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The U.S. Food and Drug Administration is reportedly considering adding its strongest safety warning, a so-called “black box” warning, to COVID-19 vaccines, CNN reported Friday, citing sources familiar with the agency’s plans. The move has stirred concern among public health experts who say there is little evidence to support such a drastic step.
A black box warning, typically reserved for life-threatening risks, appears at the top of prescribing information to alert doctors and patients. It has been used in the past for opioids, certain acne medications, and vaccines like ACAM2000 to highlight serious side effects that should be considered before use.
Vaccines from Pfizer and Moderna, which use mRNA technology, and Novavax, a protein-based vaccine, have been widely distributed, with millions of Americans, including children, receiving doses.
The push is being led by Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the Center for Biologics Evaluation and Research. The plan is still in flux, with details, including whether it would apply to mRNA vaccines only, all COVID-19 shots, or specific age groups, not yet finalized.
Vaccines from Pfizer and Moderna, which use mRNA technology, and Novavax, a protein-based vaccine, have been widely distributed, with millions of Americans, including children, receiving doses. Public health data suggests these vaccines have prevented millions of hospitalizations and deaths worldwide. For example, CDC reports show COVID vaccines significantly reduced emergency visits and severe illness among children during the 2024-25 respiratory virus season.
Experts warn the warning could undermine public confidence in vaccines. “Very rare adverse events with vaccines can occur,” said Dr. Fiona Havers, a former CDC epidemiologist. “But to focus only on potential harms without acknowledging the thousands of lives saved is irresponsible.”
The proposed warning has drawn criticism for lacking transparency. Public health specialists note there is no publicly available evidence directly linking pediatric deaths to the vaccines, despite internal memos suggesting potential cases. Many outside experts argue that the FDA has not yet convened independent advisory panels or released data for peer review.
Dr. Angela Rasmussen, a virologist, said the move seems politically motivated. “Everything so far signals a strong opposition to COVID vaccines within the administration, and it appears to be an effort to manufacture justification for the warning,” she said.
The FDA and the Department of Health and Human Services maintain that any potential safety concerns are being thoroughly evaluated using established scientific processes. “All decisions are based on rigorous, independent review of the data,” said HHS spokesperson Andrew Nixon.
The controversy highlights the tension between political pressure, public perception, and science-based decision-making, as the U.S. navigates the ongoing management of COVID-19 vaccines and public trust in immunization programs.
*Source: CNN and Reuters
