Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines: Guidance for Industry

Description

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 hemagglutininbased 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.

Scope & Applicability

Regulatory Context

• 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.

  (a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →

• 21CFR600.3§ 600.3 Definitions.

  As used in this subchapter:Read full regulation →

• 21CFR314.126§ 314.126 Adequate and well-controlled studies.

  (a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →

• 21CFR312.32§ 312.32 IND safety reporting.

  (a) Definitions. The following definitions of terms apply to this section:Read full regulation →

• 21CFR601.41§ 601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

  FDA may grant marketing approval for a biological product on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, tRead full regulation →

• 21CFR312.23§ 312.23 IND content and format.

  (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →

• Advanced Manufacturing Technologies Designation Program (Status: Final)
• Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
• Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product: Guidance for Industry (Status: Final)
• Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for Industry (Status: Final)
• Submission of Abbreviated Reports and Synopses in Support of Marketing Applications. (Status: Final)
• Use of Sterile Connecting Devices in Blood Bank Practices: Guidance for Industry (Status: Final)
• Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Status: Draft)
• Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (Status: Final)