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FDA rescinds emergency use authorizations for COVID-19 vaccines

The decision by Health and Human Services Secretary Robert F. Kennedy Jr. seeks to accomplish four key goals: end the public health emergency, eliminate vaccine mandates, keep vaccines available to people who want them, especially the vulnerable, and demand placebo-controlled trials from companies.

Vaccine vials from COVID-19 (Archive) (Photo by BAY ISMOYO / AFP)

Vaccine vials from COVID-19 (Archive) (Photo by BAY ISMOYO / AFP)AFP

Agustina Blanco
Published by
Agustina Blanco

The U.S. Food and Drug Administration (FDA) has revoked the Emergency Use Authorizations (EUAs) for COVID-19 vaccines, according to Health and Human Services Secretary Robert F. Kennedy Jr. in a release on X.

This decision seeks to accomplish four key objectives:

  • End the emergency
  • End Covid vaccine mandates
  • Keep vaccines available to people who want them, especially the vulnerable
  • Demand placebo-controlled trials from companies

In addition, Kennedy noted that the FDA has granted full marketing authorizations for vaccines from Moderna (for ages 6 months and older), Pfizer (for ages 5 months and older) and Novavax (for ages 12 months and older). These authorizations ensure that vaccines remain available to those who choose them after consultation with their physicians, especially for higher-risk populations.

The public health emergency during the Biden Administration

The COVID-19 public health emergency, declared during the Biden Administration, officially ended on May 11, 2023. During the pandemic, Pfizer and Moderna vaccines were licensed under EUAs before receiving full FDA approval in 2021 and 2022, respectively.

In 2021, Kennedy had publicly asked the FDA to rescind the EUAs for the COVID-19 vaccines, citing concerns about their widespread use.

Already as health secretary in the Trump Administration, Kennedy announced that the Centers for Disease Control and Prevention (CDC) had adjusted its recommendations, advising against COVID-19 vaccination for healthy children and pregnant women without risk factors.

Changes in recommendations

Last month, the FDA granted full approval for the Moderna vaccine for at-risk children aged 6 months to 11 years, marking an important development as the first vaccine for this age group to receive a full clearance without relying on an EUA. Previously, COVID-19 vaccines were available to all children, regardless of their health status.

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