US drugmaker Pfizer and German biotech firm BioNTech announced Wednesday that their coronavirus vaccine candidate “met all of the study’s primary efficacy endpoints,” and is ready to seek approval from the US Food and Drug Administration “within days.”

The announcement marked the first set of complete results from a phase 3 vaccine trial as the virus currently affects more than 55.7 million people in 191 countries and regions worldwide.

The final efficacy analysis showed the vaccine was 95% effective against COVID-19 beginning 28 days after the first dose, the companies said in a statement.

“The safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved.” the companies said. “These data also will be submitted to other regulatory agencies around the world.”

The FDA requires two-month follow-up data on at least half of the participants in a last-stage vaccine trial before seeking authorization of emergency use of a vaccine amid the outbreak.

While no serious safety concerns were observed, the analysis showed the most significant side effect was fatigue at a frequency of 3.8% and headache at 2%.

The analysis was based on 170 confirmed cases: 162 were in the placebo group and eight were in the vaccine group. Also, 10 severe cases were seen in the trial.

It also showed more than 94% efficiency in adults older than 65, who are the most vulnerable to the pandemic.

“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 Dr. Albert Bourla, Pfizer chairman and CEO.

“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,” he added.

Dr. Ugur Sahin, CEO and co-founder of BioNTech, underlined the vaccine candidate provides early protection and said: “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 [microgram] dose​​​​​​​”

The companies expect to produce globally up to 50 million doses in 2020 and as many as 1.3 billion doses by the end of 2021.

The phase 3 trial began July 27 on 43,661 global participants with 41,135 receiving a second dose Nov. 8.

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