Here's How Proposed COVID Vaccine Rule Changes Could Affect Your Ability To Get A Shot

The Trump Administration is considering limiting approval for COVID-19 boosters to seniors and others at high risk pending more data — leaving some Americans who want a vaccine to wonder if they will be able to get one this fall.

The new FDA framework, published Tuesday in the New England Journal of Medicine by Dr. Vinay Prasad and Martin A. Makary, lays out new standards for updated COVID shots. The doctors say the agency will continue to use a streamlined approach to make them available to adults 65 and older as well as children and younger adults with at least one high-risk health problem.

However, the new framework urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. Previous federal policy recommended an annual COVID shot for all Americans six months and older.

Prasad described the new approach as a “reasonable compromise” that will allow vaccinations in high-risk groups to continue while generating new data about whether they still benefit healthier people.

"For many Americans we simply do not know the answer as to whether or not they should be getting the seventh or eighth or ninth or tenth COVID-19 booster,” said Prasad, who joined the FDA earlier this month. He previously spent more than a decade in academia, frequently criticizing the FDA's handling of drug and vaccine approvals.

It's unclear what the upcoming changes mean for people who may still want a fall COVID-19 shot but don't clearly fit into one of the categories.

Provisional data from the Centers for Disease Control and Prevention shows more than 47,000 Americans died from COVID-related causes last year. In YOURSTATE, X deaths attributed to COVID-19 were reported in the last three months.

The new FDA approach is the culmination of a series of recent steps under Health Secretary Robert F. Kennedy Jr. scrutinizing the use of COVID shots and raising questions about the broader availability of vaccines. It was released two days ahead of the first meeting of FDA’s outside vaccine experts under Trump.

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Last week, the FDA granted full approval of Novavax's COVID-19 vaccine but with major restrictions on who can get it — and Tuesday's guidance mirrors those restrictions. The approval came after Trump appointees overruled FDA scientists' earlier plans to approve the shot without restrictions.

Pfizer and Moderna, makers of the most commonly used COVID shots, each said they would continue to work with the agency.

The nation's leading pediatrics group said FDA's approach will limit options for parents and their children.

“Is the pharmacist going to determine if you're in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.”

“If the vaccine were no longer available or covered by insurance, it will take the choice away from families who wish to protect their children from COVID-19, especially among families already facing barriers to care,” said Dr. Sean O'Leary of the American Academy of Pediatrics.

The Associated Press contributed reporting