U.S. FDA Issues New COVID-19 Vaccine Approval Guidelines

The US Food and Drug Administration (FDA) issued new guidance 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 a EUA for an investigational vaccine to prevent COVID-19.

Issued on October 6, 2020, the recommendations in the FDA’s new guidance are for the duration of the COVID-19 public health emergency and describe key information needed, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.

Currently, there is no FDA-approved or authorized vaccine for the prevention of COVID-19.

“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making,” states Stephen M. Hahn, M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, in a website statement.

“We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”

This guidance reiterates that any assessment regarding a EUA will be made 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.

Furthermore, the FDA plans to convene an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to the issuance of an EUA for a COVID-19 vaccine to discuss the EUA request and whether the available safety and effectiveness data support the authorization. 

The VRBPAC is currently scheduled to meet on October 22, 2020, to discuss the general development, authorization, and/or licensure of COVID-19 vaccines. 

While this meeting is not intended to discuss any particular vaccine candidate, the agency is prepared to rapidly schedule additional future meetings of this committee after the submission of any BLA or request for EUA to further ensure transparency.

Dr. Peter Marks added: “Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available.”

“The FDA’s new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.” 

“In addition to outlining our expectations for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety, and efficacy for any vaccine that is authorized or approved,” concluded Dr. Marks.

An updated listing of SARS-CoV-2 virus preventive vaccine candidates is published on this CoronavirusToday webpage.

The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. 

PrecisionVaccinations publishes research-based vaccine development news.