Pfizer CEO Dr. Albert Bourla said that the company will not apply for emergency authorization of its coronavirus vaccine before the third week of November, putting an end to months of outside speculation about the possibility of having a vaccine ready before Election Day.
In a statement posted to the Pfizer website, Bourla provided clarification on Pfizer's timelines "to ensure public trust and clear up a great deal of confusion."
"So let me be clear, 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," said Bourla in the statement.
The newly released FDA EUA guidance requires that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Pfizer's current trial enrollment and dosing pace means they won't reach this milestone until November.
The politicization of COVID-19 vaccines has triggered a crisis in vaccine confidence, with President Trump repeatedly promising a pre-election vaccine despite disagreement from health experts. For awhile, Pfizer was the only drugmaker involved in the Operation Warp Speed program that had expressed the possibility of an October timeline.
Read the Pfizer statement
