U.S. Big Pharma Pfizer and German biotech partner BioNTech are looking to ramp up trials of vaccines against COVID-19 with a major scaled-up test plotted for the fall.
This is according to Pfizer’s CEO and chair Albert Bourla, talking to CNBC. Pfizer penned a deal with messenger RNA biotech BioNTech a few weeks back for them to work on a COVID-19 vaccine using new mRNA tech.
The partners currently have early clinical tests ongoing in Germany and the U.S., with the latter in around 360 participants, all across four vaccine candidates. Three of these candidates contain uridine-containing mRNA or nucleoside-modified mRNA, while a fourth vaccine candidate contains self-amplifying mRNA.
“We are collecting data as we speak in real time so we know, we are monitoring the safety of the doses,” with data on which vaccine variation stands out expected in June or July, Bourla said.
If one or two variations indicate success, the company will ramp up trials and then in September launch a major study with thousands of trial participants if a vaccine proves to be successful, he added.
“If things go well, and we feel that the product is safe and efficacious, and the FDA and EMA and other regulatory agencies feel the same, we will be able to deliver millions of doses in the October time frame,” Bourla said.
The plan is to produce hundreds of millions of doses of the vaccine by next year. The use of mRNA has not been approved in vaccines before but has been a front-runner in the race of more than 100 vaccine candidates to get to market.
Pfizer and BioNTech are racing rivals CureVac and Moderna to develop and manufacture, at scale, a COVID-19 vaccine derived from an mRNA platform. This week, Moderna nabbed an FDA fast-track tag for its vaccine candidate and is plotting a phase 3 test in the next three months.