AgenciesBRUSSELS: The data submitted to the European Medicines Agency (EMA) by Pfizer/BioNTech and Moderna for their COVID-19 vaccine candidates is "very robust", its executive director said on Thursday.
"We have a data set of over 30,000 subjects who have been followed through the clinical trials. This gives us a very robust data set on which to make a decision, both on safety and efficacy," Emer Cooke said at a committee meeting of the European Parliament.
The agency is expected to complete reviews by Dec. 29 for the Pfizer/BioNTech vaccine and Jan. 12 for the Moderna vaccine at the latest.
"We cannot guarantee there will be a positive outcome," Cooke said.
"We have a data set of over 30,000 subjects who have been followed through the clinical trials. This gives us a very robust data set on which to make a decision, both on safety and efficacy," Emer Cooke said at a committee meeting of the European Parliament.
The agency is expected to complete reviews by Dec. 29 for the Pfizer/BioNTech vaccine and Jan. 12 for the Moderna vaccine at the latest.
"We cannot guarantee there will be a positive outcome," Cooke said.
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