FDA Lifts Covid-Era 'Emergency' Vaccine Mandates For Healthy Children and Adults

On Wednesday, Health and Human Services Secretary Robert F. Kennedy Jr. announced that the Food and Drug Administration (FDA), which operates under his purview, has rescinded mandates for the emergency use of Covid vaccination.

Along with ending emergency authorization for vaccines, the FDA refined eligibility standards to exclude most healthy children and adults. Vaccines from Moderna, Pfizer and Novavax are still approved for all seniors and people with health conditions.

The FDA invokes Emergency Use Authorization (EUA) to allow for otherwise unapproved novel medicines and therapeutics. This form of authorization is only used when the government declares a national health emergency.

Even though President Biden declared the Covid public health emergency over in May of 2023, the FDA did not rescind EUA for Covid-related medical products at that time.

Kennedy made the announcement on X, where he also explained the rationale.

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” the Secretary wrote. “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 further explained that, with the new decision from the FDA, he had now made good four things he had promised before joining HHS:

1. Ending Covid mandates
2. Keeping vaccines available to those who voluntarily seek them.
3. Establishing placebo-controlled trials from vaccine companies.
4. Ending the emergency use authorization of existing Covid vaccines.

In December 2020, under the guidance of former NIAID director Anthony Fauci, the government invoked EUA, granting Pfizer’s and Moderna’s competing but similar mRNA Covid vaccines the greenlight after less than a year of development and little testing.

Controversially, vaccines and other medicines taken under EUA are given a liability shield thanks to the 2005 Public Readiness and Emergency Preparedness (PREP) Act. But in July, Representative Massie (R-KY) introduced legislation that would allow individuals, who believe they were injured by vaccines created during EUA, to sue manufacturers.

Kennedy’s August 27 announcement marks a complete reversal of Biden-era mandates, many of which were struck down by the Supreme Court during the former president’s term.

“The American people demanded science, safety, and common sense,” Kennedy added in his X post. “This framework delivers all three.”