A healthcare worker holds blood samples during clinical trials of the Covid-19 vaccine at America’s Research Centers in Hollywood, Florida, on Wednesday, September 9, 2020.
Eva Marie Uzcategi Bloomberg | Getty images
Pfizer expects to provide safety data and submit documents for the authorization of the Covid-1
Regulatory vaccinations may come as soon as safety data is available in the third week of November, Pfizer said, raising shares of the company and the wider US market.
The timetable now allows the United States to allow a coronavirus vaccine this year, a key step in tackling a pandemic that has killed more than a million and devastated the global economy.
The US Food and Drug Administration has said it wants at least two months of safety data before authorizing the emergency use of any experimental coronavirus vaccine.
Pfizer CEO Albert Burla said in a letter posted on its website that the submission depended on several factors, including performance data, which may or may not be available until the end of October.
Based on current registration and the dosing rate, Pfizer expects to receive safety data in the third week of November, Burla said.
The US Food and Drug Administration’s emergency authorization statement may come “soon after” that the data is ready, Burla said.
Bourla said data on the effectiveness of the vaccine could come sooner or later based on whether a late study of the vaccine had accumulated enough patients with COVID-19 to compare its effectiveness against placebo.
Earlier, Pfizer said it expects data from the October trial period in October.
BioNTech was not immediately available for comment.
Shares of Pfizer rose 1% before market trading, while shares of BioNTech, registered in the US, rose 2.4% before the opening bell.