Covid shots may get FDA’s strongest warning

The Food and Drug Administration is considering whether to place a “black-box” warning—a high-danger label only used to flag risk of death, severe harm, or incapacitation—on Covid vaccines, CNN has reported. 

According to the Friday CNN report, the initiative to include the warning—part of a range of efforts by Trump administration health officials to limit access to, public support for, and uptake of Covid shots and other vaccinations—is being led by FDA chief medical and scientific officer Vinay Prasad, who is also director of the agency’s Center for Biologics Evaluation and Research. The plan to implement the warnings is expected to be made public by the end of December.

Prasad has a long history of dismissing the pandemic, claiming in 2021 that Covid was not more harmful to children than the common flu.

Health experts have continued to voice concerns that adding such a warning label may further reduce access to Covid vaccines by making clinicians more hesitant to recommend shots to groups who are at risk for severe Covid. Vaccines with black box warnings are particularly rare because vaccines are only approved after especially extensive safety and efficacy checks. 

The news follows reporting earlier this week that the FDA is investigating whether Covid vaccines are linked to deaths in adults, continuing a campaign public health experts have viewed with extreme skepticism. Prasad wrote to FDA staffers in a November letter that “at least 10 children have died after and because of receiving COVID-19 vaccination,” without specific evidence.

A CDC study released Thursday found that the 2024-2025 Covid vaccine was approximately 76 percent effective against emergency and urgent care visits in children aged 9 months to 4 years, and 56 percent effective for children 5-17 years old, compared to those who didn’t get the updated vaccine. 

But since June, CDC recommendations have stated that “parents of children ages 6 months to 17 years should discuss the benefits of vaccination with their doctor.”

Health and Human Services Secretary Robert F. Kennedy Jr.’s FDA has already reversed previous federal policy on Covid vaccines, restricting the most recent vaccineto people who are at elevated risk due to age or an underlying health condition. Kennedy said in November that he instructed CDC to retract its long-held public stance that vaccines do not cause autism despite evidence to the contrary. (CDC’s website now claims that the assertion that vaccines do not cause autism is not “evidence-based.”)

Health experts told my colleagues Kiera Butler and Anna Merlan earlier this year that RFK and his allies’ anti-vaccine decisions open the door to taking essential drugs off the market.

“Kennedy’s crusade will create even more doubt over vaccines’ effectiveness, as he uses his position to broadcast and legitimize debunked ideas about their risks,” they wrote. “In the end, experts warn, it will be patients who suffer.”