FDA can still approve COVID-19 vaccines on emergency use basis, despite end of health emergency

The U.S. Food and Drug Administration on Aug. 22 approved and granted emergency use authorization for updated mRNA COVID-19 vaccines.

The Pfizer and Moderna vaccines target the KP.2 omicron strain that began to spread widely in the spring. Variants closely related to that strain are behind most recent COVID-19 cases.

Dr. Jeffrey Barke, a California primary care physician, said the FDA had no right to grant emergency use authorization because the public health emergency declared for the pandemic expired in May 2023.

"Emergency use authorization requires two elements. There has to be an emergency. There isn't. And there has to be no other available effective treatment. There is," Barke said in an Aug. 23 Instagram video, wearing a T-shirt that said "Misinformation Superspreader."

Barke is a founding member of America’s Frontline Doctors — an anti-vaccine group — the co-author of a book about childhood vaccines and a frequent guest on conservative media.

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The Instagram post is wrong about the FDA’s ability to continue issuing emergency use authorizations for COVID-19-related products.

The FDA didn’t immediately return PolitiFact's request for comment. But the public health emergency’s declared end doesn’t affect the agency’s authority to issue new emergency use authorizations for vaccines or drugs, the U.S. Department of Health and Human Services said in a May 9, 2023, news release.

That’s because the COVID-19 public health emergency and the COVID-19 emergency use authorization were declared by Health and Human Services under two distinct laws.

The health emergency — first declared in January 2020 and extended every three months until May 11, 2023 — was declared under Section 319 of the Public Health Service Act. Those emergency declarations last 90 days, but the HHS secretary can extend or end them early.

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The Health and Human Services Department made an emergency use declaration for COVID-19 under Section 564 of the Federal Food, Drug, and Cosmetic Act, an FDA frequently asked questions webpage said.

That declaration allowed the FDA to grant individual emergency use authorization for COVID-19 vaccines, tests, devices and treatments. 

To make an emergency use declaration, the health secretary must declare that circumstances exist that justify the authorization, such as a public health emergency or "significant potential" for a public health emergency.

An emergency use declaration doesn’t hinge on a public health emergency declaration and it can stay in effect after a public health emergency ends, the FDA said. Former Health and Human Services Secretary Alex Azar in February 2020 made an emergency use authorization declaration for COVID-19 that current Secretary Xavier Becerra amended in March 2023.

The emergency use authorization continues until the health secretary ends it. Existing product authorizations can continue, and new ones, such as the updated COVID-19 vaccines, can be issued as long as the declaration remains in effect.

We contacted Barke for evidence to support his claim. He asked, "Is there a current COVID emergency?" He referred us to an FDA webpage about emergency use authorizations.

That page said, "The ending of the COVID-19 PHE (public health emergency) will not impact FDA's ability to authorize medical countermeasures for emergency use. Existing COVID-19 EUAs (emergency use authorizations) will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so."

Barke’s Instagram post also claimed that the new vaccines shouldn’t be approved because there are other treatments available. He named ivermectin and hydroxychloroquine in an email to PolitiFact.

Ivermectin, used to treat parasites in humans, is not FDA-approved to treat or prevent COVID-19 infection. The FDA granted an EUA for hydroxychloroquine, a malaria drug, to treat hospitalized patients for COVID-19 in March 2020, but revoked it in June of that year because of cardiac risks. Clinical trials showed hydroxychloroquine was not effective in treating or preventing COVID-19. Doctors can still prescribe either drug off-label for COVID-19.

The COVID-19 vaccines the FDA recently authorized target a new variant. The FDA grants emergency use authorization to products when there aren’t effective, approved and available alternatives. 

The claim that the FDA shouldn’t be able to approve the new COVID-19 vaccines because there is no public health emergency and that other treatments are available is False.