Jennifer Barrett is the senior editor for Drug Topics® and Total Pharmacy®.
Interim analysis results from a phase 3 clinical trial reported a vaccine efficacy rate above 90% for BNT162b2. The trial is ongoing until it meets its threshold for confirmed COVID-19 cases.
Pfizer and BioNTech’s investigational vaccine candidate for the coronavirus disease 2019 (COVID-19) was found to be more than 90% effective, according to results of an interim analysis.
“Today is a great day for science and humanity. The first set of results from our phase 3 COVID-19 vaccine trial provides initial evidence of our vaccine’s ability to prevent COVID-19,” Albert Bourla, DVM, PhD, Pfizer chairman and CEO, said in a statement.
Following successful preliminary data from phase 1/2 studies in July, BNT162b2, a mRNA-based vaccine, received Fast Track designation from the FDA. The phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 45,538 participants to date, 38,955 of whom have received the second dose. According to Pfizer, approximately 42% of global study participants and 30% of US participants in the trial have racially and ethnically diverse backgrounds.
Based on the interim results, the data showed a vaccine efficacy rate above 90% at 7 days after the second dose, meaning that protection is achieved 28 days after initiation of the 2-dose vaccination schedule.
The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. Pfizer noted that the final vaccine efficacy percentage may vary as the study continues.
In addition to the efficacy data, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data for FDA submission. The companies anticipate the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization to be available by the third week of November.
“Based on current projection we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021,” Pfizer said in the press release
1. Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study. News release. Pfizer; November 9, 2020. Accessed November 9, 2020.