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Pfizer Starts Human Trials Of Potential Coronavirus Vaccine In U.S.

BioNTech (BNTX) and its partner Pfizer (PFE) have started a phase I/II clinical trial in the U.S. for their BNT162 vaccine program to prevent COVID-19.

The phase I/II study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study.

The dose level escalation portion of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts; 18-55 and 65-85 years of age.

The companies had begun the phase I/II trial for BNT162 vaccine program in Germany last week.

In anticipation of clinical development program, the companies are working to scale up production of the vaccine for global supply.

BioNTech and Pfizer will work jointly to commercialize the vaccine worldwide upon regulatory approval, excluding China where BioNTech has a partnership with Fosun Pharma for BNT162 for both clinical development and commercialization.

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