FDA Issues Final Guidance to Boost Development of Cell-based Viral Vaccines

The Food and Drug Administration (FDA) today issued final guidance to help manufacturers who are developing safe and effective cell-based viral vaccines to address emerging and pandemic threats.

Titled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications,” the document will aid manufacturers who wish to use new cell substrates for vaccine production, such as for influenza vaccines. Currently, all licensed influenza vaccines are produced in chicken eggs.

“The development of safe and effective vaccines is critical toward protecting Americans against an influenza pandemic,” said HHS Secretary Kathleen Sebelius. “This final guidance recognizes that a new generation of medical products using innovative methods is needed to ensure we are better prepared today than we were yesterday.”

FDA scientists spent more than a decade conducting the research required for the document, as well as consulting with other scientists, the vaccine industry and the public on it. In addition to providing advice to manufacturers about the scientific principles of cell substrate development, the guidance describes tests that may be used to evaluate cell substrates intended for use in viral vaccine production.

“The availability of this final guidance is an important tool to help manufacturers advance the development and production of cell-based vaccines against infectious diseases,” FDA commissioner Margaret Hamburg, MD. “This may lead to additional vaccine options, including for pandemic influenza vaccines.”

Cell cultures are now used to produce licensed vaccines that help protect against diseases such as rubella and polio. Today's guidance outlines the best practices using current and emerging science to safely expand the types of cells that may be used to produce vaccines.

The guidance supplements recommendations on the production of viral vaccines for the prevention and treatment of infectious diseases provided in International Conference on Harmonization (ICH) documents Q5A and Q5. The FDA published the new guidance document in draft form and sought comments from the public in September 2006. The FDA received a number of scientific comments and revised the guidance as warranted based upon those comments.