Pfizer-BioNTech COVID-19 Vaccine Moves Into Pivotal Trial

Pfizer’s and BioNTech’s experimental COVID-19 vaccine BNT162b2 has been chosen for a phase 2/3 efficacy study of 9,000 participants following its success in a phase 1 trial.

BNT162b2 was selected for a late-stage trial over another candidate, BNT162b1, because the former “was associated with less systemic reactogenicity, particularly in older adults,” according to a non-peer-reviewed paper published online yesterday by medRxiv.

In the ongoing phase 1 U.S. study, 195 healthy adults in two age groups, 18-55 and 65-85, were randomized such that 156 of the volunteers got two doses at 21-day intervals of either one of two vaccine candidates, and the other 39 volunteers got a placebo.

The volunteers were sorted into 13 groups of 15 participants, in which 12 got an investigational vaccine and three got the placebo, in order to study various age groups and dosage levels.

In both younger and older adults, the two vaccine candidates elicited antibodies that could neutralize the SARS-CoV-2 virus that causes COVID-19, at levels similar to or higher than those of people who were recovering from the infection on their own.

Read the full preprint paper here: bit.ly/2YjOzbg. — Martin Berman-Gorvine