EMA: Data from Pfizer/BioNTech, Moderna for coronavirus vaccines 'very robust'

The European Medicines Agency (EMA) Executive Director Emer Cooke called the coronavirus vaccine trials data submitted by Pfizer/BioNTech and Moderna as ‘very robust’, per Reuters.

Key quotes

“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.” 

“The approval decision dates could change, depending on the assessment.”

“We cannot guarantee that there will be a positive outcome at this stage. We have to make sure we analyze those data correctly.” 

“AstraZeneca and Johnson & Johnson expected to submit in the first quarter of next year their applications for a marketing authorization of their COVID-19 vaccine candidates.”

developing story ...