Trump administration limits COVID-19 vaccine access to high-risk groups under new FDA policy
Under the Trump administration, the FDA will limit access to updated COVID-19 vaccines, approving them only for seniors and high-risk groups — a major shift from previous guidance recommending annual shots for the broader public.
The Trump administration announced a significant change in federal vaccine policy on Tuesday, stating that new COVID-19 boosters will be approved primarily for seniors and individuals with underlying health conditions. The revised guidance, released by the Food and Drug Administration (FDA), marks a sharp departure from previous policy that encouraged annual COVID-19 shots for nearly all Americans aged six months and older.
The updated framework, published in the New England Journal of Medicine, calls for additional data and clinical trials before newer vaccines can be broadly approved for healthier populations. The FDA will continue a streamlined process for high-risk groups but will now require more rigorous studies for low-risk individuals, potentially limiting vaccine access for the general public in the upcoming fall season.
Uncertainty over vaccine availability for general population
Under the new policy, the FDA plans to maintain access for approximately 100 million Americans who fall into high-risk categories, including adults over 65 and individuals with certain chronic health conditions. However, for healthy individuals, especially those between ages 50 and 64, manufacturers will be required to conduct randomized controlled trials comparing outcomes between vaccinated and unvaccinated groups.
This approach has raised concerns among health experts and pediatric organizations. Critics, including Dr. Paul Offit from the Children’s Hospital of Philadelphia, questioned how eligibility will be determined in practice and warned that reduced access could affect insurance coverage. The American Academy of Pediatrics also expressed concern, stating that the change could limit options for families who want to vaccinate their children against COVID-19.
FDA announces new policy on COVID-19 vaccines and encourages vaccine companies to conduct more extensive research. Photo: AP News
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Policy reflects new leadership and a shift in scientific approach
The new guidance reflects the broader direction of health policy under Health Secretary Robert F. Kennedy Jr., who has filled key FDA roles with longtime critics of pandemic-era vaccine strategies. The guidance was co-authored by FDA Commissioner Marty Makary and Dr. Vinay Prasad, both of whom have publicly questioned the efficacy of repeated boosters for the general population.
According to Prasad, the goal is to strike a “reasonable compromise” by continuing protection for vulnerable groups while collecting new evidence on vaccine effectiveness in others. The FDA also hinted that further restrictions could apply if the virus undergoes significant mutation. While companies like Pfizer and Moderna have said they will continue working with the agency, the announcement raises questions about the future of broad public vaccination campaigns in the United States.
