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The vaccine manufacturer MedImmune announced last year that the H1N1 vaccine had lost effectiveness because it seemed at first. However, according to U.S. officials, this does not mean that a safety issue.
The producer in thirteen withdrawn batches of vaccine against the H1N1 influenza virus from their free will, because they had lost their effectiveness because they were part of the first production.
In response, Norman Baylor, director ofthe Office of Vaccines Research and Analysis at the U.S. Food and Drug Administration, said that this situation is to create a security problem because not required each batch of pre-release testing to ensure safety, purity existed and effectiveness. He argued that the loss was the effectiveness of a light.
Thirteen lots were withdrawn were part of 4.7 million doses of intranasal vaccine, whose origin is a weakened live virus, but officials think that most ofThat was in October and November 2009, when the vaccine was administered or to make its maximum effectiveness. Upon the announcement of the manufacturer concerned or have 3,000 cans from the withdrawal, but it is unclear how many are scattered across the country.
This is not the first time many of H1N1 vaccine has been withdrawn. A few weeks after the accident, MedImmune, Sanofi-Aventis pulled 800 000 doses of vaccinechildren had decreased for the same reason, their effectiveness.
Baylor admits that this model is not normal, with two withdrawals a vaccine against seasonal influenza in the same season, but explained that this Biologicals from living organisms and are thus created, it is losing its effectiveness of the vaccine during the normal time .
E 'for this reason that the vaccine lasts for 18 weeks and which authorized the FDA requires that companies measure their effectivenessregularly. MedImmune head products on a weekly basis, and was one of these occasions that the loss of efficiency represented.
Baylor said that the withdrawal was a precautionary measure. He added that those who shot and killed vaccines, benefiting from these games are fully protected and did not need another. According to him, there are negative effects of the vaccine to all the safety and efficacy.
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