In a major breakthrough, US-based pharma company Pfizer Inc and German biotech company BioNTech announced that their mRNA-based COVID-19 vaccine candidate, BNT162b2, has demonstrated evidence of efficacy against the novel coronavirus in participants on November 9.
The result was based on the first interim efficacy analysis conducted on November 8 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
"Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis," Pfizer said in a statement.
Pfizer and German partner BioNTech SE are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have found no serious safety concerns so far, and expect to seek US emergency use authorization later this month.
Pfizer also said that both the companies are working to demonstrate the safety and quality of the vaccine product produced. "Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021," it added.
The Phase 3 clinical trial of BNT162b2 started on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.
"Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19," Dr Albert Bourla, Pfizer Chairman and CEO said.
"We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks."
"I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavour," Bourla added.
"We could not have come this far without the tremendous commitment of everyone involved."