KALAMAZOO, MI (WKZO AM/FM) — Wednesday, Pfizer and BioNTech announced that the results from a Phase 3 study indicate its COVID-19 vaccine may actually be 95 percent effective against the virus.
That comes after an announcement last week, when the companies announced the vaccine may be 90 percent effective based on a Phase 2 study.
The Phase 3 study included 43,661 participants. Officials say that no serious safety concerns have been recorded, besides 3.8 percent of participants reporting fatigue. Another two percent reported a headache.
The headaches were also reported after the second dose of the vaccine, while the fatigue is reported for both doses.
“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,” Pfizer Chairman and CEO Dr. Albert Bourla said in a statement. “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.”
In addition, the companies announced that the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved.
Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA based on the data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine. That data will also be submitted to other regulatory agencies around the world.
Based on current projections, the companies expect to globally produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
More information about the study can be viewed at Pfizer’s website here.
This also comes after an announcement from Moderna earlier this week, where officials said their COVID-19 vaccine is 94.5 percent effective.
