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Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate


Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
Johnson & Johnson today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration requesting Emergency Use Authorization for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine …
– Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE cli ....

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