Pfizer, BioNTech Begin Global COVID-19 Vaccine Trial

Pfizer and BioNTech began a phase 2/3 trial yesterday of one of their COVID-19 vaccine candidates, but not the one originally considered to be the most promising.

The companies have chosen BNT162b2, a nucleoside-modified messenger RNA (modRNA) vaccine candidate to study. It is the partners’ second candidate granted priority review by the FDA this month (DID, July 14).

If the trial is successful, the companies plan to seek Emergency Use Authorization or regulatory approval from the FDA in October.

The study will assess the vaccine’s safety and efficacy compared to placebo in more than 30,000 participants at more than 120 sites around the world, except China.

The companies said BNT162b2 demonstrated comparable safety and efficacy to BNT162b1, which was originally the lead vaccine candidate. However, their new lead candidate elicited T-cell responses that were not generated by BNT162b1. The companies believe that more T-cell epitopes could generate more consistent responses across diverse populations and older adults. — Jordan Williams