FDA Finalizes Pandemic, Seasonal Influenza Vaccine Guidances

The U.S. Food and Drug Administration (FDA) on March 31 issued final recommendations to increase the supply of safe and effective influenza vaccines for both seasonal and pandemic use with the goal of outlining the regulatory pathways for the rapid development and approval of 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, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research (CBER). "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."

In March 2006, FDA issued two draft guidance documents for public comment—one for seasonal influenza vaccines and another for pandemic influenza vaccines. The draft documents outline specific approaches for manufacturers to develop new vaccines that are safe, pure, and potent.

Both guidances recommend using recent technologies such as cell culture and recombinant manufacturing to enhance the development and evaluation of vaccines. They also indicate that manufacturers should submit a new Biologics License Application (BLA) for the initial licensure of a pandemic or seasonal influenza vaccine to ensure that each pandemic and seasonal vaccine has its own trade name and labeling.

For companies with U.S. licensed seasonal influenza vaccines, the pandemic guidance outlines the regulatory pathway for obtaining licensure for a new pandemic vaccine in 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.

For more information, visit the separate documents at "Guidance for Industry, Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines" and "Guidance for Industry, Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines".

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