US drug-maker Pfizer and its German partner BioNTech SE declared that their COVID-19 vaccine had demonstrated more than 90% efficacy against the coronavirus, providing a much-needed breakthrough to help end the global health crisis.
In the first interim analysis from the Phase 3 clinical study, the mRNA-based vaccine candidate BNT162b2 was found to be effective in preventing COVID-19 in participants without prior evidence of coronavirus infection.
The analysis was conducted on 94 confirmed cases of COVID-19 in trial participants by an external, independent Data Monitoring Committee (DMC) on November 8, 2020.
As per the analysis, the protection against COVID-19 is achieved 28 days after vaccination, consisting of a 2-dose schedule. However, the final vaccine efficacy may differ as the safety and additional efficacy data continue to be collected.
The DMC reported that no serious safety concerns had been observed in the vaccine analysis.
“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,” he added.
“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.
Pfizer and BioNTech started the Phase 3 clinical trial of their vaccine candidate on July 27 and has enrolled 43,538 participants, comprising 42% of global participants and 30% of US participants having racially and ethnically diverse backgrounds.
Among them, 38,955 have received a second dose of the vaccine candidate as of November 8, 2020.
The trial is set to continue through to the final analysis at 164 confirmed COVID-19 cases to collect data regarding the vaccine’s performance.
The companies are now working to prepare the necessary safety and manufacturing data, along with the efficacy data from the clinical trials, to submit to the US Food and Drug Administration (FDA) for approval.
Based on current expectations, Pfizer and BioNTEch are set to produce up to 50 million vaccine doses by the end of 2020 and around 1.3 billion doses in 2021.