Pfizer and BioNTech announced on November 9 that their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection during Phase 3 clinical study.

The vaccine candidate was found to be more than 90% effective in the first interim efficacy analysis.

The companies plan to make a submission for Emergency Use Authorization to the US Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November 2020.

Based on current projections, Pfizer and BioNTech expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.