WHO supports fair access to influenza A (H1N1) vaccine. An interview with Marie-Paule Kieny
WHO/L Solberg
Dr Marie-Paule Kieny
Dr Marie-Paule Kieny is director of the Initiative for Vaccine Research at the World Health Organization (WHO). She received a degree in Economics in 1977, followed by a PhD in microbiology in 1980, both from the University of Montpellier in France. Her research career began with the development of a recombinant rabies vaccine. Since then, she has worked on the design of AIDS vaccine candidates and done research on cancer immuno-gene therapy, targeting mainly breast and cervical cancers. She has also served on several expert committees on vaccine discovery, AIDS and cancer research.
The vast majority of cases of pandemic influenza A (H1N1) have been mild so far with few deaths. It remains to be seen whether the virus will mutate into a more virulent strain. Marie-Paule Kieny explains how WHO is supporting countries’ efforts to protect their populations with vaccines that should become available as of this month.
Q: When will the first doses of vaccine for the pandemic influenza A (H1N1) be ready?
A: Some manufacturers announced in July that vaccine is available, but that doesn’t mean it’s ready for use, as it needs regulatory approval. Regulatory authorities are considering the best way to register these vaccines as quickly as possible. The consensus is that the first doses will be available to governments for use in September.
Q: Who will get vaccinated first? Who decides this?
A: Vaccine will not be available on the private market and governments will decide who gets vaccinated first. WHO recommends that health workers be the first, to protect the health system and allow them to care for influenza and other patients. The strategy a country takes will depend on its policy objectives and the availability of vaccine. For example, if a country decides to concentrate on protecting essential infrastructure, it may target different people, such as truck drivers, if they are critical for food delivery. Others may try to reduce transmission of the virus. For example, the United States of America decided to immunize children before or at school entry who are in closer physical contact than adults and can amplify infection rates. Countries may also try to reduce morbidity and mortality and target specific groups, such as pregnant women. Some high-income countries have ordered enough vaccine for the whole population. Nevertheless, no countries will have vaccine for everyone from the first day it is available for use, so that each country will need to prioritize. Some middle-income countries have also placed contracts with pharmaceutical companies and have been purchasing vaccine for between 1% and 10–20% of the population. WHO is working hard with manufacturers, governments and donors to ensure that developing countries can access vaccine as soon as possible to immunize their health workers, and when more vaccine becomes available, other groups will be immunized.
Q: How are influenza vaccines produced?
A: The main method is by injecting seed virus into embryonic chicken eggs and harvesting the fluid after several days and purifying it. There are two technologies. More than 90% of influenza vaccines available are known as “inactivated vaccines”, which means you kill the virus to produce the vaccine. Less common are “live attenuated vaccines”, which are derived from a weakened form of the virus that is not killed.
Q: How many different vaccine candidates will be available for A (H1N1)?
A: About 30. Most will be inactivated virus vaccines made in eggs, some will be killed virus vaccines made in cell cultures and a few will be live attenuated virus vaccines. Then you have a lot of variation in the way vaccine is purified and in whether or not it is mixed with an additive, called an adjuvant, which is a booster of immunogenicity (which is the capacity of a vaccine to evoke an immune response) and which is used with killed virus vaccine. All vaccines create antibodies to fight the virus; some will produce a local response, such as attenuated vaccine administered in the nose to give more immunity at the port of entry of the virus. The industry will use tiered pricing, so high-income countries might pay between US$ 10–20 per dose, middle-income countries may pay about half that and low-income half that price again. These are ballpark figures but this is the order of magnitude.
Q: Isn’t it too early to produce vaccines because the pandemic virus could mutate?
A: Although the virus can mutate, we hope that there will be enough cross-protection through recognition of the new virus. But if the virus changes too much, we will need new vaccines.
Q: WHO has recommended the use of adjuvant in pandemic vaccines, but some countries don’t plan to follow this guidance.
A: Many countries, including the USA, have not licensed vaccines with adjuvants of any kind yet. Other vaccines with the same type of adjuvant as planned for pandemic influenza A (H1N1) vaccines have, however, been licensed in European countries. Countries that intend to use vaccine with adjuvant will find that there is a large body of safety data for adults and some for children. In any case, all countries will need to carry out good post-marketing surveillance to make sure that they pick up any early sign of a safety problem with a particular vaccine.
Q: These must be the fastest vaccines ever produced. Given their fast-tracking, what is the guarantee of safety and efficacy?
A: The testing of influenza vaccines is different from that of other vaccines, because the rabies and measles vaccines for example do not change. Since influenza viruses evolve constantly, it is impossible to carry out a complete clinical analysis of seasonal influenza vaccines yearly because the composition changes each year to adapt to the virus and so you are always a year behind. A complete clinical evaluation is not needed also because manufacturers produce seasonal influenza vaccines using the same procedure and equipment, but for a different virus each year. In the USA, vaccines for seasonal influenza are licensed without clinical trials on the basis of a “strain change”. The US regulatory authorities consider the change from seasonal to pandemic H1N1 influenza vaccine production (using the same procedure) as a change in the strain and therefore will not request clinical trials before registration. Having said that, all manufacturers will perform clinical trials to find out whether one or two doses are necessary, to test it in special populations and to administer it jointly with other vaccines. In Europe, a strain change is accompanied by a small clinical trial requested by the European Medicines Agency. In the last couple of years, manufacturers in the European Union registered “mock-up” or prototype H5N1 bird flu vaccines as nobody knows which H5N1 strain might become a pandemic strain. Manufacturers made clinical batches of an H5N1 vaccine with virus stocks from China, Indonesia and Viet Nam. They carried out clinical trials and submitted the results to the regulatory authorities who said the vaccines were fine. They are not allowed to sell H5N1 vaccines, since there is no H5N1 pandemic, but they can use the same procedure to make H1N1 pandemic vaccine. That way they can get a licence in a few days. This is another way vaccines can be licensed without clinical trials, while still ensuring safety on the basis of what is known about influenza vaccines. Based on the extensive knowledge available on seasonal vaccines and the results obtained through evaluation of H5N1 avian influenza vaccines, there is no doubt that it will be possible to make effective H1N1 pandemic vaccines.
Q: What’s been done to ensure that developing countries get enough vaccine?
A: It depends on what we mean by “enough”. Some countries want to vaccinate every member of the population, but there is no way we can do this for the whole world. WHO has a cross-organizational operation that is in place to secure vaccines for developing countries. This is spearheaded by the Director-General’s Office and the legal and vaccine departments. We are engaged in three types of activities. The first is to negotiate donations with manufacturers. Two have been announced: 100 million doses by sanofi-aventis and 50 million doses from GlaxoSmithKline. Second, we are working with other manufacturers to reserve a portion of their vaccine production for WHO at a reduced price. Third, we are working with governments to raise funds to purchase vaccines. We are also working with 11 vaccine manufacturers based in developing countries, providing them with seed financing and technical expertise to help them produce influenza vaccine domestically. We have also helped them access technology and given them sub-licences to use technology for producing live attenuated vaccine. These 11 companies will be manufacturing some of the 30 different expected vaccines.
Q: What happens if developing countries have only partial coverage?
A: Coverage will be partial and not only in developing countries. But we should not be “hypnotized” by vaccines. There are other measures, such as social distancing, school closure, avoidance of large gatherings, antibiotics and personal hygiene. This is not like rabies, which is 100% fatal: we are talking about a disease from which most people recover very well. We will try to help countries to gain access to as much vaccine as possible, at least to preserve their health systems functioning, but there is just not enough vaccine for every country in the world to vaccinate every member of the population twice. ■
Showing posts with label H1N1. Show all posts
Showing posts with label H1N1. Show all posts
Sunday, September 06, 2009
Sunday, August 23, 2009
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
WHO seeks flu vaccine donations for poorer nations
WHO seeks flu vaccine donations for poorer nations
By GILLIAN WONG (AP) – 2 hours ago
BEIJING — The World Health Organization's flu chief urged drug makers on Saturday to donate swine flu vaccines to the world's poorest countries, which are more vulnerable in the fight against the pandemic.
Dr. Keiji Fukuda said the agency is working hard to lobby the world's rich nations and flu vaccine makers for donations.
"It is clear that the poorest countries in general are just the most vulnerable to any number of diseases, and so it is a big concern," Fukuda said on the sidelines of a symposium of health officials and experts in Beijing. "We're continually hoping that more of the companies will step up and agree to donate more of the vaccine."
WHO says the swine flu virus — also known as H1N1 — has killed almost 1,800 people worldwide as of Aug. 13.
For the moment, swine flu is generally mild and most people recover without needing treatment. But it could have a more devastating impact in countries where populations are also fighting AIDS, malaria, tuberculosis and other diseases.
Many rich countries like Britain, Canada and France have orders for flu vaccines to cover their entire populations. But most developing countries have no such plans.
Health officials and drug makers are considering how to speed up vaccine production before the northern hemisphere enters its flu season in coming months. Estimates for when a vaccine will be available range from September to December.
Fukuda said WHO chief Margaret Chan has met with drug makers to appeal directly, but so far only two companies, GlaxoSmithKline PLC of Britain and Sanofi-Aventis of France, have pledged to donate 150 million doses to developing countries.
Novartis AG of Switzerland has said it is looking at selling vaccines to those countries at discounted prices.
Fukuda said WHO is also exploring other options such as negotiating for the vaccines to be sold at lower prices to poorer countries and helping them set up their own production facilities.
WHO Western Pacific director Shin Young-soo said Friday he hoped China, where 10 drug makers are conducting clinical trials of flu vaccines expected to be completed by mid-September, could play a part in helping poorer countries.
Once cold weather returns to the northern hemisphere, many countries could see swine flu cases double every three to four days for several months until peak transmission is reached, Shin said.
Copyright © 2009 The Associated Press. All rights reserved.
By GILLIAN WONG (AP) – 2 hours ago
BEIJING — The World Health Organization's flu chief urged drug makers on Saturday to donate swine flu vaccines to the world's poorest countries, which are more vulnerable in the fight against the pandemic.
Dr. Keiji Fukuda said the agency is working hard to lobby the world's rich nations and flu vaccine makers for donations.
"It is clear that the poorest countries in general are just the most vulnerable to any number of diseases, and so it is a big concern," Fukuda said on the sidelines of a symposium of health officials and experts in Beijing. "We're continually hoping that more of the companies will step up and agree to donate more of the vaccine."
WHO says the swine flu virus — also known as H1N1 — has killed almost 1,800 people worldwide as of Aug. 13.
For the moment, swine flu is generally mild and most people recover without needing treatment. But it could have a more devastating impact in countries where populations are also fighting AIDS, malaria, tuberculosis and other diseases.
Many rich countries like Britain, Canada and France have orders for flu vaccines to cover their entire populations. But most developing countries have no such plans.
Health officials and drug makers are considering how to speed up vaccine production before the northern hemisphere enters its flu season in coming months. Estimates for when a vaccine will be available range from September to December.
Fukuda said WHO chief Margaret Chan has met with drug makers to appeal directly, but so far only two companies, GlaxoSmithKline PLC of Britain and Sanofi-Aventis of France, have pledged to donate 150 million doses to developing countries.
Novartis AG of Switzerland has said it is looking at selling vaccines to those countries at discounted prices.
Fukuda said WHO is also exploring other options such as negotiating for the vaccines to be sold at lower prices to poorer countries and helping them set up their own production facilities.
WHO Western Pacific director Shin Young-soo said Friday he hoped China, where 10 drug makers are conducting clinical trials of flu vaccines expected to be completed by mid-September, could play a part in helping poorer countries.
Once cold weather returns to the northern hemisphere, many countries could see swine flu cases double every three to four days for several months until peak transmission is reached, Shin said.
Copyright © 2009 The Associated Press. All rights reserved.
Swine flu: Why shutting schools, malls is not necessary
Saturday, August 22, 2009 8:40:00 AM
Manjula Pooja Shroff / DNA
Many more people die in road accidents and from malaria and even childbirth than from swine flu. Yet, the scare of swine flu is gripping India a little more each day. A lack of complete information is adding to our fears. Quick communication and travel across continents is causing panic and spread of the virus. Today, we have more information about swine flu than was known about previous pandemics.
There are many reasons not to press the panic button on the H1N1 virus. The primary reason is due to its inherent nature of low fatality. Out the two lakh or more cases reported across the world, deaths are less than 1 per cent. Swine flu is not a killer virus like tuberculosis, the death rate of which is 3.5 per cent. The symptoms are moderate. The flu causes aches and pains that painkillers, under doctors’ guidance, can be taken care of.
Once the flu is gone, there are no lingering pains like in chikungunia, nor is there a slow recovery. It’s a short-duration illness, lasting from two to three days up to a week. There is no need for intravenous injections or saline drips if there is ample bed rest and lots of fluid. There is complete recovery, though there may be general weakness connected to the fever, but there is the advantage of the fever strengthening the immunity to the virus.
It is the panic that creates the complications. This widespread panic is causing places of congregation such as schools, movie theatres and malls to close for a few days. If the reports stating that pandemics last for about two years, that they occur in waves and that each wave lasts for six to eight years and may be separated by three to six months are true, closing schools for a week or two is neither here nor there.
However, creating awareness and guiding documents to keep students and parents informed of strategies to reduce occurrences is completely in order, since kids are more susceptible because of their relatively low immunity and the likelihood of them passing the virus on to others. It is being quoted in the World Health Organisation that in India the flu panic spreads faster than the virus. It is also being said that the frenzy and hysteria are disproportionate to the reality, since it is a low-fatality virus.
Boosting immunity and taking precautionary measures seem like the best way out. Proper food, proper sleep, supplements for immunity booster are being recommended. Organisations and school awareness camps are spreading information on protective measures that include social distances like reducing handshakes or hugs as a way of greeting.
Surgical masks or respirators maybe useful when directly exposed to the virus like when caring for a sick member of the family, but can we visualise a world where everyone wears masks for the next two odd years?
Hygiene and hand sanitising are a global movement. Keeping hands clean at all times by routine washes with alcohol-based products saves us from the millions of freewheeling bacteria whether air- or waterborne. Swine flu or not, it’s a good habit.
Previous global outbreaks of serious illnesses or pandemics have been reported in the years 1918, 1975 and 1968. Most experts agree that the next pandemic was expected in the first decade of 2000. Since it occurs three or four times in a century, we were long overdue! The WHO’s Influenza Centre does not know precisely how the pandemic will unfold. For the moment, India is in a more neutral zone since the flu strain is more rampant in Argentine, Australia, Brazil, Chile and New Zealand.
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© 2005-2009 Diligent Media Corporation Ltd. All rights reserved.
Manjula Pooja Shroff / DNA
Many more people die in road accidents and from malaria and even childbirth than from swine flu. Yet, the scare of swine flu is gripping India a little more each day. A lack of complete information is adding to our fears. Quick communication and travel across continents is causing panic and spread of the virus. Today, we have more information about swine flu than was known about previous pandemics.
There are many reasons not to press the panic button on the H1N1 virus. The primary reason is due to its inherent nature of low fatality. Out the two lakh or more cases reported across the world, deaths are less than 1 per cent. Swine flu is not a killer virus like tuberculosis, the death rate of which is 3.5 per cent. The symptoms are moderate. The flu causes aches and pains that painkillers, under doctors’ guidance, can be taken care of.
Once the flu is gone, there are no lingering pains like in chikungunia, nor is there a slow recovery. It’s a short-duration illness, lasting from two to three days up to a week. There is no need for intravenous injections or saline drips if there is ample bed rest and lots of fluid. There is complete recovery, though there may be general weakness connected to the fever, but there is the advantage of the fever strengthening the immunity to the virus.
It is the panic that creates the complications. This widespread panic is causing places of congregation such as schools, movie theatres and malls to close for a few days. If the reports stating that pandemics last for about two years, that they occur in waves and that each wave lasts for six to eight years and may be separated by three to six months are true, closing schools for a week or two is neither here nor there.
However, creating awareness and guiding documents to keep students and parents informed of strategies to reduce occurrences is completely in order, since kids are more susceptible because of their relatively low immunity and the likelihood of them passing the virus on to others. It is being quoted in the World Health Organisation that in India the flu panic spreads faster than the virus. It is also being said that the frenzy and hysteria are disproportionate to the reality, since it is a low-fatality virus.
Boosting immunity and taking precautionary measures seem like the best way out. Proper food, proper sleep, supplements for immunity booster are being recommended. Organisations and school awareness camps are spreading information on protective measures that include social distances like reducing handshakes or hugs as a way of greeting.
Surgical masks or respirators maybe useful when directly exposed to the virus like when caring for a sick member of the family, but can we visualise a world where everyone wears masks for the next two odd years?
Hygiene and hand sanitising are a global movement. Keeping hands clean at all times by routine washes with alcohol-based products saves us from the millions of freewheeling bacteria whether air- or waterborne. Swine flu or not, it’s a good habit.
Previous global outbreaks of serious illnesses or pandemics have been reported in the years 1918, 1975 and 1968. Most experts agree that the next pandemic was expected in the first decade of 2000. Since it occurs three or four times in a century, we were long overdue! The WHO’s Influenza Centre does not know precisely how the pandemic will unfold. For the moment, India is in a more neutral zone since the flu strain is more rampant in Argentine, Australia, Brazil, Chile and New Zealand.
About us
Contact us
Advertise with us
Subscription
Reprint rights
© 2005-2009 Diligent Media Corporation Ltd. All rights reserved.
Swine flu vaccine shows no adverse effects
Swine flu vaccine shows no adverse effects
By Tom Corwin
Staff Writer
Saturday, August 22, 2009
While testing continues on a vaccine against the novel influenza A H1N1 vaccine, the vaccine has not produced any significant adverse events in adults, federal health officials said Friday.
"There are no red flags regarding safety," said Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.
The clinical trials began in older adults Aug. 7 and because there were no significant events, testing began in children ages 6 months to 17 years old this week. First dose results are expected in mid-September and second dose results are expected in mid-October from the older adults, Dr. Fauci said.
Between 45 and 52 million doses of the novel H1N1 vaccine will be available by mid-October and will be distributed to states based on population, said Jay Butler, the director of H1N1 Vaccine Task Force at the Centers for Disease Control and Prevention.
More of the vaccine is expected to come in on a weekly basis and the federal government expects to get 195 million doses by the end of the year, Dr. Butler said.
The novel H1N1 vaccine is being distributed through the Vaccine For Children program by the states and is targeting vaccination in five primary groups:
- Pregnant women
- Those who live with an infant younger than 6 months (which is too young to vaccinate)
- Health care workers and emergency medical services personnel
- Those 6 months to 24 years old
- Adults with underlying health problems that put them at greater risk for complications from flu, such as diabetes or lung disease
To date, 7,963 people have been hospitalized and 522 have died from lab-confirmed cases of the new virus, Dr. Butler said.About 75 percent of the hospitalizations and 60 percent of the deaths have been in people younger than 49, he said.
"It's important to keep in mind that these numbers radically underestimate the number of cases that actually occur, because many cases go without testing, and in many areas, there is not routine testing of people who are not sick enough to require hospitalization," Dr. Butler said. He did not offer a new estimate but said the cases likely exceed the 1 million estimated earlier this year.
The vaccine against the new virus is important but so are other preventive measures, such as frequent hand washing, cough and sneeze etiquette and staying home if sick, Dr. Butler said."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 by preparing well and acting effectively," he said.
Reach Tom Corwin at (706) 823-3213 (706) 823-3213 or tom.corwin@augustachronicle.com.
CLINICAL TRIALS
There is a still a chance for infants and the elderly to participate in clinical trials at Emory University of the novel influenza A H1N1 vaccine. Emory is one of eight centers in the country helping to test the vaccine against the new virus and is looking at the optimal way to give the new vaccine in conjunction with the seasonal flu vaccine, either before, with or after the seasonal flu shot. Emory is still looking for volunteers ages 6 months to 36 months and those 65 and older.For more information about the H1N1 vaccine trials at Emory, call (877) 424-HOPE (877) 424-HOPE (4673) for the senior studies.
Or call (404) 727-4044 (404) 727-4044 for the pediatric studies, or e-mail vaccinestudy@emory.edu
By Tom Corwin
Staff Writer
Saturday, August 22, 2009
While testing continues on a vaccine against the novel influenza A H1N1 vaccine, the vaccine has not produced any significant adverse events in adults, federal health officials said Friday.
"There are no red flags regarding safety," said Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.
The clinical trials began in older adults Aug. 7 and because there were no significant events, testing began in children ages 6 months to 17 years old this week. First dose results are expected in mid-September and second dose results are expected in mid-October from the older adults, Dr. Fauci said.
Between 45 and 52 million doses of the novel H1N1 vaccine will be available by mid-October and will be distributed to states based on population, said Jay Butler, the director of H1N1 Vaccine Task Force at the Centers for Disease Control and Prevention.
More of the vaccine is expected to come in on a weekly basis and the federal government expects to get 195 million doses by the end of the year, Dr. Butler said.
The novel H1N1 vaccine is being distributed through the Vaccine For Children program by the states and is targeting vaccination in five primary groups:
- Pregnant women
- Those who live with an infant younger than 6 months (which is too young to vaccinate)
- Health care workers and emergency medical services personnel
- Those 6 months to 24 years old
- Adults with underlying health problems that put them at greater risk for complications from flu, such as diabetes or lung disease
To date, 7,963 people have been hospitalized and 522 have died from lab-confirmed cases of the new virus, Dr. Butler said.About 75 percent of the hospitalizations and 60 percent of the deaths have been in people younger than 49, he said.
"It's important to keep in mind that these numbers radically underestimate the number of cases that actually occur, because many cases go without testing, and in many areas, there is not routine testing of people who are not sick enough to require hospitalization," Dr. Butler said. He did not offer a new estimate but said the cases likely exceed the 1 million estimated earlier this year.
The vaccine against the new virus is important but so are other preventive measures, such as frequent hand washing, cough and sneeze etiquette and staying home if sick, Dr. Butler said."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 by preparing well and acting effectively," he said.
Reach Tom Corwin at (706) 823-3213 (706) 823-3213 or tom.corwin@augustachronicle.com.
CLINICAL TRIALS
There is a still a chance for infants and the elderly to participate in clinical trials at Emory University of the novel influenza A H1N1 vaccine. Emory is one of eight centers in the country helping to test the vaccine against the new virus and is looking at the optimal way to give the new vaccine in conjunction with the seasonal flu vaccine, either before, with or after the seasonal flu shot. Emory is still looking for volunteers ages 6 months to 36 months and those 65 and older.For more information about the H1N1 vaccine trials at Emory, call (877) 424-HOPE (877) 424-HOPE (4673) for the senior studies.
Or call (404) 727-4044 (404) 727-4044 for the pediatric studies, or e-mail vaccinestudy@emory.edu
INTERVIEW-Sanofi says on target to honor H1N1 vaccine orders
INTERVIEW-Sanofi says on target to honor H1N1 vaccine orders
Friday August 21, 2009 05:02:18 PM GMT
SANOFI-VACCINES/(INTERVIEW)
* Expects to send U.S. H1N1 vaccine in Oct-flu specialist
* Says will fill French contract on time
* U.S. vaccine to be sent in bulk
* Says virus strength stable
By Noelle Mennella
PARIS, Aug 21 (Reuters) - Sanofi-Aventis, the world leader in flu immunisation, said on Friday it was reasonably comfortable it would be able honour its contract to supply H1N1 swine flu vaccines to the United States in October.
Albert Garcia, an epidemiologist and flu vaccine specialist who acts as the company's spokesman, told Reuters in an interview that the company would also fill France's order of doses between November and early December, as planned.
The French drug maker's vaccine unit Sanofi Pasteur has a $250 million contract to provide the U.S. with the swine flu antigen in bulk.
The number of doses the U.S. will get will depend on the vaccine's formula, which will be determined by clinical trials expected to end in October.
"The United States wanted doses as of September. We are reasonably expecting to deliver in October doses in bulk, not in ready-to-use form," Garcia said in a telephone interview.
"At that time (in October), we will be able to determine the formula and obtain the necessary authorisations to sell on the market."
Governments have been putting pressure on drugs groups to come up with effective vaccines against swine flu in months, rather than years.
Sales of vaccines to contain the swine flu pandemic are expected to provide a windfall for the global drugs industry, generating billions of dollars of extra revenues at the end of this year and next, analysts have predicted.
Sanofi-Aventuis and other drugs groups, including U.S.-based Baxter, Britain's GSK and Switzerland's Novartis have been racing since June to meet orders from various countries.
GOVERNMENT PRESSURE
The World Health Organisation gave pharmaceutical groups the virus strain at the end of May. Since then, they have been using chicken eggs to cultivate the vaccine's active agents, the antigen that will enable patients to develop antibodies.
"Governments are putting pressure on us so that we deliver the doses as early as possible but cannot go faster than the wind," Garcia said.
Last week, U.S. authorities cut the amount of swine flu vaccines they expected to use as part of an immunisation campaign scheduled for this autumn.
Sanofi Pasteur's renewable contract with France is for 28 million doses.
Asked if the swine flu virus could mutate, which would render ineffective the vaccines currently being prepared, Garcia said:
"All flu viruses mutate and this happens very slowly. The H1N1 virus is being monitored. For the moment, it is continuing to progress but its virulence is still what it was a few weeks ago."
France is the world's leading producer of vaccines. The global vaccine market is estimated to be worth 10 billion euros in annual revenues, of which France makes up 570 million euros. (Writing by Astrid Wendlandt; editing by Karen Foster)
Friday August 21, 2009 05:02:18 PM GMT
SANOFI-VACCINES/(INTERVIEW)
* Expects to send U.S. H1N1 vaccine in Oct-flu specialist
* Says will fill French contract on time
* U.S. vaccine to be sent in bulk
* Says virus strength stable
By Noelle Mennella
PARIS, Aug 21 (Reuters) - Sanofi-Aventis, the world leader in flu immunisation, said on Friday it was reasonably comfortable it would be able honour its contract to supply H1N1 swine flu vaccines to the United States in October.
Albert Garcia, an epidemiologist and flu vaccine specialist who acts as the company's spokesman, told Reuters in an interview that the company would also fill France's order of doses between November and early December, as planned.
The French drug maker's vaccine unit Sanofi Pasteur has a $250 million contract to provide the U.S. with the swine flu antigen in bulk.
The number of doses the U.S. will get will depend on the vaccine's formula, which will be determined by clinical trials expected to end in October.
"The United States wanted doses as of September. We are reasonably expecting to deliver in October doses in bulk, not in ready-to-use form," Garcia said in a telephone interview.
"At that time (in October), we will be able to determine the formula and obtain the necessary authorisations to sell on the market."
Governments have been putting pressure on drugs groups to come up with effective vaccines against swine flu in months, rather than years.
Sales of vaccines to contain the swine flu pandemic are expected to provide a windfall for the global drugs industry, generating billions of dollars of extra revenues at the end of this year and next, analysts have predicted.
Sanofi-Aventuis and other drugs groups, including U.S.-based Baxter, Britain's GSK and Switzerland's Novartis have been racing since June to meet orders from various countries.
GOVERNMENT PRESSURE
The World Health Organisation gave pharmaceutical groups the virus strain at the end of May. Since then, they have been using chicken eggs to cultivate the vaccine's active agents, the antigen that will enable patients to develop antibodies.
"Governments are putting pressure on us so that we deliver the doses as early as possible but cannot go faster than the wind," Garcia said.
Last week, U.S. authorities cut the amount of swine flu vaccines they expected to use as part of an immunisation campaign scheduled for this autumn.
Sanofi Pasteur's renewable contract with France is for 28 million doses.
Asked if the swine flu virus could mutate, which would render ineffective the vaccines currently being prepared, Garcia said:
"All flu viruses mutate and this happens very slowly. The H1N1 virus is being monitored. For the moment, it is continuing to progress but its virulence is still what it was a few weeks ago."
France is the world's leading producer of vaccines. The global vaccine market is estimated to be worth 10 billion euros in annual revenues, of which France makes up 570 million euros. (Writing by Astrid Wendlandt; editing by Karen Foster)
Friday, August 21, 2009
The Associated Press: WHO: No Tamiflu for healthy people with swine flu
The Associated Press: WHO: No Tamiflu for healthy people with swine flu: "WHO: No Tamiflu for healthy people with swine flu
(AP) – 1 hour ago
LONDON — The World Health Organization says healthy people who catch swine flu don't need antiviral drugs like Tamiflu.
In new advice issued to health officials on Friday, the U.N. agency said doctors don't need to give Tamiflu to healthy people who have mild to moderate cases of swine flu.
WHO said the drug should definitely be used to treat people in risk groups who get the virus. That includes children less than five years old, pregnant women, people over age 65 and those with other health problems like heart disease, HIV or diabetes.
The new advice contradicts government policies such as those in Britain, which has been giving out Tamiflu to all people suspected of having swine flu.
Copyright © 2009 The Associated Press. All rights reserved."
(AP) – 1 hour ago
LONDON — The World Health Organization says healthy people who catch swine flu don't need antiviral drugs like Tamiflu.
In new advice issued to health officials on Friday, the U.N. agency said doctors don't need to give Tamiflu to healthy people who have mild to moderate cases of swine flu.
WHO said the drug should definitely be used to treat people in risk groups who get the virus. That includes children less than five years old, pregnant women, people over age 65 and those with other health problems like heart disease, HIV or diabetes.
The new advice contradicts government policies such as those in Britain, which has been giving out Tamiflu to all people suspected of having swine flu.
Copyright © 2009 The Associated Press. All rights reserved."
WHO Predicts 'Explosion' of Swine Flu Case
WHO Predicts 'Explosion' of Swine Flu Case: "WHO Predicts 'Explosion'
of Swine Flu
Updated: Friday, 21 Aug 2009, 5:36 AM MDT
Published : Friday, 21 Aug 2009, 5:32 AM MDT
By The Associated Press
BEIJING - The World Health Organization is urging nations to speed up their preparations for swine flu.
A WHO official warns there may soon be 'an explosion' in cases until peak transmission of the flu is reached. He says that means most countries may see swine flu cases double every three to four days -- for several months.
He says governments must act quickly to educate the public and prepare their health systems to care for severe cases. He says the swine flu strain poses the greatest threat in developing nations, with underequipped and underfunded health systems.
The swine flu strain has killed almost 1,800 people worldwide. WHO predicts that as many as 2 billion people could become infected in the next two years — nearly one-third of the world's population. The world health group has declared the situation a pandemic.
The last pandemic — the Hong Kong flu of 1968 — killed about 1 million people. Ordinary flu kills about 250,000 to 500,000 people each year."
of Swine Flu
Updated: Friday, 21 Aug 2009, 5:36 AM MDT
Published : Friday, 21 Aug 2009, 5:32 AM MDT
By The Associated Press
BEIJING - The World Health Organization is urging nations to speed up their preparations for swine flu.
A WHO official warns there may soon be 'an explosion' in cases until peak transmission of the flu is reached. He says that means most countries may see swine flu cases double every three to four days -- for several months.
He says governments must act quickly to educate the public and prepare their health systems to care for severe cases. He says the swine flu strain poses the greatest threat in developing nations, with underequipped and underfunded health systems.
The swine flu strain has killed almost 1,800 people worldwide. WHO predicts that as many as 2 billion people could become infected in the next two years — nearly one-third of the world's population. The world health group has declared the situation a pandemic.
The last pandemic — the Hong Kong flu of 1968 — killed about 1 million people. Ordinary flu kills about 250,000 to 500,000 people each year."
Wednesday, August 19, 2009
Neurologic Complications Associated with Novel Influenza A (H1N1) Virus Infection in Children
Neurologic Complications Associated with Novel Influenza A (H1N1) Virus Infection in Children --- Dallas, Texas, May 2009
Neurologic complications, including seizures, encephalitis, encephalopathy, Reye syndrome, and other neurologic disorders, have been described previously in association with respiratory tract infection with seasonal influenza A or B viruses (1--2), but not with novel influenza A (H1N1) virus. On May 28, 2009, the Dallas County Department of Health and Human Services (DCHHS) notified CDC of four children with neurologic complications associated with novel influenza A (H1N1) virus infection admitted to hospitals in Dallas County, Texas, during May 18--28. This report summarizes the clinical characteristics of those four cases. Patients were aged 7--17 years and were admitted with signs of influenza-like illness (ILI) and seizures or altered mental status. Three of the four patients had abnormal electroencephalograms (EEGs). In all four patients, novel influenza A (H1N1) viral RNA was detected in nasopharyngeal specimens but not in cerebrospinal fluid (CSF). Antiviral therapy included oseltamivir (four patients) and rimantadine (three patients). All four patients recovered fully and had no neurologic sequelae at discharge. These findings indicate that, as with seasonal influenza, neurologic complications can occur after respiratory tract infection with novel influenza A (H1N1) virus. For children who have ILI accompanied by unexplained seizures or mental status changes, clinicians should consider acute seasonal influenza or novel influenza A (H1N1) virus infection in the differential diagnosis, send respiratory specimens for appropriate diagnostic testing, and promptly initiate empirical antiviral treatment, especially in hospitalized patients.
Neurologic complications, including seizures, encephalitis, encephalopathy, Reye syndrome, and other neurologic disorders, have been described previously in association with respiratory tract infection with seasonal influenza A or B viruses (1--2), but not with novel influenza A (H1N1) virus. On May 28, 2009, the Dallas County Department of Health and Human Services (DCHHS) notified CDC of four children with neurologic complications associated with novel influenza A (H1N1) virus infection admitted to hospitals in Dallas County, Texas, during May 18--28. This report summarizes the clinical characteristics of those four cases. Patients were aged 7--17 years and were admitted with signs of influenza-like illness (ILI) and seizures or altered mental status. Three of the four patients had abnormal electroencephalograms (EEGs). In all four patients, novel influenza A (H1N1) viral RNA was detected in nasopharyngeal specimens but not in cerebrospinal fluid (CSF). Antiviral therapy included oseltamivir (four patients) and rimantadine (three patients). All four patients recovered fully and had no neurologic sequelae at discharge. These findings indicate that, as with seasonal influenza, neurologic complications can occur after respiratory tract infection with novel influenza A (H1N1) virus. For children who have ILI accompanied by unexplained seizures or mental status changes, clinicians should consider acute seasonal influenza or novel influenza A (H1N1) virus infection in the differential diagnosis, send respiratory specimens for appropriate diagnostic testing, and promptly initiate empirical antiviral treatment, especially in hospitalized patients.
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