Report: Pfizer plans to seek FDA approval for COVID vaccine in 'days,' trials find it 95% effective

Report: Pfizer plans to seek FDA approval for COVID vaccine in 'days,' trials find it 95% effective

According to a report from the Wall Street Journal, Pfizer and BioNTech SE plan to submit their vaccine to the FDA for approval in a matter of “days” after Pfizer determined through clinical trials that its coronavirus vaccine is over 95% effective and appears to be safe.

According to the report, Pfizer’s clinical trial involved 44,000 subjects. Of those subjects, 170 of them developed the coronavirus with at least one symptom; however, 162 of those subjects received the placebo. Only eight adults contracted the coronavirus who received the actual vaccine, which means that the vaccine is considered to be 95% effective — about the same as the vaccines for shingles and the measles.

Additionally, the “severe” side effects of the vaccine were found to be fatigue, which was reported by 3.8% of study participants, and headaches, which were reported by 2% of study participants. Researchers conducting the study noted that there were no “serious safety issues” with the vaccine and that the vaccine appears to be “well tolerated” thus far, but noted that they are still compiling final data.

Pfizer told the Wall Street Journal that they anticipate having this data compiled and ready to submit to regulators “within days,” which would place the vaccine on track for delivery in 2020, if the vaccine is approved by the FDA.

In a statement, Pfizer CEO Albert Bourla 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.”

Moderna, Inc. likewise appears to be close to final development of their coronavirus vaccine, which has been found to have a 94% effectiveness rate in early trials.


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