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Summary
- 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.
Source: © Akakshu | Megapixl.com
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.
MUST READ: Lab tests confirm BioNTech (NASDAQ: BNTX), Pfizer vaccine effective against new Covid-19 variants
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.
Source: © 2020 Kalkine Media Pty Ltd
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.
ALSO READ: WHO Chief cautions over inequality amid global COVID-19 vaccine rollout
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Team Kalkine Media -33709 PostsTeam Kalkine Media comprises of experts who understand various markets nuances and are enthusiastic and passionate to provide best possible offerings in the form of insights and stories. The team has rich experience of working across different market...
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Team Kalkine Media -33709 Posts
Team Kalkine Media comprises of experts who understand various markets nuances and are enthusiastic and passionate to provide best possible offerings in the form of insights and stories. The team has rich experience of working across different market...
