FDA Update on Influenza Vaccine Supply
October 17, 2005
FDA anticipates the production of more vaccine than last year. At this time, we do not know the exact number of doses to be distributed, but despite Chiron's lowered projections announced today, we still anticipate that there will be significantly more vaccine produced than last year.
"A tremendous amount of work by FDA, MHRA, and the firm has brought us to the point that will allow Chiron to distribute influenza vaccine for this flu season," said Dr. Jesse Goodman, Director of FDA's Center for Biologics Evaluation and Research. "However, as with all influenza vaccine manufacturers, Chiron's influenza vaccine must undergo safety testing and lot release evaluation before it can be released to the market."
FDA is committed to working with all of the influenza vaccine manufacturers to expedite product lot release and availability of vaccine. While occasional spot shortages may occur as manufacturers complete their final testing, we expect these shortages to resolve as vaccine continues to be released to health care providers and others who administer the vaccine.
There are four manufacturers distributing influenza vaccine this year: Sanofi Pasteur, Inc., MedImmune Vaccines, Inc., GlaxoSmithKline Biologicals, and Chiron. FDA has been actively working with them to ensure an adequate, safe, and effective supply of vaccine. As part of this overall effort, the Agency has had close interactions with the Medicines and Healthcare Products Regulatory Agency (MHRA, the U.K. regulatory authority) and Chiron, as the company has worked to correct the problems that led to its license suspension by MHRA.
Influenza season may begin as early as October and run through May. The best time to get vaccinated is in October or November, but getting vaccinating in December or later still can be beneficial.
Posted: October 2005