HHS Terminates COVID-19 Emergency Use Authorization Declarations for mRNA Shots & More
The COVID emergency framework is finally ending, but the Pfizer and Moderna mRNA injections have already moved beyond it.
This article originally appeared on Focal Points and was republished with permission.
Guest post by Nicolas Hulscher, MPH
Today, the U.S. Department of Health and Human Services finally moved to terminate the COVID-19 Emergency Use Authorization (EUA) declarations that have been in place since the early months of the pandemic.
The termination is not immediate. HHS has established a transition period of up to 12 months for EUA drugs and biologics and 180 days for EUA medical devices. According to the agency, the phased wind-down is intended to avoid disruptions and allow manufacturers and healthcare systems time to transition away from the emergency framework.
These declarations formed the legal foundation for the authorization of COVID-19 mRNA injections, monoclonal antibodies, antiviral drugs, diagnostic tests, ventilators, personal protective equipment, and numerous other medical products deployed during the pandemic response.
Unfortunately, the deadly Pfizer and Moderna mRNA injections are already fully FDA approved, meaning this action will have little practical effect on their continued use. The emergency framework that enabled their rapid rollout is finally being dismantled, but the products themselves have already moved beyond it.
While today’s announcement marks the formal beginning of the end of the COVID EUA era, it does not produce the outcome many of us had hoped for, including but not limited to the removal of mRNA products from the market.
Epidemiologist and Foundation Administrator, McCullough Foundation
www.mcculloughfnd.org
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