Titled ‘Guidance for Industry: Characterisation and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications,’ the document is expected to 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.
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 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 has 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.
Kathleen Sebelius, secretary of HHS, said: The development of safe and effective vaccines is critical toward protecting Americans against an influenza pandemic. 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.”
Margaret Hamburg, commissioner of FDA, said: “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. This may lead to additional vaccine options, including for pandemic influenza vaccines.”