By Youri Benadjaoud and Sony Salzman

Some say annual booster shots are not worth the risk for healthy people.

In a major policy change, the Food and Drug Administration has announced a plan to limit access to future COVID-19 shots only to people over 65 years old or those with an underlying health condition.

This change would apply to any future updated versions of the vaccine, a spokesperson at the department of Health and Human Services told ABC News. For the past several years, COVID shots have been updated ahead of the winter respiratory virus season to better match the evolving virus.

But FDA Commissioner Dr. Martin Makary and FDA vaccine head Dr. Vinay Prasad argued this week that annual booster shots are not worth the risk for otherwise healthy people.

The FDA plans to impose these restrictions on future shots for younger, healthy people, unless vaccine makers are willing to pay for newer and and lengthy placebo-controlled trials.

“We are evaluating the details shared today and discussions with the FDA are ongoing,” Pfizer told ABC News in a statement.

“We appreciate the FDA’s clear guidance and remain committed to working with the Agency to provide the data they need to ensure access for Americans,” Moderna told ABC News.

Since the COVID-19 virus can mutate quickly, a lengthy clinical trial may result in a vaccine that no longer protects against currently circulating variants, experts cautioned.

“By the time you finish the trial, the strain that’s out there in the community is probably long gone. So, they’re basically saying, unless you’re in those higher-risk groups, you can forget about getting the COVID vaccine,” former acting CDC director Richard Besser, now president and CEO of the Robert Wood Johnson Foundation, told ABC News.

A spokesperson for HHS, which oversees FDA, told ABC News, “The COVID-19 public health emergency has officially ended, and we are entering a new phase in our response to the virus. A rubber-stamping approach to approving COVID boosters in perpetuity without updated clinical trial data under the Biden administration is now over.”

Last month, more than 300 people died each week from COVID, according to the latest CDC data. Death rates were even higher earlier this year as the virus was spreading, with nearly 1,000 Americans dying weekly in January.

The new policy comes as the FDA’s vaccine committee of independent advisers are set to meet on Thursday to discuss the latest data on vaccine safety and efficacy, including COVID shots. Typically, FDA leadership waits until after hearing the advice of its advisers before implementing a new approval or policy change.

Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which vaccines to authorize or approve after being deemed safe and effective.