Comment to the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the 2025-2026 formula for Covid-19 vaccines
Comment to the Docket #: FDA-2025-N-1146
Vaccines and Related Biological Products Advisory Committee
May 22, 2025
Re: 2025-2026 formula for COVID-19 vaccines for use in the United States
Submitted to Federal Register: May 23, 2025
The May 22, 2025, meeting of the Food and Drug Administration’s (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) resulted in a unanimous, 9 to 0 vote in favor of formulating the 2025-2026 COVID-19 vaccines using a monovalent JN.1 lineage (strain). That vote was based on an expert review of recently generated epidemiologic, pre-clinical and clinical data compiled and presented at the meeting by the Centers for Disease Control and Prevention (CDC), and separately by the World Health Organization (WHO) as well as the three manufacturers currently licensed to sell the vaccines in the United States (Moderna, Novavax and Pfizer).
Committee members and expert presenters seemed to agree that over the past year the COVID-19 burden in United States was relatively mild compared to previous years of the pandemic. Nonetheless, SARS-CoV-2 infection killed or hospitalized tens of thousands to hundreds of thousands of Americans. The experts convened also agreed that the virus remains elusive in terms of its periodicity (seasonality) and the frequency of viral mutations that alter its transmissibility and virulence.
Despite the uncertainties, the analyses presented by CDC, WHO and the three vaccine manufacturers converged on two conclusions. First, the dominant and expanding strain of the SARS-CoV-2 virus is in the JN.1 lineage branch of the virus’ phylogeny. Second the recently deployed JN.1 strains of mRNA (Moderna and Pfizer) and protein (Novavax) vaccines were effective at reducing COVID-19 hospitalizations and deaths.
Accordingly, the VRBPAC meeting seemed efficient and successful in advising the FDA about formulation of the COVID-19 vaccine for 2025-2026.
Unfortunately, the meeting proceedings were overshadowed by two glaring topics omitted from the agenda.
First, several members of the committee expressed interest in discussing the “new FDA regulatory framework for COVID-19 vaccination.” The framework was discussed in a May 20, 2025, article in the New England Journal of Medicine, by CBER Director Dr. Vinay Prasad and FDA Commissioner Dr. Martin Makary, just two days before the VRBPAC meeting. That framework calls for substantive changes in pre-market testing standards for COVID-19 vaccines. These changes may restrict access for many people who are now eligible for COVID-19 vaccination, including healthy persons under the age of 65 years. Such individuals may have family members who are immune compromised, or they themselves may be reasonably motivated to decrease their personal risk of contracting long COVID.
Second, because of the unprecedented termination of thousands of employees of the FDA and CDC, VRBPAC and the Advisory Committee on Immunization Practices at the CDC should soon be convened to discuss whether the FDA and CDC, respectively, have sufficient resources to monitor the evolution of the SARS-CoV-2 virus, an essential activity for vaccine formulation. The review of COVID-19 surveillance data from the CDC is critical to VRPAC’s work. At the May 22, 2025, meeting, CDC staff only briefly discussed whether they had sufficient resources, including connections with scientists at the WHO, and the biomedical laboratory infrastructure to appropriately track the emergence of viral gene variants.
Public Citizen urges the FDA to promptly convene the VRBPAC again to fully discuss and advise the agency on these topics, which are critical maintain the timely and sufficient availability of COVID-19 vaccines.
Sincerely,
Michael T. Abrams, M.P.H., Ph.D.
Senior Health Researcher
Health Research Group
Public Citizen