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Johnson & Johnson submits application to the FDA for Emergency Use Authorization of its Single-Shot Janssen COVID-19 Vaccine Candidate.

Read time: 1 mins
Published:6th Feb 2021
Johnson & Johnson announced that Janssen Biotech, Inc., has submitted an application to the 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 III ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have product available to ship immediately following authorization. The Company has initiated rolling submissions with several health agencies outside the U.S., and will submit a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency in the coming weeks. The Janssen investigational vaccine is compatible with standard vaccine distribution channels. If authorized, Janssen’s investigational single-dose vaccine is estimated to remain stable for two years at -4°F (-20°C), at least three months of which can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C). The Company will ship the vaccine using the same cold chain technologies it uses today to transport other innovative medicines..
Condition: Coronavirus/COVID-19 Infection
Type: drug

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