THE HAGUE: Europe’s medicines watchdog said Monday it had begun evaluating the use of Pfizer-BioNTech’s Covid-19 vaccine for 12- to 15-year-olds, after a similar request in the US.The European Medicines Agency’s human medicines committee “will carry out an accelerated assessment of data submitted by the company that markets Comirnaty”, said an Ema statementThis included results from a large ongoing clinical study involving adolescents from 12 years of age, the Amsterdam-based agency said.
Pfizer and BioNTech on Friday asked the European regulator to authorise their Covid-19 vaccine after filing a similar request with the US authorities earlier in April.The move comes after phase 3 trial data showed the vaccine provided “robust antibody responses” and was 100% effective in warding off the disease among those aged 12 to 15, the companies said.Pfizer and BioNTech added they also planned to seek clearance from “other regulatory authorities worldwide”.
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