Pfizer Inc expects to provide safety data and file for authorisation of the Covid-19 vaccine it is developing with German partner BioNTech in late November, assuming it receives positive efficacy and safety data from late-stage human trials, said the US company on Friday.
It would be the first time that Pfizer or any other leading Western vaccine developer provided such a specific timeline, reported the Wall Street Journal. The drug giant said it continues to expect to have data on the vaccine’s effectiveness—whether it protects at least a majority of vaccinated people from the disease—later this month. It then expects to have data on the drug’s safety by the third week of November, said the Journal.
The timeline allows for possible US authorisation of a coronavirus vaccine this year, a key step in controlling a pandemic that has killed more than a million and ravaged the global economy, said Reuters UK.
USA’s Food and Drug Administration has said it wants at least two months of safety data before authorizing emergency use of any experimental coronavirus vaccine, according to the agency.
Pfizer’s Chief Executive Officer Albert Bourla noted in a letter posted on its website that the filing depended on several factors, including data on effectiveness that may or may not be available by late October.
Based on current trial enrollment and dosing pace, Pfizer expects to have the safety data in the third week of November, Bourla said.
BioNTech and Pfizer previously set a target to produce up to 100 million vaccines globally by the end of this year. That initial batch would only be enough for 50 million people, though, because the vaccine, known as BNT162, consists of two shots, a so-called prime vaccination and a booster. The two companies haven’t disclosed how many doses they have already made, said the Journal.