First Vaccine for Avian Flu Strain Wins Approval From FDA

FDA on Tuesday approved the first vaccine for the H5N1 strain of avian flu for use until more effective vaccines are developed, USA Today reports.

Sanofi Pasteur, a division of Sanofi-Aventis, developed the vaccine under a contract with HHS (Manning, USA Today, 4/18). FDA approved the vaccine for use in individuals ages 18 to 64 (CQ HealthBeat, 4/17).

According to Norman Baylor, director of the Office of Vaccines Research and Review at FDA, Sanofi will not commercially market the vaccine, but doses of the vaccine will become part of the Strategic National Stockpile and used in the event U.S. residents become at high risk for avian flu infection.

HHS to date has purchased 13 million doses of vaccine, which would protect about 6.5 million U.S. residents, and seeks to purchase additional doses to protect a total of 20 million residents, department secretary Mike Leavitt said in a statement (USA Today, 4/18).

The vaccine has "several shortcomings," according to the New York Times (Pollack, New York Times, 4/18). In clinical trials, only about 45% of trial participants who received the highest dose of the vaccine -- two 90-microgram doses administered one month apart -- produced an adequate amount of antibodies to protect them from avian flu.

FDA officials also raised concerns about the time required to administer the vaccine and the large amount of flu protein required for a single dose of the vaccine (Chong, Los Angeles Times, 4/18).

FDA in a statement said, "The vaccine may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be developed and produced." In addition, the "less than optimal antibody levels may still have the potential to help reduce disease severity and influenza related hospitalizations and deaths," FDA said (CQ HealthBeat, 4/17).

FDA Commissioner Andrew von Eschenbach said, "The threat of an influenza pandemic is, at present, one of the most significant public health issues our nation and world faces." He added, "The approval of this vaccine is an important step forward in our protection against a pandemic" (Lopes, Washington Times, 4/18).

Baylor said, "Ideally, yes, you would like a vaccine that would have a higher efficacy" and that would require a single dose, adding, "At this point, this is where we are" (New York Times, 4/18).

Jesse Goodman, director of the Center for Biologics Evaluation and Research at FDA, said, "We are working closely with other government agencies, global partners and the vaccine industry to facilitate the development, licensure and availability of needed supplies of safe and effective vaccines against the pandemic threat" (CQ HealthBeat, 4/17).

Philip Hosbach, a vice president at Sanofi, said that that the vaccine marks a "great first step" and that the company has a "robust development program underway that is working on next-generation vaccines" (Mathews et al., Wall Street Journal, 4/18).

American Public Media's "Marketplace Morning Report" on Wednesday reported on the approval of the vaccine. The segment includes comments from Baylor and Jeffrey Levi, executive director of Trust for America's Health (Palmer, "Marketplace Morning Report," American Public Media, 4/18).

Audio and a transcript of the segment are available online.