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Monday, July 27, 2020

Pfizer, BioNTech rise as they start late-stage vaccine human trial

Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) have begun their late-stage human trials for their lead mRNA COVID-19 vaccine candidate.
Pfizer is up 1.9% postmarket; BioNTech is up 6%.
The candidate BNT162b2, a nucleoside-modified messenger RNA vaccine that encodes an optimized SARS-Cov-2 full-length spike glycoprotein, is starting a 2-dose regimen in a phase 2/3 safety/efficacy study.
The study is worldwide, except for China.
“Today, we are starting our late-stage global study, which will include up to 30,000 participants. We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far,” says Pfizer’s Head of Vaccine Research and Development Kathrin U. Jansen.
Assuming clinical success, the companies claim they are on track to seek regulatory review as soon as October – and pending approval, to supply up to 100M doses by the end of 2020 (and 1.3B doses by the end of 2021).

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