Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines   [open pdf - 188KB]

"This document is intended to provide to you, sponsors of pandemic influenza vaccines, guidance on clinical development approaches to facilitate and expedite the licensure of influenza vaccines where the intended indication is for active immunization in persons at high risk of exposure to, or during a pandemic caused by, pandemic influenza viruses. We, FDA, also discuss pursuing licensure of an influenza vaccine for indication and usage during the prepandemic stage in Section III.D.5. -- Investigating Schedules for Administration for Use Prior to a Pandemic. The approaches in this guidance apply to both nonadjuvanted and adjuvanted hemagglutinin-based pandemic 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. We also address live attenuated influenza vaccines. This document does not address influenza vaccines that do not rely on immunity to a hemagglutinin component. This document does not address the nonclinical development of investigational vaccines. Successful nonclinical evaluation is an important step before proceeding with 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.' 1 Applicants may contact the Center for Biologics Evaluation and Research (CBER) for additional information about these aspects of vaccine development."

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Center for Biologics Evaluation and Research: http://www.fda.gov/cber/index.html
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