Pfizer and BioNTech has announced that its COVID-19 vaccine, BNT162b2, has been found to be more that 90% effective in preventing COVID-19 based on initial data from a large study, in the ongoing phase 3 trials.
This is good news in the midst of second wave of the pandemic currently blowing across the United Kingdom and many European countries.
Globally there has been over 50.6 million COVID-19 cases with 1.26 million deaths. (Data correct as at 9.00p.m. WAT)
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% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.
According to Dr. Albert Bourla, Pfizer Chairman and CEO “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.”
“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 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.
“When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”
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.
Based on supply projections, Pfizer and BioNTech expect to supply globally up to 50 million vaccine doses in 2020 and manufacture up to 1.3 billion doses in 2021. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
