The FDA is planning to tighten its regulations for vaccines, according to an internal email sent by Vinay Prasad, M.D., who heads up the agency’s Center for Biologics Evaluation and Research (CBER).
In the message, which was sent to CBER staffers, Prasad wrote (PDF) that the agency “will acknowledge that COVID-19 vaccines have killed American children,” and that it would be the “first time” the FDA has made this “profound revelation.”
Prasad claimed that “no fewer than 10” children had died from using COVID vaccines. The findings are based on “detailed analysis of deaths voluntarily reported to the VAERS system” between 2021 and 2024, Prasad wrote.
In the wake of the memo, several vaccine experts responded that the CBER director's claim about the deaths requires more scrutiny. In a disclaimer on the Vaccine Adverse Event Reporting System (VAERS) website, the HHS notes that the data alone "cannot be used to determine if a vaccine caused or contributed to an adverse event or illness."
Prasad explained that the conclusion is the result of a months-long review of 96 deaths reported between 2021 and 2024.
Based on the conclusion, Prasad said the FDA plans to "direct vaccine regulation towards evidence-based medicine." He said the agency will take "swift action regarding this new safety concern" and "will not be granting marketing authorization to vaccines in pregnant women based on unproven surrogate endpoints," among other policy guideposts.
The FDA leader said he's open to debate about the new regulatory approach, but stressed that these discussions should remain internal at the agency. Those at the FDA who disagreed with the "core principles and operating principles" laid out in the memo were asked to resign.
“For those who choose to remain,” Prasad wrote, “I look forward to working with you.”
Passages from the email, which was sent on Friday afternoon, were first revealed by PBS NewsHour correspondent Ali Rogan on X.com.
The email continues the effort by officials in the Trump administration—most notably former anti-vaccine activist and current Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.—to question the safety and effectiveness of the shots. In August, the FDA approved updated COVID vaccines from Moderna and Pfizer, but with narrower recommendations than in previous years.
Prasad’s message to staffers also came days before the CDC's Advisory Committee on Immunization Practices (ACIP) meeting on Thursday and Friday of this week. The session will help the agency formulate its next set of recommendations for vaccines.
Saturday on Fox News, FDA Commissioner Marty Makary backed up Prasad’s comments, saying that the agency would no longer “rubber-stamp products that don’t work.”
Prasad also told staffers that the FDA will "revise the annual flu vaccine framework,” and calling it “an evidence-based catastrophe.”
The CBER director also has pneumococcal vaccines in his crosshairs, according to the email.
“Pneumonia vaccine makers will have to show their products reduce pneumonia (at least in the post-market setting), and not merely generate antibody titers,” Prasad wrote. “Immunogenicity will no longer be used to expand indicated populations—these populations should be included in pre-market (randomized control trials).”
As anti-vaccine sentiment has grown in the U.S., sales of the shots have decreased markedly, as evidenced in recent third-quarter earnings reports from drugmakers. Pfizer’s numbers (PDF) were particularly indicative of the erosion in demand for immunizations in the U.S.
While sales of its Prevnar franchise of pneumococcal vaccines were up 18% year over year outside of the U.S., they were down 12% in the U.S. The same was true of its COVID shot Comirnaty, which saw a 9% increase in international sales and a 25% decline domestically.
Figures from other premier vaccine sellers in Q3—such as GSK, Sanofi, Merck and Moderna—also reflected the trend.