The US Food and Drug Administration (FDA) has announced a significant revision to its COVID-19 vaccination policy, restricting access to seasonal booster shots for healthy Americans under the age of 65. The agency will now require more rigorous clinical data before authorising vaccines for those not considered high-risk.
This policy marks a departure from the universal vaccination approach that has defined the US pandemic response. Health officials say the shift brings the US more in line with other high-income countries, but some medical experts and patient advocates have voiced concern that the decision may deter access for those who still wish to be vaccinated.
New Guidelines Prioritise Risk-Based Vaccine Access
Under the revised strategy, the FDA will automatically approve updated COVID-19 boosters only for individuals aged 65 and older, and for adults and children aged six months and up who have conditions that heighten the risk of severe illness.
These include obesity, asthma, diabetes, pregnancy and immunocompromising conditions, according to the Centers for Disease Control and Prevention (CDC).
The policy was detailed in a commentary published in the New England Journal of Medicine by FDA Commissioner Marty Makary and Vinay Prasad, Director of the Center for Biologics Evaluation and Research.
They stated that approval for boosters in low-risk populations will now require evidence from randomised, controlled clinical trials. According to the authors, the existing approach had overstated the benefits of repeated vaccination in healthy individuals, citing a lack of “gold-standard data” supporting boosters for this group.
The authors argue that the previous universal strategy underestimated public understanding of risk-based recommendations. “The American people, along with many health care providers, remain unconvinced,” they wrote, referencing declining booster uptake rates.
Pushback Over Concerns of Access and Insurance Coverage
The new policy has drawn criticism from several public health experts who fear it could make vaccines less accessible to those outside the high-risk categories. Dr Paul Offit, a vaccine specialist at Children’s Hospital of Philadelphia, questioned how eligibility will be assessed in practice.
“Is the pharmacist going to determine if you’re in a high-risk group?” he asked, raising concerns over potential confusion and inequality. There are also fears that insurance providers may no longer cover the cost of boosters for those not classified as high-risk.
According to Michael Osterholm, Director of the Center for Infectious Disease Research and Policy at the University of Minnesota, this could leave millions of Americans without affordable access to vaccines.
He stated the policy “violates” earlier assurances from Health and Human Services Secretary Robert F. Kennedy Jr., who had previously vowed not to remove vaccine access for any group.
Meanwhile, critics argue that younger, healthier individuals may still have valid reasons for vaccination, including the prevention of long COVID and protecting vulnerable household members.
According to Dr Peter Hotez of Baylor College of Medicine, “COVID vaccines should be made available to all age groups” given the continued circulation of the virus and the risks it poses.
