The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN. It is unclear if the warning would apply to Moderna’s, Pfizer/BioNTech’s and Novavax’s shots, or to all age groups.
The FDA may be gearing up to slap a black box warning on COVID-19 vaccines, according to two individuals who spoke with CNN on Friday.
A boxed warning, which alerts the public to the serious risks associated with a drug or medical device has been attached by the FDA to products including opioids for addiction, for example, and the acne medicine Accutane for birth defects. These risks should be weighed against the treatment’s benefits.
The plans for a black box warning, first reported by CNN on Friday morning, are expected to be rolled out by the end of this year. It is unclear, however, whether they will apply to all COVID-19 vaccines or only mRNA vaccines—which have faced considerable scrutiny since Health Secretary Robert F. Kennedy Jr. took office in February, and since being politicized by the pandemic. Moderna and Pfizer/BioNTech make the two mRNA-based vaccines approved for use in the U.S., Comirnaty and Spikevax. The only other FDA-approved COVID vaccine is Novavax’s protein-based shot Nuvaxovid.
It also isn’t clear whether the warnings will apply to all age groups, CNN reported.
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.”
In a statement to Endpoints News on Dec. 3, the FDA said it is still investigating “additional adverse event cases” and plans to make a report covering the reported 10 deaths publicly available by the end of December.
Included in these data, Offit said he would like to see autopsy data “showing that there’s severe damage to the heart muscle,” and that there are antibodies in the child’s bloodstream against SARS-CoV-2 spike protein. This, he said, would indicate that the child was vaccinated and not naturally infected with the virus that causes COVID-19.
The FDA is also expanding its investigation of deaths potentially related to COVID-19 across multiple age groups, an agency spokesperson told Bloomberg earlier this month.
Notably, the CDC on Thursday released a report showing that the 2024–2025 formulations of the COVID-19 vaccine were 76% effective at preventing emergency or urgent care visits in children aged 9 months through 4 years.
Editor’s Note (Dec. 12): This story has been updated to include comments from Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a statement from HHS.
