London: In a drive to inoculate people against swine flu before winter, many European governments say they will fast-track the testing of a new flu vaccine, arousing concern among some experts about safety issues and proper vaccine doses.
Mass swine flu vaccination campaigns will also take place in the shadow of the 1976 swine flu disaster, when hundreds of people in the US developed Guillain-Barre syndrome, a paralyzing disorder, after being vaccinated. Experts don`t know why that happened, but say modern vaccine production techniques have improved since 1976. To avoid a similar episode, some say comprehensive testing before the vaccine is rolled out is essential. "I can`t see any possible excuse to not test it for safety before it`s given to anyone," said George Annas, a bioethics expert at Boston University. If the vaccine turns out to have dangerous side effects, it could generate a public backlash, particularly in a country like Britain, where many people remain suspicious of vaccines because of unsubstantiated allegations linking the measles, mumps and rubella vaccine to autism. That could lead to millions of people refusing vaccination. When the bird flu crisis hit several years ago, the European Medicines Agency designed a special protocol to approve a vaccine for use in a pandemic as soon as possible. The agency let companies submit data for a "mock-up" vaccine, using H5N1 bird flu. The idea was to do most of the testing before the global epidemic hit so when it did, drugmakers could insert the pandemic virus into the vaccine at the last minute. When the first swine flu vaccine doses are ready, the European Medicines Agency will approve them largely based on data from the bird flu vaccine, since both will have the same basic ingredients. If the agency thinks the bird flu data predicts how the swine flu virus will work, they will approve it, said spokesman Harvey-Allchurch. The agency will then require regular reporting of the vaccine`s effects as it is being administered — monitoring that is normally done beforehand. WHO`s Fukuda said everyone involved in making the vaccine, from manufacturers to regulatory agencies, is looking at what steps can be taken to streamline the process. "But there is no one who disagrees that one of the absolutes is that there can`t be any question whether the vaccine is safe or not," he said. WHO reported that the swine flu viruses aren`t producing enough of a key vaccine ingredient, which may limit how much vaccine is available. Its laboratory network is now working to produce a new set of viruses that it hopes will work better. Drugmakers including Baxter International, GlaxoSmithKline PLC, Novartis and Sanofi-Pasteur, however, insist they will be able to start shipping the first batches of vaccine soon. British health officials have repeatedly said they will start vaccinating in August, as soon as the vaccine is approved. Other European countries, including Greece, France, Sweden, say they will use the vaccine after it gets the green light from the European agency, but none other than Britain expect to start the shots next month. Bureau Report
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