The Food and Drug Administration intends to add a “black box” warning to COVID-19 vaccines in the Trump administration’s latest attempt to question the safety and effectiveness of widely accepted vaccinations, according to a CNN report. The warning is the most serious type issued by the FDA, highlighting significant risks such as serious side effects and restrictions.
The FDA applies the black box warning for drugs as strong as fentanyl but as common as ibuprofen. However, including a vaccine that research says is overwhelmingly safe and saved countless lives during the pandemic has caused some experts to question the reasoning.
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CNN emphasized that the plan could still change, and officials declined to discuss the possible warning in detail.
“Unless the FDA announces it, any claim about what it will do is pure speculation,” Andrew Nixon, a spokesman for the Department of Health and Human Services, told CNN.
Why is the FDA adding the warning?
Sources who spoke to CNN did not say why the administration is planning to add the warning. However, the FDA, under the leadership of Health and Human Services Director Robert F. Kennedy Jr., has explicitly focused on vaccines in recent changes.
On Dec. 5, an advisory panel to the Centers for Disease Control and Prevention voted to end its recommendation that newborns receive the hepatitis B vaccine. Kennedy is a longtime vaccine skeptic who has claimed a link between vaccines and autism. However, research has never confirmed the link, despite multiple studies.
What is the evidence on vaccines and death?
The FDA reported that at least 10 children died after receiving COVID-19 vaccines. The administration made the claim in a memo circulated to staff in late November.
“This is a profound revelation,” Dr. Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research, wrote in the memo. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
The administration based its findings on data from the Vaccine Adverse Event Reporting System, or VAERS, a national surveillance platform that monitors potential safety issues following vaccination. Straight Arrow News analyzed the data and found 83 reports of a child dying within two weeks of receiving a vaccine. However, VAERS collects only raw, unverified reports of side effects and does not contain information about further investigations.
Why are health experts concerned?
Researchers and public health experts have questioned and criticized the FDA’s findings.
“Currently, this is a completely unfounded claim unless they publish the report with data, methods and procedures to establish causality,” said Domenico Motola, an associate professor of pharmacology in Italy who also analyzed the data.
Experts say VAERS is an imperfect source since anyone can submit a report if they experience a health problem after vaccination. The CDC and FDA are supposed to review that data for unusual patterns or trends that might signal a widespread safety concern.
Many health officials criticized the findings from Prasad’s memo.
“It’s irresponsible science at best and it’s dangerous to the public at the very least,” Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told Stat News.
