FDA Commissioner Marty Makary said the agency has no plans of placing a black box warning on the COVID-19 jabs. “When it comes to the black box warning, we have no plans to put that on the COVID vaccine,” Makary said. “The safety and epidemiology center within the FDA did recommend that. It was a recommendation formally put out. But some of our scientists and leadership, like Dr. Vinay Prasad, have said they may be different today than it was in the first year of COVID when the shot came out,” he continued. “When you have those two doses three months apart, that’s when you see the side effects go way up, like myocarditis in young people. Now that it’s annual, you may not see that same prevalence, so we don’t want to extrapolate findings to today if it’s not transferable,” he added. Footage below: FDA Commissioner Dr. Marty Makary & Vinay Prasad stepping back from potential Covid shot black box warning: pic.twitter.com/5RciL5WgNw — Jefferey Jaxen (@JeffereyJaxen) December 16, 2025 Reuters explained further: Last month, Prasad told staffers in a memo that COVID shots probably contributed to the deaths of at least 10 children who died of heart inflammation. The FDA is investigating deaths potentially related to COVID-19 vaccines across multiple age groups as part of a safety review. Health Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, has sharply changed government policy on COVID vaccines, limiting access to people aged 65 and above as well as those with underlying conditions. CNN reported last week the agency was planning to put a black box warning on the COVID-19 jabs. Black boxes are the agency’s most serious warning and typically accompany products that carry a risk of life-threatening or disabling reactions. The FDA is finalizing plans to put a "black box" warning on Covid-19 vaccines, sources tell CNN, its most serious alert meant to warn about drug risks.https://t.co/toYYb357fN — CNN (@CNN) December 12, 2025 BioSpace shared more: In a statement to the publication on Thursday, Department of Health and Human Services spokesperson Andrew Nixon said, “Unless the FDA announces it, any claim about what it will do is pure speculation.” In an email to BioSpace Friday morning, Nixon reiterated this statement and added, “The FDA takes very seriously any death that is attributed to a regulated medical product.” The black box initiative is being led by Center for Biologics Evaluation and Research head Vinay Prasad, according to one of the people who spoke with CNN. This follows Prasad’s claim in an internal FDA memo late last month that the deaths of 10 children could be linked to COVID-19 vaccinations. The alleged deaths were first flagged by acting Center for Drug Evaluation and Research director Tracy Beth Høeg, then a senior advisor to the agency. The memo set off an eruption of protest from healthcare and ex-regulatory leaders. More than a dozen former FDA and CDC officials in an editorial published in The New England Journal of Medicine earlier this month decried the proposed vaccine policy changes laid out in Prasad’s memo. “I think it’s irresponsible and unprofessional,” Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told BioSpace of the FDA’s reported black box warning plans, “because this agency, either Vinay Prasad or [FDA Commissioner] Marty Makary, have not in any way made clear why it is they think the COVID-19 vaccine killed children.”