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False vaccine claim stems from edited video of former FDA head

April 30, 2021 GMT

CLAIM: Video proves the U.S. Food and Drug Administration will not authorize or approve any COVID-19 vaccine.

AP ASSESSMENT: False. The FDA has issued emergency use authorizations for the Pfizer-BioNTech, Moderna and Johnson & Johnson COVID-19 vaccines. Social media users are sharing an edited video clip of former FDA Commissioner Dr. Stephen Hahn speaking before vaccines were authorized in the U.S.

THE FACTS: Selectively edited videos from Hahn’s Senate testimony are circulating online to support the false narrative that COVID-19 vaccines are unauthorized and unsafe.

The testimony being used in the video pre-dates the approval of COVID-19 vaccines in the U.S., and Hahn’s comments are taken out of context.

“In the end, the FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families,” Dr. Hahn is heard saying at the beginning of the edited clip.

The caption embedded over the edited video falsely asserts: “FDA WILL NOT AUTHORIZE OR APPROVE ANY COVID-19 VACCINE.”

But the claim is misleading on several levels.

The clip of Hahn was taken from his comments in front of a Sept. 23 Senate Health, Education, Labor, and Pensions Committee hearing, in which the White House Coronavirus Task Force updated committee members on the federal response to the COVID-19 pandemic.

At the time, the FDA had not yet approved any vaccines for emergency use authorization. In the full clip, it is clear Hahn is detailing the FDA’s safety standards for that process.

The FDA issued emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines in December, and the Johnson & Johnson vaccine in February. The FDA can give emergency authorization for medical products to address a public health crisis, in this case the pandemic, as long as the benefits outweigh the risks.

The FDA’s emergency use authorizations for the vaccines followed rigorous three-phase trials, and multiple levels of review. The process also includes post-authorization monitoring systems to track the impact of the vaccines.

A review of Hahn’s testimony shows he said: “Before we issue an EUA, FDA would have to determine among other things that the statutory standard is met. We expect that this would be demonstrated based on adequate manufacturing data to ensure a vaccine’s quality and consistency and data from at least one well-designed phase three clinical trial that demonstrates safety and efficacy in a clear and compelling manner.”

Hahn added: “FDA also expects that an EUA request would include a plan for active follow-up to monitor safety among individuals who receive the vaccine. In the end, FDA will not authorize or approve a vaccine that we wouldn’t feel comfortable giving to our own families.”

Vaccines that have received emergency use authorization are also expected to receive full licensure by the FDA after submitting six months of safety follow-ups, AP reported.

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This is part of The Associated Press’ ongoing effort to fact-check misinformation that is shared widely online, including work with Facebook to identify and reduce the circulation of false stories on the platform.


Here’s more information on Facebook’s fact-checking program: https://www.facebook.com/help/1952307158131536