Pfizer, BioNTech to ramp up COVID-19 vaccine tests, plot major trial boost in fall

Albert Bourla incoming Pfizer CEO
Albert Bourla, Pfizer CEO and chair (Pfizer)

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.

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today.

“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.

RELATED: Pfizer, BioNTech finish dosing in COVID-19 vax test; emergency use could start in the fall

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.

Suggested Articles

Biotech IPOs are up over 40% year-to-date, but today’s markets have rewritten the rules for going public. Find out the new best practices for IPOs.

ATAI Life Sciences is topping off a busy year with a $125 million financing, which will push two programs through phase 2 readouts.

After more than a decade working on heart failure programs with Cytokinetics, Amgen is handing two programs back to its partner.