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.”
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