FDA overhauls its guidance on COVID shots

The changes may make it harder for many people to get the vaccination.

- By RONG-GONG LIN II

CARLIN STIEHL For The Times
BREIONA LANG administers a COVID-19 vaccination at the Kaiser Permanente clinic in Venice last fall.

New federal guidance surrounding COVID vaccine authorization could make it more difficult for many people to be inoculated against the circulating — and, now, seasonally spiking — coronavirus.

Under the approval for the updated COVID-19 vaccines issued this week by the Food and Drug Administration, adults younger than 65 who are otherwise healthy would need to consult with a healthcare provider before getting the shot.

It’s the latest move by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a vaccine skeptic, and his allies aimed specifically at COVID vaccines, which were developed during President Trump's first term in an effort dubbed Operation Warp Speed.

It also came just hours before the Trump administration said it had fired the director of the U.S. Centers for Disease Control and Prevention, Susan Monarez, who was confirmed to the post by the U.S. Senate just 29 days earlier.

Monarez was forced out after Kennedy and other officials asked her if she was aligned with efforts to change vaccine policy, and she declined to agree without consulting her advisors, the Washington Post reported Wednesday.

“Secretary Kennedy and HHS have set their sights on weaponizing public health for political gain and putting millions of American lives at risk,” Monarez’s attorneys, Mark S. Zaid and Abbe David Lowell, said in a statement posted on social media. "When CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda."

White House Press Secretary Karoline Leavitt said the lawyers' comments "made it abundantly clear... that she was not aligned with the president's mission to Make America Healthy Again."