The U.S. Food and Drug Administration (FDA) announced plans this week to only recommend updated COVID-19 vaccines for adults 65 and older and people at high risk of severe illness from infection.
The FDA is now questioning the benefit of repeat dosing, particularly among otherwise healthy people at low risk, who may have previously received multiple doses of COVID-19 vaccines, had multiple COVID-19 infections, or both.
FDA Calls for More Trials on Vaccine Effectiveness
The FDA wants this new data so they can evaluate how COVID shots in this population currently affect symptomatic infection and rates of hospitalization and death.
“We simply don’t know whether a healthy 52-year-old woman with a normal BMI [body mass index] who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose,” wrote FDA Commissioner Martin Makary, MD, and Vinay Prasad, MD, director of the FDA’s Center for Biologics Evaluation and Research, in The New England Journal of Medicine editorial. “This policy will compel much-needed evidence generation.”
FDA Cites Vaccine Hesitancy as a Reason to Limit COVID Immunization
Drs. Makary and Prasad added that restricting shots to older Americans and more vulnerable individuals would align with vaccination policies established by several European nations.
They wrote that they expect the benefits of vaccination will continue for adults 65 and over and for everyone 6 months and up with one or more health conditions that put them at high risk for severe COVID-19.
The editorial also pointed out that COVID booster uptake over the past two seasons has been low, with fewer than one-quarter of Americans receiving shots each year — ranging from less than 10 percent of children younger than 12 in the 2024–2025 season, to 50 percent of adults over 75.
Makary and Prasad argue that COVID vaccine hesitancy may be having a “ripple effect,” leading to a decline in public trust regarding vaccination in general that is affecting vital immunization programs like the measles-mumps-rubella (MMR) shot.
Who Will Be Eligible for the COVID Vaccine?
It’s uncertain at this point whether anyone younger than 65 or without high-risk health conditions will be able to get the COVID vaccine.
But estimates suggest that 100 million to 200 million Americans will still have access to COVID shots under the new policy, according to the editorial.
In a livestream about the policy shift, Prasad said that the definition of what makes someone high risk is a “tremendously broad category.”
In addition to age, the editorial listed the following conditions as raising the risk of severe COVID-19 infection, as defined by the CDC:
Robert H. Hopkins Jr., MD, medical director of the National Foundation for Infectious Diseases, says that the FDA’s description of who will have access to vaccination needs further clarification.
“The editorial implies that the list of conditions that put people at increased risk for severe COVID-19 could be reevaluated, but this is not clearly stated,” says Dr. Hopkins.
The Pros of the Planned Changes
Hopkins sees both strengths and weaknesses in the proposed plan.
On one hand, he views it as encouraging that the process for evaluating and approving new versions of COVID-19 vaccines will continue, which is in line with longstanding regulatory practices in the United States and other countries. Also, continued access to COVID-19 vaccines is assured for adults age 65 and older, as well as for people at risk of severe illness.
He notes that new clinical trials could provide more robust evidence about the impact of vaccination across different age groups and other subpopulations.
Why the Plan May Be Risky
Hopkins points out that questions remain about who will bear the cost of the new clinical trials.
“If the financial burden falls too heavily on manufacturers, it could reduce their willingness to continue producing updated vaccines, possibly increasing costs and limiting availability,” he says.
The greatest weakness of the plan, however, is that it’s likely to limit vaccine access and coverage, Hopkins says. He believes that broad vaccination is key to reducing community transmission and protecting public health.
“Since the early stages of the pandemic, we have struggled to achieve high vaccination coverage across the general population,” says Hopkins. “As a result, COVID-19 has continued to circulate in our communities. The risk remains that a new, more transmissible or severe variant could emerge. If that happens, limited vaccination access could leave us vulnerable — not only medically, but also in terms of the strain on our healthcare system and the broader social and economic impact.”
The possibility of COVID-19 returning to pandemic levels remains.
“Limiting widespread access to vaccination increases the risk of future outbreaks and weakens our ability to respond quickly if the virus evolves,” says Hopkins. “We should remain vigilant and flexible in our policies to ensure we are prepared for whatever comes next.”