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regular-article-logo Monday, 23 December 2024

Robert F. Kennedy Jr's lawyer asks FDA to revoke approval of the polio vaccine

Aaron Siri, who specializes in vaccine lawsuits, has been at Robert F. Kennedy Jr.’s side reviewing candidates for top jobs at the Department of Health and Human Services

Christina Jewett, Sheryl Gay Stolberg New York Published 14.12.24, 06:17 AM
Robert F. Kennedy Jr.

Robert F. Kennedy Jr. File photo.

The lawyer helping Robert F. Kennedy Jr pick federal health officials for the incoming Trump administration has petitioned the government to revoke its approval of the polio vaccine, which for decades has protected millions of people from a virus that can cause paralysis or death.

That campaign is just one front in the war that the lawyer, Aaron Siri, is waging against vaccines of all kinds.

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Siri has also filed a petition seeking to pause the distribution of 13 other vaccines; challenged, and in some cases quashed, Covid vaccine mandates around the country; sued federal agencies for the disclosure of records related to vaccine approvals; and subjected prominent vaccine scientists to gruelling videotaped depositions.

Much of Siri’s work — including the polio petition filed in 2022 — has been on behalf of the Informed Consent Action Network (ICAN), a nonprofit whose founder is a close ally of Kennedy. Siri also represented Kennedy during his presidential campaign.

Kennedy, President-elect Donald J. Trump’s choice for health secretary, has said that he does not want to take away access to any vaccines. But as he prepares for his confirmation hearing and plans a fresh health agenda, his continuing close partnership with Siri suggests that vaccine policy will be under sharp scrutiny.

It is a chilling prospect to many public health leaders, especially those who recall the deadly toll of some vaccine-mediated diseases.

Kennedy has privately expressed interest in having Siri serve in the health and human services department’s top legal job, general counsel. However, Siri has suggested he may have more influence outside the administration. At his law firm, Siri & Glimstad, he oversees about 40 professionals working on vaccine cases and policy.

“Somebody on the outside needs to be petitioning them,” he said on a podcast in late November.

Either way, it’s clear that his voice will be heard at the highest levels.

Like Kennedy, Siri insists he does not want to take vaccines away from anyone who wants them. “You want to get the vaccine — it’s America, a free country,” he told Arizona legislators last year after laying out his concerns about the vaccines for polio and other illnesses.

He did not mention the petitions he has lodged on behalf of ICAN with the Food and Drug Administration (FDA), asking regulators to withdraw or suspend approval of vaccines not only for polio but also for hepatitis B.

Siri is also representing ICAN in petitioning the FDA to “pause distribution” of 13 other vaccines, including combination products that cover tetanus, diphtheria, polio and hepatitis A, until their makers disclose details about aluminium, an ingredient researchers have associated with a small increase in asthma cases.

Siri declined to be interviewed but said all of his petitions were filed on behalf of clients. Katie Miller, a spokesperson for Kennedy, said Siri has been advising Kennedy but has not discussed his petitions with any of the health nominees. She added: “Kennedy has long said that he wants transparency in vaccines and to give people choice.”

If the Senate confirms Kennedy as health secretary, he will oversee the FDA. In that capacity, he could take the rare step of intervening in the FDA’s review of the petitions.

Vaccines undergo extensive testing before they are approved, and are monitored for safety after they come on the market. The process of taking an established drug off the market can be lengthy. The FDA would need to outline a new safety concern in writing and give the vaccine’s maker a chance to respond. The FDA would then hold a hearing and render a decision. If the company did not agree with the outcome, it could sue.

Trump and Kennedy have spoken about vaccines, the President-elect told Time magazine in an interview published on Thursday. Trump pledged to do “very serious testing” and to get rid of some vaccines “if I think it’s dangerous, if I think they are not beneficial”.

During an appearance last weekend on NBC’s Meet the Press, Trump said he was open to a review of vaccines and autism. But he singled out the polio vaccine as a potential exception.

“The polio vaccine is the greatest thing,” Trump said. “If someone told me get rid of the polio vaccine, they’re going to have to work really hard to convince me.”

Public health experts describe the polio petition as troubling. In 2022, an unvaccinated man in New York became paralysed after contracting polio, and experts say the virus is still circulating worldwide.

Siri’s ascent is concerning to some doctors, who note that it comes at a time of falling vaccination rates in the US and a rise in cases of measles and whooping cough.

One critic is Dr Stanley Plotkin, who in the 1960s invented the vaccine that eliminated rubella. Plotkin said having Siri in a position of influence “would be a disaster”.

The placebo issue

One of Siri’s arguments against vaccines is that some, including the polio and hepatitis B vaccines, have not been tested against placebos in randomised, double-blind clinical trials — the gold standard for medical research, in which some patients get inert vaccines and doctors don’t know which patients get which.

Siri’s petition to withdraw the polio vaccine also claims that the manufacturer “only assessed safety for up to three days after injection”, and therefore did not meet the FDA’s standard for safety.

Ayman Chit, head of vaccines for Sanofi, which makes the polio vaccine that is subject to the petition, said the vaccine has been widely used in North America and Europe and studied carefully in trials with as long as six months of safety follow-up.

New York Times News Service

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