Today Pfizer and BioNTech have jointly announced they are prepared to begin their Phase II/III global trials for their COVID-19 vaccine partnership. Following on review of Phase I/II trial results, the partnership worked with the FDA to select BNT162b2 as the vaccine candidate in the next phases.
"This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “Many steps have been taken towards this important milestone and we would like to thank all those involved for their extraordinary commitment.”
The mRNA vaccine encodes an "optimized SARS-CoV-2 full length spike glycoprotein (S)" and will be administered in two 30µg doses. These doses will be administered by up to 30,000 participants. Other vaccine candidates will continue to receive support as part of a separate, less urgent track.
“Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine. The Phase 2/3 study protocol follows all the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic, and we look forward to generating additional data as the program progresses.”
Pfizer remains on track to potentially become one of the earliest vaccines available in the US. The CEO Albert Bourla predicts an availability date of 100M vaccines by October of this year provided Emergency Use Authorization is granted.