive care at home by a designated caregiver and only referred to health care facilities if they deteriorate or develop danger signs."
-- Such danger signs may include: weakness or inability to stand, lethargy, unconsciousness, convulsions, very difficult or obstructed breathing or shortness of breath, inability to drink fluids, high fever.
-- Treatment at home should entail rest, fluids, medication for fever, and good nutrition, with patients kept separate from other people except one designated carer who should wash their hands and household surfaces frequently.
-- It is more important in the home that the patient wears a mask than the caregiver. The mask need not be worn all day and only when close contact with the caregiver is anticipated.
-- If enough masks are available, caregivers should also use them to cover their mouth and nose during close contact.
-- Windows should be kept open to allow good ventilation.
IN HEALTH CLINICS:
-- Medical facilities with limited resources and beds should aggressively triage patients and ensure those with respiratory symptoms are kept separately from other patients
-- Essential medical services should be continued, while elective medical services should be temporarily suspended.
-- Admission criteria may change depending on bed availability, but should be reserved for severe cases most likely to benefit from treatment.
-- "Health facilities should anticipate a very high demand for treatment," the WHO said. "Based on current estimates, agencies should anticipate that up to 10 percent of those who fall ill may require inpatient treatment."
-- The WHO recommends this order of priority for antiviral drugs: a) treatment of sick health-care and other essential staff, b) treatment of sick individuals from the community, c) post-exposure treatment for essential staff at high risk, d) pre-exposure prophylaxis for critical staff with anticipated high-risk exposure
© Thomson Reuters 2009 All rights reserved
So far, no "red flags" seen in H1N1 vaccine
So far, no "red flags" seen in H1N1 vaccine
By Julie SteenhuysenCHICAGO (Reuters) - Clinical trials for the new swine flu vaccine have turned up no red flags, U.S. health officials said on Friday.
First results from studies of the new vaccines in adults and the elderly will be available in mid-September, but so far, the only complaints seem to be a bit of local soreness and redness in the arm at the injection site, they said.
"There are no red flags regarding safety," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, one of the National Institutes of Health.
Fauci said no side effects were seen 10 to 14 days after the first studies in adults, giving officials the confidence to start trials of the vaccines in children this week.
Two trials are under way in adults for the safety and effectiveness of two doses of the vaccine. The trials, which are also looking at whether one or two vaccinations will be needed, are nearly fully enrolled.
"We expect first dose data somewhere around mid-September if all goes well, and second dose data by mid-October," Fauci said in a telephone news briefing.
Fauci said studies in pregnant women should begin in September, as will studies using an immune system booster called an adjuvant. In all, the vaccines will be tested on nearly 4,600 people.
The U.S. Centers for Disease Control and Prevention said swine flu is still spreading widely across the United States, with 75 percent of serious cases and 60 percent of deaths among people under the age of 49. Alaska and Maine had "widespread" activity.
MORE THAN A MILLION CASES
CDC has confirmed 7,963 hospitalizations and 522 deaths from the pandemic H1N1 flu, said CDC's Dr. Jay Butler. He said there were likely more than a million actual cases, as most patients never get tested.
"It is important to remember that at this time of year we don't normally have influenza," Butler said.
He said the government expected to have 45 million to 52 million swine flu vaccine doses by mid October, when vaccination is expected to begin, and 195 million by the end of the year.
Fauci said even after people are vaccinated they should be aware they are not immediately protected -- the immune response from a vaccine takes about two weeks to develop.
Five companies are making both seasonal and H1N1 flu vaccines for the U.S. market -- AstraZeneca's MedImmune unit, CSL, GlaxoSmithKline Plc, Novartis AG and Sanofi-Aventis SA. Shares of all companies were up slightly in mid-afternoon trading on various exchanges.
Sanofi said on Friday it expects to deliver a bulk supply of H1N1 vaccine to the United States in October. The number of doses will depend on the vaccine's formula, which will be determined in October once clinical trial results are in.
Health officials said they expect an upsurge of flu cases in the autumn, as weather cools and students return to school. U.S. government officials have urged schools and businesses to encourage people to stay home when they are sick, to wash their hands frequently and keep workspaces clean.
"We can't stop the tide of flu any more than we can turn a hurricane in its course or stop the earth shaking during an earthquake, but we can mitigate the effects and help prevent people from becoming severely ill," Butler said.
(Editing by Phil Stewart)
(Additional reporting by Noelle Mennella in Paris)
Saturday, August 22, 2009
Swine Flu Shot May Protect at Regular Dose, Data Show (Update3)
Swine Flu Shot May Protect at Regular Dose, Data Show (Update3)
By Jason Gale
Aug. 22 (Bloomberg) -- A single standard dose of vaccine may be enough to protect most people against swine flu, according to preliminary research in China that suggests twice as many people as projected could receive the pandemic shot.
An experimental vaccine gave a protective immune response in 85 percent of adults who received an initial dose at the same strength used in seasonal flu shots, Xiaofeng Liang, director of the national immunization program at the Chinese Center for Disease Control and Prevention, told a meeting in Beijing today.
The results provide the earliest indication of the formula that Sanofi-Aventis SA, GlaxoSmithKline Plc and other drugmakers may need to use in making hundreds of millions of doses of vaccine to fight the new H1N1 influenza strain. Authorities in the U.S. and U.K. have predicted two shots would probably be needed, a regimen that would reduce the number of people who could be protected before the northern hemisphere’s winter.
“This is very promising information, and if we are able to get an immunogenic response with one dose as opposed to two doses, this would be a very significant change in our expectations,” Keiji Fukuda, the World Health Organization’s assistant director-general of health security and environment, told the meeting. “Up until now, most of us have been thinking that two doses would be necessary to develop an immunogenic response.”
Health officials are awaiting more data from China, as well as studies overseas, to confirm the results. More results will become available in mid September, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, told reporters yesterday.
‘Waiting Anxiously’
“We are waiting anxiously for the immunogenicity data to get a better handle on how well one dose and two doses might work,” Ira Longini, a University of Washington statistician who advises the U.S. government on flu, told the Beijing meeting today. “It may turn out that one is sufficient. Then we could obviously get a lot more vaccine into people much faster. It could essentially double the supply.”
The China data are based on interim results from two of the 10 companies conducting studies in the country on vaccines to fight the new H1N1 virus. The first of the 13,000 test subjects to receive an experimental shot were vaccinated on July 22 and none had a serious adverse reaction to it, Liang said.
Chinese Studies
Several vaccine types and strengths are being tested in seven provinces of China across four age groups in studies supervised by the country’s CDC, he said.
The trials are assessing the safety and effectiveness of at least three different vaccine strengths in single or two-dose programs, and involving inoculations based on whole and split viral particles, he said. The studies also looked at whether an aluminum-based chemical called an adjuvant boosted the body’s ability to produce infection-fighting antibodies.
Vaccines produced annually for seasonal flu combine 15 micrograms of antigen -- the protein that prompts the production of antibodies -- from each of the three most common influenza strains.
Liang said that a similar dose may be needed to protect most people against the pandemic strain.
“Adolescents and adults had a better response than children and the elderly,” he said. “Taking into consideration the safety, immunogenicity and the cost, a 15-microgram, split vaccine without adjuvant could be used for future vaccination.”
No data is available in children younger than 3, Liang said. A final decision on whether one or two doses will be required to provide protection across all age groups in China won’t be taken until all the data has been collected and analyzed, he said.
Sinovac Biotech, CSL
Sinovac Biotech Co., a Beijing-based company created in 2001 to make immunizations for hepatitis, said last week that its H1N1 vaccine was safe and protected people against the pandemic virus after a single shot. The announcement was based on preliminary results from a study involving 1,614 volunteers.
CSL Ltd., the southern hemisphere’s only flu vaccine maker, expects preliminary results on the first dose of its vaccine next week, Rachel David, a company spokeswoman, said last week. No severe adverse reactions have been observed so far, and the Melbourne-based company plans to submit the data to the Australian government on Sept. 4, she said.
To contact the reporter on this story: Jason Gale in Beijing at j.gale@bloomberg.net
By Jason Gale
Aug. 22 (Bloomberg) -- A single standard dose of vaccine may be enough to protect most people against swine flu, according to preliminary research in China that suggests twice as many people as projected could receive the pandemic shot.
An experimental vaccine gave a protective immune response in 85 percent of adults who received an initial dose at the same strength used in seasonal flu shots, Xiaofeng Liang, director of the national immunization program at the Chinese Center for Disease Control and Prevention, told a meeting in Beijing today.
The results provide the earliest indication of the formula that Sanofi-Aventis SA, GlaxoSmithKline Plc and other drugmakers may need to use in making hundreds of millions of doses of vaccine to fight the new H1N1 influenza strain. Authorities in the U.S. and U.K. have predicted two shots would probably be needed, a regimen that would reduce the number of people who could be protected before the northern hemisphere’s winter.
“This is very promising information, and if we are able to get an immunogenic response with one dose as opposed to two doses, this would be a very significant change in our expectations,” Keiji Fukuda, the World Health Organization’s assistant director-general of health security and environment, told the meeting. “Up until now, most of us have been thinking that two doses would be necessary to develop an immunogenic response.”
Health officials are awaiting more data from China, as well as studies overseas, to confirm the results. More results will become available in mid September, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, told reporters yesterday.
‘Waiting Anxiously’
“We are waiting anxiously for the immunogenicity data to get a better handle on how well one dose and two doses might work,” Ira Longini, a University of Washington statistician who advises the U.S. government on flu, told the Beijing meeting today. “It may turn out that one is sufficient. Then we could obviously get a lot more vaccine into people much faster. It could essentially double the supply.”
The China data are based on interim results from two of the 10 companies conducting studies in the country on vaccines to fight the new H1N1 virus. The first of the 13,000 test subjects to receive an experimental shot were vaccinated on July 22 and none had a serious adverse reaction to it, Liang said.
Chinese Studies
Several vaccine types and strengths are being tested in seven provinces of China across four age groups in studies supervised by the country’s CDC, he said.
The trials are assessing the safety and effectiveness of at least three different vaccine strengths in single or two-dose programs, and involving inoculations based on whole and split viral particles, he said. The studies also looked at whether an aluminum-based chemical called an adjuvant boosted the body’s ability to produce infection-fighting antibodies.
Vaccines produced annually for seasonal flu combine 15 micrograms of antigen -- the protein that prompts the production of antibodies -- from each of the three most common influenza strains.
Liang said that a similar dose may be needed to protect most people against the pandemic strain.
“Adolescents and adults had a better response than children and the elderly,” he said. “Taking into consideration the safety, immunogenicity and the cost, a 15-microgram, split vaccine without adjuvant could be used for future vaccination.”
No data is available in children younger than 3, Liang said. A final decision on whether one or two doses will be required to provide protection across all age groups in China won’t be taken until all the data has been collected and analyzed, he said.
Sinovac Biotech, CSL
Sinovac Biotech Co., a Beijing-based company created in 2001 to make immunizations for hepatitis, said last week that its H1N1 vaccine was safe and protected people against the pandemic virus after a single shot. The announcement was based on preliminary results from a study involving 1,614 volunteers.
CSL Ltd., the southern hemisphere’s only flu vaccine maker, expects preliminary results on the first dose of its vaccine next week, Rachel David, a company spokeswoman, said last week. No severe adverse reactions have been observed so far, and the Melbourne-based company plans to submit the data to the Australian government on Sept. 4, she said.
To contact the reporter on this story: Jason Gale in Beijing at j.gale@bloomberg.net
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