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US-based pharma company Pfizer Inc and German biotech company BioNTech today announced their mRNA-based covid vaccine candidate, BNT162b2, against coronavirus has demonstrated evidence of efficacy against COVID-19 in participants. This is 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.
"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.
Along with the efficacy data generated from the clinical trial, Pfizer said both the companies are working to prepare the necessary safety and manufacturing data to submit to the US drug regulator 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.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
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.
“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.”
“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 endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”
Futures tracking the S&P 500 hit a record high today after U.S. drugmaker Pfizer said its experimental vaccine was more than 90% effective in preventing COVID-19 based on initial data from a large study while gold prices dropped sharply.
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech co-founder and CEO.
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