Pfizer To Seek FDA Emergency Use Authorization For Vaccine ‘Within Days,’ Final Analysis Shows 95% Effective

by Thomas Catenacci

Pharmaceutical companies Pfizer and BioNTech concluded Phase 3 of their coronavirus vaccine trial and will ask the Food and Drug Administration for emergency use authorization “within days.”

Pfizer and BioNTech said the final analysis of the trial showed the vaccine was 95% effective in preventing new infections, according to a press release Wednesday. The companies initially announced their vaccine was over 90% effective on Nov. 9.

“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,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “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,” he continued. 

The companies said they planned to submit an emergency use authorization request “within days” based on the safety and efficacy of the vaccine demonstrated throughout the trial, according to the press release.

The trial showed that there were 170 cases of coronavirus, 162 of which were observed in the placebo group, according to the press release. The large-scale phase began on July 27 and enrolled 43,661 participants worldwide.

“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,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech, according to the press release.

Meanwhile, Moderna announced Monday that its vaccine was 94.5% effective in combating coronavirus during its large-scale human trials. President Donald Trump celebrated the progress of Operation Warp Speed, the federal government’s multiagency effort to produce a coronavirus vaccine quickly, during a news conference Friday.

Average coronavirus cases and deaths per million have been increasing rapidly nationwide for several weeks, according to The COVID Tracking Project. On Tuesday, the U.S. reported 1,567 new coronavirus-related deaths and 155,835 new cases while 76,823 Americans remained hospitalized from the virus.