The COVID-19 vaccine duo, Pfizer Inc. (NYSE: PFE) and BioNTech S.E. (NASDAQ: BNTX) on Wednesday announced their late-stage coronavirus study had concluded, and after conducting the final efficacy analysis for the Phase 3 study of the mRNA-based COVID-19 vaccine candidate, BNT162b2, it achieved all the study’s primary efficacy endpoints.
Analysis of the data indicated a vaccine efficacy rate of 95% 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).
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 eight cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.
There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.
In terms of safety, BNT162b2 was well tolerated. The only Grade 3 solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following the second dose. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination.
As it stands, the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) had been achieved. Pfizer and BioNTech are planning to submit a request to the FDA for an EUA in the coming days, as well as to other regulatory agencies around the world.
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 stock traded up about 3% to $37.07 on Wednesday, in a 52-week range of $26.45 to $39.84. The consensus price target is $41.88.
BioNTech stock was up about 3%, at $89.76 in a 52-week range of $18.60 to $115.00. Analysts have a consensus price target of $105.64.