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The Food and Drug Administration (FDA) has issued recommendations to aid manufacturers in developing seasonal and pandemic influenza vaccines. FDA's goal is to expedite the development and availability of safe and effective vaccines needed to protect against influenza.
"This action illustrates FDA's high level of commitment and key role in preparing for influenza pandemic, which is a top priority for our nation" said Acting FDA Commissioner Dr. Andrew von Eschenbach.
In two guidance documents released last week, one for seasonal, and the other for pandemic influenza vaccines, the FDA provides manufacturers with clear guidance on developing and submitting clinical data to show safety and effectiveness for new vaccines. Consistent with the aims of FDA's Critical Path Initiative to get products to market more quickly and to advance the development and use of new technologies, these documents outline specific approaches that vaccine developers may follow.
For licensed vaccines, they describe the process for changing rapidly from the currently-licensed seasonal vaccine to a new pandemic vaccine by supplementing the existing license. For new vaccines, they describe defined pathways for both traditional and accelerated approval approaches. Accelerated approval allows for evaluation based on biological indicators (e.g., the immune response to the vaccine) likely to demonstrate effectiveness.
Because these guidances will assist manufacturers in the development and evaluation of seasonal and pandemic influenza, the direction that they provide to new manufacturers, in turn, helps address the increased demand for influenza vaccine. The guidance also helps support and defines steps needed for development and evaluation of vaccines using new technologies (such as cell culture and recombinant manufacturing) and potential approaches to stretching limited pandemic vaccine supplies (such as with the use of ingredients added to a vaccine to improve the immune response it produces, known as adjuvants and different vaccine delivery methods).
The accelerated approval pathway was critical in allowing last year's rapid approval of a new influenza vaccine, Fluarix, and broke new ground in that it was the first vaccine approved using that approval process.
In issuing this advice, FDA aims to facilitate manufacturers in increasing the number of doses to ensure that enough influenza vaccine is available to vaccinate each person in the at-risk population. Having additional diversity in our vaccine supply helps enhance the capacity to produce more doses of influenza vaccine and contributes to the nation's pandemic preparedness.
"These guidance documents provide important advice for manufacturers on how to develop needed vaccines more quickly," said Dr. Jesse Goodman, director of the Center for Biologics Evaluation and Research at the FDA. "FDA is committed to helping companies develop safe and effective vaccines to prevent influenza, including pandemic influenza, and is very engaged with product developers."
The release of these guidances is part of the comprehensive effort that FDA is undertaking to work with manufacturers to facilitate the development of vaccines. Other examples include a recent CBER advisory committee meeting to discuss novel approaches to develop influenza vaccine such as using cell technology rather than eggs, frequent interactions with vaccine manufacturers to provide both scientific and regulatory guidance, as well as CBER's preparation of material for testing the potency of new vaccines, which are made available to manufacturers.
A copy of the guidance, "Draft Guidance for Industry, Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines," is available at: http://www.fda.gov/cber/gdlns/trifluvac.pdf.
A copy of the guidance, "Draft Guidance for Industry, Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines," is available at: http://www.fda.gov/cber/gdlns/panfluvac.pdf.
The public has 90 days to comment on the drafts. When finalized, the guidances will represent the FDA's current thinking on these topics.