Safety, Effectiveness of Pfizer’s Vaccine Candidate Will Be Known in October, CEO Says

Pfizer’s CEO Albert Bourla said that it is “highly likely” that the ongoing phase 3 trial of its mRNA-based COVID-19 vaccine candidate, BNT162, will show in October whether the vaccine is safe and effective — and said the company plans to seek the FDA’s approval the same month if the data support it.

The drugmaker has already started manufacturing the vaccine candidate at its own risk in preparation for an FDA green light and plans to have quantities sufficient to begin shipping the vaccine if all goes well, Bourla said yesterday in an online discussion hosted by the Washington Post.

The company expects to have approximately 100 million doses manufactured for global use this year, he said. The U.S. government has already granted the company a $1.95 billion contract — its largest agreement yet under Operation Warp Speed — to secure 100 million doses of the vaccine candidate for distribution to the American public (DID, July 23).

Enrollment for the late-stage study of 30,000 participants is expected to be completed this month, Bourla said, noting that more than 1,000 patients have already been vaccinated.

“We are already in the first week, and things are moving very, very nicely,” he said. “There are things that we can control as we are planning and things that we cannot control. What we can control is that we execute the study according to the plan.” — James Miessler