Pfizer and BioNTech Recruit for Large-Scale Vaccine Trial

On July 27, drug giant Pfizer and German partner BioNTech announced they were beginning a combined Phase 2/3 trial of a COVID-19 vaccine. The trial will recruit 30,000 volunteer participants between 18 and 35 from across the world, including the U.S., Germany and Brazil. Half of participants will receive the vaccine, while half receive a placebo. The first four participants were dosed July 27 at the University of Rochester Medical Center, CNN reported.

Pfizer and BioNTech were comparing a number of mRNA vaccine candidates, which use messenger RNA to encode a key portion of the spike protein that SARS-CoV-2 uses to enter cells. Thus, the vaccine allows the body to recognize SARS-CoV-2 and produce an appropriate immune response.

On July 1, the companies announced results in a preprint publication showing that one vaccine candidate, BNT162b1, prompted an immune response in patients. The Phase 2/3 trial continues with a slightly different vaccine candidate than BNT162b1, however. The new candidate has more consistent immunoresponses and causes fewer side effects.

“There were fewer reactions to immunization, and that was an important mark in its favor,” said Philip Dormitzer, Vice President of Pfizer, as reported by Stat.

Pfizer and BioNTech are currently recruiting participants for their study. Participants will receive two injections into the muscle of the upper arm about three weeks apart. Six total study visits will be required. To find out if you qualify and are near a participating research laboratory, visit https://www.covidvaccinestudy.com/

If the vaccine is successful, Pfizer and BioNTech have said they will seek regulatory approval by October and could supply up to 100 million doses by the end of 2020. Mere hours before Pfizer announced the trial, Moderna, who is producing a slightly different vaccine, announced their intentions to proceed with a Phase 3 trial.