Experts say strict new FDA protocol for vaccine approval is ‘dangerous and irresponsible’ | US news

The Food and Drug Administration’s (FDA) lead vaccine regulator has announced a much stricter process for federal vaccine approvals, following allegations from its team that Covid vaccines have been linked to the deaths of at least 10 children.

Experts suggest that the announcement will significantly complicate the vaccine approval process.

Dr., whose vaccine policy guidance is supported by US health secretary Robert F Kennedy Jr. Vinay Prasad told FDA staff that the agency would rethink its approach to vaccine programs, according to an internal email distributed Friday and later obtained by various media outlets.

Prasad said the agency plans to reexamine annual flu vaccine policies, evaluate limitations on concurrent vaccines and request more robust safety and effectiveness data from drugmakers before approval.

The internal memo said a recent investigation determined that at least 10 children had died “after and because of” the Covid vaccine. Prasad noted that these deaths appeared to be due to myocarditis, or inflammation of the heart muscle.

“This is a profound revelation,” Prasad wrote in a memo to staff. “For the first time, the US FDA will admit that Covid-19 vaccines are killing American children.”

He also wrote that the new rules would impose strict restrictions on vaccines for pregnant women, marking another significant change in the agency’s approval framework.

“I remain open to robust discussion and debate,” Prasad wrote, reportedly adding that staff who did not accept the core tenets of his new approach should submit their resignations.

A PBS NewsHour reporter first reported the contents of the memo on: a post In X. New York Times He noted that the document did not include descriptive details such as the ages of the children, their current health conditions, or how the causal relationship between the vaccine and death was determined. The names of the vaccine manufacturers involved were also not specified.

Dr. from the Children’s Hospital of Philadelphia, who reviewed the note. This is a “dangerous and irresponsible thing to do,” Paul Offit told MedPage Today.

“[Prasad] “He says he has evidence that this vaccine killed 10 children, but it doesn’t work that way,” said Offit, and continued: “If you think you have an extraordinary claim, you must support it with extraordinary evidence. He should have submitted it to an excellent journal, where it could be reviewed by experts on the subject and say, ‘Yes, this is clear evidence,’ and then it could be published. That’s how it works.”

Prasad’s predecessor, Dr. Prasad, who led the FDA division throughout the pandemic. Peter Marks said: New York Times He noted that he was surprised by the “clearly political tone of the communication” and that case reports of child deaths should be further investigated.

“Since these cases are often quite complex, I wouldn’t be surprised if the attributions turned out to be controversial,” Marks told the Times after reading the memo.

Current and former FDA staff, as well as outside public health experts, said the new plan could significantly slow down vaccine development. Washington Post. Requiring much larger studies before approval could delay product launches, cause companies to be more cautious about developing or expanding vaccines and discourage innovation in vaccine research, they said.

Additionally, Prasad’s insistence on reevaluating whether multiple vaccines should be given together could upend years of established federal guidance. The Centers for Disease Control and Prevention’s (CDC) immunization schedule currently recommends receiving more than one childhood vaccine at the same medical visit. It also encourages adults to get multiple vaccinations for respiratory viruses, including flu, Covid and RSV, during a single appointment for convenience.

D., a vaccine expert and professor emeritus at Vanderbilt University in Nashville, Tennessee. Kathryn Edwards told MedPage Today that “determining the cause of death in cases temporally related to vaccination is a very difficult task.”

“To say definitively that the vaccine caused death requires careful evaluation; this is best done through autopsy examination and to exclude other causes of death,” he said. “The Covid vaccine may have caused death due to myocarditis, this may indeed be the case. But [we] I need to see the details.”

Edwards added that such details “would be best presented in a peer-reviewed text where experts can review the details.”

“We must not forget that Covid disease causes deaths.” [in kids]”More than 10,” he said. “I’ve spent the entire pandemic reviewing adverse event cases, I’d be happy to review those cases and evaluate the evidence that says they were caused by the vaccine.”

Prasad’s new framework reflects several themes long developed by Kennedy and members of the anti-vaccine movement who have pressed for additional evidence on vaccine safety and effectiveness. In August, the FDA imposed new restrictions on who can receive the Covid vaccine.

The agency has authorized Covid vaccines for people aged 65 and over, who are known to be at greater risk of serious illness from Covid infections. But younger people were only eligible if they had an underlying medical condition that made them particularly vulnerable.

In September, Kennedy’s vaccine panel, which advises the CDC, voted against recommending that people get a prescription for the Covid-19 vaccine, but added that coronavirus vaccines should be based on “individual-based decision making.”

Last week, it was reported that top Louisiana health official Ralph Abraham, who has stopped supporting mass vaccination policies and once called Covid-19 vaccines “dangerous,” had been appointed as the new deputy director of the CDC.

Previous FDA leaders and independent scientists have emphasized that Covid-19 vaccines have been subjected to extensive testing, including in pediatric studies, and have been proven safe and effective. They argue that the benefits of vaccination far outweigh the rare risks.