Pfizer said its COVID-19 vaccine is 95 percent effective after conducting a final efficacy analysis for its phase 3 trial.
The analysis showed 170 cases of COVID-19 in participants — 162 in the placebo group and eight in the vaccine group. The efficacy was consistent across age, gender, race and ethnicity demographics.
Pfizer said it observed 10 severe cases of COVID-19 in the trial, nine of which were in the placebo group and one in the vaccine group.
No serious safety concerns were found, though some people experienced fatigue and headache after the second dose. Older adults tended to report fewer, milder adverse events.
Pfizer plans to submit an application to the FDA for an emergency use authorization within days and will also submit applications to regulatory agencies around the world, the drugmaker said.
"The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world," said Pfizer CEO Albert Bourla, PhD. "With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world."
Pfizer will continue to monitor participants for two years to collect efficacy and safety data.
The drugmaker said it expects to produce 50 million doses of the vaccine in 2020 and 1.3 billion by the end of 2021.
Read the full news release here.