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Pfizer Begins Human Testing Of Coronavirus Vaccine In US, Michigan Among Manufacturing Centers

Pfizer Begins Human Testing Of Coronavirus Vaccine In US, Michigan Among Manufacturing Centers

Pfizer Inc. (NYSE: PFE) and BioNTech SE – ADR (NASDAQ: BNTX) said Tuesday that a Phase 1/2 trial of their coronavirus vaccine candidates has commenced in the U.S.

Human testing of the vaccine candidate is already underway in Germany

U.S. Phase 1/2 Trial Begins

The first participants in the trial have been dosed in the U.S., the companies said. The study will evaluate the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates in a single continuous study.

Pfizer and BioNTech plan to enroll about 360 healthy volunteers in two age cohorts: ages 18-55 years and 65-85 years.

To start with, healthy adults ages 18-55 will be enrolled into the study. Older adults will be tested only after testing of the vaccine candidate and dose level in younger adults provides initial evidence of safety and immunogenicity, Pfizer and BioNTech said. 

See Also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates

The sites where patients are being dosed include the NYU Grossman School of Medicine and the University of Maryland School of Medicine, while the University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children's Hospital Medical Center will begin enrollment shortly.

"The short, less than four-month timeframe in which we've been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19," Pfizer CEO Albert Bourla said in a statement. 

Updating on their German study, the companies said the dosing of the first cohort in Germany was completed last week.

Hundreds Of Millions Of Vaccine Doses In 2021

BioNTech will supply vaccines for clinical studies from its GMP-certified mRNA manufacturing facilities in Europe.

To scale up production to meet global supply, Pfizer intends to use its sites in three U.S. states — Massachusetts, Michigan and Missouri, as well as Purus in Belgium.

"The breadth of this program should allow production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021," the companies said.

PFE, BNTX Price Action

Pfizer shares were up 2.74% at $38.68 at the time of publication Tuesday, while BioNTech shares were up 9.9% at $50.31. 


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