The Food and Drug Administration (FDA) had rescinded emergency use authorizations (EUAs) for COVID-19 vaccines, Health and Human Services Secretary Robert F. Kennedy Jr. announced Wednesday, saying the move was made to end vaccine mandates.
In a post on the social platform X, Kennedy wrote, “I promised 4 things: 1. to end the emergency. 2. to end covid vaccine mandates. 3. to keep vaccines available to people who want them, especially the vulnerable. 4. to demand placebo-controlled trials from companies.”
“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for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” he added.
“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.”
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.
Doses of COVID-19 vaccines had been available to all children regardless of risk factors, but Kennedy announced earlier this year that the Centers for Disease Control and Prevention (CDC) would no longer be recommending the shots for healthy children and pregnant women.
Major medical organizations including the American Academy of Pediatrics have recently released their own guidance continuing to recommend COVID-19 immunizations for all children, not just those with underlying conditions.
Updated at 1:45 p.m. EDT
