FDA Revokes Emergency Authorization for COVID-19 Vaccines

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The vaccines are still cleared for a number of Americans under regulatory approval.

Federal regulators have revoked emergency authorization for COVID-19 vaccines, according to Health Secretary Robert F. Kennedy Jr.

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy, the head of the Department of Health and Human Services (HHS), said on X on Aug. 27.

At the same time, the Food and Drug Administration has approved the Pfizer-BioNTech COVID-19 vaccine for older adults as well as children as young as 5 years of age who have at least one condition that officials say puts them at higher risk of severe COVID-19 outcomes, Pfizer said in a statement on Wednesday.

The FDA, which is part of HHS, did not immediately respond to a request for comment.

Regulators previously issued similar approvals for two COVID-19 vaccines from Moderna and one COVID-19 vaccine from Novavax.

Those approvals diverged from previous approvals, which had not limited access to any populations save for infants less than 6 months old.

Combined, the actions mean that FDA clearance is no longer in place for an estimated 240 million Americans, although doctors could still provide the vaccines off-label to those people.

“These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy stated.

This is a developing story that will be updated.

By Zachary Stieber

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