The interim analysis showed that BNT162b2 vaccine candidate is over 90% effective in preventing Covid-19 in participants without evidence of prior SARS-CoV-2 infection.
BioNTech co-founder and CEO Ugur Sahin 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.”
Both companies decided to stop the 32-case interim analysis and carried out the first interim analysis at a minimum of 62 cases, after discussion with the FDA.
The evaluable case count reached 94 and the DMC conducted its first analysis on all cases, upon the conclusion of discussions.
To date, the BNT162b2’s phase 3 clinical study recruited 43,538 participants, of which 38,955 have secured a second dose of the vaccine candidate.
The trial will continue to recruit patients, as well as intends to continue through the final analysis when a total of 164 confirmed Covid-19 cases have accrued.
Both firms will also assess the potential of the vaccine in offering protection against Covid-19 in those who have had prior exposure to SARS-CoV-2 and vaccine prevention against severe Covid-19 disease.
The final analysis will also include new secondary endpoints that assess efficacy based on cases accruing 14 days after the second dose, in addition to the primary efficacy endpoints that assess confirmed Covid-19 cases accruing from seven days after the second dose.
Both firms are planning to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021 based on current projections.
Pfizer chairman and CEO Dr Albert Bourla 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.”
In July, the US government placed an order worth $1.95bn with Pfizer and BioNTech to procure 100 million doses of their BNT162 vaccine candidate for Covid-19.