FDA Chief Claims COVID-19 Vaccines Linked to 10 Pediatric Deaths, Sparking Expert Criticism and Market Decline
核心洞察
Dr. Vinay Prasad, head of FDA's Center for Biologics Evaluation and Research (搜索), claimed in an internal memo that at least 10 children died "after and because of receiving" COVID-19 vaccines (搜索), linking deaths to myocarditis (搜索).
The memo lacked supporting evidence and relied on unsubstantiated VAERS data, prompting criticism from vaccine experts who questioned the transparency and scientific rigor of the claims.
Vaccine maker stocks declined significantly following the news, with Moderna falling 7%, BioNTech down 6%, and other manufacturers experiencing similar drops amid concerns about stricter regulatory oversight.
Dr. Vinay Prasad, who heads the FDA's Center for Biologics Evaluation and Research (搜索) (CBER), sent shockwaves through the pharmaceutical industry last week with an internal memo claiming that COVID-19 vaccines (搜索) have caused the deaths of at least 10 American children. The explosive allegation, made without supporting evidence, has drawn sharp criticism from vaccine experts and triggered significant declines in vaccine manufacturer stock prices.
Controversial Claims Without Evidence
In the six-page memo entitled "Deaths in children due to COVID-19 vaccines (搜索) and CBER's path forward," Prasad stated that at least 10 children had died "after and because of receiving" COVID-19 vaccines. He linked these deaths to myocarditis (搜索), an inflammation of the heart muscle, and suggested that the "true numbers" of deaths due to COVID-19 (搜索) vaccinations could be even higher.
The investigation into these cases was reportedly led by Tracy Beth Høeg, described as a "COVID contrarian" and advisor to FDA Commissioner Marty Makary. However, Prasad provided no specific data, manufacturer details, or timeline information to support his claims.
"When you make a sensational claim like that, a frightening claim like that, at the very least, you owe it to the public to provide the evidence," said Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia.
Expert Criticism of Methodology
The memo's reliance on data from the Vaccine Adverse Event Reporting System (VAERS) has drawn particular scrutiny from experts. VAERS collects reports of adverse events following vaccinations but does not establish cause and effect relationships on its own.
Peter Lurie, president of the Center for Science in the Public Interest and former FDA associate commissioner, questioned the criteria used to determine whether vaccinations were involved in the reported deaths. "After years of working at the FDA I've never seen a memo like that," Lurie told reporters. "It's a screed that veers into things of no clear relevance whatsoever."
Lurie noted that adverse events reported to VAERS are unsubstantiated, and the FDA typically follows up with people who submitted those reports to gain more information. It remains unclear whether such follow-up investigations were conducted in this case.
Broader Policy Changes Announced
Beyond COVID-19 vaccines (搜索), Prasad's memo outlined plans for sweeping changes to vaccine policy. He announced intentions to revise the annual influenza vaccine framework and raised questions about administering multiple vaccines simultaneously. The memo also stated that the FDA would no longer authorize vaccines for use in pregnant women without stronger supporting data and stricter safety requirements.
Dorit Reiss, professor of law at UC Law San Francisco, criticized Prasad's approach: "He's expressly not doing cost/benefit analysis, even though it's his job. This is a bad way to do policy."
The memo concluded with Prasad explicitly asking those who disagree with his views at the FDA to resign, while emphasizing that dissenting opinions should be raised behind closed doors.
Market Impact and Industry Concerns
Vaccine manufacturer stocks experienced significant declines following news of the memo. Moderna shares fell 7% to $24.16, while BioNTech dropped 3.9% to $98.44. Other vaccine makers also saw declines, with Pfizer slipping nearly 2%, Novavax down 5%, and Vaxcyte falling more than 8%.
The market reaction reflects broader concerns about the potential impact of stricter regulatory oversight on the vaccine industry. William Blair analysts noted particular pressure on Moderna, writing: "We see further headwinds towards [Moderna's] declining COVID-19 (搜索) franchise alongside further negative sentiment that this memo and subsequent actions may generate."
Regulatory Context and Future Implications
The developments come under the current leadership of the Department of Health and Human Services under Robert F. Kennedy Jr., a well-known vaccine skeptic. Earlier this year, Kennedy dismissed all members of a key CDC (搜索) advisory committee and replaced them with individuals who reportedly share his views on vaccines.
FDA Commissioner Marty Makary backed up the memo's contents in a Saturday interview, stating that information about these deaths will be made available soon. He also mentioned that the FDA will not "rubber-stamp" new vaccines without evidence supporting their clinical benefits.
The timing is particularly significant as a CDC (搜索) advisory committee is scheduled to meet December 4-5, 2025, to discuss the childhood vaccine schedule and hepatitis B (搜索) vaccination protocols. While the FDA determines whether vaccines can be marketed, the CDC establishes who should receive them and under what conditions.
Industry leaders have expressed concerns about the independence of public health decision-making, as the vaccine sector faces continued headwinds following shifts in public sentiment and policy approaches to vaccination programs.