FDA Limits COVID Vaccine Eligibility to High-Risk Groups: What You Need to Know

The FDA has approved the next round of COVID-19 vaccines with new restrictions. The updated shots are now limited to those who are at risk for serious complications, including individuals 65 years old or older, or those with other health problems. The change brings back questions reminiscent of the early days of the pandemic, and NPR is seeking input from listeners on their concerns.

The Food and Drug Administration (FDA) has approved the next round of COVID-19 vaccines with new restrictions, limiting their use to individuals at risk for serious complications. The updated shots are now available to those who are 65 years old or older, or who have other health problems, such as asthma, cystic fibrosis, obesity, or a history of smoking. This change brings back questions reminiscent of the early days of the pandemic and has sparked concern among health experts and the public.

Infectious disease experts, including Tina Tan, M.D., president of the Infectious Diseases Society of America (IDSA), have criticized the FDA's decision. Tan argued that the narrow approval contradicts the evidence base and severely undermines trust in science-driven policy. She warned that the decision dangerously limits vaccine access, removing millions of Americans' choice to be protected and increasing the risk of severe outcomes from COVID-19 [1].

The FDA's approval letters require vaccine makers to carry out postmarketing studies to address unresolved questions. Pfizer and BioNTech committed to four studies of their Comirnaty vaccine, Moderna to four studies of its Spikevax and updated Mnexspike vaccines, and Novavax to two studies of Nuvaxovid. These trials will follow participants for at least six months and examine endpoints such as symptomatic COVID, hospitalization, and death [1].

The new approval significantly narrows access compared to prior years when boosters were recommended for nearly all adults. Now, eligibility includes older adults, who are at higher risk of severe illness, and younger people with at least one of 23 underlying conditions identified by the CDC [1]. This change creates a gap between FDA policy and CDC recommendations, which continue to advise that everyone six months and older receive the updated vaccine [1].

The decision has also raised concerns about vaccine safety and long-term outcomes. One of Pfizer and Novavax's studies will specifically examine the controversial claim of "post-COVID-19 vaccination syndrome," which some researchers link to persistent symptoms resembling long COVID [1].

The new label presents challenges for providers. While physicians can still administer vaccines off-label, pharmacists' ability to do so may be severely constrained. Tan urged physicians and other clinicians to continue recommending and administering vaccination based on the best available science [1].

Looking ahead, Tan and IDSA are urging insurers and policymakers to support continued access. They call on insurers to continue covering COVID vaccines consistent with medical society recommendations and scientific evidence, and urge Congress to conduct strong oversight of the Administration's decision [1].

With hospitalization rates already climbing in older adults and new variants spreading, experts have expressed concern that the timing of the FDA's narrowed approval could have consequences. Tan stressed that decision-makers should be doing everything possible to expand protection, not limit it. Vaccines remain one of our most powerful tools to prevent illness, hospitalization, and death [1].

References:

[1] https://www.managedhealthcareexecutive.com/view/infectious-disease-expert-warns-fda-s-latest-covid-19-vaccine-approval-puts-millions-at-risk
[2] https://sjodaily.com/2025/08/27/fda-sharply-restricts-covid-19-vaccine-access-ending-broad-vaccination-recommendations/