ACP Experts Say FDA, CDC Moves May Undermine COVID-19 Vaccine Coverage for Millions

The COVID-19 pandemic forced scientists and policymakers to make life-or-death decisions with limited and rapidly evolving data—a process likened to “flying the plane while building it,” in a new commentary published in Annals of Internal Medicine.¹ The authors, from the American College of Physicians (ACP), called for humility, transparency, and more thoughtful, inclusive strategies moving forward to restore public trust and better prepare for future health crises.

Experts raise concerns about the growing politicization of science and public health.

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The growing politicization of science and public health was a central concern raised by ACP’s president, Jason M. Goldman, MD, MACP, and its executive vice president and CEO, Darilyn V. Moyer, MD, MACP. They reflected on previous generations, when vaccination was viewed as both a personal and civic duty. But the pandemic revealed a shifting landscape in which scientific consensus was often drowned out by political noise and misinformation.

“Science must be allowed to exist outside of the realm of political influence,” the authors wrote. “In the highly effective contemporary model, the FDA considers the safety and efficacy of vaccines, while the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices considers implementation of vaccination to best protect personal and public health.”

Referencing the recent CDC decision to no longer recommend routine COVID-19 vaccines for pregnant women and healthy children,² the article urged policymakers to consider the real-world context of people who may not be high-risk themselves but care for or live with vulnerable individuals.¹

According to a May 2025 commentary by FDA Commissioner Marty Makary, MD, MPH, and Vinay Prasad, MD, MPH, the director of the FDA’s Center for Biologics Evaluation and Research (CBER), in The New England Journal of Medicine, “The FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk. These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people.”

However, Goldman and Moyer explained that this move will lead to complications for health care providers and patients seeking access to care. The Affordable Care Act (ACA) requires insurers to cover all Advisory Committee on Immunization Practices (ACIP)-recommended vaccines. The FDA's recent limit on COVID-19 booster vaccines and the CDC's lack of recommendations for young children and pregnant women complicate ACIP's ability to approve off-label vaccine use.

“The decision of the FDA to limit the use of COVID-19 booster vaccines, as well as Secretary Kennedy’s recent statement that the CDC no longer recommends COVID-19 vaccines for young children and pregnant women (in advance of ACIP making formal recommendations), places ACIP in a difficult situation to potentially approve the off-label use of these vaccines,” they wrote. “This could jeopardize payment coverage for millions of Americans who could not otherwise afford the vaccine to protect themselves, their families, and their fellow citizens.”

The authors call for a more nuanced, risk-based approach to COVID-19 boosters, looking beyond age and underlying conditions to include social factors such as living arrangements, work responsibilities, and caregiving roles.

"Political directives should not prevent individuals from seeking safe and effective care that they desire and deserve," they stated. "People in the US should have agency and autonomy to decide how they should best receive care in the framework of mutual respect and reciprocity of rights, so that their actions do not negatively impact another’s."

As the nation prepares for future public health challenges, the authors stress the importance of learning from the past without being constrained by it, using history as a guide, "not a captor."

References

1. Goldman JM, Moyer DV. Flying the plane while building it: lessons from the COVID-19 pandemic. Ann Intern Med. Published online June 3, 2025. https://www.acpjournals.org/doi/10.7326/ANNALS-25-02436

2. Klein H. CDC pulls COVID-19 vaccine recommendation for pregnant women, healthy children. May 27, 2025. Accessed June 2, 2025. https://www.ajmc.com/view/cdc-pulls-covid-19-vaccine-recommendation-for-pregnant-women-healthy-children