An ally of RFK Jr. once filed petition to revoke FDA approval for polio vaccine

An ally of Robert F. Kennedy Jr. petitioned the government in 2022 to reconsider its approval of a widely used polio vaccine, which is credited with staving off a debilitating virus that can result in permanent paralysis.

Aaron Siri - a lawyer with a history of seeking to expand exemptions to vaccines - asked the Food and Drug Administration to suspend or withdraw approval of Sanofi’s polio vaccine for children, which federal health officials recommend to ward off a potentially deadly disease for which there is no cure.

The New York Times first reported on the polio petition. Siri filed the petition on behalf of the Informed Consent Action Network, an influential anti-vaccine group. In the 2022 petition, he raised questions about the safety of the polio vaccine and argued for more studies to be conducted.

Scientific studies have repeatedly shown the polio vaccine, the first formulations of which emerged in the 1950s, to be safe.

President-elect Donald Trump last month selected Kennedy to lead the nation’s sprawling Department of Health and Human Services. If confirmed by the Senate, Kennedy, founder of a prominent anti-vaccine group, would have authority over the FDA, which is responsible for vaccine safety. Kennedy, who has denied being anti-vaccine, has repeatedly linked the childhood vaccine schedule to autism - a claim that has been debunked by scientists.

Siri has been working as a top adviser for Kennedy as he builds out his staffing and plans for HHS, according to one person with direct knowledge who spoke on the condition of anonymity to be candid. Siri declined to comment.

“Mr. Siri has never had a conversation about these petitions with Mr. Kennedy or any of the HHS nominees at any point,” Katie Miller, a Trump transition spokeswoman for Kennedy, said in an interview. The vaccine “should be investigated and studied appropriately. We should be as transparent as possible, as it relates to vaccines, but it should be available to the public.”

FDA spokeswoman Cherie Duvall-Jones said the agency is continuing to review Siri’s petition and cannot comment further.

“The FDA will consider the concerns outlined in the petition as a final decision is made,” she said.

In response to reporting about Siri’s petition, Senate Republican leader Mitch McConnell (Kentucky), who battled polio as a child, forcefully denounced attempts to cast doubt on the polio vaccine, which he said has “saved millions of lives and held out the promise of eradicating a terrible disease.”

“I have never flinched from confronting specious disinformation that threatens the advance of lifesaving medical progress, and I will not today,” McConnell said in a statement. “Efforts to undermine public confidence in proven cures are not just uninformed - they’re dangerous. Anyone seeking the Senate’s consent to serve in the incoming Administration would do well to steer clear of even the appearance of association with such efforts.”

Public health experts have called vaccines the greatest public health achievement of the 20th century, concluding that they have helped stamp out diseases such as polio that used to terrify Americans.

“People forget that a president of the United States was paralyzed by polio. FDR struggled to use his legs for the rest of his life,” said Richard Hughes IV, a former vice president of public policy at Moderna who teaches vaccine policy at the George Washington Law School. “Every summer, mothers were afraid. They lived in fear of letting their children go off to the swimming pool.”

Despite the overwhelming evidence available about the safety of the polio vaccine, Hughes said Kennedy and his allies have “consistently made false safety claims and said that we need additional safety data.”

“I foresee a potential situation where they try to put forward alternative safety data or insist that the safety data isn’t there,” he said.

Trump has said he will do “very serious testing” of vaccines and suggested in a Time magazine interview published Thursday that he could get rid of some vaccines if they are “dangerous” and “not beneficial.”

But he has repeatedly praised the polio vaccine, including on Meet the Press this month.

“Hey, look, I’m not against vaccines. The polio vaccine is the greatest thing,” Trump said in the interview. “If somebody told me to get rid of the polio vaccine, they’re going to have to work real hard to convince me. I think vaccines are - certain vaccines - are incredible. But maybe some aren’t.”

Vaccines go through several stages of clinical trials and are typically studied by thousands of people to determine their safety and effectiveness before they are approved for the market.

Ayman Chit, medical head of Sanofi’s North America vaccines division, said the polio vaccine has undergone nearly 50 years of clinical studies and safety monitoring, and the absence of polio outbreaks in North American and European countries that have robust vaccination programs is a “testament of their contribution to polio eradication.”

“Sanofi’s vaccines undergo continuous monitoring and evaluation to ensure their safety and effectiveness,” Chit said in a statement. The vaccines “have been widely used showing not only to provide an acceptable safety profile but also high levels of long-lasting immunity.”

Georges C. Benjamin, executive director of the American Public Health Association, said vaccines are “clearly the most important prevention tool that we have.”

“We are on the cusp globally of the eradication of polio,” he said.

The Washington Post had previously reported that Informed Consent Action Network had risen to prominence by capitalizing on the spread of medical misinformation and nearly quadrupled its revenue during the pandemic. The group paid Siri’s law firm nearly $5.3 million in 2022 - more than four times what it had paid him in 2019.

The Informed Consent Action Network did not immediately respond to requests for comment about Siri’s petition. Siri has filed other petitions on behalf of the organization to reconsider other vaccines for children, including one to revoke the emergency use authorization for the coronavirus vaccine and another to revoke or suspend the approval of hepatitis B vaccines.