Posted: Fri Oct 16, 2009 6:54 pm Post subject: Officials Lower Vax Manufacturing Expectations Again
About 25% fewer doses than expected of vaccine against the pandemic H1N1 influenza virus will be available this month because of delays in production, health authorities said this morning.
Officials at the federal Centers for Disease Control and Prevention had expected about 40 million doses of the swine flu vaccine to be distributed by the end of the month, but it now looks like a maximum of 28 million to 30 million will actually be shipped, Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases said in a news conference.
"Vaccine production is pretty complex, and it is taking a bit longer than we would hope," she said. In particular, growing the virus in eggs has not yielded as much antigen -- the crucial component of the vaccine -- as is normally obtained with the seasonal flu.
Despite the current low production, however, there are no plans to use adjuvants to extend the supply of the vaccine, said Dr. Jesse Goodman of the Food and Drug Administration.
As of Wednesday, 11.4 million doses of vaccine were available, slightly more than half of that in the injectable form. As of the same day, states had ordered 8 million doses.
Anne Schuchat, the director of that National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, said it appears the 40 million-dose estimate will be reduced by 10 million to 12 million doses. However, she said the doses should be available by the beginning of next month.
The production process involving the antigen, or active ingredient, used in the H1N1 vaccine has been slower than usually seen with seasonal vaccines. Viruses for both vaccines are grown in chicken eggs before going through a purification process.
Dr. Schuchat said the vaccines also need to undergo various tests before the FDA signs off on their release.
The U.S. has purchased 95 million H1N1 vaccines and enough bulk ingredients from five companies to make up to make a total of 251 million vaccine doses if needed.
Other companies, including a unit of Sanofi Aventis, Novartis AG, CSL Ltd. and GlaxoSmithKline PLC, are making H1N1 flu shots for the U.S. market. Glaxo's vaccine is still pending FDA approval.
Federal officials today during a pandemic H1N1 planning update dialed back the number of novel flu vaccine doses they expect in October from 120 million to 45 million, listing several reasons for the smaller projection.
the latest expectation is 45 million doses by mid October, with manufacturers delivering 20 million doses per week after that.
vaccine makers have a limited number of fill-and-finish sites, which are just completing seasonal flu vaccine production, but that federal officials are looking for ways to maximize the current capacity.
one of the companies making seasonal flu vaccine is having problems finishing up production so that it can clear the decks to make novel flu vaccine, Robinson said. The delay has impacted vaccine timelines by 4 to 6 weeks
federal officials will be working with manufacturers over the next 2 weeks to see if the improved yields are also seen in commercial production. _________________ https://twitter.com/mixin1771
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