U.S. drugmaker Pfizer and partner BioNTech say their COVID-19 vaccine candidate is on track for regulatory review as soon as October, if it continues to provide positive results.
The companies provided more data Thursday on what they called “positive” results from the Phase 1 study for the vaccine candidate, BNT162b2.
A pivotal Phase 2/3 global study for the potential vaccine with as many as 30,000 participants is now underway.
“BNT162b2 remains under clinical study and is not currently approved for distribution anywhere in the world. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020,” they said in a statement. “If regulatory authorization or approval is obtained, [we] currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.”