Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry

Description

FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  FDA is committed to providing timely guidance to support the response to COVID-19.

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR601.40§ 601.40 Scope.

  This subpart applies to certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or inRead full regulation →

• 21CFR600.80§ 600.80 Postmarketing reporting of adverse experiences.

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

• 21CFR601.20§ 601.20 Biologics licenses; issuance and conditions.

  (a) Examination—compliance with requirements. A biologics license application shall be approved only upon examination of the product and upon a determination that the product complies with the standards established in the biologics license application and the requirements prescribed in the regulatioRead full regulation →

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• 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 →

• 21CFR211.110§ 211.110 Sampling and testing of in-process materials and drug products.

  (a) To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be establiRead full regulation →

• 21CFR211.100§ 211.100 Written procedures; deviations.

  (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, inRead full regulation →

• 21CFR211.166§ 211.166 Stability testing.

  (a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include:Read full regulation →

• 21CFR610.10§ 610.10 Potency.

  Tests for potency shall consist of either in vitro or in vivo tests, or both, which have been specifically designed for each product so as to indicate its potency in a manner adequate to satisfy the interpretation of potency given by the definition in § 600.3(s) of this chapter .Read full regulation →

• 21CFR211.42§ 211.42 Design and construction features.

  (a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.Read full regulation →

• 21CFR211.46§ 211.46 Ventilation, air filtration, air heating and cooling.

  (a) Adequate ventilation shall be provided.Read full regulation →

• 21CFR211.56§ 211.56 Sanitation.

  (a) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste mattRead full regulation →

• 21CFR211.22§ 211.22 Responsibilities of quality control unit.

  (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no eRead full regulation →

• In Vivo Bioavailability-Bioequivalence Studies – Clinical

  Maria A. Carballosa, M.D.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  SV Labs Corporation

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Guangdong Renhe Guozhuang Biotechnology Co., Ltd.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Medinatura New Mexico, Inc.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Sklar Personal Care Inc.

  2025-12-16

• CGMP/Deviations/Biologics License Application (BLA)

  Microvascular Tissue, Inc.

  2025-12-16

• CGMP/Finished Pharmaceuticals/Adulterated

  Catalent Indiana, LLC

  2025-12-11

• CGMP/Finished Pharmaceuticals/Adulterated

  DeVere Manufacturing Inc.

  2025-12-09

• CGMP/Finished Pharmaceuticals/Adulterated

  CDL Services, Inc. DBA Technichem

  2025-12-09

• CGMP/Finished Pharmaceuticals/Adulterated

  Seaway Pharma Inc.

  2025-12-09

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