Editor's Note: See Oct 5 CIDRAP News story for important developments regarding the supply of flu vaccine since the story below was published.
Sep 30, 2004 (CIDRAP News) – Flu vaccine should be on time for the 2004-2005 influenza season, and it will be safe, according to testimony this week by Howard Pien, President and CEO of Chiron, maker of Fluvirin, before the US Senate Committee on Aging.
Chiron announced on Aug 26 that it was halting production of its vaccine temporarily because some lots, containing about 4 million doses, did not meet sterility standards. The company's plans for this flu season are to ship 48 million doses—about half the US supply.
Pien told the committee that the company expects to make shipment plans in the next few days and that their product should reach distributors in October and November, in time for peak flu season.
He said that established protocol calls for retesting of any apparently contaminated product, followed by determination of where contamination arose. No cause has yet been found, but Chiron is working with the Food and Drug Administration to guarantee that the product to be shipped is pure.
In the 2003-2004 season, flu cases began occurring early and were severe, spurring high demand for flu vaccinations. The supply of 83 million doses produced turned out to be inadequate, so this year 100 million doses of vaccine are to be made available.
Among the supply will be about 1.5 doses of MedImmune's FluMist inhalable vaccine, licensed for use in 5- to 49-year-olds. David Mott, CEO of the company said in a presentation at the UBS Global Life Sciences Conference in New York this week that the cost of FluMist has been cut in half; its greater expense in relation to flu shots was thought to be a reason that the product was not received as hoped for in last year's flu season.
Mott also said that late-stage studies of a newer version of FluMist will begin this fall, with results hoped for before the 2007 flu season. The reformulated version would be targeted at younger children and the elderly, the populations most in need of vaccination, and would not require frozen storage, making it easier to distribute and use.
Aug 27 CIDRAP News story on vaccine delay