The FDA’s new approach to boosters could mean that kids will no longer be able to get vaccinated against the disease to begin with.

U.S. Food and Drug Administration advisers unanimously recommended on Thursday that COVID-19 vaccines for the 2025-26 period should target newer strains of the JN.1 variant. COVID vaccine makers are seeing increased regulatory scrutiny under the new FDA leadership,

We want to know more about what these products are doing,” said Dr. Vinay Prasad during a recent FDA livestreamed presentation. This statement comes amidst a significant shift in the U.S. Food and Drug Administration’s (FDA) policy on Covid-19 booster shots.

Two weeks into his tenure leading the FDA’s biologics center, Vinay Prasad has made his mark with a new framework for approving future Covid-19 vaccines that he feels will counteract existing “dogma.”

The FDA’s new policy limits COVID-19 vaccine eligibility to older adults and high-risk groups, excluding millions from routine protection, including against Long COVID and future infection waves.

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.

Healthy and under the age of 65? You might not need to receive an annual COVID-19 booster. What to know about new guidelines.

The U.S. Food and Drug Administration’s decision to limit COVID vaccines to people 65 and older and others with underlying health conditions has alarmed some medical experts who worry the change will lead to more infections and more deaths.

The FDA may limit annual COVID-19 boosters to high-risk groups unless clinical trials prove benefits for healthy adults under 65. Pfizer is reviewing the plan, while officials call for more evidence on booster effectiveness.

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen ...

For a brief period in 2022, Dr. Vinay Prasad faked a concern about routine vaccines to infect unvaccinated children with COVID.