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Date COVID vaccine receives full FDA approval

Healthy Communities Keep Virginia Safe Tournament

Question

There are currently three SARS-CoV-2 vaccines under Emergency Use Authorizations (EUAs) in the U.S.: the two-dose Pfizer-BioNTech vaccine, the two-dose Moderna vaccine, and the single-dose Janssen vaccine. As of 30 July 2021, no SARS-CoV-2 vaccines are fully approved under Biologics Use Authorizations (BLA).

According to Harvard’s Petrie-Flom Center, an EUA differs from BLA in the following way:

an EUA is “an authorization to distribute an otherwise unapproved product (or an approved product for an unapproved use) during an emergency formally declared by the Secretary of Health & Human Services,” while a BLA is “FDA’s standard ‘full approval’ mechanism for biological products, including therapeutics and vaccines. A company seeking a BLA for its product must demonstrate that the product is ‘safe, pure, and potent,’ which generally means completing robust, well-controlled clinical trials.”

Both Pfizer and Moderna have submitted applications to the FDA for full BLA approval — Pfizer submitted its application on 7 May 2021 and Moderna did so on 1 June 2021. The FDA says it makes a decision on full approval within 6 months of application submission.

On 30 July, STAT News reported that “the Food and Drug Administration center that reviews vaccines is planning to deprioritize some of its existing work, like meetings with drug sponsors and plant inspections, in an effort to accelerate its review of Pfizer’s application for the formal approval of its Covid-19 vaccinea senior agency official told STAT … Now, the senior agency official said, the agency will initiate a ‘sprint.’”

When will a SARS-CoV-2 vaccine receive full BLA approval by the U.S. FDA?

Resolution will be determined by the date of the first FDA press release announcing the full BLA approval of a SARS-CoV-2 vaccine.

If this does not occur before 31 January 2022, then this resolves as > 31 January 2022.

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