FDA Will No Longer Approve Annual COVID Vaccine For Younger, Healthy Patients

A new policy rolled out on Tuesday will limit recommendations for an annual COVID-19 booster shot to the elderly and to children and younger adults who have at least one health condition that puts them at greater risk for developing severe disease.

According to a report published Tuesday morning by The Associated Press, the Food and Drug Administration (FDA) would recommend annual booster shots for adults over the age of 65 in addition to younger adults and children whose pre-existing conditions or health concerns put them at greater risk of hospitalization or death from contracting COVID-19.

An article published on Tuesday by the New England Journal of Medicine provides a framework for developing and testing annual vaccines that might eventually be offered to generally healthy people who don’t fall into the currently recommended age and risk categories.

“For all healthy persons — those with no risk factors for severe Covid-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted,” the article read. “Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment.”

The article, titled “An Evidence-Based Approach to COVID-19 Vaccination” and written by FDA Commissioner Marty Makari and Dr. Vinay Prasad, noted that COVID vaccine recommendations in European nations already reflected a move toward protecting the elderly and those at greatest risk rather than blanket coverage of the entire population, and their goal was to shift the United States to a similar standard.

“The FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk. These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people.”