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 change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new commissioner described as a “one-size-fits-all regulatory framework.”

"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.

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.

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.

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

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.

With new testing requirements, it’s not even clear whether new Covid or flu shots can be made available this fall.

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