Pfizer and BioNTech announced today that their experimental COVID-19 vaccine appears to be safe and effective, according to preliminary data. They explain that the vaccine was “more than 90% effective” in preventing the disease in people who received two doses of the vaccine 3 weeks apart.
Protection against COVID-19 begins 1 week after the second dose.
It is important to reiterate that these are preliminary findings. However, to date, they include data from 43,538 people in six countries. Importantly, the press release explains that “no serious safety concerns have been observed.”
So far, the analysis includes data from 94 people with COVID-19. The study will continue until there are 164 confirmed cases.
Once the required safety milestone is reached in the third week of November, the companies plan to submit the vaccine for Emergency Use Authorization to the Food and Drug Administration (FDA).
“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.
“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.”