The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

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

In a major policy shift, federal health officials anticipate the shots will be made available to adults 65 and older as well as children and younger adults who have one or more risk factors that make them more vulnerable to severe COVID-19.

"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk," the agency said in an article published by The New England Journal of Medicine, authored by FDA Commissioner Dr. Martin Makary and his new top vaccines official, Dr. Vinay Prasad.

FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.

A change in recommending Covid vaccines for children and pregnant women would circumvent an expert panel but please many MAHA fans.

Leaders at the FDA, HHS and elsewhere are putting guardrails around COVID-19 boosters, which could mean delayed shots or eligibility changes this fall.