The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the virus, and those older than age 65.

"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 Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct major new clinical trials before approving them for wider use,

The VRBPAC meeting comes the week after the World Health Organization (WHO) recommended that members consider using monovalent JN.1- or KP.2-lineage COVID-19 vaccine formulations -- the same as last year's -- with monovalent LP.8.1 lineage as a suitable alternative formulation.

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

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are healthy

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.

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.