In the furor over FDA vaccines

In the furor over FDA vaccines

Six days after a top FDA official sent a sweeping internal email claiming that Covid vaccines had caused the deaths of “at least 10 children,” 12 former FDA commissioners published an extraordinary warning in the Dec. 3 issue of the New England Journal of Medicine.

They wrote that the claims and policy changes in the memo from Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research, "pose a threat to evidence-based vaccination policy and public health safety" and represent a sharp break from longstanding scientific norms.

What's happening inside the FDA isn't a narrow argument over Covid vaccines. According to critics and vaccine scientists, it is an attempt to rewrite the rules for the entire U.S. vaccination system — how risks are weighed, how benefits are proven and how quickly life-saving shots reach the public. Former agency leaders warn that if these changes take hold, the consequences could be lasting: fewer vaccines, slower updates, weakened public trust and more preventable outbreaks.

Prasad made it clear that he sees the moment as corrective. “Never again will the FDA commissioner himself have to find child deaths for employees to identify,” he wrote, telling employees that the agency’s mission and its “worldview” would be changing.

Prasad's email reignited old arguments about Covid vaccines, relying on findings widely considered weak and misleading in the peer-reviewed research community. He claimed that FDA staff used reports from the Vaccine Adverse Event Reporting System to identify “at least 10” child deaths that occurred “after and because of” the Covid vaccination.

The VAERS system is known to be a crowdsourcing system, meaning anyone can contribute, and scientists say it merely serves as a clearinghouse for reports. For example, a person might file a report saying that their hair turned purple after a flu shot. Although this report remains in the database pending review, it cannot prove the cause of medical events. However, Prasad argued that the actual number of deaths is likely higher because many cases go unreported.

On Substack,In medicinereported on December 11 that Prasad used incomplete information and that an internal FDA memo dated December 5 put the pediatric death toll from Covid vaccinations somewhere between zero and seven. Emily Hilliard, a spokeswoman for the Department of Health and Human Services, wrote: "The FDA's investigation into Covid vaccine deaths is ongoing and there is no final count of these deaths."

Prasad also accused the FDA and the Centers for Disease Control and Prevention of downplaying the risk of heart inflammation called myocarditis in young men; criticized the agency for approving youth recordings; and suggested that vaccination requirements in schools and workplaces may have "harmed more children than we saved," adding, "We don't know if, all things considered, we have saved lives."

By comparison, more than 2,100 American children have died from Covid itself since the pandemic began, the CDC reported.

Based on his false and misleading claims about Covid vaccines, Prasad proposed a major overhaul in the way vaccines are approved. He said the FDA should stop relying on immune markers to determine the effectiveness of vaccinations, such as antibody levels, and instead require large, placebo-controlled, randomized trials that track hospitalizations and deaths before approving most new vaccines.

Many immunologists and vaccine experts say it is unethical to test vaccines known to be effective against disease on a control group that would receive a placebo, thereby exposing them to infection.

"There is a bedrock principle in bioethics that it is unethical to test a drug or vaccine against a placebo if it is known to be safe and effective. The reason is that such placebo-controlled trials would effectively deny patients access to a vaccine that could prevent a dangerous infectious disease," said Lawrence Gostin, a professor of global health law at Georgetown University.

Calling the current flu vaccination system an "evidence-based disaster," Prasad questioned the approval of vaccines for pregnant women based on immune response alone and raised concerns about administering multiple vaccines at the same time. He urged staff to rewrite FDA guidelines to conform to his new "worldview" and said anyone who disagreed with his "core principles" should resign.

The former FDA leaders expressed their concerns in the NEJM article. They said Prasad was exploiting public frustration over the federal response to Covid to stoke doubts about the entire childhood vaccination system, which could undo decades of success in protecting children from deadly diseases.

"This is really different. And it's really dangerous. And people are getting hurt, particularly by the vaccination decisions," former FDA Commissioner Robert Califf said in an interview. He also warned that Prasad's proposed guidelines — which he said reflect the positions on vaccines of Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaxxer — could shake up the entire vaccine market.

“RFK’s goal appears to be to make vaccine availability impossible in the United States,” he said. If the proposals go forward, he added, “it will not be a viable business.”

Hilliard strongly dismissed these concerns, writing: "The American people deserve evidence-based science. Prasad's email lays out a philosophical framework that holds us to this higher standard. We will soon release documents laying out this framework and data confirming how the COVID vaccine has resulted in child deaths that previous leadership failed to properly investigate."

For generations, the childhood vaccination program has relied on clear rules, strong safety systems and public trust. Experts say Prasad's ideas, based on claims they say are not supported by real evidence, could make it much harder to test, approve and deliver vaccines to families.

Fueling parents' doubts

Prasad's memo indicates that he views VAERS reports as evidence that vaccines have caused child deaths. However, the system is designed solely as an “early warning system” for potential vaccine safety issues that can be further investigated.

“VAERS signals should never be taken as evidence of real vaccine risks without careful, confirmatory studies,” said Katherine Yih, an epidemiologist and longtime researcher at Vaccine Safety Datalink, a CDC program.

This, scientists say, directly fuels public fear at a time when many parents are already unsure who to trust.

“Causation requires converging evidence, not just one report or coincidence,” said Robert Hopkins, medical director of the National Foundation for Infectious Diseases.

However, Prasad's framework views uncertainty as a reason to stop development entirely.

Experts fear this doubt will not be limited to Covid vaccines. Once parents begin to question the FDA's honesty, they may begin to doubt the long-standing vaccines against measles, polio or whooping cough—vaccines that have protected children for decades.

“Science has to be transparent,” Gostin said. If families believe the FDA is misusing data or silencing experts, trust in the entire vaccine system can collapse, he said. "There is a public narrative that people have lost trust in science, but that is not true. The vast majority want the FDA to make decisions based on the best scientific evidence. Once they believe the agency is marginalizing scientists and cherry-picking evidence, their trust will decline."

Delicate vaccine pipeline

Prasad's new framework is likely to make it significantly more difficult for companies to produce or update vaccines. The 12 former FDA commissioners warned that requiring clinical trials for any new or updated shots would slow vaccine improvements and leave people vulnerable. His plan, they wrote, “would impact the ability to update vaccines in a timely manner, particularly against respiratory viruses.”

For rapidly changing viruses like flu and Covid, this could have catastrophic consequences. There simply isn't enough time to conduct full clinical trials every time a virus mutates.

There are also big business implications. Vaccine development is costly and companies may decide the U.S. is no longer worth the risk. As companies slow down or exit the market, families could face shortages, less innovation and less protection for their children.

“Checks and Balances”

Science depends on an open and public debate. Prasad's memo warned his staff about this. In addition to calling for the resignation of FDA employees who disagreed with him, he also said their disputes should remain confidential and called the leaks "unethical" and "illegal."

Susan Ellenberg, a former director of the FDA's Office of Biostatistics and Epidemiology, warned that Prasad risked destroying the process that makes science credible. “When disagreement is treated as disloyalty, you lose the only mechanism that keeps science honest,” she said.

Without intense internal debate, security clearances become weaker. “You lose the checks and balances that make vaccine safety science credible,” said Kathryn Edwards, a pediatric infectious disease specialist at Vanderbilt University Medical Center who served on the Clinical Immunization Safety Assessment Network during the Covid pandemic.

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