(refiles with correct spelling of BioNTech in headline)
BRUSSELS, Dec 10 (Reuters) - 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.
(Reporting by Francesco Guarascio and Matthias Blamont; Editing
by Jon Boyle and Elaine Hardcastle)
Astrazeneca (AZN)
