HHS Formally Terminates Remaining COVID-19 Emergency Use Authorizations
In a significant post-pandemic policy milestone, the U.S. Department of Health and Human Services (HHS), led by Secretary Robert F. Kennedy, Jr., announced the formal termination of remaining Emergency Use Authorizations (EUAs) for COVID-19 drugs, biological products, and medical devices. The declaration, published in the Federal Register, states that the emergency circumstances that originally justified these temporary authorizations no longer exist.
The termination of these EUAs will officially take effect in one year (July 2027), giving manufacturers a transition window to either secure traditional, full FDA approvals or phase out their products.
Impact on Authorized COVID-19 Treatments
While major COVID-19 vaccines (such as Pfizer/BioNTech's Comirnaty) and therapeutics (such as Paxlovid and Veklury) already possess full FDA approvals, several other products remain on the market solely under EUAs.
A notable example is Invivyd's Pemgarda (pemivibart), an authorized prophylactic monoclonal antibody for immunocompromised individuals. Following the announcement, Invivyd confirmed it is in dialogue with the FDA regarding a path to a Biologics License Application (BLA) submission, citing robust clinical and post-authorization data.
The move represents a clear effort by the current HHS leadership to transition the U.S. healthcare system entirely away from emergency-era regulatory frameworks.
"By ending these COVID-19 emergency use authorization declarations, we're reinforcing public confidence that emergency authorities are temporary and targeted." — Robert F. Kennedy, Jr., HHS Secretary
"At Invivyd, we believe Pemgarda has sufficient clinical and post-authorization data to support Biologics License Application (BLA) submission and approval, and we regret that procedural uncertainty has needlessly intruded into our work on behalf of vulnerable Americans..." — Marc Elia, Board Chairman of Invivyd