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# Makary Says ‘No Plans’ for Covid Vaccine Boxed Warning
- URL: https://www.fdaweb.com/makary-says-no-plans-for-covid-vaccine-boxed-warning/
- Published: 2025-12-16T12:00:00.000Z
- Updated: 2026-09-14T15:29:16.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160396

FDA has “no plans” to add a Black Box Warning to Covid vaccines, FDA commissioner **Marty Makary** said in a Bloomberg TV interview, emphasizing that the agency’s focus is on transparency and updated risk assessments rather than broad changes to vaccine policy. Makary said the FDA’s safety and epidemiology staff previously recommended considering a Black Box Warning for the vaccines, but he stressed that no such warning is currently planned.

Makary noted that internal debate has centered on whether safety data from the early rollout of Covid-19 vaccines, when doses were administered months apart, still apply to today’s annual vaccination model. Early side effects, including myocarditis in younger patients, were more common when shots were given in closer succession, Makary said. “We don’t want to extrapolate findings to today if it’s not transferable,” he said.

Makary’s clarification of the agency’s recommendation to add the Warning to Covid vaccines contradicts a recent CNN report claiming otherwise ([see story](https://www.fdaweb.com/fda-weighs-black-box-warning-on-covid-vaccines/)). The plan, which has not been finalized, is reportedly being advanced by CBER director **Vinay Prasad**, according to CNN. Key details remain preliminary, including whether the warning would apply only to mRNA vaccines, or to all licensed Covid-19 vaccines, and whether it would apply across all age groups. The warning could be announced before the end of the year, CNN says.

In the interview, Makary also confirmed that FDA is conducting a safety review of Covid-19 vaccines to determine whether they may be linked to rare deaths in adults. Makary said the review follows reports submitted to the agency during the Biden administration and reflects a “moral dilemma” faced by current leadership over whether such cases should be made public.

“It’s been known that there have been rare cases of death following the Covid shot,” Makary said, citing publications in the *New England Journal of Medicine*, a Senate subcommittee report, and testimonials from affected families. “The question is, should they be public information or not? We believe they should, but only after we make sure there is truly a link.”

Additionally, Makary outlined a broader shift in U.S. vaccine policy toward a risk-stratified approach, similar to strategies used in Europe, rather than universal recommendations for all age groups. “In France, you have to be 80 years old or high risk for the shot to be recommended. In the UK, it’s about 75,” he said. “We’re moving more toward that approach internationally.”