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FDA Issues Updated Guidance on Emergency Use Authorization for COVID-19 Vaccines

On October 6, FDA issued updated guidance for industry concerning “Emergency Use Authorization for Vaccines to Prevent COVID-19,” updating the previous guidance issued in June.  The updated guidance, which is being “implemented immediately” and “without prior public comment,” is intended “to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA . . . for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.”

In its guidance, FDA explained that, while “[t]here are currently no FDA-licensed vaccines to prevent COVID-19,” “[c]ommercial vaccine manufacturers and other entities are developing COVID-19 vaccine candidates using different technologies including RNA, DNA, protein, and viral vectored vaccines.” FDA’s current 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” and “are not necessarily applicable to drugs and biological products intended for treatment of COVID-19.”

To be approved, an EUA application must demonstrate that: (i) SARS-CoV-2 “can cause a serious or life-threatening disease or condition”; (ii) “it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition”; (iii) the “known and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks”; and (iv) there “is no adequate, approved, and available alternative to the product.”  EUA applications will be assessed “on a case by case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product.”  In particular, FDA emphasized that “for a COVID-19 vaccine for which there is adequate manufacturing information to ensure its quality and consistency, issuance of an EUA would require a determination by FDA that the vaccine’s benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner.”

The guidance also provides an overview of the information that should be submitted in a request for an EUA for a COVID-19 vaccine, including detailed regulatory, chemistry, manufacturing, controls, safety, and effectiveness information.  It further explains that “FDA expects to convene the VRBPAC [Vaccines and Related Biological Products Advisory Committee] for consideration of any EUA request for a COVID-19 vaccine” in a public meeting.  An appendix outlines “Submission of Information in Preparation for a VRBPAC Meeting” and provides information about the advisory committee meeting process.

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