The US pharma giant Pfizer Inc and German firm BioNTech on Monday said that their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19. The trail result was based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. The COVID-19 vaccine, BNT162b2, being developed by Pfizer Inc. and BioNTech are in late-stage vaccine trial.
Based on success achieved in first interim analysis from Phase 3 study, the drug makers plan to soon apply for Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA) after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
This is a major break through which would help bring an end to this global health crisis, Pfizer Inc said in a press release.
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 per cent of global participants and 30 per cent of the 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," Pfizer Inc said.
Based on current projections, the drug makers expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
"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 study will also 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.
"Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate - the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorisation - will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose," the drug maker said.
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