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DJ JNJ Seeks EUA From FDA For Single-Shot Janssen Covid-19 Vaccine Candidate

· 02/04/2021 17:51
By Stephen Nakrosis

Johnson & Johnson on Thursday said it submitted an application seeking emergency use authorization for its investigational single-dose Janssen Covid-19 vaccine candidate to the U.S. Food and Drug Administration.

The company said its submission "is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints."

JNJ also said it is ready to begin shipping the product upon authorization for emergency use, adding it "expects to supply 100 million doses to the U.S. in the first half of 2021."

The company also said it "initiated rolling submissions with several health agencies outside the U.S.," and added it will submit a Conditional Marketing Authorisation Application with the European Medicines Agency in the coming weeks.

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

February 04, 2021 17:51 ET (22:51 GMT)

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