Infectious Disease Expert Warns FDA’s Latest COVID-19 Vaccine Approval Puts Millions at Risk

Infectious disease experts say the FDA’s decision to narrow COVID-19 vaccine approval ignores the science and risks limiting protection for millions of Americans. Yesterday, the FDA granted full approval to updated vaccines from Pfizer-BioNTech, Moderna and Novavax, but only for folks 65 and older or those younger with certain health conditions.

Tina Tan, M.D., president of the Infectious Diseases Society of America (IDSA), said in a released statement that this FDA approval “completely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access, removing millions of Americans’ choice to be protected and increasing the risk of severe outcomes from COVID.”

Tan, M.D.

The FDA’s approval letters require all three vaccine makers to carry out postmarketing studies to address questions that regulators and clinicians say remain unresolved.

According to the FDA’s Center for Biologics Evaluation and Research (CBER), 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 are expected to follow participants for at least six months, with endpoints including symptomatic COVID, hospitalization and death, according to a New England Journal of Medicine opinion piece released in May 2025.

The FDA’s decision significantly narrows access compared to prior years, when boosters were recommended for nearly all adults. Now, eligibility will include 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. These conditions range from asthma and cystic fibrosis to obesity, smoking history and physical inactivity.

Critics say this change leaves a gap between FDA policy and CDC recommendations. The CDC continues to advise that everyone six months and older receive the updated vaccine, and its Advisory Committee on Immunization Practices (ACIP) has not yet voted on the new approvals.

Tan warned that the FDA’s narrow approval risks both public health and public confidence.

“COVID-19 vaccines remain our best tool to prevent severe disease, hospitalization and death due to COVID-19—for healthy adults, children, pregnant patients and others at higher risk,” she said. “The scientific evidence continues to strongly support broad vaccination far beyond the limited populations outlined in the Food and Drug Administration’s new label.”

She added that professional medical societies stand on broader recommendations.

“The American Academy of Pediatrics recently reaffirmed its recommendation for vaccination in children, and IDSA is working with other medical societies to finalize updated guidelines for COVID vaccination in both healthy and immunocompromised adults as part of our comprehensive respiratory virus guidance for this fall and winter,” Tan said.

Those guidelines are expected to be released in September.

The FDA’s approval letters also revealed ongoing debates about vaccine safety and long-term outcomes.

For example, 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.

For providers, the new label presents challenges, according to Tan. Physicians may continue administering vaccines off-label, but pharmacists’ ability to do so will likely be limited.

“Physicians can still provide COVID vaccines off-label, and IDSA strongly urges doctors to continue recommending and administering vaccination to their patients based on the best available science,” Tan said. “However, pharmacists’ ability to provide off-label vaccines may be severely constrained, underscoring the vital role of physicians and other clinicians in maintaining access.”

Looking ahead, Tan and IDSA are urging both insurers and policymakers to support continued access.

“IDSA calls on insurers to continue covering COVID vaccines consistent with multiple medical society recommendations and scientific evidence, and we urge Congress to conduct strong oversight of the Administration’s decision to restrict Americans’ freedom to choose vaccination as we approach the upcoming respiratory virus season,” she said.

With hospitalization rates already climbing in older adults and new variants spreading, experts in the media have said the timing of the FDA’s narrowed approval could have consequences.

Tan stressed that decision-makers in the industry “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.”