Flu Vaccination
Tamiflu: Millions wasted on flu drug, claims major report
By James Gallagher
Hundreds of millions of pounds may have been wasted on a drug for flu that works no better than paracetamol, a landmark analysis has said. The UK has spent £473m on Tamiflu, which is stockpiled by governments globally to prepare for flu pandemics.
The Cochrane Collaboration claimed the drug did not prevent the spread of flu or reduce dangerous complications, and only slightly helped symptoms.
The manufacturers Roche and other experts say the analysis is flawed.
The antiviral drug Tamiflu was stockpiled from 2006 in the UK when some agencies were predicting that a pandemic of bird flu could kill up to 750,000 people in Britain. Similar decisions were made in other countries.
Hidden data The drug was widely prescribed during the swine flu outbreak in 2009.
Drug companies do not publish all their research data. This report is the result of a colossal fight for the previously hidden data into the effectiveness and side-effects of Tamiflu.
It concluded that the drug reduced the persistence of flu symptoms from seven days to 6.3 days in adults and to 5.8 days in children. But the report's authors said drugs such as paracetamol could have a similar impact.
On claims that the drug prevented complications such as pneumonia developing, Cochrane suggested the trials were so poor there was "no visible effect".
Another justification for stockpiling was to slow the spread of the disease to give time for a vaccine to be developed. The report's authors said "the case for this is simply unproven" and "there is no credible way these drugs could prevent a pandemic".
It also claimed that the drug had a number of side-effects, including nausea, headaches, psychiatric events, kidney problems and hyperglycaemia.
Carl Heneghan, Professor of Evidence-Based Medicine at the University of Oxford and one of the report's authors, told the BBC: "I think the whole £500m has not benefited human health in any way and we may have harmed people.
"The system that exists for producing evidence on drugs is so flawed and open to misuse that the public has been misled."
Dr Tom Jefferson, a clinical epidemiologist and former GP, said: "I wouldn't give it for symptom relief, I'd give paracetamol."
The Cochrane Collaboration researchers have not placed the blame on any individual or organisation, instead saying there had been failings at every step from the manufacturers to the regulators and government.
'Wrong statistics' However, there is disagreement about the findings and accusations that a simultaneous campaign to open up drug research is influencing the findings.
The pharmaceutical company Roche said "we disagree with the overall conclusions" and warned they could "potentially have serious public health implications".
Its UK medical director, Dr Daniel Thurley, told the BBC News website: "The definitive piece of research stands as the randomised control trials, which were shared with the regulators, which led to them in 100 countries around the world approving Tamiflu for treatment and prevention of flu."
He said the Cochrane group had used the wrong statistics, which "systematically underestimate the benefits" of the drug, and used "unorthodox" methods to analyse the side-effects.
He concluded: "One of the challenges we have here is actually knowing what they've done."
Prof Wendy Barclay, who researches the influenza virus at Imperial College London, said reducing symptoms in children by 29 hours would be "pretty beneficial".
She told the BBC: "Tamiflu works as well as any drug we have now or [that] is on the cards.
"Yes, I think they should replenish the stockpile. What else can you do if a pandemic strikes? We won't have a vaccine for the first six months."
Prof Kevin McConway Open University She also questioned the validity of the research as it analysed the impact during seasonal flu: "If it works a little bit in season flu, the chances are they'll work quite a lot better in a pandemic situation and get more people back to school and work."
Kevin McConway, a professor of applied statistics at the Open University, said it was an "impressive" piece of work.
He said: "It is a potential limitation of this study that the work has been carried out alongside campaigning on access to trial data.
"The writers of the review have a clear position in this controversy, and, although I personally do generally agree with their position, I feel it does at times lead to some confusion between reporting the results of the review of these particular drugs and commenting on the general position on access to and use of unpublished data."
The Department of Health, which took the lead for the UK, said Britain was recognised as "one of the best prepared countries in the world for a potential flu pandemic" and "our stockpile of antivirals is a key part of this.
"We regularly review all published data and will consider the Cochrane review closely."
The World Health Organization, which classes Tamiflu as an essential medicine, said: "We welcome a new and rigorous analysis of available data, and look forward to consideration of its findings after it appears."
Source : BBC (April 2014)
Brain-Damaged UK Victims of Swine Flu Vaccine to Get £60 Million Compensation
Patients who suffered brain damage as a result of taking a swine flu vaccine are to receive multi-million-pound payouts from the UK government.
The government is expected to receive a bill of approximately £60 million, with each of the 60 victims expected to receive about £1 million each.
Peter Todd, a lawyer who represented many of the claimants, told the Sunday Times: "There has never been a case like this before. The victims of this vaccine have an incurable and lifelong condition and will require extensive medication."
Following the swine flu outbreak of 2009, about 60 million people, most of them children, received the vaccine.
It was subsequently revealed that the vaccine, Pandemrix, can cause narcolepsy and cataplexy in about one in 16,000 people, and many more are expected to come forward with the symptoms.
Across Europe, more than 800 children are so far known to have been made ill by the vaccine.
Narcolepsy affects a person's sleeping cycle, leaving them unable to sleep for more than 90 minutes at a time, and causing them to fall unconscious during the day. The condition damages mental function and memory, and can lead to hallucinations and mental illness.
Cataplexy causes a person to lose consciousness when they are experiencing heightened emotion, including when they are laughing.
The Pandemrix vaccine was manufactured by pharmaceuticals giant Glaxo Smith Kline, which refused to supply governments unless it was indemnified against any claim for damage caused. The company will pay the bill, and claim the money back from the government.
"There's no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries - and probably in most countries," Emmanuelle Mignot, a specialist in sleep disorder at Stanford University in the United States told Reuters.
Mignot has been paid by GSK to research the effects of the drug.
Among those affected are NHS medical staff, many of whom are now unable to do their jobs because of the symptoms brought on by the vaccine. They will be suing the government for millions in lost earnings.
However, the vast majority of patients affected - around 80% - are children.
Among them is Josh Hadfield, 8, from Somerset, who is on anti-narcolepsy drugs costing £15,000 a year to help him stay awake during the school day.
"If you make him laugh, he collapses. His memory is shot. There is no cure. He says he wishes he hadn't been born. I feel incredibly guilty about letting him have the vaccine," said his mother Caroline Hadfield, 43.
Despite a 2011 warning from the European Medicines Agency against using the vaccine on those under 20 and a study indicating a 13-fold heightened risk of narcolepsy in vaccinated children, GSK has refused to acknowledge a link.
"Further research is needed to confirm what role the vaccine may have played in the development of narcolepsy in those affected," the company said in a statement.
Source : IBTimes
Flu Shots May Not Protect the Elderly or the Very Young
Despite government recommendations, there is little evidence that flu vaccines help individuals older than 65 or younger than two
Every year around this time, 120 million Americans roll up their sleeves to get their annual flu shots. Since 2010, the U.S. Centers for Disease Control and Prevention has recommended yearly jabs for every healthy American over the age of six months. The goal is to curb the spread of infection and minimize the risk for potentially dangerous complications such as pneumonia, particularly among the elderly and the very young. But science on the vaccine’s efficacy is scant among those two vulnerable groups. And although healthy adults do get some protection, it may not be as robust as they expect.
One oft-cited claim, based on several large meta-analyses published more than a decade ago, is that seasonal flu shots cut the risk of winter death among older people by half. But the research behind that claim has been largely debunked. A 2005 study published in the Archives of Internal Medicine noted that influenza only causes about 5 percent of all excess winter deaths among the elderly—which works out to one death from flu per 1,000 older people each season—so it’s impossible for the shot to prevent half of all their winter deaths. The following year, a study reported that as vaccine coverage increased among the elderly in Italy in the late 1980s, there was no corresponding drop in excess deaths. In another 2006 paper, Lisa Jackson, an infectious disease epidemiologist at the Group Health Research Institute in Seattle, and her colleagues showed that although vaccinated seniors were 44 percent less likely to die during flu season than unvaccinated seniors were, the vaccinated ones were also 61 percent less likely to die before flu season even started. “Naturally, you would not expect the vaccine to work before the thing it protects against is going around,” says Lone Simonsen, a research professor in global health at George Washington University and a co-author of the 2005 study in the Archives of Internal Medicine.
Researchers now attribute these odd findings to a “healthy user” effect. People who don’t get vaccinated often “are the most frail or [those] whose health has gone down dramatically in the last few months,” explains CDC epidemiologist David Shay. People who choose to get flu shots, in other words, are already healthier and therefore the least likely to die.
So how much does the vaccine truly help older people? In January 2012, Michael Osterholm, an epidemiologist at the University of Minnesota’s Center for Infectious Disease Research and Policy, and his colleagues published a meta-analysis in The Lancet Infectious Diseases that analyzed the results of all randomized controlled clinical trials conducted between 1967 and 2011 on the effects of flu shots. It found that there have been no clinical trials evaluating the effects of the traditional flu vaccine in the elderly. The only vaccine shown to protect against infection or death in older adults, it said, is the live-attenuated vaccine—an inhalable vaccine that contains a live, modified version of the virus—which is not approved in the U.S. for adults over age 50.
The traditional vaccine may not work so well in older people because of an idea known as immune senescence, which posits that as people age, their immune systems weaken, resulting in poor vaccine response, especially to inactivated strains. Although the U.S. Food and Drug Administration licensed a high-dose vaccine for seniors in 2009 that could theoretically overcome this problem, no studies have yet been published on how effective it is. “The higher dose produces a higher level of antibodies, but we don’t really know what that correlates to,” says Jackson. A 2010 systematic review published by the Cochrane Collaboration, an independent, nonprofit organization that promotes evidence-based medicine, concluded that “until such time as the role of vaccines for preventing influenza in the elderly is clarified, more comprehensive and effective strategies for the control of acute respiratory infections should be implemented.”
The dearth of controlled research on seniors stems in part from the fact that the U.S government considers such clinical trials unethical. Based on an idea known as clinical equipoise, scientists can’t test, in a randomized controlled trial, a treatment that the larger medical community already considers to be effective, because doing so would involve denying treatment to half of the participants, potentially putting them at risk. “We’re in a difficult spot,” Shay says—since the CDC already recommends flu shots to seniors, the agency can’t suddenly turn around and ask them to participate in a clinical trial that might deny them the standard of care.
What about kids? In 2010, the U.S. Advisory Committee on Immunization Practices began recommending flu vaccination for all healthy children older than six months, an expansion that they claimed was “supported by evidence that annual influenza vaccination is a safe and effective preventive health action with potential benefit in all age groups.” Yet a July 2012 Cochrane Collaboration systematic review concluded that for kids under the age of two, the currently licensed vaccines “are not significantly more efficacious than placebo.” The review highlighted a single small study conducted on children under two—the only controlled study that has evaluated the efficacy of the shot currently licensed for young kids—which found, overall, that vaccines provided no statistically significant protection over the course of two flu seasons. “One season, the vaccine did something to prevent some symptoms, but in the second, nothing,” says co-author Tom Jefferson, an epidemiologist with the Cochrane group. In kids older than 2, however, flu vaccines do seem to work; according to the Cochrane analysis, the shot reduces the absolute risk that a child will catch the flu by about 3.6 percent, whereas the live (inhaled) vaccine reduces the absolute risk by about 17 percent.
In healthy adults under the age of 65, flu vaccines work, too. A 2010 Cochrane review, also co-authored by Jefferson, estimated that during “good” vaccine years—when the vaccines match the circulating viral strain well, which Jefferson says happens about half the time—the vaccine reduces the relative risk that an adult under 65 will catch the flu by about 75 percent. In absolute terms, however, this means adults have about a four percent chance of catching the flu if they don’t get the vaccine and about a one percent chance if they do. Shay notes that while this estimate is reasonable, some flu seasons are worse than others, so the risk may be higher than 4 percent in some years (and some people) and lower than 4 percent in others. (And of course, the vaccine won’t protect against the nearly 200 viruses that cause flu-like symptoms but aren’t actually the flu.) Although scientists generally believe that the flu vaccine slows the spread of the virus through communities, there are no data showing that this is true, because “those studies are very difficult to do,” Shay explains.
So should people still dutifully line up for their flu shots? Older kids and healthy adults do get some protection from them; just perhaps not as much as they want or expect. But for seniors and toddlers, there may never be a clear answer to this question, particularly because the U.S. government is unlikely to conduct additional clinical trials. On Monday, Osterholm and a group of five other scientists at the University of Minnesota’s Center for Infectious Disease Research and Policy published a report highlighting the need for better alternatives. Although the current options may—for most people—be better than nothing, “we can no longer accept the status quo,” they wrote. “The perception that current vaccines are already highly effective in preventing influenza is a major barrier to pursuing game-changing alternatives.”
Source : Scientific American
H1N1 Vaccine Associated With Small but Significant Risk of Guillain-Barre Syndrome
Guillain-Barre syndrome (GBS) is usually characterized by rapidly developing motor weakness and areflexia (the absence of reflexes). “The disease is thought to be autoimmune and triggered by a stimulus of external origin. In 1976-1977, an unusually high rate of GBS was identified in the United States following the administration of inactivated ‘swine’ influenza A(H1N1) vaccines. In 2003, the Institute of Medicine (IOM) concluded that the evidence favored acceptance of a causal relationship between the 1976 swine influenza vaccines and GBS in adults. Studies of seasonal influenza vaccines administered in subsequent years have found small or no increased risk,” according to background information in the article. “In a more recent assessment of epidemiologic studies on seasonal influenza vaccines, experimental studies in animals, and case reports in humans, the IOM Committee to Review Adverse Effects of Vaccines concluded that the evidence was inadequate to accept or reject a causal relationship.”Philippe De Wals, M.D., Ph.D., of Laval University, Quebec City, Canada and colleagues conducted a study to assess the risk of GBS following pandemic influenza vaccine administration. In fall 2009 in Quebec an immunization campaign was launched against the 2009 influenza A(H1N1) pandemic strain. By the end of the year, 4.4 million residents had been vaccinated. The study included follow-up over the 6-month period of October 2009 through March 2010 for suspected and confirmed GBS cases reported by physicians, mostly neurologists, during active surveillance or identified in the provincial hospital summary discharge database. Immunization status was verified.
Over the 6-month period, 83 confirmed GBS cases were identified. Twenty-five confirmed cases had been vaccinated against 2009 influenza A(H1N1) 8 or fewer weeks before disease onset, with most (19/25) vaccinated 4 or fewer weeks before onset. Analysis of data indicated a small but significant risk of GBS following influenza A(H1N1) vaccination. The number of cases attributable to vaccination was approximately 2 per 1 million doses. The excess risk was observed only in persons 50 years of age or older.
“In Quebec, the individual risk of hospitalization following a documented influenza A(H1N1) infection was 1 per 2,500 and the risk of death was 1/73,000. The H1N1 vaccine was very effective in preventing infections and complications. It is likely that the benefits of immunization outweigh the risks,” the authors write.
(JAMA. 2012;308[2]:175-181. Available pre-embargo to the media at http://media.jamanetwork.com)
Source : Newswise
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Annual childhood flu vaccines may interfere with development of crossresistance
Vaccinating children annually against influenza virus interferes with their development of cross-reactive killer T cells to flu viruses generally, according to a paper in the November Journal of Virology.
In this study, first author Rogier Bodewes of Erasmus Medical Center, Rotterdam, The Netherlands and his collaborators collected blood samples from Dutch children with cystic fibrosis, who are vaccinated annually against influenza, and from healthy control children who are not vaccinated, and tested both sets of blood samples for the presence of virus-specific killer T cells. The majority of virus-specific killer T cells are directed to conserved viral proteins, that is, proteins that are very similar among different flu viruses, unlike the rapidly evolving, highly variable proteins which are targets of antibodies induced by influenza vaccines.
In unvaccinated children, the investigators found that the number of virus-specific T cells rises with age, while such an increase was absent in children vaccinated annually. In fact, vaccination appeared to interfere with induction of such killer T cells, says Bodewes.
“Vaccinated children with [cystic fibrosis] will develop lower cross-reactive virus-specific CD8+ T cell responses than unvaccinated children,” says the study.
“Most countries recommend annual flu vaccination of certain high risk groups to protect against seasonal influenza,” says Bodewes. “Furthermore, some countries recommend annual influenza vaccination of all healthy children more than six months of age.”
The research points up potentially conflicting policy outcomes. Annual flu vaccines are effective against seasonal flu, but could leave people more vulnerable to novel pandemics, says Bodewes, as induction of virus-specific killer T cells caused by childhood flu infection may reduce morbidity and mortality rates from pandemic influenza viruses. Referring to the paper, he says that the findings “highlight the need for the development and use of universal influenza A virus vaccines for children, especially in light of the pandemic threat of avian influenza A/H5N1.” Nonetheless, he says that efforts to develop such vaccines have for several decades been stymied by the sheer complexity of targeting inner proteins.
More information: R. Bodewes, P.L.A. Fraaij, M.M. Geelhoed-Mieras, C.A. van Baalen, H.A.W.M. Tiddens, A.M.C. van Rossum, F.R. van der Klis, R.A.M. Fouchier, A.D.M.E. Osterhaus, and G.F. Rimmelzwaan, 2011. Annual vaccination against influenza virus hampers development of virus-specific CD8+ T cell immunity in children. J. Virol. 85:11995-12000.
Source : MedicalXpress
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HHS: 386 injury claims filed over H1N1 countermeasures
Mar 16, 2011 (CIDRAP News) – The US Department of Health and Human Services (HHS) has so far received 386 claims of injuries related to the 2009 pandemic H1N1 vaccine and related pandemic countermeasures, HHS officials reported today.
The claims describe a wide range of complaints, from breathing difficulties and numbness to seizures and even death, according to Dr. Vito Caserta, director of the Countermeasures Injury Compensation Program (CICP).
"To date, 54 claims have been filed that appear to have been submitted with sufficient medical records to place them in line for review. Of these, 26 have begun a medical review," Caserta told CIDRAP News in response to a query.
Studies have generally shown that the monovalent 2009 H1N1 vaccine was just as safe as seasonal flu vaccines, but people who believe they were harmed by the vaccine, or by other pandemic countermeasures such as antiviral drugs, can file claims with the CICP.
The program, administered by the Health Resources and Services Administration (HRSA), was set up under the Public Readiness and Emergency Preparedness Act of 2005. It is designed to give claimants an avenue for pursuing damages without going to court, while shielding drug companies and medical providers from most lawsuits claiming harm from medical countermeasures for pandemic flu and other public health emergencies, such as bioterrorist attacks.
In purpose, the CICP is similar to the Vaccine Injury Compensation Program (VICP), established in 1988, which handles damage claims related to seasonal flu vaccines and other vaccines. Both programs have the aim of ensuring adequate supplies of vaccines and other countermeasures by protecting manufacturers from a flood of lawsuits that could drive them out of the market.
Caserta provided a long list of conditions cited in the H1N1-related claims that HRSA has received so far: "Guillain Barre Syndrome (GBS), breathing difficulties, numbness/tingling, soreness/pain at injection site, fever, headaches/migraines, weakness/fatigue, acute allergic reaction, rash, tachycardia, miscarriage, dizziness/nausea, muscle cramps/spasms, paralysis, cough, flu symptoms, neuropathy, vision problems, swelling, vomiting/diarrhea, transverse myelitis, pneumonia, seizures, neurologic conditions, loss of hearing/balance, joint infection, death, myalgias, ADEM [acute disseminated encephalomyelitis], encephalopathy, serum reaction, and some other conditions at a lower frequency."
He did not list numbers for any particular kinds of claims.
In addition to the pandemic vaccine, the CICP covers the anthrax and smallpox vaccines, which many US military personnel receive, and countermeasures for botulism and radiation exposure. Caserta said the program has received eight claims related to those vaccines.
The CICP first published its administrative procedures and regulations last October, permitting people to begin filing formal claims. Before that, HRSA accepted letters from people explaining their intent to file a formal claim later, after publication of the administrative procedures. To be considered, reports of alleged injuries must be submitted within 1 year from when the person was vaccinated or treated.
Caserta said each claim is reviewed by a physician working under the supervision of another physician who is experienced in handling such evaluations. Other experts can also be called in if needed.
If a claim is denied, the claimant can ask for a "Reconsideration Panel" review, Caserta said. After reviewing the case, that panel makes a recommendation to the associate administrator of HRSA's Healthcare Systems Bureau, who is charged with making the final decision.
The CICP covers only the monovalent version of the 2009 H1N1 vaccine. The 2009 H1N1 virus was included in the 2010-11 seasonal flu vaccine, which is covered by the VICP.
The two programs process claims somewhat differently, according to HHS. In the VICP, physicians review claims and write reports, but special masters or judges of the US Court of Claims make the decisions on entitlement and benefits.
An HRSA information chart concerning the VICP program shows that 537 injury claims related to influenza vaccines had been filed as of Oct 12, 2010. Of those, 189 led to compensation and 49 were dismissed.
See also:
CICP page on HRSA site
HRSA chart of information on VICP claims and awards
Source : CIDRAP News
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Flu jab linked to fits in under fives: officials
GPs have been told not to use a particular flu jab on 110,000 children under five after it was linked with a tenfold increase in fits, it can be revealed.
Doctors should stock alternative vaccines for under fives who are due to have the seasonal flu vaccine this winter, a letter from the head of immunisation at the Department of Health has said.
The action is being taken as rate of convulsions caused by high fever among children in Australia given the jab was ten times higher than normal.
Up to one in 100 children given the jab, made in Australia by CSL and marketed in the UK by Pfizer, suffered febrile convulsions in the following hours and days.
It is not known what is causing the problem and no other flu vaccines have been linked to an increased risk of fits. Adults given the vaccine do not appear to have been affected.
Children under five are only routinely vaccinated against seasonal flu if they are in designated 'risk groups' because they have chronic asthma, have been admitted to hospital with a respiratory infection previously or have other long-term conditions which means they would be particularly badly affected if they caught flu.
Seasonal flu vaccines contain three strains which have been identified by the World Health Organisation as the most common in circulation that year. This year the vaccines contain the pandemic strain H1N1.
The letter to all GPs from Prof David Salisbury, said: "Epidemiological information from Australia indicates that there has been a higher than expected increase in febrile convulsions in children related to the use of Fluvax (manufactured by CSL).
"This is the same product that will be marketed in the UK by Pfizer as Enzira and generic influenza vaccine for the 2010/11 influenza vaccination season.
"Evidence from Australia suggests a rate of febrile convulsions of about one per 100 for children who were vaccinated with Fluvax. This increased risk appears to be a product specific reaction and evidence from Australia of vaccination with other products has so far not indicated a similar level of risk.
"It is important that children over six months of age who are in clinical risk groups receive influenza vaccination. Given the availability of other influenza vaccine products, you should avoid offering Enzira or CSL Biotherapies generic influenza vaccine marketed by Pfizer to children aged under five years."
He added that the medicines regulator will be monitoring the situation.
Febrile convulsions affect around one in 20 children and are normally caused by an infection. The body reacts to the high fever with the child losing consciousness and their legs and arms jerk. They may go pale or turn blue briefly and after a few minutes the shaking normally stops.
The attacks can be very frightening for parents and children are usually admitted to hospital after the first convulsion to establish the cause. Some children are particularly prone to them but they are not normally dangerous.
In Australia, which is in its winter, stopped vaccinating all children under five when the increased rate of convulsions was found. It has since restarted vaccinating with other products.
A spokesman for Pfizer said: "The cause of the unexpected increased frequency of febrile convulsions remains unknown and investigations continue. Pfizer and CSL are working closely with regulatory authorities, health agencies and distribution partners to determine the most appropriate way to provide influenza vaccine for the Northern Hemisphere 2010/2011 influenza season.
"While, Pfizer supports the current precautionary approach to the use of our influenza vaccine in children under five years of age, it should be noted that the vast majority of patients in the UK receiving the influenza vaccine are adults, and febrile convulsions are not seen in the adult population.
"In addition, there is no evidence that the vaccine poses any increased risks to other groups, including pregnant women and those aged over 65.
"Pfizer and CSL are committed to ensuring the quality and safety our products. Pfizer is in ongoing dialogue with the Department of Health to help ensure the successful implementation of the 2010/11 Flu immunisation programme."
A spokesman for the Department of Health said: "As part of the Australian flu vaccination programme, a number of children were given a brand of flu vaccine known as Enzira (Fluvax in Australia). A small proportion of these children, aged under 5, had fits after they had this vaccine.
"The vaccine is also marketed in the UK as CSL Biotherapies generic influenza vaccine. It contains three strains of the flu virus that experts predict are most likely to be around this winter including swine flu (H1N1).
"We are asking GPs in the UK to avoid offering this vaccine to the under 5s in the coming flu season, there are several other vaccines available that are suitable for this age group. There is currently no indication that the vaccine poses any increased risks to other groups.
"Having the flu jab remains the best protection against flu and we recommend that people get vaccinated when they’re offered it in the autumn."
Source : Telegraph.co.uk
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Tamiflu: Millions wasted on flu drug, claims major report
By James Gallagher
Hundreds of millions of pounds may have been wasted on a drug for flu that works no better than paracetamol, a landmark analysis has said. The UK has spent £473m on Tamiflu, which is stockpiled by governments globally to prepare for flu pandemics.
The Cochrane Collaboration claimed the drug did not prevent the spread of flu or reduce dangerous complications, and only slightly helped symptoms.
The manufacturers Roche and other experts say the analysis is flawed.
The antiviral drug Tamiflu was stockpiled from 2006 in the UK when some agencies were predicting that a pandemic of bird flu could kill up to 750,000 people in Britain. Similar decisions were made in other countries.
Hidden data The drug was widely prescribed during the swine flu outbreak in 2009.
Drug companies do not publish all their research data. This report is the result of a colossal fight for the previously hidden data into the effectiveness and side-effects of Tamiflu.
It concluded that the drug reduced the persistence of flu symptoms from seven days to 6.3 days in adults and to 5.8 days in children. But the report's authors said drugs such as paracetamol could have a similar impact.
On claims that the drug prevented complications such as pneumonia developing, Cochrane suggested the trials were so poor there was "no visible effect".
Another justification for stockpiling was to slow the spread of the disease to give time for a vaccine to be developed. The report's authors said "the case for this is simply unproven" and "there is no credible way these drugs could prevent a pandemic".
It also claimed that the drug had a number of side-effects, including nausea, headaches, psychiatric events, kidney problems and hyperglycaemia.
Carl Heneghan, Professor of Evidence-Based Medicine at the University of Oxford and one of the report's authors, told the BBC: "I think the whole £500m has not benefited human health in any way and we may have harmed people.
"The system that exists for producing evidence on drugs is so flawed and open to misuse that the public has been misled."
Dr Tom Jefferson, a clinical epidemiologist and former GP, said: "I wouldn't give it for symptom relief, I'd give paracetamol."
The Cochrane Collaboration researchers have not placed the blame on any individual or organisation, instead saying there had been failings at every step from the manufacturers to the regulators and government.
'Wrong statistics' However, there is disagreement about the findings and accusations that a simultaneous campaign to open up drug research is influencing the findings.
The pharmaceutical company Roche said "we disagree with the overall conclusions" and warned they could "potentially have serious public health implications".
Its UK medical director, Dr Daniel Thurley, told the BBC News website: "The definitive piece of research stands as the randomised control trials, which were shared with the regulators, which led to them in 100 countries around the world approving Tamiflu for treatment and prevention of flu."
He said the Cochrane group had used the wrong statistics, which "systematically underestimate the benefits" of the drug, and used "unorthodox" methods to analyse the side-effects.
He concluded: "One of the challenges we have here is actually knowing what they've done."
Prof Wendy Barclay, who researches the influenza virus at Imperial College London, said reducing symptoms in children by 29 hours would be "pretty beneficial".
She told the BBC: "Tamiflu works as well as any drug we have now or [that] is on the cards.
"Yes, I think they should replenish the stockpile. What else can you do if a pandemic strikes? We won't have a vaccine for the first six months."
Prof Kevin McConway Open University She also questioned the validity of the research as it analysed the impact during seasonal flu: "If it works a little bit in season flu, the chances are they'll work quite a lot better in a pandemic situation and get more people back to school and work."
Kevin McConway, a professor of applied statistics at the Open University, said it was an "impressive" piece of work.
He said: "It is a potential limitation of this study that the work has been carried out alongside campaigning on access to trial data.
"The writers of the review have a clear position in this controversy, and, although I personally do generally agree with their position, I feel it does at times lead to some confusion between reporting the results of the review of these particular drugs and commenting on the general position on access to and use of unpublished data."
The Department of Health, which took the lead for the UK, said Britain was recognised as "one of the best prepared countries in the world for a potential flu pandemic" and "our stockpile of antivirals is a key part of this.
"We regularly review all published data and will consider the Cochrane review closely."
The World Health Organization, which classes Tamiflu as an essential medicine, said: "We welcome a new and rigorous analysis of available data, and look forward to consideration of its findings after it appears."
Source : BBC (April 2014)
Brain-Damaged UK Victims of Swine Flu Vaccine to Get £60 Million Compensation
Patients who suffered brain damage as a result of taking a swine flu vaccine are to receive multi-million-pound payouts from the UK government.
The government is expected to receive a bill of approximately £60 million, with each of the 60 victims expected to receive about £1 million each.
Peter Todd, a lawyer who represented many of the claimants, told the Sunday Times: "There has never been a case like this before. The victims of this vaccine have an incurable and lifelong condition and will require extensive medication."
Following the swine flu outbreak of 2009, about 60 million people, most of them children, received the vaccine.
It was subsequently revealed that the vaccine, Pandemrix, can cause narcolepsy and cataplexy in about one in 16,000 people, and many more are expected to come forward with the symptoms.
Across Europe, more than 800 children are so far known to have been made ill by the vaccine.
Narcolepsy affects a person's sleeping cycle, leaving them unable to sleep for more than 90 minutes at a time, and causing them to fall unconscious during the day. The condition damages mental function and memory, and can lead to hallucinations and mental illness.
Cataplexy causes a person to lose consciousness when they are experiencing heightened emotion, including when they are laughing.
The Pandemrix vaccine was manufactured by pharmaceuticals giant Glaxo Smith Kline, which refused to supply governments unless it was indemnified against any claim for damage caused. The company will pay the bill, and claim the money back from the government.
"There's no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries - and probably in most countries," Emmanuelle Mignot, a specialist in sleep disorder at Stanford University in the United States told Reuters.
Mignot has been paid by GSK to research the effects of the drug.
Among those affected are NHS medical staff, many of whom are now unable to do their jobs because of the symptoms brought on by the vaccine. They will be suing the government for millions in lost earnings.
However, the vast majority of patients affected - around 80% - are children.
Among them is Josh Hadfield, 8, from Somerset, who is on anti-narcolepsy drugs costing £15,000 a year to help him stay awake during the school day.
"If you make him laugh, he collapses. His memory is shot. There is no cure. He says he wishes he hadn't been born. I feel incredibly guilty about letting him have the vaccine," said his mother Caroline Hadfield, 43.
Despite a 2011 warning from the European Medicines Agency against using the vaccine on those under 20 and a study indicating a 13-fold heightened risk of narcolepsy in vaccinated children, GSK has refused to acknowledge a link.
"Further research is needed to confirm what role the vaccine may have played in the development of narcolepsy in those affected," the company said in a statement.
Source : IBTimes
Flu Shots May Not Protect the Elderly or the Very Young
Despite government recommendations, there is little evidence that flu vaccines help individuals older than 65 or younger than two
Every year around this time, 120 million Americans roll up their sleeves to get their annual flu shots. Since 2010, the U.S. Centers for Disease Control and Prevention has recommended yearly jabs for every healthy American over the age of six months. The goal is to curb the spread of infection and minimize the risk for potentially dangerous complications such as pneumonia, particularly among the elderly and the very young. But science on the vaccine’s efficacy is scant among those two vulnerable groups. And although healthy adults do get some protection, it may not be as robust as they expect.
One oft-cited claim, based on several large meta-analyses published more than a decade ago, is that seasonal flu shots cut the risk of winter death among older people by half. But the research behind that claim has been largely debunked. A 2005 study published in the Archives of Internal Medicine noted that influenza only causes about 5 percent of all excess winter deaths among the elderly—which works out to one death from flu per 1,000 older people each season—so it’s impossible for the shot to prevent half of all their winter deaths. The following year, a study reported that as vaccine coverage increased among the elderly in Italy in the late 1980s, there was no corresponding drop in excess deaths. In another 2006 paper, Lisa Jackson, an infectious disease epidemiologist at the Group Health Research Institute in Seattle, and her colleagues showed that although vaccinated seniors were 44 percent less likely to die during flu season than unvaccinated seniors were, the vaccinated ones were also 61 percent less likely to die before flu season even started. “Naturally, you would not expect the vaccine to work before the thing it protects against is going around,” says Lone Simonsen, a research professor in global health at George Washington University and a co-author of the 2005 study in the Archives of Internal Medicine.
Researchers now attribute these odd findings to a “healthy user” effect. People who don’t get vaccinated often “are the most frail or [those] whose health has gone down dramatically in the last few months,” explains CDC epidemiologist David Shay. People who choose to get flu shots, in other words, are already healthier and therefore the least likely to die.
So how much does the vaccine truly help older people? In January 2012, Michael Osterholm, an epidemiologist at the University of Minnesota’s Center for Infectious Disease Research and Policy, and his colleagues published a meta-analysis in The Lancet Infectious Diseases that analyzed the results of all randomized controlled clinical trials conducted between 1967 and 2011 on the effects of flu shots. It found that there have been no clinical trials evaluating the effects of the traditional flu vaccine in the elderly. The only vaccine shown to protect against infection or death in older adults, it said, is the live-attenuated vaccine—an inhalable vaccine that contains a live, modified version of the virus—which is not approved in the U.S. for adults over age 50.
The traditional vaccine may not work so well in older people because of an idea known as immune senescence, which posits that as people age, their immune systems weaken, resulting in poor vaccine response, especially to inactivated strains. Although the U.S. Food and Drug Administration licensed a high-dose vaccine for seniors in 2009 that could theoretically overcome this problem, no studies have yet been published on how effective it is. “The higher dose produces a higher level of antibodies, but we don’t really know what that correlates to,” says Jackson. A 2010 systematic review published by the Cochrane Collaboration, an independent, nonprofit organization that promotes evidence-based medicine, concluded that “until such time as the role of vaccines for preventing influenza in the elderly is clarified, more comprehensive and effective strategies for the control of acute respiratory infections should be implemented.”
The dearth of controlled research on seniors stems in part from the fact that the U.S government considers such clinical trials unethical. Based on an idea known as clinical equipoise, scientists can’t test, in a randomized controlled trial, a treatment that the larger medical community already considers to be effective, because doing so would involve denying treatment to half of the participants, potentially putting them at risk. “We’re in a difficult spot,” Shay says—since the CDC already recommends flu shots to seniors, the agency can’t suddenly turn around and ask them to participate in a clinical trial that might deny them the standard of care.
What about kids? In 2010, the U.S. Advisory Committee on Immunization Practices began recommending flu vaccination for all healthy children older than six months, an expansion that they claimed was “supported by evidence that annual influenza vaccination is a safe and effective preventive health action with potential benefit in all age groups.” Yet a July 2012 Cochrane Collaboration systematic review concluded that for kids under the age of two, the currently licensed vaccines “are not significantly more efficacious than placebo.” The review highlighted a single small study conducted on children under two—the only controlled study that has evaluated the efficacy of the shot currently licensed for young kids—which found, overall, that vaccines provided no statistically significant protection over the course of two flu seasons. “One season, the vaccine did something to prevent some symptoms, but in the second, nothing,” says co-author Tom Jefferson, an epidemiologist with the Cochrane group. In kids older than 2, however, flu vaccines do seem to work; according to the Cochrane analysis, the shot reduces the absolute risk that a child will catch the flu by about 3.6 percent, whereas the live (inhaled) vaccine reduces the absolute risk by about 17 percent.
In healthy adults under the age of 65, flu vaccines work, too. A 2010 Cochrane review, also co-authored by Jefferson, estimated that during “good” vaccine years—when the vaccines match the circulating viral strain well, which Jefferson says happens about half the time—the vaccine reduces the relative risk that an adult under 65 will catch the flu by about 75 percent. In absolute terms, however, this means adults have about a four percent chance of catching the flu if they don’t get the vaccine and about a one percent chance if they do. Shay notes that while this estimate is reasonable, some flu seasons are worse than others, so the risk may be higher than 4 percent in some years (and some people) and lower than 4 percent in others. (And of course, the vaccine won’t protect against the nearly 200 viruses that cause flu-like symptoms but aren’t actually the flu.) Although scientists generally believe that the flu vaccine slows the spread of the virus through communities, there are no data showing that this is true, because “those studies are very difficult to do,” Shay explains.
So should people still dutifully line up for their flu shots? Older kids and healthy adults do get some protection from them; just perhaps not as much as they want or expect. But for seniors and toddlers, there may never be a clear answer to this question, particularly because the U.S. government is unlikely to conduct additional clinical trials. On Monday, Osterholm and a group of five other scientists at the University of Minnesota’s Center for Infectious Disease Research and Policy published a report highlighting the need for better alternatives. Although the current options may—for most people—be better than nothing, “we can no longer accept the status quo,” they wrote. “The perception that current vaccines are already highly effective in preventing influenza is a major barrier to pursuing game-changing alternatives.”
Source : Scientific American
H1N1 Vaccine Associated With Small but Significant Risk of Guillain-Barre Syndrome
Guillain-Barre syndrome (GBS) is usually characterized by rapidly developing motor weakness and areflexia (the absence of reflexes). “The disease is thought to be autoimmune and triggered by a stimulus of external origin. In 1976-1977, an unusually high rate of GBS was identified in the United States following the administration of inactivated ‘swine’ influenza A(H1N1) vaccines. In 2003, the Institute of Medicine (IOM) concluded that the evidence favored acceptance of a causal relationship between the 1976 swine influenza vaccines and GBS in adults. Studies of seasonal influenza vaccines administered in subsequent years have found small or no increased risk,” according to background information in the article. “In a more recent assessment of epidemiologic studies on seasonal influenza vaccines, experimental studies in animals, and case reports in humans, the IOM Committee to Review Adverse Effects of Vaccines concluded that the evidence was inadequate to accept or reject a causal relationship.”Philippe De Wals, M.D., Ph.D., of Laval University, Quebec City, Canada and colleagues conducted a study to assess the risk of GBS following pandemic influenza vaccine administration. In fall 2009 in Quebec an immunization campaign was launched against the 2009 influenza A(H1N1) pandemic strain. By the end of the year, 4.4 million residents had been vaccinated. The study included follow-up over the 6-month period of October 2009 through March 2010 for suspected and confirmed GBS cases reported by physicians, mostly neurologists, during active surveillance or identified in the provincial hospital summary discharge database. Immunization status was verified.
Over the 6-month period, 83 confirmed GBS cases were identified. Twenty-five confirmed cases had been vaccinated against 2009 influenza A(H1N1) 8 or fewer weeks before disease onset, with most (19/25) vaccinated 4 or fewer weeks before onset. Analysis of data indicated a small but significant risk of GBS following influenza A(H1N1) vaccination. The number of cases attributable to vaccination was approximately 2 per 1 million doses. The excess risk was observed only in persons 50 years of age or older.
“In Quebec, the individual risk of hospitalization following a documented influenza A(H1N1) infection was 1 per 2,500 and the risk of death was 1/73,000. The H1N1 vaccine was very effective in preventing infections and complications. It is likely that the benefits of immunization outweigh the risks,” the authors write.
(JAMA. 2012;308[2]:175-181. Available pre-embargo to the media at http://media.jamanetwork.com)
Source : Newswise
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Annual childhood flu vaccines may interfere with development of crossresistance
Vaccinating children annually against influenza virus interferes with their development of cross-reactive killer T cells to flu viruses generally, according to a paper in the November Journal of Virology.
In this study, first author Rogier Bodewes of Erasmus Medical Center, Rotterdam, The Netherlands and his collaborators collected blood samples from Dutch children with cystic fibrosis, who are vaccinated annually against influenza, and from healthy control children who are not vaccinated, and tested both sets of blood samples for the presence of virus-specific killer T cells. The majority of virus-specific killer T cells are directed to conserved viral proteins, that is, proteins that are very similar among different flu viruses, unlike the rapidly evolving, highly variable proteins which are targets of antibodies induced by influenza vaccines.
In unvaccinated children, the investigators found that the number of virus-specific T cells rises with age, while such an increase was absent in children vaccinated annually. In fact, vaccination appeared to interfere with induction of such killer T cells, says Bodewes.
“Vaccinated children with [cystic fibrosis] will develop lower cross-reactive virus-specific CD8+ T cell responses than unvaccinated children,” says the study.
“Most countries recommend annual flu vaccination of certain high risk groups to protect against seasonal influenza,” says Bodewes. “Furthermore, some countries recommend annual influenza vaccination of all healthy children more than six months of age.”
The research points up potentially conflicting policy outcomes. Annual flu vaccines are effective against seasonal flu, but could leave people more vulnerable to novel pandemics, says Bodewes, as induction of virus-specific killer T cells caused by childhood flu infection may reduce morbidity and mortality rates from pandemic influenza viruses. Referring to the paper, he says that the findings “highlight the need for the development and use of universal influenza A virus vaccines for children, especially in light of the pandemic threat of avian influenza A/H5N1.” Nonetheless, he says that efforts to develop such vaccines have for several decades been stymied by the sheer complexity of targeting inner proteins.
More information: R. Bodewes, P.L.A. Fraaij, M.M. Geelhoed-Mieras, C.A. van Baalen, H.A.W.M. Tiddens, A.M.C. van Rossum, F.R. van der Klis, R.A.M. Fouchier, A.D.M.E. Osterhaus, and G.F. Rimmelzwaan, 2011. Annual vaccination against influenza virus hampers development of virus-specific CD8+ T cell immunity in children. J. Virol. 85:11995-12000.
Source : MedicalXpress
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HHS: 386 injury claims filed over H1N1 countermeasures
Mar 16, 2011 (CIDRAP News) – The US Department of Health and Human Services (HHS) has so far received 386 claims of injuries related to the 2009 pandemic H1N1 vaccine and related pandemic countermeasures, HHS officials reported today.
The claims describe a wide range of complaints, from breathing difficulties and numbness to seizures and even death, according to Dr. Vito Caserta, director of the Countermeasures Injury Compensation Program (CICP).
"To date, 54 claims have been filed that appear to have been submitted with sufficient medical records to place them in line for review. Of these, 26 have begun a medical review," Caserta told CIDRAP News in response to a query.
Studies have generally shown that the monovalent 2009 H1N1 vaccine was just as safe as seasonal flu vaccines, but people who believe they were harmed by the vaccine, or by other pandemic countermeasures such as antiviral drugs, can file claims with the CICP.
The program, administered by the Health Resources and Services Administration (HRSA), was set up under the Public Readiness and Emergency Preparedness Act of 2005. It is designed to give claimants an avenue for pursuing damages without going to court, while shielding drug companies and medical providers from most lawsuits claiming harm from medical countermeasures for pandemic flu and other public health emergencies, such as bioterrorist attacks.
In purpose, the CICP is similar to the Vaccine Injury Compensation Program (VICP), established in 1988, which handles damage claims related to seasonal flu vaccines and other vaccines. Both programs have the aim of ensuring adequate supplies of vaccines and other countermeasures by protecting manufacturers from a flood of lawsuits that could drive them out of the market.
Caserta provided a long list of conditions cited in the H1N1-related claims that HRSA has received so far: "Guillain Barre Syndrome (GBS), breathing difficulties, numbness/tingling, soreness/pain at injection site, fever, headaches/migraines, weakness/fatigue, acute allergic reaction, rash, tachycardia, miscarriage, dizziness/nausea, muscle cramps/spasms, paralysis, cough, flu symptoms, neuropathy, vision problems, swelling, vomiting/diarrhea, transverse myelitis, pneumonia, seizures, neurologic conditions, loss of hearing/balance, joint infection, death, myalgias, ADEM [acute disseminated encephalomyelitis], encephalopathy, serum reaction, and some other conditions at a lower frequency."
He did not list numbers for any particular kinds of claims.
In addition to the pandemic vaccine, the CICP covers the anthrax and smallpox vaccines, which many US military personnel receive, and countermeasures for botulism and radiation exposure. Caserta said the program has received eight claims related to those vaccines.
The CICP first published its administrative procedures and regulations last October, permitting people to begin filing formal claims. Before that, HRSA accepted letters from people explaining their intent to file a formal claim later, after publication of the administrative procedures. To be considered, reports of alleged injuries must be submitted within 1 year from when the person was vaccinated or treated.
Caserta said each claim is reviewed by a physician working under the supervision of another physician who is experienced in handling such evaluations. Other experts can also be called in if needed.
If a claim is denied, the claimant can ask for a "Reconsideration Panel" review, Caserta said. After reviewing the case, that panel makes a recommendation to the associate administrator of HRSA's Healthcare Systems Bureau, who is charged with making the final decision.
The CICP covers only the monovalent version of the 2009 H1N1 vaccine. The 2009 H1N1 virus was included in the 2010-11 seasonal flu vaccine, which is covered by the VICP.
The two programs process claims somewhat differently, according to HHS. In the VICP, physicians review claims and write reports, but special masters or judges of the US Court of Claims make the decisions on entitlement and benefits.
An HRSA information chart concerning the VICP program shows that 537 injury claims related to influenza vaccines had been filed as of Oct 12, 2010. Of those, 189 led to compensation and 49 were dismissed.
See also:
CICP page on HRSA site
HRSA chart of information on VICP claims and awards
Source : CIDRAP News
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Flu jab linked to fits in under fives: officials
GPs have been told not to use a particular flu jab on 110,000 children under five after it was linked with a tenfold increase in fits, it can be revealed.
Doctors should stock alternative vaccines for under fives who are due to have the seasonal flu vaccine this winter, a letter from the head of immunisation at the Department of Health has said.
The action is being taken as rate of convulsions caused by high fever among children in Australia given the jab was ten times higher than normal.
Up to one in 100 children given the jab, made in Australia by CSL and marketed in the UK by Pfizer, suffered febrile convulsions in the following hours and days.
It is not known what is causing the problem and no other flu vaccines have been linked to an increased risk of fits. Adults given the vaccine do not appear to have been affected.
Children under five are only routinely vaccinated against seasonal flu if they are in designated 'risk groups' because they have chronic asthma, have been admitted to hospital with a respiratory infection previously or have other long-term conditions which means they would be particularly badly affected if they caught flu.
Seasonal flu vaccines contain three strains which have been identified by the World Health Organisation as the most common in circulation that year. This year the vaccines contain the pandemic strain H1N1.
The letter to all GPs from Prof David Salisbury, said: "Epidemiological information from Australia indicates that there has been a higher than expected increase in febrile convulsions in children related to the use of Fluvax (manufactured by CSL).
"This is the same product that will be marketed in the UK by Pfizer as Enzira and generic influenza vaccine for the 2010/11 influenza vaccination season.
"Evidence from Australia suggests a rate of febrile convulsions of about one per 100 for children who were vaccinated with Fluvax. This increased risk appears to be a product specific reaction and evidence from Australia of vaccination with other products has so far not indicated a similar level of risk.
"It is important that children over six months of age who are in clinical risk groups receive influenza vaccination. Given the availability of other influenza vaccine products, you should avoid offering Enzira or CSL Biotherapies generic influenza vaccine marketed by Pfizer to children aged under five years."
He added that the medicines regulator will be monitoring the situation.
Febrile convulsions affect around one in 20 children and are normally caused by an infection. The body reacts to the high fever with the child losing consciousness and their legs and arms jerk. They may go pale or turn blue briefly and after a few minutes the shaking normally stops.
The attacks can be very frightening for parents and children are usually admitted to hospital after the first convulsion to establish the cause. Some children are particularly prone to them but they are not normally dangerous.
In Australia, which is in its winter, stopped vaccinating all children under five when the increased rate of convulsions was found. It has since restarted vaccinating with other products.
A spokesman for Pfizer said: "The cause of the unexpected increased frequency of febrile convulsions remains unknown and investigations continue. Pfizer and CSL are working closely with regulatory authorities, health agencies and distribution partners to determine the most appropriate way to provide influenza vaccine for the Northern Hemisphere 2010/2011 influenza season.
"While, Pfizer supports the current precautionary approach to the use of our influenza vaccine in children under five years of age, it should be noted that the vast majority of patients in the UK receiving the influenza vaccine are adults, and febrile convulsions are not seen in the adult population.
"In addition, there is no evidence that the vaccine poses any increased risks to other groups, including pregnant women and those aged over 65.
"Pfizer and CSL are committed to ensuring the quality and safety our products. Pfizer is in ongoing dialogue with the Department of Health to help ensure the successful implementation of the 2010/11 Flu immunisation programme."
A spokesman for the Department of Health said: "As part of the Australian flu vaccination programme, a number of children were given a brand of flu vaccine known as Enzira (Fluvax in Australia). A small proportion of these children, aged under 5, had fits after they had this vaccine.
"The vaccine is also marketed in the UK as CSL Biotherapies generic influenza vaccine. It contains three strains of the flu virus that experts predict are most likely to be around this winter including swine flu (H1N1).
"We are asking GPs in the UK to avoid offering this vaccine to the under 5s in the coming flu season, there are several other vaccines available that are suitable for this age group. There is currently no indication that the vaccine poses any increased risks to other groups.
"Having the flu jab remains the best protection against flu and we recommend that people get vaccinated when they’re offered it in the autumn."
Source : Telegraph.co.uk
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