FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines

SILVER SPRING, Md., Oct. 6, 2020 /PRNewswire/ -- The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research:

"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."

Additional information:

    --  Today, the U.S. Food and Drug Administration issued guidance 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 recommendations in the guidance describe key 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.
    --  This guidance provides further information on the EUA process for
        investigational vaccines and provides 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, as noted in the June
        guidance, 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.
    --  This guidance reiterates 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 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/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 submission of any BLA or request for
        EUA to further ensure transparency.

Additional Resources:

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

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: ocod@fda.hhs.gov, 888-INFO-FDA

The FDA, 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. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration