Pfizer Inc. will not seek emergency authorization of its coronavirus vaccine any earlier than the third week in November, when it projects it will hit important testing milestones, the company’s CEO said Friday.
In a letter posted on the company’s website, CEO Albert Bourla said that the vaccine must be first proven safe as well as effective before it is made available to the public.
“Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years,” Bourla wrote.
For a vaccine to qualify for emergency-use authorization by the Food and Drug Administration, trials must track at least half the participants in large-scale studies for two months after their second dose, the time period in which side effects could surface.
Bourla said his company’s trial will reach the two-month goal in November’s third week.
“We are operating at the speed of science,” he wrote.