FOR IMMEDIATE RELEASE
Doctors for America
PO Box: 21161
2300 18th St NW Lbby
Washington, DC 20009-9996
May 30, 2025
Doctors for America Calls for Transparency in COVID-19 Vaccine Regulation
WASHINGTON, D.C. – Doctors for America’s (DFA) welcomes the approval of the Novavax protein-based COVID-19 vaccine by the Food and Drug Administration (FDA) on May 16, 2025. The role of vaccination as a cornerstone of public health has been underscored by the COVID-19 pandemic. As physicians, we know that access to these evidence-based tools to prevent severe illness, disability, and death, are essential to the care of our patients and our shared goal to improve the health of all Americans. Therefore, vaccine regulations must be guided by science, not political ideology.
COVID-19 infection continues to result in hundreds of thousands of hospitalizations annually, and causes the deaths of hundreds of Americans each week. Millions of Americans continue to live with complications of this disease and long COVID. Vaccines against COVID-19 infection are among the best-studied vaccines, including undergoing the “most intensive safety analysis in U.S. history” during the COVID-19 pandemic, in addition to ongoing safety monitoring after approval. These vaccines have been shown again and again to be safe and effective. Since Novavax uses protein subunit technology, it is an appealing option for those who may have adverse effects or concerns about mRNA vaccines, but still want protection against this disease.
We need all tools available to prevent complications of COVID-19. Therefore, the unprecedented political actions recently taken by the FDA regarding COVID-19 vaccinations raise serious concerns. FDA approval of Novavax was delayed – without clear justification – by nearly two months beyond FDA’s deadline of April 1st, even though it had been on track to meet this deadline. FDA has now approved the vaccine for a limited population of patients: patients aged 65 years and older, or patients aged 12-64 with “at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.” The decision by FDA to restrict the vaccine diverges from the established approval processes by which the FDA licenses vaccines and the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) makes recommendations for use.
The process surrounding this approval raises profound concerns about the current FDA administration’s approach to vaccination. FDA Commissioner, Dr. Martin Makary, has doubled-down on Secretary Kennedy’s pledge of “radical transparency,” but the decisions regarding both the delayed approval and the restricted indication were made out of public view and via a process that remains obscured from the American people. Moreover, on May 20th, Dr. Vinay Prasad, now the Director of the FDA’s Center for Biologics Evaluation and Research (CBER) and Dr. Makary published a Sounding Board commentary in the New England Journal of Medicine (NEJM), titled “An Evidence-Based Approach to Covid-19 Vaccination,” which outlined changes to the regulatory framework that the FDA will use to evaluate COVID-19 vaccines moving forward. The re-drafting of a regulatory framework by political appointees is unprecedented. It eschews input from independent scientific experts and public comments and circumvents the well-established process for guideline development and the important role of the CDC in this process, implying vaccine regulation and approval moving forward will be a politically-determined, rather than scientifically-driven, process.
The May 27th decision to remove the recommendation that healthy children and pregnant women receive the COVID-19 vaccine limits patients’ freedom to make decisions about their health. This decision further demonstrates this Administration’s repeated pattern of political appointees unilaterally making decisions that buck the established processes meant to protect the public’s health and protect the independence of scientific and health agencies. Instead, having political appointees with ideological views make such decisions signals a disregard for the essential role of expert committees composed of vaccines scientists, infectious disease specialists, and public health experts in guiding vaccine recommendations. Moreover, these restrictions assume that preexisting diagnoses perfectly predict a patients’ risk of severe COVID-19 disease, ignoring several years of scientific evidence to the contrary. As a key example of how this recommendation will increase confusion among patients and providers, “pregnancy and recent pregnancy” are on the CDC’s list of underlying medical conditions that increase a person’s risk of severe illness from COVID-19; the very list referred to by Drs. Makary & Prasad in Figure 2 of their NEJM commentary. This distressing change in recommendations will further strip access to COVID-19 vaccines from those who want them and end the opportunity for patients to make decisions about their own health risk with their doctors.
All Americans depend on the FDA for licensing of vaccines. These vaccine policy decisions impact the health of our patients and, as such, we expect the best practices to be followed. However, we are deeply concerned by the opaque process by which the Novavax vaccine was ultimately approved; the restrictions on the use of Novavax vaccines – and now all COVID-19 vaccines – that stand in sharp contrast to prior evidence-based recommendations; and the proposed subjective vaccine approval framework as outlined by political appointees through social media, podium announcements, and commentary pieces. Blinding the public, vaccine scientists, and public health experts from the rationale behind vaccine guideline decisions, while simultaneously disregarding prior best practices, is unacceptable. Commissioner Makary has pledged that new guidance for vaccine producers will be published shortly, and we would welcome such a step if this guidance promotes a good faith, transparent, and scientifically rigorous evaluation of vaccines. As medical professionals, Doctors for America advocates for transparent, expeditious, and fair processes for approval and guidelines for therapeutics used in the prevention and treatment of COVID-19 and other infectious diseases.
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About Doctors for America:
Doctors for America mobilizes doctors and medical students to be leaders in putting patients over politics to improve the health of our patients, communities, and nation. DFA is an organization of over 27,000 physician and medical student advocates in all 50 states, representing all areas of specialization. DFA teaches physicians and medical students advocacy skills and does advocacy at a state and federal level. Our impact areas focus on access to affordable care, community health and prevention, and health justice and equity. DFA focuses solely on what is best for our patients, not on the business side of medicine, and does not accept any funding from pharmaceutical or medical device companies, which uniquely positions DFA as the organization that puts patients over politics and patients over profits. Find out more at doctorsforamerica.org and on X drsforamerica or Bluesky drsforamerica.bsky.social.