Pfizer said on Friday it could apply for U.S. emergency use of its COVID-19 vaccine candidate being developed along with Germany’s BioNTech as soon as a safety milestone is achieved in the third week of November.
The US Food and Drug Administration has said it wants at least two months of safety data before authorizing emergency use of any experimental coronavirus vaccine.
Based on current trial enrollment and dosing pace, Pfizer expects to have that safety data in the third week of November, Chief Executive Officer Albert Bourla said in a statement.
“Assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency. The timelines above reflect our best estimates of when these important milestones could be achieved. For 171 years Pfizer has been known for our high-quality standards. Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine,” the open letter reads.
Pfizer had said previously that it expected late-stage trial data in October.
