The FDA plans to alter its vaccine approval process based on allegations that the Covid vaccine resulted in the death of 10 children. In an internal memo obtained by CNN, Vinay Prasad, MD, MPH, FDA chief medical and scientific officer, director of the Center for Biologics Evaluation and Research (CBER), revealed FDA’s plans to alter its vaccine approval process, stating “Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death.”¹

In the memo, Prasad discussed plans to change the vaccine approval process, writing, “This is a profound revelation, for the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”

In his memo, Prasad did not include details regarding the deaths, or how FDA came to the correlation between the deaths and the Covid vaccine, but instead pointed to “an initial analysis,” examining 96 deaths that were reported to the Vaccine Adverse Event Reporting System (VAERS). He then linked 10 of these deaths to Covid vaccination.¹ Prasad added that Covid-19 “was never highly lethal for children,” saying that Covid symptoms “are comparable” to other respiratory viruses that don’t have annual vaccines.¹

According to a report by STAT, Prasad said he asked FDA’s Office of Biostatistics and Pharmacovigilance to analyze 96 deaths reported to VAERS that occurred between 2021 and 2024. Dr. Prasad stated in the memo that “no fewer than 10 are related” to Covid vaccines, and that “the real number is higher.”

“I have no doubt that many vaccines have saved millions of lives globally, and many have benefits that far exceed risks, but vaccines are like any other medical product,” Prasad wrote in the memo. “The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm.”

FDA’s new vaccine approval process

Based on this analysis, the FDA is expected to adapt a new approval process for vaccines, requiring increased evidence of both safety and value before being approved for marketing.¹ Additional changes include stricter requirements for vaccine authorizations for use from pregnant women, along with trials for pneumonia vaccines providing proof that the shots reduce disease, instead of showing that the vaccine produces enough antibodies to fight the illness.¹

Prasad continued to mention that the agency will also “revise the annual flu vaccine framework,” and “ re-appraise safety and be honest in vaccine labels.”¹ He added that FDA may also adjust its stance on administering multiple shots at once, a decision that could affect the childhood vaccine schedule.

Expert express skepticism on claims about Covid deaths and vaccination

Following the release of Dr. Prasad’s memo, industry experts began to voice their skepticism of claims made in the memo, citing a lack of information and evidence correlating the deaths to the Covid vaccine.² Michael Osterholm, director of the University of Minnesota’s center for infectious disease research and policy, told STAT that “It’s irresponsible science at best and it’s dangerous to the public at the very least.”

In the same report, Dr. Paul Offit, a pediatrician and the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, touched on the memo, calling it “irresponsible” and “dangerous,” and continued to say, “This is sort of science by press release.”

Prasad has had a tumultuous tenure at the FDA since he was appointed to run CBER in May, starting his resignation from the agency in late July. Just weeks later, Prasad returned to head the agency at the FDA Commissioner Marty Makary.

The CDC Advisory Committee on Immunization Practices is scheduled set to meet next week to address the current childhood vaccine schedule as well as timing for administration of the hepatitis B vaccine.

Sources

1. FDA official plans to change vaccine approval process, claiming that Covid-19 shots caused child deaths CNN November 29, 2025 https://edition.cnn.com/2025/11/29/politics/vaccine-approval-process-fda-official
2. Experts say top FDA official’s claim that Covid vaccines caused kids’ deaths requires more evidence STAT November 29, 2025 https://www.statnews.com/2025/11/29/covid-vaccine-deaths-fda-memo-vinay-prasad/