London: The UK on Friday approved Pfizer/BoiNTech coronavirus vaccine for use in children aged between 12 and 15 years.
Britain’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) said on Friday the=at the decision followed a “rigorous review” of safety and effectiveness in the lower age groups.
“We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech COVID-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk,” said Dr June Raine, MHRA Chief Executive.
“No extension to an authorisation would be approved unless the expected standards of safety, quality and effectiveness have been met,” June said.
Raine added the UK’s surveillance regime for monitoring the safety of all approved Covid-19 vaccines would now include those aged 12 to 15 receiving doses.
The British regulator’s approval follows that of the European Medicines Agency and US Food and Drug Administration last month for the younger cohort to receive the Pfizer/BioNTech jab.
Until now, COVID-19 vaccines being administered in the U.K. have been approved for adults aged 16 and over.
More than three-quarters of adults have received at least a single dose.