There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, HHS issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.
The SARS-CoV-2 pandemic presents an extraordinary challenge to global health. There are currently no FDA-licensed vaccines to prevent COVID-19. Commercial vaccine manufacturers and other entities are developing COVID-19 vaccine candidates using different technologies including RNA, DNA, protein, and viral vectored vaccines. This guidance was first developed prior to issuance of an EUA for a COVID-19 vaccine and takes into account the EUAs currently in place for COVID-19 vaccines.
This guidance describes FDA’s current recommendations regarding the data and information needed to support the issuance of an Emergency Use Authorization (EUA) under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19, including chemistry, manufacturing, and controls information (CMC); nonclinical data and information; and clinical data and information, as well as administrative and regulatory information. In addition, the guidance provides recommendations regarding key information and data that should be submitted to a relevant investigational new drug application (IND) or cross-referenced master file (MF) prior to submission of an EUA request in order to facilitate FDA’s complete and timely review of such a submission, including convening the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This guidance also discusses FDA’s current thinking regarding the circumstances under which the issuance of an EUA for a COVID-19 vaccine would be appropriate, providing additional context to the discussion regarding EUAs in the guidance for industry entitled “Development and Licensure of Vaccines to Prevent COVID-19” (Ref. 1).
These recommendations are specific to COVID-19 vaccines, which are complex biological products that are intended to be administered to millions of individuals, including healthy people, to prevent disease. These vaccines have the potential for broad use under an EUA. The recommendations in this guidance are not necessarily applicable to drugs and biological products intended for treatment of COVID-19, for which there may be significantly different considerations under the standard set forth in section 564 of the FD&C Act (21 U.S.C. 360bbb-3), reflecting the products’ characteristics and anticipated clinical uses.
Sponsors engaged in the development of vaccines to prevent COVID-19 should refer to the guidance for industry entitled “Development and Licensure of Vaccines to Prevent COVID-19” (Ref. 1), the guidance for industry and investigators entitled “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products” (Ref. 2), and the guidance for industry and other stakeholders entitled “Emergency Use Authorization of Medical Products and Related Authorities” (Ref. 3).
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