By Kaanita Iyer, Adam Cancryn, Amanda Sealy, CNN

(CNN) — A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children.

In an internal memo obtained by CNN, Dr. Vinay Prasad — the FDA’s chief medical and scientific officer and the director of the Center for Biologics Evaluation and Research — claimed, “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.”

Prasad did not provide details about the deaths or how the FDA came to that conclusion, but pointed to “an initial analysis” that examined 96 deaths and linked 10 to the Covid-19 vaccination. He also claimed that Covid-19 “was never highly lethal for children” and that the effects of it “are comparable” to respiratory viruses for which there aren’t annual vaccines.

“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 said. “The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm.”

Prasad said as a result of the FDA analysis, the agency will adopt a new approval process for vaccines that will require more evidence of their safety and value before they can be marketed. Among the changes would be stricter requirements for authorization of vaccines used for pregnant women and trials for pneumonia vaccines that will need to prove the shots reduce disease, instead of showing that the vaccine produces enough antibodies to fight the illness.

The agency will also “revise the annual flu vaccine framework,” Prasad said, and “will re-appraise safety and be honest in vaccine labels.”

Although Prasad’s memo didn’t provide details about how the process would change, it could require larger studies that take longer to complete, slowing the process significantly.

In the memo, Prasad said he’s open to discussion about the changes but said such debates should be internal to the FDA. “Some staff may not agree with these core principles and operating principles,” he wrote before urging those staffers to submit their resignation letters.

CNN has reached out to the FDA and the Department of Health and Human Services, which oversees the agency, for comment.

Friday’s memo is in line with arguments long made by HHS Secretary Robert F. Kennedy Jr., who has repeatedly raised doubts about the effectiveness of vaccines and previously founded the anti-vaccine group Children’s Health Defense.

As the HHS secretary, Kennedy has slashed funding for mRNA vaccine development, removed all members of the vaccine advisory committee at the Centers for Disease Control and Prevention, and directed the CDC to change its website to include false claims that link autism and vaccines.

The CDC’s Advisory Committee on Immunization Practices, handpicked by Kennedy, is set to meet next week to discuss the childhood vaccine schedule and the timing of the hepatitis B vaccine, according to a draft agenda of the meeting.

For more than 30 years, the first in the series of hepatitis B shots has been recommended for infants shortly after birth — a strategy that nearly eradicated the potentially fatal disease among children in the US. Although there is no new evidence about the vaccine’s safety or effectiveness, the new advisory panel has been considering whether to delay the first shots by months or years.

CNN’s Jamie Gumbrecht contributed to this report.

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