Polio vax petition could preview more challenges

Driving the news: The concerns have amped up in recent days following a report that an ally of Health and Human Services Secretary-designate Robert F. Kennedy Jr. filed a citizen petition in 2022 to revoke the approval of polio vaccines for infants and children.

• Attorney Aaron Siri has also joined Kennedy in questioning and choosing candidates for top health positions, the New York Times reported, citing an unnamed source who witnessed the interactions.

State of play: Siri and others successfully challenged COVID vaccine mandates, sued federal agencies for vaccine approval records and put prominent vaccine scientists through lengthy videotaped depositions, the Times wrote.

• In the case of polio, critics are zeroing in on a vaccine using inactivated, or killed, virus that causes the body to produce its own antibodies against the virus that causes polio and stop it from spreading to the central nervous system.
• The virus can still multiply inside the intestines and be shed in the stool. But the risk of continued circulation is low in the U.S. because of vaccination efforts.

The petition asks the FDA to suspend the vaccine's approval for infants and toddlers "until a properly controlled and properly powered double-blind trial of sufficient duration is conducted."

• It claims that the studies FDA cited in its 1990 approval of updated polio vaccine don't properly investigate the vaccine's long-term safety.
• And it calls for a warning label stating the vaccine "does not prevent intestinal infection and therefore does not prevent poliovirus transmission."

Between the lines: Public health experts say vaccine skeptics, including Kennedy, have repeatedly questioned the safety and efficacy of the shots while insisting they're not anti-vaccine.

• "There is much more behind this than just rhetoric," Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota told Axios.
• "They say 'We just want more studies. We're only concerned about vaccine safety.' The real objective to get vaccines off the market," said Angela Rasmussen, a virologist at the University of Saskatchewan's Vaccine and Infectious Disease Organization.
• She said she expects Kennedy would follow a similar path of calling for more clinical trials and research as a pretext for removing vaccines from federal schedules of recommended shots.

Between the lines: Beyond direct challenges like citizen petitions, vaccines could be undermined by outside committees of advisers, whose recommendations determine the jabs' availability and how they are paid for.

• Kennedy and Siri's vetting of key health positions in the incoming administration also indicates anyone who gets a top job should ascribe to vaccine skepticism, the experts say.
• "Having Siri be the gatekeeper of who gets these positions or not is a worst-case scenario," Rasmussen said. "These picks are all the picks I would pick if I were trying to destroy the U.S. vaccine program."

The other side: In a statement posted online, Siri called the Times report a "hit piece" and said the petition challenging the polio vaccine was filed on behalf of the Informed Consent Action Network and not himself.

• He also said the vaccine in question, IPOL, "is not the polio vaccine of old," saying there are "clear safety gaps in licensing this particular product."

• In 2000, the U.S. stopped using the oral polio vaccine, which blocks the spread of the virus by inducing immunity in the gut but can result in vaccine-derived poliovirus due to its use of a weakened strain of polio.
• Vaccine-derived polio virus can cause outbreaks where vaccine coverage is low, per the Centers for Disease Control and Prevention.

"Vaccines have been so effective we don't appreciate what it was like prior to the vaccines when, during the summer, sending your kid to the swimming pool might result in them living in an iron lung the rest of their life," Rasmussen said.

Reality check: It still will difficult to upend the regulatory system that's in place to vet vaccines for safety and efficacy, Osterholm said.

• "I don't think there's this imminent danger that sometime in January where, all of a sudden, we won't see vaccines available," Osterholm said.
• That's particularly true now that the Supreme Court has scrapped a decades-old legal doctrine that gave the FDA, Centers for Medicare and Medicaid Services and other health agencies the discretion to interpret vague or ill-defined laws. Legal challenges to any vaccine rollback are likely.
• There is also the question of popular opinion. Americans have expressed mistrust of Kennedy on health, with a majority disagreeing with his views about vaccine requirements in schools, per the latest Axios-Ipsos American Health Index.

Americans worried about vaccine safety should be aware the shots are among the most scrutinized medical products, Joshua Sharfstein, a former FDA deputy commissioner and public health professor at Johns Hopkins University, told Axios.

• That doesn't mean safety discussions should be off the table, but that "we don't want to have a conversation about vaccine safety led by people who have irresponsibly called for the removal of vaccines," he added.

What to watch: Kennedy is expected to spend this week on the Hill meeting with senators.

• The New York Times report of Kennedy's collaboration with Siri generated a strong rebuke on Friday from Senate Minority Leader Mitch McConnell, who had polio as a child and is an important vote for Trump's nominees to win over.