Health Experts Criticize FDA's Possible 'Black Box' Warning on COVID Vaccines
The FDA is reportedly considering adding high-level warning labels to COVID vaccines, a move that some experts say could raise unfounded safety concerns.
PATRICK T. FALLON/AFP via Getty Images
The US Food and Drug Administration is reportedly considering whether it will place a “black box” warning label on COVID vaccines. according to CNNdespite studies and real-world data demonstrating their safety.
Black box warnings are the FDA's highest health warning for drugs and medical devices. Adding them to COVID vaccines “would be an unprecedented move by the FDA and would likely lead to a significant reduction in the use of this product,” says Dr. Robert Hopkins, medical director of the National Foundation for Infectious Diseases.
It is unclear whether the warning, if applied, would apply to some or all of the available COVID vaccines made by Pfizer, Moderna and Novavax, or whether it would affect specific groups such as pregnant people or children.
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The report comes a week after a memo allegedly written by FDA Chief Medical and Scientific Officer Vinay Prasad was leaked detailing plans to change COVID vaccine approvals and without evidence linked the deaths of 10 children to vaccines.
In response to Scientific American Department of Health and Human Services spokesman Andrew Nixon called the claims “pure speculation” and said that “the FDA takes any death associated with a regulated medical product very seriously.”
Black box warningsalso called boxed warnings, are intended to inform people of the major health risks associated with a drug, treatment, or other medical intervention, including a vaccine, and usually indicate the risk of serious injury or life-threatening harm. For example, opioid painkillers contain such a warning. The FDA has possibility to add these labels, update them or delete them at any time the data becomes available to the agency.
More than 400 drugs approved for use in the United States carry a black box warning label. Vaccines with black box warnings are “extremely rare,” says Peter Chin-Hong, an infectious disease physician and professor of medicine at the University of California, San Francisco, because vaccines undergo rigorous testing and safety and effectiveness assessments before the FDA clears them for use.
And although some vaccines, such as live vaccine ACAM2000 while smallpox and smallpox carry health risk warnings, these examples “certainly mean nothing.” [as] “big” is the FDA's potential decision to place a “black box” warning on COVID vaccines, says Caitlin Jetelina, an epidemiologist and founder of the newsletter Your Local Epidemiologist.
“The science is clear: the benefits continue to far outweigh the risks,” Jetelina says. “If the FDA disagrees, then transparency of their data and reasoning is essential. Reviewing behind closed doors will not help. Americans deserve better.”
COVID vaccines have been safely administered to billions of people around the world and have been proven to be effective. prevented millions of deaths from the virus that causes the disease. Initial and ongoing safety monitoring continues to show that the benefits of these vaccines outweigh the risks for most populations, Hopkins said.
He and other experts have expressed concern that strict safety warnings could ultimately make access to vaccines more difficult. The black box label could make doctors more wary of recommending vaccinations to groups of people who are at high risk of severe COVID disease, such as children and pregnant women, Chin-Hong said.
If a black box label is added, “vaccine hesitancy will increase among the groups that need it most,” he says. “But above all, the continued erosion of trust in the proven effectiveness of vaccines overall will lead to more illness and death—and more suffering among Americans.”
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