The American pharmaceutical company Pfizer Inc and the German biotechnology company BioNTech announced today that their mRNA-based covid vaccine candidate BNT162b2 against the 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 and independent Data Monitoring Committee (DMC) of the Phase 3 clinical study.
“The candidate vaccine was found to be more than 90% effective in preventing COVID-19 in participants with no 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 drug manufacturers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have found no serious security problems so far and hope to apply for an emergency use authorization in the United States later this month.
Along with the efficacy data generated from the clinical trial, Pfizer said both companies are working to prepare the necessary manufacturing and safety data for submission to the US drug regulator. To demonstrate the safety and quality of the drug’s product. vaccine produced.
“Based on current projections, we expect to globally produce up to 50 million doses of vaccines in 2020 and up to 1.3 billion doses in 2021,” he added.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific publication for peer review.
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 candidate vaccine 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 initial evidence of our vaccine’s ability to prevent COVID-19, “said Dr. Albert Bourla, President and CEO of Pfizer.
“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 approaching overcapacity and economies struggling to reopen. With today’s news, we are a significant step closer to giving people around the world a much-needed breakthrough to help end this global health crisis. We look forward to sharing additional efficacy and safety data generated by 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 researchers at study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial effort. Bourla added. “We couldn’t have gotten this far without the tremendous commitment of everyone involved.”
Futures tracking the S&P 500 hit a record today after US drugmaker Pfizer said its experimental vaccine was more than 90% effective in preventing COVID-19 according to initial data from a large study, while gold prices fell sharply.
“The first interim analysis of our global phase 3 study provides evidence that a vaccine can effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort, “said Professor Ugur Sahin, BioNTech co-founder and CEO.
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