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HHS Secretary Kennedy Announces End of COVID-19 Vaccine Emergency Use Authorizations
Washington D.C. – Health and Human Services Secretary Robert F. Kennedy Jr. announced Wednesday that the Food and Drug Administration (FDA) has rescinded the emergency use authorizations (EUAs) for COVID-19 vaccines. This move, according to Kennedy, fulfills his promise to end vaccine mandates while ensuring continued vaccine access, particularly for vulnerable populations.
In a social media post, Kennedy outlined his four key goals: ending the emergency, ending COVID-19 vaccine mandates, maintaining vaccine availability for those who want them, and requiring placebo-controlled trials from pharmaceutical companies. He stated that the FDA’s actions achieve all four objectives.
The rescission of the EUAs, which were used to justify mandates during the Biden administration, comes as the FDA has granted full marketing authorization for COVID-19 vaccines from Moderna (for individuals 6 months and older), Pfizer (5 years and older), and Novavax (12 years and older). These vaccines are now available to all patients who choose to receive them after consulting with their physicians.
This action follows Kennedy’s 2021 petition to the FDA to rescind the EUAs. It also comes after the Biden administration’s official end to the COVID-19 public health emergency in May 2023.
The FDA issues EUAs for medical products when no approved alternative exists. The difference between an EUA and full FDA approval lies in the evidentiary standards.
EUAs require a demonstration that potential benefits outweigh potential risks, while full approval necessitates proof of safety and effectiveness. Both Pfizer and Moderna initially offered their COVID-19 vaccines under EUAs before receiving full FDA approval in 2021 and 2022, respectively.
Last month, Moderna’s COVID-19 vaccine received full FDA approval for at-risk children aged 6 months to 11 years, marking the first full approval for a vaccine in this age group. While vaccines were previously available to all children regardless of risk, Kennedy announced earlier this year that the Centers for Disease Control and Prevention (CDC) would no longer recommend them for healthy children and pregnant women. This contrasts with recommendations from organizations like the American Academy of Pediatrics, which continues to advise COVID-19 vaccination for all children.