Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines [open pdf - 166KB]
"This document is intended to provide to you, sponsors of seasonal inactivated influenza vaccines, guidance on clinical development approaches to support a Biologics License Application (BLA). The approaches in this guidance apply to both nonadjuvanted and adjuvanted hemagglutinin-based seasonal vaccines, including 'split virus,' subunit, and whole virus inactivated vaccines propagated in embryonated chicken eggs or cell-culture, and to recombinant hemagglutinin-based protein vaccines, and DNA vaccines that express hemagglutinin. This document does not address live attenuated influenza vaccines or influenza vaccines that do not rely on immunity to a hemagglutinin component. We, FDA, recognize that in the past there have been monovalent and bivalent inactivated influenza vaccines for seasonal influenza. To provide flexibility for evolving public health needs, including the development of vaccines with either more than three or fewer than three antigens, this guidance uses the term 'seasonal inactivated influenza vaccine.' This document does not address the nonclinical or early clinical development of investigational vaccines. Successful evaluations of nonclinical and early clinical development are important steps before proceeding with additional clinical development (Ref 1). This document also does not address the chemistry, manufacturing, control, or inspection of the manufacturing facility needed for licensure. These aspects of the license application are addressed in the guidance document entitled, 'Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related Product.' Applicants may contact the Center for Biologics Evaluation and Research (CBER) for additional information about these aspects of vaccine development."
Center for Biologics Evaluation and Research (U.S.): http://www.fda.gov/cber/guidelines.htm