Comment from Alliance for Aging Research

The Alliance for Aging Research (“Alliance”) thanks the U.S. Food & Drug Administration (FDA) for the opportunity to comment in response to the December 8, 2025 “Citizen Petition” from Children’s Health Defense (CHD) calling for the revocation of BLAs for the FDA-approved COVID-19 vaccines. COVID-19 vaccines—including Moderna’s SPIKEVAX and Pfizer/BioNTech’s Comirnaty—have saved millions of lives and prevented millions more cases of serious illness and hospitalization. We oppose the CHD’s petition, and we believe that revoking the FDA licenses for these vaccines would endanger countless Americans and is not legally supported. The Alliance for Aging Research fully supports the comments submitted by the Alliance for mRNA Medicines on March 19, 2026. As detailed in the comments, we believe that: •Moderna and Pfizer satisfied the Institutional Review Board (IRB), Investigational New Drug (IND), and clinical trial requirements; •Vaccines that are initially distributed under an Emergency Use Authorization (EUA) can later satisfy the requirements of a Biologics License Application; and •The manufacturers did not take steps that would negate their licensures. Vaccines offer the single best method for preventing infection, severe illness, and death from COVID-19 for all age groups. And while the benefits of vaccination in terms of protection against death are disproportionately realized by older Americans and other immunocompromised individuals, vaccines remain an important protective option for both adults and children to reduce acute morbidity from COVID-19 as well as long COVID. We believe that the Citizen Petition is frivolous and that revoking licensure of the COVID-19 mRNA vaccines would endanger Americans. We urge the FDA to deny this petition.