FDA Opts Out of Widely Condemned Plan for “Black Box” Warnings on COVID Shots

On Monday, the Food and Drug Administration’s (FDA) top official Marty Makary announced that the agency has opted not to put “black box” warnings on coronavirus vaccines, despite reports that FDA officials were considering such a move last week.

Black box warnings are considered the most serious designation from the FDA. Such warnings are placed on opioid medication, for example, to warn users about the risks of overusing the drug, including addiction, overdose, and death.

The news that the FDA was considering black box labels for COVID vaccines was widely condemned by medical experts as yet another attempt by the Trump administration to undermine public trust in the vaccine, which studies have consistently shown is safe and effective.

Following last week’s report, FDA commissioner Marty Makary told Bloomberg News on Monday that the heads of the agency had determined that there isn’t a need for the black box warnings after all.

Among the agency leaders who decided that the designation isn’t necessary is noted anti-vaxxer Vinay Prasad, director of the Center for Biologics Evaluation and Research at the FDA.

However, the news comes as Prasad has pursued other avenues to sow distrust in the vaccine. A recently leaked FDA memo, authored by Prasad, announced that the agency would investigate whether there is a link between COVID vaccinations and deaths in the U.S. The memo sparked concerns from medical experts, who noted that many of Prasad’s claims are not backed by evidence.

Prasad claimed, for instance, that COVID itself “was never highly lethal for children” and that its effects “are comparable” to other respiratory viruses — despite one study indicating that the virus was more lethal to children than the flu.

The memo also claimed that the agency has found “at least 10 children [who] have died after and because of receiving COVID-19 vaccination.” But an investigation from Inside Medicine discovered that Prasad’s statement was made before a preliminary examination of deaths — and that the actual number of deaths from adverse reactions to the vaccine could be as high as seven or as low as zero.

Notably, a recent Centers for Disease Control and Prevention (CDC) report has demonstrated, like many others before it, that vaccines are both safe and beneficial for children. That report examined hundreds of children who had received dosages of COVID vaccines and compared outcomes with children who hadn’t received them. Researchers found that “vaccine effectiveness…was an estimated 76 percent against COVID-19-associated emergency department or urgent care visits” among kids 9 months to 4 years old. The vaccines also had 56 percent effectiveness against such visits for kids 5-17 years old, versus those who did not receive a vaccine.

The memo is just one of many anti-vaccination moves by agencies within the Department of Health and Human Services (HHS) under the leadership of Secretary Robert F. Kennedy Jr. The memo also comes as the U.S. is dealing with a resurgence of measles — which were deemed virtually eradicated in the U.S. just two decades ago — in large part due to Kennedy’s disinformation campaign about vaccines.

Hundreds are currently quarantined in communities in northern parts of South Carolina, and an outbreak along the Utah-Arizona border has also led to quarantines in that area. In both places, low mumps, measles and rubella (MMR) vaccination rates have likely led to the outbreaks.

Spartanburg County, South Carolina, for example, has an MMR vaccine rate around 90 percent — 5 points below the 95 percent vaccine rate that health experts say is needed to protect against community-level outbreaks. Mohave County, Arizona, has a 79.4 percent rate of MMR vaccination, while Washington County, Utah, has a rate of 82.7 percent.

As of December 9, there have been 1,912 measles cases confirmed across the U.S., a 570 percent increase from the total number of cases counted in 2024.