Pfizer chief Albert Bourla says his firm and its partner BioNTech have a 60% chance of knowing the efficacy of their still experimental vaccine by end of October
Pfizer chief Albert Bourla said its coronavirus vaccine being developed in partnership with BioNTech could “likely” be given to Americans before 2021, contingent on an approval from U.S. regulators at the U.S. Food and Drug Administration.
New York-based Pfizer and Germany’s BioNTech are seen as frontrunners in the race to develop a coronavirus vaccine, alongside Moderna Inc. and AstraZeneca Plc.
Bourla said Pfizer and its partner have a 60% chance of knowing the efficacy of its still experimental vaccine by the end of October. Meanwhile, AstraZeneca announced on Saturday that it would resume its phase 3 trial after temporarily halting global trials last week to investigate an unexplained illness in a woman participant.
“I cannot say what the FDA will do,” Bourla said during an interview on CBS’ ‘Face the Nation’. “But I think it’s a likely scenario, and we are preparing for it.”
Pfizer-BionTech COVID-19 vaccine is moving to the phase 3 clinical trial. The companies said in a statement Saturday that they expect to enroll the 30,000 patients they originally sought for its final-phase clinical trial this week. They are also expanding that target to 44,000 participants to include people as young as 16, and to allow those with HIV and Hepatitis B and Hepatitis C.
“We will also focus on recruiting more people of color, including African Americans and Latinos, to the late-stage trial in coming weeks, says Bourla. He also mentioned that the study participants are currently 60% White and 40% people of color, and that older volunteers make up 44% of the cohort.
The companies joined other vaccine developers last week in an unusual pledge to submit applications with the FDA for vaccine clearance when the drugs have shown to be safe and effective in large clinical trials. That followed concerns that President Donald Trump is pushing the agency to cut corners to get a vaccine to market before the November 3 election.