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J&J Submits EUA Request for COVID-19 Vaccine

FRIDAY, Feb. 5, 2021 -- A U.S. Food and Drug Administration committee will meet on Feb. 26 to discuss Emergency Use Authorization (EUA) of the COVID-19 vaccine candidate from Janssen Biotech, the agency announced Thursday.

Johnson & Johnson submitted the EUA request based on data from the Phase 3 ENSEMBLE clinical trial. Interim data demonstrated that the single-dose vaccine, which can be stored in a refrigerator for months, met all primary and secondary end points. The company has said it will ship the vaccine immediately upon authorization.

In the interim analysis of ENSEMBLE data from 44,325 volunteers in eight countries, researchers found the vaccine was 66 percent effective in preventing moderate-to-severe COVID-19 at 28 days after vaccination. Efficacy varied by region, however, with 72 percent efficacy in the United States and 57 percent efficacy in South Africa, where more cases are due to infection with a B.1.351 variant of the virus. Overall, the vaccine was 85 percent effective in preventing severe or critical COVID-19.

The Vaccines and Related Biological Products Advisory Committee, constructed of independent scientific and public health experts, will hold a public discussion about the safety and efficacy data submitted by Janssen Biotech, similar to the public discussions held for EUA recommendation of the Moderna and Pfizer/BioNTech vaccines. The FDA will provide background information to the public two days prior to the Feb. 26 meeting.

The FDA will livestream the meeting on its YouTube, Facebook, and Twitter channels. The meeting will be webcast from the FDA website.

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