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 by Jan. 12 for the Moderna vaccine “at the latest.”
Cooke said that the approval decision dates could change, depending on the assessme…
Keep on reading: Data from Pfizer/BioNTech, Moderna for COVID-19 vaccines ‘very robust’ – EMA