Pfizer and BioNTech announced that the BNT162b2 mRNA-based vaccine candidate has been shown to be more than 90% effective in the prevention of Covid-19 in participants of a phase 3 trial who were not previously exposed to the SARS-CoV-2 infection.
The data is based on the first interim efficacy analysis from the phase 3 clinical study carried out by an external, independent data monitoring committee (DMC).
Dr. Albert Bourla – Pfizer Chairman and CEO said: “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 the BNT162b2 mRNA-based vaccine candidate started in late July and has enrolled 43,538 participants so far. According to Pfizer, 38,955 of these had taken a second dose of the vaccine candidate as of 8 November 2020.
Among the participants, nearly 42% of the global participants, and 30% of them are US participants are of racially and ethnically diverse backgrounds.
Ugur Sahin – BioNTech co-founder and CEO said: “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.”
In July 2020, Pfizer and BioNTech signed a $1.95 billion deal with the US government for delivering 100 million doses of the BNT162 COVID-19 vaccine candidate.