Pharmaceutical firms Pfizer and BioNTech have said their COVID-19 vaccine has proved to be effective in preventing the disease caused by the new coronavirus, putting the candidate ahead of others in the vaccine race.
After discussion with the FDA, the companies decided to analyse 94 cases from the 43,538 cases under study and an independent committee found a vaccine efficacy rate above 90 percent.
The interim analysis indicated that protection was achieved 28 days after the first dose in the two-dose vaccine. No serious safety concerns were reported and the study continues to collect additional safety and efficacy data as planned.
“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,” said Dr Albert Bourla, Pfizer Chairman and CEO.
“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," the Pfizer chief added.
Pfizer said the Phase 3 clinical trial of BNT162b2 began 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.
"Approximately 42 percent of global participants and 30 percent of US participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued," the company said.
The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.
(Edited by : Pfizer)
First Published: IST