Mainz, Germany | THE INDEPENDENT | Drug companies Pfizer and BioNTech have conclude Phase 3 Study of their COVID-19 Vaccine candidate BNT162b2 , whose primary efficacy analysis demonstrates it to be 95% effective against COVID-19 beginning 28 days after the first dose.
According to a statement, efficacy was consistent across age, gender, race and ethnicity demographics. Observed efficacy in adults over 65 years of age was over 94%.
The companies say data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled and they plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. Pfizer stated that they are confident in their vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world.
The result comes just a week after the German company BioNtech and Pfizer from the US first announced success in phase three study of the experimental vaccine to prevent COVID-19 infections.
The Phase 3 clinical trial of BNT162b2 began on July 27 and enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.
“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 said last week.