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Pfizer, BioNTech first to test COVID-19 vaccine candidate on two continents

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The announcement Tuesday that healthy volunteers in the U.S. have received a candidate RNA vaccine from Pfizer and BioNTech marks the first COVID-19 vaccine to enter clinical testing on two continents.

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) completed the first dosing cohort of a Phase I/II trial of their BNT162 vaccine candidate in Germany on April 29.

A trial of BNT162 in China is expected to begin “upon regulatory approval,” a BioNTech spokesperson said.

The companies are jointly developing and commercializing BNT162 globally, with the exception of China, where BioNTech is partnered with Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKEX:2196).

The companies are testing four BNT162 candidates: three that contain uridine containing mRNA (uRNA) or nucleoside modified mRNA (modRNA), and a fourth that contains self-amplifying mRNA (saRNA).

The dose escalation portion of the Phase I/II trials in Germany and the U.S. will target a dose range of 1 µg to 100 µg. Single- and two-dose regimens will be tested.

Pfizer announced plans to ramp up production of the vaccine candidate at-risk. The company said it will have the capacity to produce “millions of vaccine doses increasing to hundreds of millions in 2021.”

It said it will manufacture BNT162 at three sites in the U.S., at a plant in Belgium, and at additional sites that haven’t yet been selected.

BioNTech will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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