The Covid-19 vaccine was already approved in the country for use in adults and adolescents aged 16 years and above
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the approval for Pfizer and BioNTech’s Covid-19 vaccine to include use in children aged 12 to 15 years.
The Pfizer-BioNTech Covid-19 vaccine has already been approved in the country, for use in adults and adolescents aged 16 years and above.
The expanded regulatory approval follows a strict review of the safety, quality and effectiveness of the vaccine by the MHRA and the Commission on Human Medicines (CHM).
CHM is a non-departmental public body that advises ministers and the MHRA on the safety, efficacy and quality of medicinal products.
Commission on Human Medicines chair Munir Pirmohamed said: “We have been very careful to take into consideration the younger age group and the benefits of this population being vaccinated against any potential risk of side effects.
“There has been a thorough assessment and review of this data which was also looked at specifically by the CHM’s Paediatric Medicines Expert Advisory Group who are scientific experts within this age group, as well as the CHM’s Covid-19 Vaccines Benefit Risk Expert Working Group.”
More than 2000 children, aged 12-15 years were studied as part of the randomised, placebo-controlled clinical trials in the UK.
In the study, no new side effects were identified and the safety data in children was comparable with that seen in young adults.
Based on the quality, effectiveness and safety data, CHM concluded that the benefits of the Pfizer-BioNTech Covid-19 vaccine do outweigh any known risk.
The UK regulator said that the Joint Committee on Vaccination and Immunisation (JCVI) is required to decide whether to vaccinate this age group as part of the UK’s vaccination programme.
MHRA chief executive June Raine said: “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.
“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-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.
Pfizer and BioNTEch’s Covid-19 vaccine is also approved in Switzerland, for vaccinating children aged 12 to 15 years.