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US President-elect Donald Trump has praised the polio vaccine as the "greatest thing," but a lawyer affiliated with Trump's pick to lead the country's top health agency has petitioned the US Food and Drug Administration to revoke approval of the vaccine used in the United States.
The lawyer, Aaron Siri, filed the petition in 2022 on behalf of the Informed Consent Action Network, or ICAN, a nonprofit that challenges the safety of vaccines and vaccine mandates. Siri has been working closely with Robert F. Kennedy Jr. - a vaccine skeptic and Trump's pick to lead the US Department of Health and Human Services - to choose officials to serve in the incoming administration. He was also Kennedy's personal lawyer during his own presidential campaign.
"The FDA is continuing to review the petition," an agency spokesperson said in an email to CNN on Friday. "We cannot predict when the reviews will be completed. The FDA will consider the concerns outlined in the petition as a final decision is made. The FDA will respond directly to the petitioner, and that response will be posted on the docket. Until such time, we cannot comment further."
If Kennedy is confirmed as head of HHS, he'll oversee the FDA and could take the rare step of intervening in its petition review process. In a recent interview, Kennedy told NBC News that he wasn't going to take away anybody's vaccines but said, "People ought to have a choice, and that choice ought to be informed by the best information."
Trump told Time magazine in an interview that was conducted in late November but published this week that more research will get underway and that he would consider getting rid of some vaccines for children, "if I think it's dangerous, if I think they are not beneficial."
But Trump has also praised polio vaccination.
"The polio vaccine is the greatest thing. If somebody told me to get rid of the polio vaccine, they're going to have to work real hard to convince me," Trump said told NBC's Meet the Press in an interview aired Sunday.
Robert F. Kennedy Jr., a vaccine skeptic, is Trump's pick to lead the US Department of Health and Human Services. Photo: Olivier Touron / AFP
The petition and Kennedy's affiliation with the lawyer who filed it were first reported by the New York Times.
CNN reached out to the Trump transition team and ICAN for comment but did not get a response.
Senate Minority Leader Mitch McConnell, himself a polio survivor, issued a warning about the issue Friday that was apparently intended for Kennedy.
"The polio vaccine has saved millions of lives and held out the promise of eradicating a terrible disease," he 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."
Studying polio vaccines
Polio vaccination is considered one of the greatest achievements in global public health. it was once a disease that paralysed and killed thousands of Americans during outbreaks, but the advent of a vaccine in the 1950s has greatly reduced the incidence around the world, putting the goal of disease eradication on the cusp of becoming a reality.
In the 1950s, before a vaccine was available, polio killed or paralysed more than half a million people globally each year, according to the World Health Organization.
Siri's petition asks the FDA to withdraw or suspend approval for the inactivated poliomyelitis vaccine until "a properly controlled and properly powered double-blind trial of sufficient duration is conducted to assess the safety of this product."
Siri filed the petition the same year health officials in New York stepped up vaccine campaigns against polio after a young unvaccinated adult was paralysed by the infection and the virus turned up in local wastewater. That case was the first in the US in almost a decade.
The petition homes in on what sounds like an alarming fact - that there was no placebo-controlled clinical trial to prove the vaccine's safety - and but experts say it distorts reality to make it seem like risks of polio vaccination could outweigh the benefits, which isn't true.
In fact, placebo-controlled trials aren't considered ethical for most vaccines because a portion of the people who participate in them wouldn't get the shot, leaving them unprotected. Polio isn't widely circulating, and it wouldn't be ethical to deliberately infect a healthy person with the virus. There is no cure for polio, and someone who's unprotected could be left paralysed for the rest of their life.
"You're substituting a theoretical risk for a real risk," Dr. Paul Oft, a vaccine expert at the Children's Hospital of Philadelphia, told the New York Times. "The real risks are the diseases."
The US Centers for Disease Control and Prevention says that no serious adverse events related to the use of inactivated polio vaccine have been documented. Rarely, people can have reactions to the vaccine if they are allergic to certain types of antibiotics, such as streptomycin, polymyxin B or neomycin.
Different types of polio vaccines
Siri's petition focuses on the inactivated polio vaccine, which has been used in the United States for more than two decades.
The US switched away from the oral vaccine - which uses a weakened but live version of the virus - because about once in every 3 million times that it is given, the weak virus can cause paralysis in the vaccine recipient. However, the oral vaccine is still used in some other countries.
The inactivated polio vaccine used in the United States is given by injection and doesn't carry that risk, making it even safer for the people who get it. But the injected vaccine doesn't create so-called mucosal immunity, meaning it doesn't stop the virus from being able to infect people if it enters the body.
Rather, the injected vaccine protects people against this worst-case scenario: It helps the immune system recognize the virus and fight it off before it gets to the nervous system.
It also does not stop transmission of the virus, because people who get it can still be infected and shed the virus in their stool.
In the United States, however, this hasn't been problem because - thanks to vaccination - poliovirus doesn't usually circulate.
How polio spreads
Poliovirus is spread from person to person through the fecal-oral route. People infect each other when they get the virus on their hands after using the bathroom and then shake hands or touch surfaces.
The weakened virus from the oral vaccine can also be shed in stool, and that can become a problem in populations that aren't adequately vaccinated. If this transmission happens in a population that isn't well-vaccinated, there's a chance it could mutate back to a form that can cause paralysis.
Most of the world's polio cases are now caused by vaccine-derived virus. In 2023, the number of polio cases caused by vaccine-derived strains was 524, down from 881 in 2022.
- CNN
