Pfizer and BioNTech COVID-19 Vaccine Candidate Meets All Primary Efficacy Endpoints in Phase 3 Study
Pfizer and BioNTech announced their COVID-19 vaccine candidate, BNT162b2, met all primary efficacy endpoints in its Phase 3 study. The vaccine demonstrated 95% efficacy.
Pfizer Inc. and BioNTech SE announced that their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study's primary efficacy endpoints following the final analysis of their ongoing Phase 3 study.
The analysis of the data indicates a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection. The study evaluated 170 confirmed COVID-19 cases, with 162 observed in the placebo group versus 8 in the vaccine group. Efficacy was consistent across age, gender, race, and ethnicity demographics, with over 94% efficacy observed in adults over 65 years of age.
The companies have also achieved the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The study, which enrolled over 43,000 participants, reported no serious safety concerns related to the vaccine. The most frequent Grade 3 solicited adverse events were fatigue and headache, which were mild and resolved shortly after vaccination.
Pfizer and BioNTech plan to submit an EUA request to the FDA within days and will share the data with other regulatory agencies globally. The companies expect to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.