Data from by Pfizer/BioNTech, Moderna for COVID-19 vaccines 'very robust': EMA

BRUSSELS: 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.