The U.K.’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 U.K. 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.
Safety strategy
“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all U.K.-approved COVID-19 vaccines and this surveillance will include the 12- to 15-year age group. No extension to an authorisation would be approved unless the expected standards of safety, quality and effectiveness have been met,” she said.
It will now be for the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether this age group will be vaccinated as part of the deployment programme, the MHRA said.
The regulator said no new side effects were identified and the safety data in children was comparable with that seen in young adults. As in young adults, the majority of “adverse events” were mild to moderate and relating to “reactogenicity”, such as a sore arm or tiredness.
A Department of Health and Social Care spokesperson said the next step was for the JCVI to advise whether routine vaccination should be offered to those aged 12 to 17. The vaccine was approved for use for 16-and 17-year-olds in December 2020.
