The U.S. Food and Drug Administration (FDA) is preparing to present data next week that reportedly connects COVID-19 vaccinations to dozens of child deaths, according to multiple reports. The information, which will be shared with the Centers for Disease Control and Prevention (CDC), comes as political leaders, medical experts, and the public remain sharply divided over vaccine safety.
The Washington Post reported that the FDA presentation will cite at least 25 claims of child deaths found in the Vaccine Adverse Event Reporting System (VAERS), a federal database that collects reports of possible vaccine side effects. While VAERS plays a key role in spotting early safety signals, health officials stress that it contains unverified entries and does not, by itself, prove a vaccine caused harm.
“VAERS is a starting point, not an endpoint,” the CDC explained in a statement earlier this year, noting that each report of a serious event, including death, is followed up with a formal investigation.
The forthcoming FDA presentation is reportedly being led by Dr. Tracy Beth Hoeg, a senior clinical science adviser. It will be delivered before an advisory panel tasked with shaping new recommendations for COVID-19 vaccines, including which groups of Americans should receive updated shots and whether they should be subsidized by the federal government.
Political and Public Pressure
The news comes at a politically charged moment. President Donald Trump, who oversaw Operation Warp Speed during his earlier administration, has recently questioned both the effectiveness of COVID-19 vaccines and the transparency of pharmaceutical companies.
In a social media post earlier this month, Trump claimed he had seen “great numbers” from companies such as Pfizer but pressed for more openness: “With CDC being ripped apart over this question, I want the answer, and I want it NOW.”
Trump’s comments have added to ongoing skepticism about vaccines, a topic that continues to divide voters and fuel sharp debate across the political spectrum.
Expert Skepticism Over VAERS Use
Some medical professionals criticized the FDA’s decision to highlight VAERS data in its report, warning that the system is often misused by vaccine opponents.
“Manipulating VAERS is one of the oldest tricks in the anti-vax book,” said Dr. Angela Lynn Rasmussen, a virologist at the University of Saskatchewan’s Vaccine and Infectious Disease Organization. In a post on X (formerly Twitter), she argued the FDA was leaning on weak evidence: “There was no meaningful analysis here. This decision was already made and VAERS is being used to manufacture justification.”
Rasmussen warned that undermining confidence in vaccines could lead to avoidable deaths if fewer people get immunized.
Divided Public Opinion
A new poll suggests public sentiment on the issue remains sharply split. According to a Rasmussen Reports survey released Thursday, 56% of likely U.S. voters believe it is “likely” that COVID-19 vaccines have caused a significant number of unexplained deaths. In contrast, about one-third of respondents said they don’t think vaccine side effects have caused significant fatalities, with 17% saying it is “not at all likely.”
The poll, conducted by Pulse Opinion Research from September 7–9, surveyed 1,158 likely voters with a margin of error of three percentage points.
What Comes Next
The FDA’s presentation to the CDC is expected to influence vaccine policy decisions this fall, particularly regarding updated COVID-19 boosters tailored to newer variants. While officials emphasize that the benefits of vaccination continue to outweigh potential risks, the renewed focus on child safety and the use of VAERS data are sure to keep the debate in the public eye.
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