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The Pfizer and BioNTech SARS-CoV-2 vaccine has shown an efficacy rate above 90%, at seven days after the second dose based on the first interim efficacy analysis.
The vaccine demonstrated evidence of efficacy against Covid-19 in participants without prior evidence of SARS-CoV-2 infection and the case split between vaccinated individuals and those who received the placebo indicates that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
As the study continues, the final vaccine efficacy percentage may vary. The Data Monitoring Committee has not reported any serious safety concerns and recommends that the study continues to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.
A much-needed breakthrough for Covid-19
Dr Albert Bourla, Pfizer Chairman and CEO, said: “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.”
The Phase 3 clinical trial of 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 candidate as of November 8, 2020. Approximately 42% of global participants and 30% of US participants have racially and ethnically diverse backgrounds.
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. The study also will 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 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.
Professor Ugur Sahin, BioNTech Co-founder and CEO, added: “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.”