BioNTech and Pfizer Kick Off Human Trials for COVID-19 Vaccine

BioNTech SE (NASDAQ: BNTX) and Pfizer Inc. (NYSE: PFE | PFE Price Prediction) stocks each made a handy gain on Monday after the companies announced the beginning of human trials for a COVID-19 vaccine.

Specifically, the firms announced that the first participants have been dosed in the United States in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. This U.S. trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week.

The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18 to 55 and 65 to 85 years of age). The first subjects immunized in Stage 1 of the study will be healthy adults 18 to 55 years of age. Older adults will only be immunized with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity.

This program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. The novel design of the trial allows for the evaluation of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate to be evaluated in a greater number of volunteers.

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Albert Bourla, board chair and CEO of Pfizer, commented:

With our unique and robust clinical study program underway, starting in Europe and now the U.S., we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most. 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.

BioNTech stock traded up about 6% to $48.65 on Tuesday. The 52-week range is $12.52 to $105.00, and the consensus price target is $43.78.

Pfizer stock was up about 2.5%, at $38.56 in a 52-week range of $27.88 to $44.56. The consensus price target is $41.36.

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