Pfizer and BioNTech have announced their mRNA-based vaccine candidate for COVID-19, tested in a Phase 3 study involving 43,538 participants, was more than 90% effective, according to the first interim efficacy analysis. Submission for Emergency Use Authorization (EUA) to the FDA is expected to occur in the third week of November.
The encouraging news comes as drug development companies and research centers scramble to deliver a safe and effective vaccine to help bring an end to the COVID-19 pandemic, which has claimed more than 1.2 million lives worldwide since it officially began at the beginning of 2020.
Pfizer and BioNTech’s COVID-19 vaccine more than 90% effective in Phase 3 trial
The Phase 3 clinical trial of the COVID-19 vaccine candidate BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine as of November 8, 2020. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate of more than 90%, at 7 days after the second dose. This means that protection against SARS-CoV-2 infection is achieved 28 days after the start of the vaccination, which consists of a 2-dose schedule. As the study is still ongoing, the final vaccine efficacy percentage may vary. The new data will be discussed with regulatory bodies worldwide.
“Today is a great day for science and humanity”
Dr. Albert Bourla, Pfizer Chairman and CEO stated:
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
Following talks with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the Data Monitoring Committee (DMC) performed its first analysis on all cases. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned.
Dr. Bourla added:
“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor. We could not have come this far without the tremendous commitment of everyone involved.”
Prof. Ugur Sahin, BioNTech co-founder and CEO stated:
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”
The enrolled study participants come from diverse backgrounds, with approximately 42% of participants from around the world and 30% of U.S. participants having racially and ethnically diverse backgrounds. So far the 94 confirmed cases of COVID-19 in trial participants have been evaluated and the trial is still continuing to enroll participants and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued.
The study will also evaluate the potential for the mRNA-based vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. Both companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms.
The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.