(Reuters) – Pfizer said on Friday it could apply for approval for the emergency use in the United States of its Covid-19 combat vaccine candidate, which is being developed together with Germany’s BioNTech SE, as soon as a safety milestone is reached in the third week of November.
The US drug regulatory agency, FDA, said it wanted at least two months of safety data before authorizing the emergency use of any experimental coronavirus vaccine.
Based on the current test enrollment and dosing rate, Pfizer expects to have this safety data in the third week of November, said executive director Albert Bourla in a statement.
Pfizer had previously said it expected final-stage test data in October.
(Por Manojna Maddipatla e Manas Mishra em Bengaluru)