FDA issues new COVID-19 vaccine approval guidelines

The U.S. Food and Drug Administration (FDA) issued new guidance earlier today with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent the novel coronavirus (COVID-19).

The updated and stricter guidelines, which were previously blocked by White House officials but cleared by the Office of Management and Budget, describe information and data that would support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information, according to a statement released by the FDA.

The guidance, officials say, provides further information on the EUA process for investigational vaccines and additional context to the information provided in the agency's June guidance regarding the development and licensure of COVID-19 vaccines. An EUA is a different standard than an approval, however, in the case of an investigational vaccine developed for the prevention of COVID-19, both pathways require the submission of data demonstrating any vaccine's safety and effectiveness, the statement says.

Additionally, the guidelines reiterate that any assessment regarding an 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.

The FDA said it plans to convene an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to issuance of any 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 Oct. 22 to discuss the general development, authorization, and licensure of COVID-19 vaccines. While this meeting is not intended to discuss any particular vaccine candidate, the agency said it is prepared to rapidly schedule additional future meetings of this committee after submission of any BLA or request for EUA to further ensure transparency.

"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,” said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, in a statement. “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."

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