No Vaccine Application From Pfizer Before The Election, CEO Says
Pfizer CEO Albert Bourla says his company's mid-October target to apply for FDA emergency use authorization for its COVID-19 vaccine candidate has shifted to mid-November, at the earliest.
AP:
Pfizer: Mid-November Earliest It Can Seek Virus Vaccine OK
Pfizer Inc. cannot request emergency authorization of its COVID-19 vaccine before the third week of November -- and that’s if everything goes well, the company’s CEO announced Friday. Despite President Donald Trump’s repeated promises of a vaccine before Election Day, scientists have been cautioning that it’s unlikely data showing a leading shot actually works would come until November or December. (10/16)
Stat:
Pfizer Won't Seek Covid-19 Vaccine Approval Before Mid-November
An analysis of the efficacy of the vaccine could be available sooner, the company said in an open letter from its CEO, Albert Bourla, but required safety data will take longer. The timelines included in the letter are not new, based on disclosures the company has previously made about the status of its vaccine effort with the German biotechnology firm BioNTech. But the need for Bourla, who had previously said a vaccine could be available by October, to make a public announcement emphasizes the tense political conditions surrounding the race for a vaccine. (Herper, 10/16)
The New York Times:
Pfizer Says It Won’t Seek Vaccine Authorization Before Mid-November
Close watchers of the vaccine race had already known that Pfizer wouldn’t be able to meet the requirements of the Food and Drug Administration by the end of this month. But Friday’s announcement represents a shift in tone for the company and its leader, who has repeatedly emphasized the month of October in interviews and public appearances. In doing so, the company had aligned its messaging with that of [President Trump], who has made no secret of his desire for an approved vaccine before the election. (Thomas and Weiland, 10/18)
