FDA Approves GSK Flu Vaccine, Says Chiron Making Progress
FDA on Wednesday approved GlaxoSmithKline's Fluarix, which will become the third flu vaccine available on the U.S. market, and said Chiron has made progress toward correcting manufacturing problems that prevented it from distributing vaccine last year, the Philadelphia Inquirer reports. Sanofi-Aventis already has committed to manufacturing between 50 million and 60 million doses of its Fluzone vaccine for sale in the U.S., and MedImmune has promised three million doses of its FluMist vaccine.
FDA's fast-track approval of GSK's Fluarix will add at least eight million doses to the national stockpile. National supplies currently total about 61 million doses, officials have said (Ginsberg, Philadelphia Inquirer, 9/1). Bloomberg/New York Times reports that federal officials "want to prevent a recurrence of the 2004-2005 season," during which the expected U.S. supply of 100 million flu vaccine doses was almost halved after British health regulators closed Chiron's manufacturing plant in Liverpool, England (Bloomberg/New York Times, 9/1).
HHS Secretary Mike Leavitt said, "FDA's approval of Fluarix is a big step toward providing an adequate supply of flu vaccine for the American public" (Rockoff, Baltimore Sun, 9/1). Leavitt added, "Having more manufacturers of influenza vaccine licensed in the U.S., and having more vaccine dosages, is critical to public health" (Manning, USA Today, 9/1).
FDA in a letter to Chiron last week said inspectors found Chiron's manufacturing facility "generally acceptable" (Philadelphia Inquirer, 9/1). If Chiron wins FDA approval to distribute vaccine in 2005, it plans to supply 18 million to 26 million doses of its Fluvirin vaccine, roughly half of the supply it had promised for 2004, the Wall Street Journal reports (Hamilton, Wall Street Journal, 9/1).
Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, said the agency issued Chiron a letter that was "a positive development and shows significant progress on their part." Goodman added that more work is necessary "to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season" (Kerr, Long Island Newsday, 9/1).
Chiron spokesperson Alison Marquiss said the company got "favorable results" from its FDA inspection and added that "there are no regulatory hurdles except supplemental approvals and regular batch release ... and the fact that we have to finish manufacturing (the vaccine)" (USA Today, 9/1).
In related news, CDC officials on Thursday urged doctors and other health officials during the 2005-2006 flu season to provide the first batch of vaccine to people with increased risk of severe complications. CDC said that vaccine should be made available to everyone after Oct. 24. Although CDC officials said they do not anticipate severe shortages, they urged the following groups to obtain vaccinations first:
- People over age 65;
- Pregnant women;
- Children ages six months to 23 months; and
- People with health conditions that put them at increased risk of severe flu complications (Baltimore Sun, 9/2).