FDA Issues Guidances on Seasonal and Pandemic Influenza Vaccines

Rockville, MD (May 31)-The US Food and Drug Administration finalized guidances for seasonal and pandemic influenza vaccines. The goal of the guidances is to outline the regulatory pathways for developing and approving these products.

“FDA continues its commitment to help increase the supply of influenza vaccines and support the development of new approaches to vaccine production,” said Jesse L. Goodman, director of FDA's Center for Biologics Evaluation and Research, in an agency release. “Having additional manufacturers of licensed influenza vaccines will enhance the capacity to produce more doses of seasonal influenza vaccines as well as contribute to the nation's pandemic preparedness, one of our top priorities.”

FDA issued the two draft guidances-one for seasonal influenza vaccines and another for pandemic influenza vaccines-for public comment in March 2006 and issued the final guidances following input from vaccine manufacturers and public-health officials. Both guidances recommend using recent technologies such as cell-culture and recombinant manufacturing to enhance the development and evaluation of vaccines. They also recommend adding substances such as novel adjuvants that improve the immune response to the vaccine.

The guidances describe conventional and accelerated approval pathways to vaccine licensure. Companies selecting the conventional pathway must provide  clinical evidence that their vaccine prevents influenza. Adequate and well-controlled clinical trials also are required for accelerated approval, but companies may use a biological indicator, such as an immune response to the vaccine, to predict effectiveness, an approach that may reduce the vaccine's development time. Further clinical studies are then required to verify the vaccine's clinical benefit.

The guidances indicate that manufacturers should submit a new biologics license application for the initial licensure of a pandemic or seasonal influenza vaccine to ensure that each vaccine has its own trade name and labeling.

For companies with US-licensed seasonal influenza vaccines, the pandemic guidance outlines the regulatory pathway for obtaining licensure for a new pandemic vaccine for which the manufacturing process is the same as for the seasonal vaccine. For manufacturers developing vaccines using a new manufacturing process, both guidance documents explain the process for obtaining licensure using the accelerated approval pathway.

Guidance for Industry, Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines may be found at www.fda.gov/cber/gdlns/panfluvac.htm