Pfizer says vaccine is 95% effective in final data, will seek authorization

Pfizer and BioNTech reported Wednesday their experimental COVID-19 vaccine was 95% effective in the final results of a key study. According to the companies, Pfizer intends to seek FDA authorization for the vaccine within days. The data found that 170 adults in the nearly 44,000-participant study developed COVID-19 with at least one symptom: 162 who received the placebo and 8 who received the vaccine. There do not appear to be any serious safety concerns. A review of data from 8,000 study participants indicated the vaccine appears to be well-tolerated. The companies reported that 3.8% of participants reported fatigue and 2% reported headaches. The companies have collected the 2 months of safety data for 19,000 study participants requested by FDA, but they are still reviewing the findings. “The study results mark an important step in this historic 8-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” said Pfizer CEO Albert Bourla. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.” A spokesperson said the company is waiting to fully analyze the data and gather the requisite documentation before seeking authorization.