Pfizer-BioNTech Covid-19 Vaccine Found To Be 95% Effective - Quick Facts

Pharmaceutical giant Pfizer Inc. (PFE) and German biotech firm BioNTech SE (BNTX) announced Wednesday that their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the Phase 3 study's primary efficacy endpoints.

Following the news, shares of Pfizer were trading up nearly 4% in pre-market trade.

The primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose. Though the efficacy was consistent across age, gender, race and ethnicity demographics, the observed efficacy in adults over 65 years of age was over 94%.

The analyzed data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose.

The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group.

Data from the study demonstrates that the vaccine was well tolerated across all populations with over 43,000 participants enrolled. There were 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%.

The companies stated that they plan to submit the data to the U.S. Food and Drug Administration (FDA) within days for Emergency Use Authorization (EUA) as the safety data milestone required by the FDA has been achieved. They will also share data with other regulatory agencies around the globe.

Based on current projections, 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 noted that it is confident of its existing cold-chain infrastructure to distribute the vaccine around the world by utilizing dry ice to maintain temperature conditions of -70°C±10°C.

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