Tuesday, May 11, 2021

EMA - PFIZER VACCINE LIKELY TO BE APPROVED BY END OF MAY FOR 12-15 YEAR OLDS

 Filenews 11 May 2021



Pfizer and BioNTech's vaccine against COVID-19 could likely receive European approval for use in children as young as 12 at the end of this month, the executive director of the European medicines regulator told Handelsblatt newspaper.

"At the moment, the target we are setting for approval is sometime in June. We are trying to see if we can speed this up at the end of May," European Medicines Agency (EMA) head Emer Cook said in a joint interview with Handelsblatt and other European newspapers.

"We were promised data from the study done by Canada over the next two weeks or so and this could speed up the evaluation," she said, adding that it was up to EU member states when to start administering the vaccine to the 12-15 age group following the EMA's 'green light'.

The EMA began assessing the use of the comirnaty vaccine in the 12-15 age group on 3 May, saying it is awaiting the results of its evaluation in June.US regulators yesterday approved the vaccine for children aged 12 and has already been approved for use in 16-year-olds in the US and Europe.

Source: RES-BE