BERLIN (Reuters) – BioNTech Chief Executive Ugur Sahin expects efficacy results from its late-stage trial of its potential coronavirus vaccine to be available shortly and said the company could file for U.S. approval in mid-November if the data are positive.
“We will certainly be smarter in a fortnight,” Sahin said in a video interview with regional publisher VRM posted online late on Thursday, adding he expects first efficacy data in late October, early November.
“We are optimistic,” he said, adding if the data are positive, a request for emergency approval could be submitted to the US Food and Drug Administration (FDA) in mid-November.
BioNTech and its US partner Pfizer are among the leading companies in the race to develop a coronavirus vaccine, along with the US biotech group Moderna and the British company AstraZeneca.
Pfizer said on Tuesday there had not yet been enough infections in the 44,000-volunteer trial to trigger an analysis of whether or not the vaccine works. An independent panel will conduct the first analysis when it reaches 32 infections.
Pfizer also said that if the trial is successful, it expects to file for emergency authorization shortly after it has enough safety data in late November.
(Reporting by Patricia Weiss; Writing by Caroline Copley; Editing by Ludwig Burger; Editing by Ludwig Burger)