A petition filed by a lawyer affiliated with Robert F. Kennedy Jr., President-elect Donald Trump's nominee for Secretary of Health and Human Services, is drawing intense scrutiny for its attempt to revoke FDA approval of the polio vaccine. The move, initiated by attorney Aaron Siri on behalf of the Informed Consent Action Network (ICAN), raises questions about Kennedy's stance on vaccine policies as he prepares for Senate confirmation hearings.
The petition, submitted in 2022, argues for a halt in the distribution of the inactivated polio vaccine pending a placebo-controlled trial to assess its safety. This proposal comes despite decades of scientific consensus on the vaccine's efficacy in preventing paralysis and death caused by poliovirus. The vaccine has been a cornerstone of global health efforts, reducing polio cases by over 99% since the late 1980s, according to the World Health Organization.
"The FDA is continuing to review the petition," an agency spokesperson said Friday, declining to predict when a final decision might be issued. The agency underscored that it would carefully evaluate the concerns raised before making a determination.
Critics argue that the petition misrepresents the vaccine's safety record and risks undermining public trust in a life-saving intervention. Dr. Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia, warned, "You're substituting a theoretical risk for a real risk. The real risks are the diseases." The Centers for Disease Control and Prevention (CDC) has documented no serious adverse events linked to the inactivated polio vaccine.
Kennedy has distanced himself from outright opposition to vaccines, stating in a recent interview, "People ought to have a choice, and that choice ought to be informed by the best information." However, his ties to vaccine skeptics like Siri and ICAN are fueling concerns about his leadership at HHS. Kennedy's lawyer, Siri, has a history of filing petitions against vaccines, including those for Hepatitis B and COVID-19.
The debate has drawn bipartisan criticism. Senate Minority Leader Mitch McConnell, a polio survivor, called efforts to discredit the vaccine "uninformed" and "dangerous." McConnell stated, "The polio vaccine has saved millions of lives and held out the promise of eradicating a terrible disease. Efforts to undermine public confidence in proven cures are not just uninformed-they're dangerous."
Senate Majority Leader Chuck Schumer echoed these concerns, calling on Kennedy to clarify his position. "This would undoubtedly make America sick again. RFK Jr. must state his position on this," Schumer said in a social media post.
Polio vaccination is widely regarded as one of the greatest public health achievements in history. Before the vaccine's introduction in the 1950s, the disease killed or paralyzed over half a million people annually. The CDC estimates that vaccination efforts have saved more than 1.5 million lives and prevented millions from suffering paralysis.
The petition specifically targets the inactivated polio vaccine, which replaced the oral vaccine in the United States due to the latter's rare risk of causing vaccine-derived poliovirus. Unlike the oral version, the inactivated vaccine uses a killed virus that cannot replicate or mutate, making it safer for recipients.
Siri's petition comes at a time when vaccine safety is a politically charged topic, particularly in light of misinformation campaigns during the COVID-19 pandemic. Kennedy's association with figures like Siri and his own history of vaccine skepticism have prompted public health experts to question his suitability to lead the HHS.
Despite Kennedy's reassurances that he does not intend to restrict vaccines, the controversy underscores the potential challenges of reconciling his past rhetoric with the demands of public health leadership. As his nomination advances, Kennedy is likely to face tough questions about his views on vaccines and his ability to separate personal affiliations from public health policy.
The FDA has not provided a timeline for its review of the petition, but the debate is expected to remain a contentious issue as Kennedy's confirmation hearings approach.
