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Pfizer, BioNTech Rise On ‘Positive’ Early Data Of Potential Coronavirus Vaccine
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Pfizer, BioNTech Rise On ‘Positive’ Early Data Of Potential Coronavirus Vaccine

Pfizer Inc. (PFE) and BioNTech SE (BNTX) shares advanced after the drugmakers disclosed early “positive” data from an ongoing study of BNT162b1, one of its potential coronavirus vaccine candidates.

The drugmakers said that overall, the preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated, generated immune defenses and was able to produce neutralizing antibody responses in humans. Pfizer and BioNtech’s joint BNT162 program is evaluating at least four experimental vaccines, each of which uses a combination of messenger RNA (mRNA) format and target antigen.

Pfizer shares rose 4% to $34.03 in early morning trading and German partner BioNtech soared $9.8% to $72.30.

“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings,” said Kathrin U. Jansen, Senior VP and Head of Vaccine R&D at Pfizer. “We are dedicated to develop potentially groundbreaking vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency. We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible.”

The ongoing U.S. Phase 1/2 randomized, placebo-controlled study is evaluating the safety, tolerability, and immunogenicity of dose levels of BNT162b1. The first part of the study included 45 healthy adults aged 18 to 55 years. The preliminary data for BNT162b1 was evaluated based on 24 patients who received two doses of the vaccine and showed “significantly elevated” antibodies within 28 days of their first injection. No serious adverse reactions were reported.

Based on the preliminary data, together with additional preclinical and clinical data being generated, the two companies hope to progress to a large, global Phase 2b/3 safety and efficacy trial. The trial may involve up to 30,000 healthy participants and is expected to begin in late July, pending regulatory approval.

If the ongoing studies of the BNT162b1 candidate are successful, the companies expect 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.

In that event, BioNTech and Pfizer would work jointly to distribute the potential COVID-19 vaccine worldwide, excluding China, where BioNTech has a collaboration with Fosun Pharma.

Shares in Pfizer have in recent months recouped a big chunk of their losses but are currently still trading down 13% year-to-date and analysts have a cautiously optimistic outlook on the stock’s prospects. The Moderate Buy consensus is based on 5 Buy ratings versus 8 Hold ratings. 

The $40.66 average price target for Pfizer implies 19% upside potential for the drugmaker’s shares in the coming 12 months. (See Pfizer stock analysis on TipRanks).

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