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Pfizer And BioNTech' Potential Covid-19 Vaccine Shows Positive Data In Human Trial

Pfizer Inc. (PFE) and BioNTech SE (BNTX) said their investigational Covid-19 vaccine developed neutralizing antibodies in healthy patients, while causing low grade fever after the second dose.

The ongoing U.S. Phase 1/2 study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1. The initial part of the study included 45 healthy adults 18 to 55 years of age.

Preliminary data for BNT162b1 was evaluated for 24 participants who received two injections of 10 µg and 30 µg, 12 participants who received a single injection of 100 µg, and 9 adults who received 2 doses of placebo control.

All 24 participants in the Phase 1/2 clinical trial who received one of two lower doses of a COVID-19 vaccine candidate developed neutralizing antibodies.

The companies said that they will use the preliminary data to determine a dose level and select among multiple vaccine candidates to seek to progress to a large, global Phase 2b/3 safety and efficacy trial. That trial may involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval to proceed is received.

In case the safety and efficacy study is successful, and the vaccine receives regulatory approval, the companies are expecting 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.

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