FDA Approves New Vaccine, Afluria, for Upcoming Flu Season

The Federal Drug Administration has announced in a press release that a new influenza vaccine has been approved for adults 18 and older. Afluria has been developed to protect adults from influenza type A and B viruses that are common during the annual flu season. The approval of Afluria bring s the total number of flu vaccines to six. The Center for Disease Control and Prevention estimated that a record number of 132 million doses of flu vaccines will be available for the 2007-2008 flu season.

Afluria is manufactured by CSL Limited of Australia. The vaccine comes as a pre-filled syringe and contains inactivated influenza viruses that are grown in chicken eggs. People with egg allergies should not receive Afluria. Afluria is also available in a multi-dose vial, but contains thimerosal, which is a mercury derivative.

The flu season in the US can start as early as October, so the FDA and CDC recommend receiving the vaccine as early as September. However, if the vaccine is not available in September, it is advisable to get the flu shot as soon as possible after September and at any time during the flu season as the season can peak later. The flu season usually lasts until as late as May. More than 200,000 people in the US are hospitalized yearly for influenza, and 36,000 people die every year from complications of the virus.

The director of the FDA's Center for Biologics Evaluation and Research, Jesse L. Goodman, M.D., M.P.H stated in the press release that "routine immunization is the most effective way to prevent influenza and decrease influenza-related complications." He continues, "The licensure of this additional manufacturer contributes to having an adequate supply of seasonal influenza vaccine for Americans, one of FDA's highest priorities."

Afluria, CSL's first drug to be approved for use in the US, did take the FDA's accelerated pathway for serious or life-threatening diseases, which cuts the normal time period needed for approval for much-needed medications and vaccines to be become available to the public. Afluria did demonstrate that it induced antibody levels in the bloodstream enough to be considered effective in preventing seasonal flu viruses. The company is required to continue testing the vaccine to verify that the drug does indeed prevent the influenza virus after being administered.

Common side effects include tenderness, pain, swelling, redness, headache, fatigue, and muscle aches. The CSL Biotherapies also released news about the approval on their website. In that press release, the company also cautions that people with compromised immune systems should not be given Alfuria as they will not have the optimal immune response on Afluria.

Source: Federal Drug Administration