BRUSSELS (Reuters) – The European Medicines Agency said on Wednesday that Pfizer and BioNTech had submitted data from large-scale trial of their potential COVID-19 vaccine for the agency’s rolling review, but had not yet applied for approval.
The two companies earlier in November said their experimental COVID-19 vaccine was more than 90% effective based on initial trial results, making them the first vaccine makers to announce results from large-scale, phase III clinical trials.
“The companies have now submitted to EMA this emerging data and we will assess it as part of the rolling review,” EMA said in an emailed statement.
The drug regulator launched a rolling review of the Pfizer-BioNTech vaccine on Oct. 6, in a procedure meant to speed up the possible approval of the vaccine.
“They have not submitted an application for a conditional marketing authorisation,” EMA added.
(Reporting by Francesco Guarascio @fraguarascio Editing by Catherine Evans)