US drug company Pfizer says it plans to submit its COVID-19 vaccine for approval with regulators 'within days'.
In an update, the company says its vaccine candidate BNT162b2 was 95% effective against the virus, beginning 28 days after the first dose.
It says 170 confirmed cases of coronavirus were evaluated, with 162 observed in the placebo group versus eight in the vaccine group.
It says effectiveness was consistent across age, gender, race and ethnicity demographics.
While its effectiveness in adults aged over 65 years of age was over 94%.
It says the mRNA-based vaccine "met all of the study's primary efficacy endpoints".
The company says a "safety data milestone", required by the US Food and Drug Administration (FDA) for emergency use, has also been achieved.
It plans to submit to the FDA "within days" and share data with other regulatory agencies around the globe.
1.3 billion doses
The company - along with German partner BioNTech - expects to produce up to 50 million vaccine doses globally in 2020, and up to 1.3 billion doses by the end of 2021.
The phase three clinical trial began on July 27th, and enrolled 43,661 participants to date - 41,135 of whom received a second dose of the vaccine as of November 13th.
Of those who took part, a small number experienced headaches (2.0%) and symptoms of fatigue (3.8%).
While older adults tended to report fewer and milder effects following vaccination.
Approximately 42% of global participants and 30% of US participants have "racially and ethnically diverse backgrounds" - and 41% of global and 45% of US participants are between 56 and 85 years of age.
Pfizer says the trial will continue to collect efficacy and safety data in participants for an additional two years.
An earlier trial found the vaccine had a 90% effective rate, with no evidence of side effects.
The European Union has already bought 200 million doses of the vaccine, with the option to buy another 100 million.
Dr Albert Bourla, Pfizer chairman and CEO, 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.
"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."
Ugur Sahin, CEO and co-founder of BioNTech, added: "We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection.
"These achievements highlight the potential of mRNA as a new drug class.
"Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages.
"We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities."