US pharmaceutical giant Pfizer expects to apply for emergency federal authorization of its coronavirus vaccine by late November, the company's CEO Albert Bourla said in a statement on Friday
WASHINGTON (Pakistan Point News / Sputnik - 16th October, 2020) US pharmaceutical giant Pfizer expects to apply for emergency Federal authorization of its coronavirus vaccine by late November, the company's CEO Albert Bourla said in a statement on Friday.
"So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November," Bourla said.
Bourla noted that the US food and Drug Administration requires companies to provide at least two months worth of safety data before seeking emergency authorization of any potential vaccine. Pfizer expects to reach that milestone by late November, based on its current enrollment and dosing pace, he said.
"All the data contained in our US 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," Bourla added.
Bourla also reiterated that Pfizer may know by the end of October whether or not its vaccine candidate is effective.
