Another COVID-19 Vaccine on the Horizon
Pfizer and BioNTech’s COVID-19 vaccine is 95% effective beginning 28 days after the first dose, Pfizer announced in a press release.
The announcement comes after the final efficacy analysis from their phase 3 study of BNT162b2, their mRNA-based coronavirus vaccine candidate. Data demonstrated a vaccine efficacy rate of 95% in persons without prior SARS-CoV-2 infection, as well as persons with or without prior SARS-CoV2 infection.
“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing protection,” CEO and Cofounder of BioNTech Ugur Shain, MD, said in the press release. “Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this.”
The study’s primary objective was vaccine efficacy in persons without prior COVID-19 infection, and the secondary objective was persons with and without prior COVID-19 infection.
There were 170 confirmed COVID-19 cases evaluated in study participants, 162 of which occurred in the placebo group. Efficacy was consistent across all demographics including age, gender, race, and ethnicity. Adults older then age 65 years had an observed efficacy of more than 94%. A total of 10 severe COVID-19 cases were reported in the trial, 9 of which occurred in the placebo group and 1 in the BNT162b2-vaccinated group.
According to the Data Monitoring Committee for the study, there were no serious safety concerns related to the vaccine. Two-thirds of participants tolerated the vaccine well; most adverse effects resolved quickly following vaccination. The only severe adverse effects that occurred greater than or equal to 2% in efficacy were fatigue (3.8%) and headache (2%).
The safety milestones required by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) have been achieved. Pfizer and BioNTech plan to submit a request for an Emergency Use Authorization to the FDA over the next few days.
The companies plan on producing up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
—Audrey Amos, PharmD
Reference:
Pfizer and BioNTech conclude phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints. News Release. Pfizer. November 18, 2020. Accessed November 18, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine