Pfizer Inc (PFE) and BioNTech SE (BNTX) have announced that two of the companies’ four investigational Covid-19 vaccine candidates from their BNT162 mRNA-based vaccine program have received Fast Track designation from the U.S. Food and Drug Administration (FDA).
Shares in Pfizer are up 3% in Monday’s pre-market trading, while BioNTech has soared 9%.
The two candidates, BNT162b1 and BNT162b2, are the most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.
Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs and vaccines to treat or prevent serious conditions with an unmet medical need.
This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies.
The BNT162 program is evaluating at least four experimental vaccines, each of which represent a unique combination of messenger RNA (mRNA) format and target antigen. BNT162b1 and BNT162b2 are both nucleoside modified RNAs, formulated in lipid nanoparticles. BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.
The “Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” cheered Peter Honig of Pfizer, adding: “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”
The Project Lightspeed vaccine development program is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities.
Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects. If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies aim to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.
Analysts have a cautiously optimistic take on Pfizer’s outlook, with a Moderate Buy consensus. This breaks down into 6 buy ratings and 8 hold ratings. Meanwhile the $42 average analyst price target indicates upside potential of over 20%.
After PFE/ BNTX announced initial Phase 1/2 mRNA vaccine BNT162b1 results, RBC Capital analyst Randall Stanicky reiterated his Pfizer buy rating and $43 price target. “Results were encouraging, adding hope that an approved vaccine can come before year- end” he told investors.
“Data from the 10 and 30 μg doses supported advancement into Phase 2b/3 and could put approval ~late 2020 with more meaningful scale-up announced. This amplifies a catalyst for a stock that has seen pullback” he added. (See PFE stock analysis on TipRanks).
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