The organization headed by Health Secretary Robert F. Kennedy Jr. before he became health secretary has formally requested an agency under his purview to revoke its approvals for most of the COVID-19 vaccines available in the United States.
Children’s Health Defense, in a filing made public on Dec. 9, said that two of the vaccines manufactured by Moderna and one made by Pfizer are misbranded and in violation of federal law.
The shots have been manufactured under standards for emergency authorization, but are now only cleared under normal approval, the filing states. That means “they cannot remain in interstate commerce because they are, in fact, misbranded products. By law, their licenses must be revoked,” according to the petition to the Food and Drug Administration.
Pfizer and Moderna, whose vaccines utilize messenger ribonucleic acid (mRNA) technology, did not respond to requests for comment.
“This petition not only challenges COVID-19 vaccine licensure, but it sends a clear message to the FDA that it can no longer get away with licensing rushed mRNA technology under emergency standards,” Ray Flores, senior outside counsel for Children’s Health Defense, told The Epoch Times in an email. “We ask the FDA to admit that COVID-19 vaccines should never have been deemed ‘safe and effective,’ and to concede that they are actually Emergency Use Authorization vaccines that only ‘may be effective.’”
Flores encouraged people to submit comments on the petition.
A spokesperson for Kennedy’s agency, the Department of Health and Human Services, told The Epoch Times in an email that the FDA has received the petition. The FDA is reviewing it and will respond directly to the petitioner, the spokesperson said.
Kennedy chaired Children’s Health Defense from 2015 to 2023, when he launched a bid for president. Kennedy later endorsed President Donald Trump, who named Kennedy as health secretary after winning the 2024 election.
Children’s Health Defense has regularly advocated against vaccine mandates and the use of some vaccines, asserting evidence is inadequate to support their administration.
In 2021, Kennedy, in a similar petition, asked the FDA to revoke emergency authorization for the COVID-19 vaccines and not approve them. He and Dr. Meryl Nass, a member of the Children’s Health Defense scientific advisory board, said that the risks of adverse events following vaccination outweighed the benefits, and that there were effective alternatives to vaccination, including ivermectin.
In the new petition, Children’s Health Defense attorneys and scientists said they were focused on labeling criteria and that they were not touching on the safety or efficacy of the COVID-19 vaccines.
When the FDA first cleared shots against COVID-19 in 2020, it did so under emergency use authorization, which enables regulators to act with a lower degree of evidence under emergency conditions. To approve products, the FDA must be confident they are effective. For emergency authorization, the FDA can find that “based on the totality of the scientific evidence available, it is reasonable to believe that the product may be effective for the specified use.”
Even after later approving the vaccines, regulators kept the emergency authorization partially in place, until withdrawing the authorization this year. At the same time, the FDA approved updated versions of four shots, two from Moderna, one from Pfizer, and a protein-based immunization made by Novavax.
“These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy said when the FDA announced the moves.
Dr. Vinay Prasad, the FDA’s top vaccine official, said in memorandums that evidence shows benefits outweigh harms for vaccinating certain populations, including children with risk factors, such as obesity.
The Centers for Disease Control and Prevention, acting on advice from a panel selected by Kennedy, recently shifted broad recommendations for COVID-19 vaccines to stating that each person should take into account various factors, such as their own health, and consult with health care professionals before taking one of the shots. Some outside groups and states still recommend COVID-19 vaccination for nearly all Americans.