The FDA is seeking greater oversight of vaccine trials and approvals
The Trump administration is casting further doubt on the safety of vaccines by linking the deaths of at least 10 children to the Covid vaccine in an internal Food and Drug Administration memo and proposing new regulatory measures as a result.
The memo was obtained by The New York Times and was not released publicly. Details such as the children’s ages, whether they had any health problems or how the agency determined the connection between vaccination and death were not disclosed. The manufacturer of the vaccines in question was also not disclosed.
The results were not published in a peer-reviewed medical journal, drawing suspicion from some critics of Health and Human Services Secretary Robert F. Kennedy Jr., who has repeatedly criticized Covid vaccinations as deadly despite scientific consensus that they are safe.
The memo was written by Dr. Vinay Prasad, director of the FDA’s vaccine division. He sent it to agency staff on Friday outlining the results of a review of reports of childhood deaths and attributing them to myocarditis, or inflammation of the heart muscle.
The Covid vaccine, like many other vaccinations, poses some health risks in certain cases, and mainstream scientists have been studying the vaccine’s effects on people for years, particularly the occurrence of myocarditis in teenagers and young men.
“This is a profound revelation,” wrote Dr. Prasad in a memo to employees. “For the first time, the USFDA will acknowledge that Covid-19 vaccines have killed American children.”
Dr. Prasad said he would propose a range of new oversight and review measures for vaccines, although it was unclear whether the White House had been briefed on the contents of the memo. The proposals could be refined by government officials or challenged by lawmakers and drug companies.
A spokesman for the Department of Health and Human Services, which oversees the FDA, did not respond to a request for comment.
The memo represents a further escalation of vaccine broadsides by federal regulators under Mr. Kennedy, who has used his position as minister to repeatedly cast doubt on vaccinations and name other skeptics for positions of authority.
Mr Kennedy’s team has issued new guidelines that limit access to the Covid vaccinations to people aged 65 and over and younger people with underlying health conditions. He and FDA officials also called for further studies of existing vaccines that have been considered safe for decades.
Health officials in the first Trump administration, when vaccines were developed during the pandemic, and in the Biden years strongly advocated Covid vaccinations as a life-saving measure. Public health experts have pointed to the number of lives saved by the Covid vaccine and that the virus has caused more than a million deaths among Americans. According to the American Academy of Pediatrics, about 2,100 children have died from Covid since the pandemic began.
Dr. Prasad’s memo arrives just before next week’s meeting of the Centers for Disease Control and Prevention’s influential vaccine committee. Mr. Kennedy’s hand-picked panel includes supporters of the so-called medical freedom community, who often oppose vaccinations and oppose mandates. The committee is expected to discuss the vaccination schedule for children and the hepatitis B vaccine for newborns.
Michael Osterholm, a critic of Kennedy’s oversight of the health agency and an infectious disease expert at the University of Minnesota, said he believed the memo was intentionally released before the meeting.
“This is an irresponsible way of dealing with a very critical public health issue such as vaccinations and adverse events,” he said.
Among the changes that Dr. Dr Prasad’s oversight and approval brief outlined a requirement that studies examining people using a vaccine or placebo include all subgroups, such as pregnant women. Additionally, he called the annual process of updating flu vaccines to match a circulating strain a “disaster of low-quality evidence” and said it would also be reviewed. (The chosen variety is sometimes a bad fit.)
He also said companies would need to conduct larger studies before they could promote vaccines as safe to administer together, such as the flu and Covid vaccines. And vaccine makers would have to conduct large, randomized trials of pneumonia vaccines to show that they reduce cases of the disease, rather than prove that they produce antibodies.
The changes would most likely increase costs for vaccine manufacturers to submit studies of their products to the FDA for review and approval decisions. Public health experts also warn that high-profile statements suggesting vaccines are not safe will undermine trust as cases of measles and whooping cough soar in the United States.
Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia and a critic of Mr. Kennedy’s vaccination policies, called the memo an example of science “by press release.”
He said there was a lack of context, such as the number of deaths from the virus even among vaccinated and unvaccinated children.
Dr. Offit said children with vaccine-related myocarditis have shown up at the hospital and the cases have cleared up quickly. “On the other hand, we saw children admitted to our hospital with myocarditis due to the virus,” he said. “It was quite severe and resulted in intensive care unit admissions.”
The memo from Dr. Prasad also took aim at the Biden administration, claiming that requirements for vaccinations in schools and workplaces “forced” people to get Covid vaccines that could lead to death.
His predecessor, Dr. Peter Marks, who led the FDA division during the pandemic, said he was surprised by the “clearly political tone of the communication.” He agreed that the case reports of childhood deaths needed to be subjected to further scrutiny to determine whether they were caused by the vaccines.
“It wouldn’t surprise me if the attributions were controversial, as these cases are often quite complex,” said Dr. Marks after reading the memo.
The vaccination letter followed Dr. Prasad’s recent letter admonishing staff not to publish “obviously flawed work” rather than studies that further the agency’s mission.
Dr. Prasad, whose leadership style has angered some people inside and outside the agency, complained in the latest memo about employees who disagreed with the vaccine department’s direction and the new guidelines and said they were leaking information. He then explained how employees could submit their resignations.
