FDA commissioner: It’s up to drug makers developing vaccines to seek approval or EUA

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Drug makers developing COVID-19 vaccines will decide to seek full approval from the Food and Drug Administration or the less rigorous emergency use authorization (EUA), according to remarks made by FDA commissioner Dr. Stephen Hahn during a congressional hearing on Wednesday. “This will be based upon the trial meeting pre-specified success criteria that were established by that sponsor,” Hahn said. The EUA option was put into place during the pandemic to speed up the arrival of new tests, treatments, and vaccines; however, once the U.S. ends the public health emergency, the EUA is no longer valid. Four COVID-19 vaccine candidates are currently in Phase 3 clinical trials, including candidates developed by AstraZeneca’s and the University of Oxford, BioNTech and Pfizer Inc. , Johnson & Johnson , and Moderna Inc. .
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