Last year's flu-shot shortage was scary enough, but now scientists see the specter of a bona fide pandemic if the bird-flu strain known has H5N1 were to mutate into an infection that could spread to people.
In addition, less than half of school-age children -- the population mainly responsible for spreading the flu virus -- got the flu shot, experts said.
But if it does, all 6.4 billion people on the planet would need a flu shot--many times the current capacity of about 300 million doses annually.
In the Protein Sciences quality control labs this week, the focus is on testing the company's traditional, seasonal flu shot -- FluBlok -- and making sure all the documents are in line should the FDA and other agencies have any questions.
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The two types of vaccine that have been approved -- a flu shot made from inactivated or dead virus and a nasal spray made from live, weakened virus -- will be available free of charge, though some providers may charge an "administration fee, " Sebelius said.
Those who should not be vaccinated include persons with a severe reaction to a previous flu shot, people who developed Guillain- Barre syndrome within 6 weeks of a flu shot, and children less than 6 months of age.
Finally, the flu shot does not always work -- particularly among the elderly and people with weak immune systems.
Frequent travellers are exposed to germs more often than non-travellers, so consider getting a flu shot early in the season.
Last year, the U.S. flu shot market was so unappealing that only two players were producing injectable vaccine--leading to a serious shortage when one of them, Chiron, had to shut down its plant.
So far this year, the flu shot has failed to show a significant drop in doctor visits for people over sixty-five.
Both companies are working on a nasally inhaled flu vaccine that they hope doctors will start prescribing in lieu of a once-a-year shot.
"At this point we have mounting evidence - data and studies - that show it's not getting the shot that causes the problem, but getting the flu that's the problem, " Dolan says.
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