FDA limits annual COVID-19 vaccines to high-risk groups, seniors

The Food and Drug Administration is limiting who can receive an annual COVID-19 vaccine.

Under a new policy announced Tuesday by the Trump administration, only people age 65 and older and children or young adults with certain health conditions that puts them at risk will be approved for the shot.

Dr. Michael Calderwood, an infectious disease physician at Dartmouth Hitchcock Medical Center, said the policy brings the U.S. in line with countries like Canada and Australia.

“And the question is, why not continue to recommend the COVID-19 vaccine like we do for the flu vaccine for everyone, regardless of age or other illness? And the thing that is being said is that we don’t have enough evidence, and this is what’s being hotly debated,” he said.

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The FDA is encouraging companies to conduct larger, lengthier studies before expanding approval to healthier populations.

Calderwood referenced a recent article in the New England Journal of Medicine that explains some of the reasoning behind the decision.

“We have seen, particularly over the last, few years that probably has gone on for even longer than that. But a degradation in the community’s thoughts about vaccine safety. And there is some thoughts that if people begin to think that not just COVID-19, but all vaccines are unsafe, they’ll be choosing to not administer vaccines that we’ve known and studied for years to protect themselves, their children, the community against things like measles,” said Calderwood.

Conducting longer studies would require randomized trials in low-risk populations, which Calderwood said could cost hundreds of millions of dollars.

The question is whether companies will be willing to make that investment.

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