The Trump administration is making it more challenging to access COVID booster shots by introducing stricter regulations for vaccine development aimed at healthy individuals. The Food and Drug Administration (FDA) has announced that it will prioritize approving COVID vaccines primarily for adults over 65 and for children over 6 months who have at least one risk factor for severe illness. In a recent commentary published in the New England Journal of Medicine, FDA officials explained their approach: they will focus on approving vaccines for high-risk groups while demanding more comprehensive data before authorizing shots for low-risk populations.
This policy shift comes amid political shifts within the Department of Health and Human Services, with notable figures like Robert F. Kennedy influencing the direction of public health strategies. Some experts express concern that these new guidelines could limit access to boosters for many Americans. Anna Durbin, a leading immunization researcher at Johns Hopkins University, warned that the restrictions might prevent eager vaccine recipients from getting their shots. Similarly, vaccine scientist Dr. Paul Offit suggested that tighter regulations could make vaccines less accessible and less insurable.
The FDA emphasizes that more clinical trial data will be necessary before approving COVID vaccines for those considered healthy and at lower risk. Despite these changes, the agency estimates that about 100 to 200 million Americans—less than 60% of the population—will still have access to COVID vaccines annually. Recently, the FDA approved the Novavax COVID shot only for older adults and high-risk groups, reflecting this cautious approach.
The NEJM commentary highlights the uncertainty around vaccinating healthy individuals, questioning whether a 52-year-old woman who has had COVID-19 multiple times and received several vaccine doses would benefit from another booster. However, CDC studies have shown that boosters can effectively reduce mild to moderate COVID cases and shorten illness duration, even for those at lower risk. Vaccination also lowers the chances of developing long COVID and severe disease.
During the 2024–25 season, COVID-19 hospitalizations are projected to be around 71.2 per 100,000 people, although reporting requirements for COVID-related hospital stays have been relaxed. Vaccines remain a critical tool, especially for immunocompromised individuals, but the new FDA policies raise questions about whether healthy people will be able to get vaccinated to protect vulnerable loved ones.
The NEJM notes that COVID booster uptake in the U.S. has been relatively low, with less than a quarter of eligible individuals getting their shots each year. The article suggests that this decline in vaccination rates could erode public trust in vaccines overall. Critics argue that the current approach may be driven more by political motives than by transparency, with some former FDA officials claiming that truth and openness are being sacrificed in favor of aligning with misinformation.
As the landscape of COVID vaccination policies continues to evolve, many are left wondering how these changes will impact public health and the ability of Americans to stay protected against COVID-19.
