Flu vaccine manufacturers expect to have a record 132 million doses ready for the 2007-2008 flu season, and there could be even more available if a fifth company joins their ranks, officials said Thursday.
CSL Biotherapies, and Australian company, applied last month for federal approval to sell its inactivated flu vaccine in the United States this fall.
The vaccine estimates were announced at an Atlanta meeting of flu vaccine manufacturers, health care providers and public health officials.
If approved, CSL would join four other companies providing flu vaccine in the United States. Three make flu shots - Sanofi Pasteur Inc., which projects 50 million doses; Novartis Vaccines, which expects to make up to 40 million doses; and GlaxoSmithKline, which is planning 30 million to 35 million doses.
In addition, MedImmune Vaccines Inc. plans to manufacture about 7 million doses of FluMist, a nasal mist recommended only for healthy people between 5 and 49. It contains live virus and carries a slight chance of causing flu symptoms.
Federal guidelines call for 218 million Americans to get vaccinated, so the supply for shots still falls far short of where it should be, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases. In recent years, a lack of usable supply led to long lines and concerns about providing the most vulnerable people with the vaccine.
Comment: Let's hope there is no "mistake" which would adversely affect over 200 million Americans.
Influenza kills an estimated 36,000 Americans each year, and hospitalizes another 200,000, according to CDC officials.
The companies said they are ramping up production. Sanofi is completing a new production facility that will allow it to double its production. MedImmune is planning to more than triple its production in the next few years.
CSL has asked for an expedited approval from the U.S. Food and Drug Administration, which would be needed if it joins the U.S. flu vaccine market in time for the 2007-2008 season, said Paul Perreault, CSL's executive vice president for worldwide commercial operations.
CSL has manufactured flu vaccine since 1968, and currently provides it to 16 countries in Europe, South America and Asia.
During his presentation at the National Influenza Vaccine Summit meeting, Perreault did not say how many doses CSL might add to the market this year. Later, he said it would depend on when FDA approval comes. The company has production capacity to add more than 20 million doses to the U.S. market, he said.
In the United States, nearly 121 million doses - the current record - were produced for the 2006-2007 flu season, but not all were used. More than 18 million doses probably will be destroyed after their June 30 expiration, health officials said.
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