The agency will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to green-lighting shots that have been recommended broadly to the public.

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the Center for Biologics Evaluation and research at the FDA, and Dr. Martin Makary, FDA commissioner, explained their plan for how the FDA will evaluate and recommend COVID-19 vaccines going forward.

In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people getting the shot each year. “There may even be a ripple effect: public trust in vaccination in general has declined,” it says.

The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over the age of 65 years and for all persons above the age of 6 months with

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of serious illness

The Trump administration announced Tuesday that going forward, COVID-19 vaccines would be FDA-approved only for people over age 65 or those at risk for severe infection.

The agency will require manufacturers to conduct randomized, controlled trials to secure approval for healthy Americans.

The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 and up, along with people ages 12 and up who have at least one underlying condition that puts them at risk of severe disease.

President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could spell major changes in what is required to get regulatory approval for immunizations.