In a remarkable progress, Pfizer Inc. and BioNTech SE has today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 to have demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.
In a remarkable progress, Pfizer Inc. and BioNTech SE has today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 to have demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.
Describing today, as a great day for science and humanity, the first interim analysis of the global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. The vaccine has been tested on 43,500 people in six countries and no safety concerns have been raised.
Based on current projections, Pfizer Inc. and BioNTech SE expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. However there are logistical challenges, as the vaccine has to be kept in ultra-cold storage at below minus 80C.
“The first interim analysis of the 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.
“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", said Dr. Albert Bourla, Pfizer Chairman and CEO 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% of global participants and 30% of U.S. 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.
The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide, the release said.
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.