London, June 4: The UK’’s medicines regulator on Friday approved the Pfizer/BioNTech coronavirus vaccine for 12 to 15 year olds, saying it is “safe and effective” in this age group and the benefits outweigh any risks.
Until now, COVID-19 vaccines being administered in the UK have been approved for adults aged 16 and over.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the decision followed a “rigorous review” of safety and effectiveness in the lower age groups and its conclusion is that the benefits of the vaccine far outweigh any risks.
“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.