Pfizer plans to seek authorization for Covid-19 vaccine in November: company
US pharmaceutical giant Pfizer expects to file for emergency use authorization for its Covid-19 vaccine in late November, around two weeks after the November 3 US presidential election, it said 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," the company's chairman and CEO Albert Bourla said in an open letter.
The Food and Drug Administration (FDA), which authorizes pharmaceuticals for distribution in the US -- asked vaccine developers last week to spend two months monitoring for serious side effects after the second dose is given to trial participants.
Pfizer and Modern, both funded by the US government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses.
They aim to be in a position to deliver tens of millions of doses to the US by the end of the year.
"I've said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October," Bourla said.