Last week, the two partners announced that the first participant in the US had been dosed with the BNT162 vaccine, an mRNA vaccine designed to protect against COVID-19.
The Phase I/II clinical trial is a global trial that had already been initiated in German participants, as the companies look to recruit 360 healthy individuals to test the vaccine.
Pfizer and BioNTech’s development program includes four vaccine candidates, with these being tested simultaneously to identify the most promising program.
At the clinical-stage, BioNTech will be responsible for providing supply of the vaccine from its facilities in Mainz and Idar-Oberstein, Germany.
Both partners are also preparing for manufacturing should a vaccine program prove successful, which saw Pfizer release more details on how this would be managed.
Within its own network, Pfizer would leverage three sites across the US: its Kalamazoo, Michigan, facility for formulation & fill, its St. Louis, Missouri, facility for raw material, and its Andover, Massachusetts, facility for drug substance. The company will also utilize its Puurs, Belgium, facility.
In order to scale up manufacturing at its sites, Pfizer stated that it would be hiring additional staff members and investing at risk to produce the potential vaccine.
For its part, BioNTech stated that it is also set to invest to increase production capacity to be ready to supply commercial product.
In terms of numbers, this will allow the two partners to produce millions of doses in 2020, which would be increased to hundreds of millions in 2021.
Pfizer’s announcement follows similar actions to rapidly scale manufacturing capacity, such as Johnson & Johnson’s plan to boost capacity for one billion doses and a similar target by Moderna.
