FILE PHOTO: Syringes are seen in front of displayed Biontech and Pfizer logos in this illustration taken November 10, 2020. REUTERS/Dado Ruvic/Illustration
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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.
“They have not submitted an application for a conditional marketing authorisation,” EMA added.
(Reporting by Francesco Guarascio @fraguarascio Editing by Catherine Evans)
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Codx Stock – EU drug regulator says it received data from Pfizer on COVID vaccine large-scale trial
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