A potential COVID-19 vaccine being developed by American pharma giant Pfizer and Germany-headquartered BioNTech is 90% effective, early data from a phase III trial suggests.
The phase III trial of Pfizer and BioNTech’s COVID-19 vaccine candidate – named BNT162b2 – involved 43,538 individuals, who received two doses of the vaccine or a placebo.
In an announcement released today, Pfizer and BioNTech said that their vaccine achieved an efficacy rate of over 90% seven days after receiving the second dose.
Within the trial, 94 participants developed the novel coronavirus, SARS-CoV-2, which causes COVID-19. The trial is continuing to enrol participants and is set to reach the final analysis when a total of 164 COVID-19 cases have occurred.
The companies added that they are accumulating safety data and currently estimate that a median of two months of safety data following the second dose of the vaccine will be ready by the third week of November.
Pfizer and BioNTech also plan to submit the full phase III data for scientific peer-review and publication.
“Today is a great day for science and humanity. The first set of results from our phase III COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Albert Bourla, Pfizer chairman and chief executive officer.
The final analysis will also include new secondary endpoints evaluating efficacy of the vaccine based on cases accruing 14 days after the second dose.
The companies hope that the addition of these new secondary endpoints will help to ‘align data’ across all COVID-19 vaccine studies, by enabling for cross-trial learnings and comparisons between novel vaccine platforms.
"When we embarked on this journey ten months ago this is what we aspired to achieve,” said Ugur Sahin, BioNTech co-founder and chief executive officer.
“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,” he added.