BioNTech/Pfizer to seek emergency approval for coronavirus vaccine within days
A study of a phase 3 clinical trial shows the vaccine candidate is 95 percent effective.
BioNTech and Pfizer announced on Tuesday that they completed a study of a phase 3 clinical trial of their coronavirus vaccine candidate, showing it’s 95 percent effective.
They plan to submit data to the European Medicines Agency (EMA) within days, a Pfizer spokesperson confirmed. The companies said they’ll also submit an application for emergency authorization with the U.S. Food and Drug Administration (FDA) and other international regulators in the same time frame.
In an interview on Tuesday at the POLITICO Health Care Summit, the EMA’s new executive director, Emer Cooke, said she expects a vaccine could be authorized “before the end of the year.”
The EMA launched a rolling review of the vaccine’s data at the beginning of October, and Cooke said that the agency has seen the preliminary results from the companies. Still, the actual data has to be reviewed by the agency’s experts: “Everything sounds great, but the devil is in the details,” she said.
The agency has also reviewed its processes to make the process as “efficient and effective as possible,” she said.
The two drugmakers reached a deal with the European Commission on November 11 to have up to 300 million doses purchased, following their announcement, via press release on November 9, that their jab was 90 percent effective.