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Summary
- Pfizer and BioNTech have taken a significant step in the development of their COVID-19 vaccine candidate, BNT162b2 with an interim analysis revealing that it was over 90% effective.
- The Companies have planned the submission for an Emergency Use Authorization (EUA) to the FDA soon after achieving the safety milestone anticipated in the third week of this month.
- The clinical trial will continue through to final analysis at 164 confirmed cases of COVID-19 to gather further data.
On 9 November 2020, Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced that their vaccine candidate, BNT162b2 was found to be over 90% effective for the prevention of COVID-19 in Phase 3 participants with no evidence of an earlier SARS-CoV-2 infection in the first interim efficacy analysis. Following this significant announcement, the share prices of both companies moved up on NASDAQ.
On 9 November 2020 (4:00 PM ET), the share price of Pfizer was noted at US$39.20, up by 7.69%. BNTX ADS stood at US$104.80, up by 13.91%.
Let us dive deep and discuss in detail-
BNT162b2 Found to be Over 90% effective at preventing the pandemic
Pfizer and BioNTech are conducting Phase 3 COVID-19 vaccine trials of an mRNA-based COVID-19 vaccine candidate, BNT162b2.
The two partners announced yesterday that BNT162b2 was found to be over 90% effective in the prevention of COVID-19 infection in subjects without any evidence of a previous infection by the novel coronavirus in the first interim efficacy study.
The Companies disclosed that after their discussion with the Food and Drug Administration (FDA), they selected to drop the 32-case interim analysis and perform the 1st interim analysis at a minimum of 62 cases.
After the conclusion of discussions, the evaluable case count was 94 confirmed cases of COVID-19, and the DMC completed its first analysis on all cases.
The study enrolled almost 43.5k participants, with 42% of the subjects from diverse backgrounds. No serious safety concerns have been noted so far. The Companies stated that they would continue to gather safety and additional efficacy data.
It is noteworthy to mention that the duo has planned submission for Emergency Use Authorization (EUA) to the FDA for soon after the required safety milestone is achieved, which is currently anticipated to happen during the 3rd week of November.
Along with the clinical trial efficacy data, the Companies are working to prepare the necessary manufacturing and safety data to submit to the FDA for the safety and quality determination of the final vaccine product.
Pfizer and BioNTech also disclosed that the clinical trial to continue through to final analysis at 164 confirmed cases of COVID-19 for collection of further information and characterize the performance of vaccine candidate against other study endpoints.
Based on the current estimates, the Companies anticipate manufacturing up to almost 50 million vaccine doses in the year 2020 and up to 1.3 billion doses in the year 2021 globally.
Management Commentary
Dr Albert Bourla Pfizer Chairman and CEO commented-
BioNTech co-founder and CEO, Prof. Ugur Sahin said-
