Two companies considered advanced in their quest for a coronavirus vaccine, Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX), selected a candidate to advance to a phase 2/3 clinical study. The two companies, which are collaborating on the vaccine effort, said in a joint press release Monday that they had chosen BNT162b2, one of four candidates they were testing.
Selection was made after evaluating data from phase 1/2 clinical trials of the four candidates. Pfizer and BioNTech said they also consulted with the Food and Drug Administration (FDA) Center for Biological Research and Evaluation and other regulators about the choice.
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The companies said that “[p]Preliminary clinical phase 1/2 data from nearly 120 patients demonstrated a favorable overall tolerability profile for BNT162b2, compared to BNT162b1, with generally mild to moderate and transient (1-2 days) systemic events such as fever, fatigue, and shaking chills. and without serious adverse events. “
Pfizer and BioNTech added that they have finalized the phase 2/3 study protocol, again incorporating responses from healthcare regulators around the world. Up to 30,000 people will enroll in this clinical trial, and will consist of a diverse population of adults ages 18 to 85. It will take place in 39 US states and in countries like Argentina and BioNTech’s native Germany.
All Pfizer-BioNTech coronavirus vaccine candidates work by using messenger RNA (mRNA) to teach cells in the body how to make antibodies that can attack the COVID-19 virus.
The fortune of the two companies was mixed in the trade on Monday. Pfizer fell marginally by 0.3%, while BioNTech outperformed many peer biotech stocks and highest equity indices by 2.8%.
