Pfizer, Inc. PFE and its Germany-based partner BioNTech SE (NASDAQ:BNTX) BNTX began rolling submission of their mRNA-based coronavirus vaccine candidate, BNT162b2 to the European Medicines Agency (EMA) to speed up its review process.
Preliminary data from pre-clinical and early clinical studies on BNT162b2 in adults showed that the candidate triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2, the virus that causes COVID-19. The EMA accepted rolling review on the candidate based on available preclinical and clinical data.
As part of the rolling review process, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has begun evaluating the pre-clinical data. After the rolling review process is complete, the final/formal marketing application will be filed once the EMA is satisfied that the submitted data are adequate and demonstrate the vaccine’s efficacy and safety
Shares of BioNTech were up 6.1% on Monday while Pfizer’s shares declined 1.6%. However, so far this year, Pfizer’s shares have lost 7.7% compared with the industry’s 0.5% decline.
Pfizer and BioNTech selected BNT162b2, out of four mRNA-based coronavirus vaccine candidates, for late-stage development as it demonstrated better results in early-stage studies. They began global phase III development with 30,000 participants in July. The companies later increased the targeted number of participants in the late-stage studies from 30,000 subjects to approximately 44,000. More than 37,000 participants have already been enrolled in the phase III clinical trial currently being conducted in the United States, Brazil, Argentina and Europe. Of these, 28,000 have received their second dose of the vaccine.
Pfizer and BioNTech will conduct regular and open dialogue with the EMA providing them data from their ongoing phase III study.
BioNTech and Pfizer expect to file regulatory applications for BNT162b2 in the United States this month and it is being viewed as one of the first candidates to reach the market.
Eventually, if the vaccine is approved, Pfizer/BioNTech plan to manufacture up to 100 million doses by the end of this year and potentially more than 1.3 billion doses by the end of 2021. Pfizer has already signed advance purchase deals with the governments of the United Kingdom, United States, Canada, and Japan for the vaccine, if approved.
Other than Pfizer/BioNTech, COVID-19 vaccine candidates of AstraZeneca (NYSE:AZN) AZN/Oxford University Moderna (NASDAQ:MRNA) and J&J (NYSE:JNJ) JNJ are also in late-stage development. J&J began a pivotal phase III study last month. While J&J is testing a single dose of its investigational COVID-19 vaccine candidate, JNJ-78436735, Pfizer/BioNTech, AstraZeneca/Oxford University and Moderna are testing two shots of their respective candidates.
Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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