Data from Pfizer/BioNTeh, Moderna for COVID-19 vaccines 'very robust'-EMA

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 assessment. "We cannot guarantee that there will be a positive outcome at this stage" Cooke said, adding that the agency's experts had to examine very large data sets.

"We have to make sure we analyse those data correctly," she said. Cooke added that EMA analysts were also checking data against the new information that emerged in Britain on Wednesday when two people had anaphylaxis and one a possible allergic reaction after the rollout of the Pfizer/BioNTech vaccine began.

She added that she expected AstraZeneca and Johnson & Johnson to submit in the first quarter of next year their applications for a marketing authorisation of their COVID-19 vaccine candidates. The agency has been assessing preliminary data of the AstraZeneca shot since early October, and Johnson & Johnson's data since early December.

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