Pfizer, Inc. ( PFE Quick Quote PFE - Free Report) and its Germany-based partner, BioNTech ( BNTX Quick Quote BNTX - Free Report) announced that their mRNA-based coronavirus vaccine candidate, BNT162b2, received a temporary authorization for emergency use in the United Kingdom. With this authorization, BNT162b2 becomes the first coronavirus vaccine in the world that can be made available for the general public in any country.
The decision to grant temporary authorization to BNT162b2 was based on rolling submission to the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, which included data from the phase III study evaluating the candidate. We note that the candidate demonstrated an efficacy rate of 95% in final analysis of the study. Please note that the companies already have a supply agreement for 40 million doses of their candidate in place with the United Kingdom for 2020 and 2021, and are ready to start delivery of the vaccine immediately.
Investors cheered the encouraging news and shares of Pfizer and BioNTech were up 3.9% and 8.8%, respectively, in pre-market trading on Dec 2.Pfizer’s stock is up 0.6% this year so far compared with 1.4% increase of the
industry. BioNTech’s shares are up 236.5% this year compared with the industry’s increase of 3.7%.
We note that Pfizer and BioNTech also requested the FDA to grant Emergency Use Authorization (“EUA”) last month. An advisory committee meeting to discuss study data and decide on EUA grant is scheduled on Dec 10. The companies have also requested the European Medicines Agency for Conditional Marketing Authorization (“CMA”) and have initiated rolling submissions in several other countries. The EMA is expected to meet with the companies on Dec 29 to discuss their regulatory submission.
Meanwhile, the companies have built specially designed, temperature-controlled shippers for the BNT162b2 to overcome their logistical disadvantage as the candidate needs to be stored at ultra-low temperatures. With Pfizer’s vast experience and expertise in cold-chain shipping and established infrastructure to supply the vaccine worldwide, the ultra-low temperature recommendation seems not much of a headwind for vaccine distribution.
Apart from Pfizer and BioNTech,
Moderna ( MRNA Quick Quote MRNA - Free Report) is another company that has requested for EUA and CMA for its mRNA-based coronavirus vaccine candidate in the United States and Europe, respectively.The FDA has scheduled an advisory committee meeting on Dec 17 to discuss Moderna’s EUA. The EMA is expected to meet with the company on Jan 12 to discuss its regulatory submission. AstraZeneca ( AZN Quick Quote AZN - Free Report) is another company that has reported data from a late-stage study evaluating its coronavirus vaccine candidate, AZD1222. Data from the first interim analysis showed that AZD1222 was about 70% effective in preventing COVID-19, on an average. However, the company is yet to file for emergency use anywhere Zacks Rank
While Pfizer has a Zacks Rank #3 (Hold), BioNTech has a Zacks Rank #4 (Sell).
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