Pfizer and BioNTech Announce Successful COVID-19 Vaccine Candidate
Pfizer Inc. and BioNTech SE announced that their mRNA-based vaccine candidate BNT162b2 against SARS-CoV-2 demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection. The findings are based on the first interim efficacy analysis of the Phase 3 clinical trial, conducted on 8 November 2020 by an independent, external Data Monitoring Committee (DMC).
Following discussions with the FDA, the companies recently abandoned an interim analysis at 32 cases and elected to conduct the first interim analysis at a minimum of 62 cases. After completion of these discussions, the number of evaluable cases reached 94, and the DMC conducted its first analysis on all cases. The case split between vaccinated individuals and placebo recipients shows a vaccine efficacy rate exceeding 90% at 7 days after the second dose.
Protection is achieved 28 days after the start of vaccination, which consists of a two-dose regimen. While the study continues, the final vaccine efficacy percentage may change. The DMC reported no serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.
Dr. Albert Bourla, Chairman and CEO of Pfizer, said: "Today is a great day for science and humanity. The first results from our Phase 3 COVID-19 vaccine trial provide the first 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 approaching capacity, and economies struggling to reopen.
With today's news, we are taking an important step closer to providing people around the world with a much-needed breakthrough to help end this global health crisis. We look forward to sharing additional efficacy and safety data from thousands of trial participants in the coming weeks."
Bourla added: "I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and researchers in the study sites, and our colleagues and collaborators around the world who have devoted their time to this important effort. We could not have come this far without the extraordinary commitment of everyone involved."
Prof. Uğur Şahin, co-founder and CEO of BioNTech, said: "The first interim analysis of our global Phase 3 trial provides evidence that a vaccine can effectively prevent COVID-19. This innovation is a triumph for science and a global collaboration effort.
"This is what we hoped to achieve when we embarked on this journey ten months ago. Especially today, when we are all in the midst of a second wave and many of us are in isolation, we even more appreciate how important this milestone is on the path to ending this pandemic and regaining a sense of normalcy for all of us. The trial will continue to collect more data while enrolling participants for a planned final analysis when a total of 164 confirmed COVID-19 cases have occurred. I thank everyone who made this important success possible."
The Phase 3 clinical trial of BNT162b2 began on 27 July and has enrolled 43,538 participants to date, of whom 38,955 had received a second dose of the vaccine candidate as of 8 November 2020. Approximately 42% of global participants and 30% of U.S. participants are from racially and ethnically diverse backgrounds. The trial continues to enroll participants and is expected to proceed to final analysis when a total of 164 confirmed COVID-19 cases have occurred.
The trial will also evaluate the vaccine candidate's potential to provide protection against COVID-19 in individuals previously exposed to SARS-CoV-2, as well as the vaccine's potential for prevention of severe COVID-19 disease.
In addition to efficacy data from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
Based on current estimates, production of up to 50 million vaccine doses worldwide in 2020 and 1.3 billion doses in 2021 is expected.
Pfizer and BioNTech plan to submit data from the Phase 3 trial for peer-reviewed publication.
