FDA outlines stricter Covid vaccine booster approval standards for healthy people

The Food and Drug Administration outlined new regulatory guidance for future Covid-19 vaccine boosters, setting stricter approval standards for healthy Americans.

The FDA recommended different standards of evidence for approval based on patients’ risk of getting severely sick from Covid.

The agency said it wants to see new clinical trials showing Covid shots are still safe and effective before approving them for healthy adults and children, a costly new requirement for pharmaceutical companies that could potentially limit who gets new jabs each year.