The F.D.A. May Restrict Covid Shots. Who Will Be Able to Get Them?

New York Times

23-05-2025

The Food and Drug Administration announced this week that it was likely to limit access to Covid vaccines among healthy children and adults this fall.
While the shots will most likely still be available for people 65 and older or with certain underlying conditions, F.D.A. officials say more research is needed to determine whether healthy Americans need a shot every year.
But critics say it is dangerous to limit access to vaccines for a virus that still leads to hospitalizations and deaths every day, and continues to evolve. Covid has been linked to more than 1.2 million deaths in the United States, though the rate of hospitalizations and deaths has fallen considerably.
The ongoing risk means that many people in the healthy category may still want a vaccine to avoid virus complications, or to protect a high-risk loved one or an infant who has never had Covid.
Here's what experts expect if the plan goes forward.
Who will be eligible for the vaccine?
Historically, almost everyone has been eligible for Covid vaccines; the C.D.C. recommended the most recent vaccine for all Americans over 6 months of age.
But in an article published in The New England Journal of Medicine on Tuesday, F.D.A. officials said they would require new research into how effective the Covid vaccines are in healthy people before issuing an updated approval for a broader population. The vaccine is expected to remain available for anyone who is at least 65 or who has a medical condition that can increase the risk of severe illness or death.
Those conditions, laid out in a list from the Centers for Disease Control and Prevention, include asthma, cancer, heart disease, diabetes, obesity and mood disorders, among other common conditions. It also includes people with compromised immune systems.
The article says an estimated 100 million to 200 million Americans will have access because of underlying conditions, which would amount to roughly 30 to 60 percent of the U.S. population.
But that would still leave many Americans ineligible to be vaccinated, including people who are themselves healthy but live with someone who is at high risk.
Can people still get the shot at a pharmacy?
Right now, yes. For the new round of shots expected this fall, though, the picture is less clear for anyone who isn't deemed eligible.
It's possible that some doctors could prescribe Covid vaccines 'off label' — meaning for reasons not included in the F.D.A.'s approval — to people who don't qualify under the agency's proposed plan. But in some states, pharmacists cannot provide an off-label medical product, said Richard Hughes, a lawyer who specializes in vaccine policy.
Pharmacies and insurers are also likely to vary in how they deal with people who say they have a qualifying condition, which can be as vague as 'physical inactivity.'
Samuel Bagenstos, a law professor at the University of Michigan who served as general counsel to the Department of Health and Human Services under the Biden administration, said the government could potentially require documentation that people meet the eligibility criteria, but that it would be 'extraordinarily unusual.'
More likely, Mr. Bagenstos said, insurance companies will serve as the gatekeepers by demanding medical documentation of an underlying condition before agreeing to cover the cost.
Currently, neither the government nor major pharmacy chains require medical documentation for people to get a shot, even for the more frequent boosters recommended for some immunocompromised people.
Experts say that many of the potential barriers could be overcome by motivated patients who can search for an individual doctor or pharmacist willing to administer the vaccine, and who can afford to pay out of pocket if insurance denies coverage.
But, they warn, people with lower incomes — who also face some of the worst outcomes from Covid — may not have the time or resources to find a willing provider or pay for the shots.
Will the changes affect insurance coverage?
Those who are eligible should see no change, said Troyen Brennan, an adjunct professor at the Harvard T.H. Chan School of Public Health and the former chief medical officer of CVS Health.
But everyone else is likely to face new costs, if they're able to get the vaccine at all, he said.
That could leave many people in the position of having to pay out of pocket — roughly $140 for the Pfizer or Moderna shot — or appealing after an insurer denies them coverage.
These appeals could waste time and money, said Jesse Goodman, the director of Georgetown University's Center on Medical Product Access, Safety and Stewardship.
What will the restrictions mean for children?
Experts are concerned about how the plan could affect healthy infants and toddlers; the C.D.C. currently recommends that they get a series of Covid shots starting at 6 months.
This is because very young children are at higher risk of serious illness. The hospitalization risk for children from birth to 6 months is on par with the risk faced by people who are 65 to 74 years old, and there is also an elevated risk of hospitalization for children up to 2 years old, said Dr. Sean O'Leary, a vaccine expert for the American Academy of Pediatrics.
The youngest infants can be covered by immunity from their mothers. The F.D.A. listed pregnant women as a group that would likely be eligible to get the vaccine.
But under the new F.D.A. framework, healthy children 6 months or older do not appear to be eligible for Covid vaccinations. Dr. O'Leary said he would be concerned if that were put into practice.
A spokeswoman for H.H.S. did not respond to a question about whether children could still get initial vaccines.