BioNTech (NASDAQ:BNTX) and Pfizer (NYSE:PFE) have dosed the first two U.S. volunteers with a vaccine candidate that could protect people from the coronavirus responsible for COVID-19. The partners began the global clinical trial of the vaccine in April, when they dosed a group of patients in Germany.

Trying something different 

Traditional drug development is a long process featuring clearly defined steps -- and BioNTech and Pfizer aren't exactly following them. For example, instead of carefully winnowing down its potential treatments to a single COVID-19 vaccine candidate to advance into human studies, the partners will dose people with four related vaccine candidates during the early stages of clinical trials.

Healthcare professional in personal protective equipment.

Image source: Getty Images.

The BNT162 vaccine program is enrolling patients aged 18 to 55 and  65 to 85 in separate groups that will be injected with the new vaccine candidates at increasing doses. Patients in the younger cohorts will try ascending dosages before they're given to the older patient groups.

Thinking ahead

During BNT162's clinical development, BioNTech will supply investigators with vaccine candidates produced in its European facilities. To prepare for widespread distribution in the event the program succeeds,  the partners are prepared to invest in developing large-scale manufacturing capacity before any trial results are in.

Pfizer-owned sites in three U.S. states and another in Belgium have been identified as potential SARS-CoV-2 vaccine production centers. BioNTech has a couple of sites in Germany that could add to partners' manufacturing capacity.

With multiple sites scaling up production of BNT162 before anybody knows if it works, the partners will be ready to manufacture millions of doses before the end of 2020, and hundreds of millions in 2021.