- Johnson & Johnson has applied for an Emergency Use Authorization for Janssen’s COVID-19 vaccine candidate.
- The Company intends to distribute its COVID-19 vaccine to the US government immediately after the FDA Authorization.
- The vaccine candidate’s Phase 3 trial data showed that it was ~66% effective in protecting against coronavirus.
Johnson & Johnson (NYSE:JNJ) updated the market that Janssen Biotech Inc has submitted an application to the US regulator for an Emergency Use Authorization (EUA) of its COVID-19 vaccine candidate.
Let us deep dive and discuss in detail:
The New Jersey-based multinational firm submitted the EUA application based on top-line efficacy and safety information from the Phase 3 ENSEMBLE clinical trial. The trial data demonstrated that a single-dose vaccine met all primary as well as major secondary endpoints. The trial data showed the vaccine was almost 66% effective in protecting against coronavirus.
Johnson & Johnson anticipates having its vaccine available for shipment immediately after the Food and Drug Administration (FDA) Authorization.
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If the US regulator authorizes J&J’s application, it would be the 3rd COVID-19 vaccine in the US available for emergency use. Two vaccines developed by Pfizer Inc (NYSE:PFE)-BioNTech SE (NASDAQ:BNTX) and Moderna Inc (NASDAQ:MRNA) were authorized for emergency use in December 2020.
Moreover, Johnson & Johnson has commenced rolling submissions with several health organizations outside the US. The Company will submit a cMAA (Conditional Marketing Authorization Application) with the EMA (European Medicines Agency) in the forthcoming weeks.
Johnson & Johnson to supply 100 million doses to the US
J&J also highlighted that the Janssen COVID-19 vaccine is compatible with the distribution channels of a standard vaccine.
On authorization by the FDA, Janssen’s COVID-19 vaccine is expected to remain stable for a minimum of two years at -4°F (-20°C). Further, the Company highlighted that the vaccine could be stored in standard refrigerators at temperatures of 36°-46°F (2°-8°C) for at least three months.
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Johnson & Johnson plans to ship its COVID-19 vaccine applying similar cold chain technologies that the Company uses to transport other innovative medications.
It is noteworthy to mention that the Company intends to distribute its COVID-19 vaccine to the US government immediately after the FDA authorization. J&J also anticipates supplying almost 100 million doses to the US in 1H 2021.
Janssen vaccine met primary endpoints in Phase 3 ENSEMBLE trial
On 29 January 2021, Johnson & Johnson updated the market with the top-line efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The trial results demonstrated that the investigational vaccine met all primary and secondary endpoints.
The Company notified that vaccine candidate was 72% Effective in the US and almost 66% effective overall for preventing moderate to severe symptoms of COVID-19.