As coronavirus cases surge in the United States and elsewhere, with little relief in sight, the world got good news on Monday. Pfizer and its partner, the German company, BioNTech, announced preliminary results that suggested their vaccine was more than 90 percent effective.
Pfizer Inc. and BioNTech SE today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints.
Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
Companies 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 is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world.
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