On Friday, Pfizer Inc said it may file for authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before US elections as President Donald Trump has promised.
The regulatory filing for the vaccine could come as soon as safety data is available, possibly in the third week of November, Pfizer said.
This allows for a possible US authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.
The US Food and Drug Administration said earlier this month it wants at least two months of safety data on half of the trial participants before authorizing emergency use of any experimental coronavirus vaccine.
Based on current trial enrollment and dosing in a late-stage trial, Pfizer expects to have that safety data in the third week of November, Chief Executive Officer Albert Bourla said in an open letter posted on the company’s website.
Bourla noted in the letter that the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October.
He said the company plans to share efficacy data with the public as soon as practical.
