Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced the emergency use authorization (EUA) for the COVID-19 jabs are rescinded.
RFK Jr. said he promised four things:
1. To end covid vaccine mandates.
2. To keep vaccines available to people who want them, especially the vulnerable.
3. To demand placebo-controlled trials from companies.
4. To end the emergency.
"In a series of FDA actions today we accomplished all four goals. The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded," RFK Jr. explained.
"FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+). These vaccines are available for all patients who choose them after consulting with their doctors," he continued.
"The American people demanded science, safety, and common sense. This framework delivers all three," he added.
Kennedy in 2021 petitioned the FDA to rescind the emergency use authorizations for COVID-19 vaccines.
The Biden administration ended the COVID-19 public health emergency on May 11, 2023.
EUAs are granted to medical products by the FDA when no approved, alternative product is available. The COVID-19 vaccines developed by Pfizer and Moderna were both made available through EUAs prior to receiving full FDA approval in 2021 and 2022, respectively.
The standards for EUAs and full FDA approval are different. In order for a product to receive an EUA, it must be determined that its potential benefits outweigh the potential risks. This differs from the standard that products must reach to gain full FDA approval, in which it must be established that they are safe and effective.
Last month, the FDA granted full approval to Moderna's COVID-19 vaccine for at-risk children, making it the first vaccine available for children aged between 6 months and 11 years of age not through an EUA.
Some X users criticized RFK Jr.'s announcement, saying it's not enough because of the harms caused by the experimental injection.
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The only shots that had been still been authorized under an EUA were kids ages 11 and under. The move could hinder access to shots for healthy kids.
In a statement, Dr. Susan Kressly, president of the American Academy of Pediatrics AAP, called the decision "deeply troubling."
"As we enter respiratory virus season, any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families. Respiratory illnesses can be especially risky for infants and toddlers, whose airways and lungs are small and still developing," Kressly said.
Doctors will still be able to prescribe the vaccines off-label, to people not specified in the FDA approvals. However, that adds yet another barrier to access as many people get their shots at the pharmacy, not prescribed through a doctor.
The approval is expected to go to the Centers for Disease Control and Prevention's vaccine advisory committee, which will make a recommendation on who should be able to get the shots. In June, Kennedy fired all 17 members of the panel and replaced them with his own picks, including several Covid vaccine skeptics.
The new restrictions -- which were expected -- are likely to affect what insurers cover for people who don't qualify for the updated Covid shots.