Kennedy’s lawyer has asked the FDA to revoke approval of the polio vaccine

Kennedy’s lawyer has asked the FDA to revoke approval of the polio vaccine



CNN

President-elect Donald Trump has hailed the polio vaccine as the “biggest thing,” but a lawyer linked to Trump’s pick to head the nation’s top health agency has filed a petition with the U.S. Food and Drug Administration to revoke the approval of the vaccine used in the United States.

Attorney Aaron Siri filed the petition in 2022 on behalf of the Informed Consent Action Network (ICAN), a nonprofit organization that questions the safety of vaccines and vaccination regulations. Siri has worked closely with Robert F. Kennedy Jr. — a vaccine skeptic and Trump’s pick to head the U.S. Department of Health and Human Services — to select officials for the new administration. He was also Kennedy’s personal lawyer during his own presidential campaign.

“The FDA continues to review the petition,” an agency spokesperson said in an email to CNN on Friday. “We cannot predict when the reviews will be completed. FDA will consider the concerns raised in the petition in making the final decision. FDA will respond directly to the applicant and that response will be published in the file. We cannot make any further comments until then.”

If Kennedy is confirmed as head of HHS, he will assume oversight of 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 would not take vaccines away from anyone, but said, “People should have a choice, and that choice should be based on the best information.”

Trump told Time magazine in an interview conducted in late November but published this week that more research is being done and he would consider eliminating some childhood vaccines “if I think they’re dangerous, if I think they’re dangerous.” are not useful.” .”

But Trump has also praised the polio vaccine.

“The polio vaccine is the best. If someone told me to get rid of the polio vaccine, they would have to work really hard to convince me,” Trump said in an interview on NBC’s “Meet the Press” that aired Sunday.

The New York Times first reported the petition and Kennedy’s connection to the lawyer who filed it.

CNN has reached out to the Trump transition team and ICAN for comment but has not received a response.

Senate Minority Leader Mitch McConnell, himself a polio survivor, issued a warning on the issue Friday that appeared aimed at Kennedy.

“The polio vaccine has saved millions of lives and delivered on the promise of eradicating a terrible disease,” he said in a statement. “Efforts to undermine public trust in proven remedies are not just uninformed – they are dangerous. Anyone seeking Senate approval to serve in the new administration would do well to avoid even the appearance of a connection to such efforts.”

Polio vaccination is considered one of the greatest achievements in global public health. It used to be a disease that paralyzed and killed thousands of Americans during outbreaks, but the introduction of a vaccine in the 1950s has greatly reduced its incidence worldwide, so the goal of eradicating the disease is close to becoming a reality.

According to the World Health Organization, in the 1950s, before there was a vaccine, polio killed more than half a million people worldwide each year.

Siri’s petition asks the FDA to withdraw or suspend approval of the inactivated poliomyelitis vaccine until “a properly controlled and properly conducted double-blind trial of sufficient duration is conducted to evaluate the safety of this product.”

Siri submitted the petition the same year that health officials in New York stepped up their polio vaccination campaigns after a young, unvaccinated adult was paralyzed by the infection and the virus showed up in local wastewater. This case was the first in the United States in nearly a decade.

The petition addresses a seemingly alarming fact – that there was no placebo-controlled clinical trial to prove the vaccine’s safety – but experts say it distorts reality to make it appear that the risks of polio vaccination outweigh the benefits could, which is not the case Not true.

In fact, placebo-controlled trials for most vaccines are not considered ethical because some of the people participating in them would not receive the vaccination and would therefore remain unprotected. Polio is not widespread and it would be ethical to intentionally infect a healthy person with the virus. Polio has no cure and those who are unprotected can be paralyzed for the rest of their lives.

“You replace a theoretical risk with a real risk,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, told The New York Times. “The real risks are the diseases.”

The U.S. Centers for Disease Control and Prevention says no serious adverse events associated with the use of inactivated polio vaccine have been documented. In rare cases, people may have a reaction to the vaccine if they are allergic to certain types of antibiotics, such as streptomycin, polymyxin B, or neomycin.

Siri’s petition focuses on the inactivated polio vaccine, which has been used in the United States for more than two decades.

The U.S. has moved away from the oral vaccine, which uses a weakened but live version of the virus, because the weak virus can cause paralysis in vaccine recipients about once in every three million times it is administered. However, the oral vaccine is still used in some other countries.

The inactivated polio vaccine used in the United States is administered by injection and does not pose this risk, making it even safer for the people who receive it. However, the injected vaccine does not produce so-called mucosal immunity, meaning it does not stop the virus from infecting people if it enters the body.

Rather, the injected vaccine protects against this worst-case scenario: it helps the immune system recognize and fight off the virus before it enters the nervous system.

It also doesn’t stop the transmission of the virus because people who become infected with it can still become infected and shed the virus in their stool.

However, this was not a problem in the United States because the poliovirus does not normally circulate thanks to vaccination.

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The poliovirus is transmitted from person to person through the fecal and oral route. People infect each other when they catch the virus on their hands after using the toilet and then shake hands or touch surfaces.

The virus weakened by the oral vaccine can also be excreted in the stool, which can become a problem in populations that are not adequately vaccinated. If this transmission occurs in a population that is not well vaccinated, there is a chance that it could mutate again into a form that can cause paralysis.

Most polio cases worldwide are now caused by vaccine-caused viruses. In 2023, the number of polio cases caused by vaccine-derived strains was 524, up from 881 in 2022.

CNN’s Manu Raju and Morgan Rimmer contributed to this report.

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