Pfizer and BioNTech have today announced their new vaccine candidate (BNT162b2) is 90% effective against SARS-CoV-2. This mRNA-based vaccine has shown to be effective in participants without prior knowledge of SARS-CoV-2.
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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,” 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.”
Pfizer has also recently dropped the 32-case analysis and aimed to carry out the first interim analysis with a minimum of 62 cases. After this discussion, the DMC conducted its first analysis of these cases. The DMC discovered a vaccine efficacy rate above 90% just 7 days after the second dose, meaning that protection is achieved 28 days after the initial vaccination. As the study is only in its clinical trial, the final vaccine efficacy percentage could vary.
However, so far, the DMC has yet to report any serious safety concerns and has allowed the study to continue to collect extra safety and efficacy data. After this, the data will be discussed with other regulatory authorities worldwide.
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.”
“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 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 making this important achievement possible.”
Overview of BNT162b2 trial
On July 27, the phase 3 clinical trial began and has enlisted 43,538 participants so far with 38,955 of them receiving a second dose of the BNT162b2 vaccine by November 8, 2020.
The trial is still enrolling new participants and will continue through its final analysis until 164 confirmed COVID-19 cases have accrued. The trial is also assessing the potential for the vaccine to not only provide protection against those who have not had prior exposure to COVID-19 but to those who have had exposure, as well as providing protection against severe cases of COVID-19.
The final analysis of the trial will now include, approval dependent on the FDA, secondary efficacy endpoints of the vaccine based on cases of COVID-19 accrued 14 days after the second dose, as well as the primary efficacy endpoints after 7 days as already evaluated.
The aim of including these secondary efficacy endpoints is to allow for cross-trial learnings and comparisons between COVID-19 vaccine studies allowing data to be aligned with higher accuracy.
To find an updated version of their protocol, please click here: https://www.pfizer.com/science/coronavirus.
Both companies hope to have a median of two months of safety data available by the third week of November. Participants will however be continually monitored for an additional two years following their second dose of the vaccine for long-term protection.
50 million vaccine doses should be produced globally in 2020 and 1.3 billion in 2021 based on current projections in their data.
Both Pfizer and BioNTech aim to submit their data from their Phase 3 clinical trial of BNT162b2 for scientific review.