mRNA-based vaccine candidate developed by Pfizer and BioNTech demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of infection, according to first interim efficacy analysis in early November 2020.
For the study, a total of 43,538 participants were recruited since the Phase 3 clinical trial began on 27 July 2020. The vaccine candidate that was tested is a mRNA-based vaccine known as BNT162b2. Out of all the participants, 38,955 of them received a second dose of the vaccine candidate as of 8 November 2020. Approximately 42 percent of global participants and 30 percent of U.S. participants have racially and ethnically diverse backgrounds. The trial is continuing to enrol and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued.
Based on the first interim efficacy analysis conducted in early November 2020 by an external, independent Data Monitoring Committee (DMC) from this Phase 3 clinical trial, the vaccine candidate was found to be more than 90 percent effective in preventing COVID-19 in participants without evidence of previous infection by the virus – SARS-CoV-2. There was also no report of serious safety concerns and the DMC recommended that the study continue to collect additional safety and efficacy data as planned.
“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,” said Dr Albert Bourla, Pfizer Chairman and CEO.
“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.”
“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 endeavour,” added Dr Bourla.
“We could not have come this far without the tremendous commitment of everyone involved. 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,” said Prof. Ugur Sahin, BioNTech Co-founder and CEO.
“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 enrol 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.”
As the clinical trial continues, it will also evaluate the potential for the 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 seven days after the second dose, the final analysis now will include, with the approval of the US Food and Drug Administration (FDA), new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The 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.
Pfizer and BioNTech are continuing to accumulate safety data as specified by the FDA in its guidance for potential Emergency Use Authorization.
Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose. Along with the efficacy data generated 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. Based on supply projections, the companies expect to supply globally up to 50 million vaccine doses in 2020 and manufacture up to 1.3 billion doses in 2021. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication. [APBN]