The vaccine developed by Pfizer Inc. and partner BioNTech SE may very well be ready to use for emergency-use authorization of its COVID-19 vaccine by late November, assuming it proves better than expected at protecting people from COVID-19 in pivotal research, a milestone within the hunt for shots that may stop the worldwide pandemic.
The vaccine proved to be greater than 90% efficient within the first 94 subjects who had been infected by the new coronavirus and developed a minimum of one symptom, the companies mentioned Monday.
The positive, though incomplete, results bring the vaccine a big step nearer to getting cleared for widespread use.
Pfizer mentioned it’s on track to ask health regulators for permission to sell the shot earlier than the end of this month if pending data indicate the vaccine is safe.
The timetable suggests the vaccine might go into distribution this month or next, though U.S. health regulators have indicated they are going to take a while to conduct their evaluation.
“Hopefully now we will transfer on and get this vaccine on the market and ensure it is doing what it is supposed to do and stop” the virus, mentioned Kathrin Jansen, Pfizer’s head of vaccine research and development, in an interview.
The findings got here too early for researchers to evaluate the security of the vaccine, which the U.S. Food and Drug Administration says should include two months of monitoring a minimum of half the study’s topics for side effects.
The vaccine is among the most advanced in development in the West, with others in late-stage testing from Moderna Inc., Johnson & Johnson, and AstraZeneca PLC.
