The UK has approved the Pfizer/BioNTech coronavirus vaccine for use in children aged 12-15.
The Medicines and Healthcare products Regulatory Agency (MHRA) authorised the use of the jab in the younger age group on Friday following a review of its safety, quality and effectiveness.
The Pfizer Covid-19 jab was the first to be authorised for use in the UK at the end of last year.
MHRA chief executive Dr June Raine said: “We have carefully reviewed clinical trial data in children aged 12-15 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.
“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.”
A Department of Health spokeswoman said: “The Government has asked the independent experts at the Joint Committee on Vaccination and Immunisation (JCVI) to advise whether routine vaccination should be offered to younger people aged 12-17.
“We will be guided by the expert advisers and will update in due course.”
More than 2,000 children aged 12-15 were studied as part of the randomised, placebo-controlled clinical trials.
There were no cases of the virus from seven days after the second dose in the vaccinated group, compared with 16 cases in the placebo group.
In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25.
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 related to reactogenicity, such as a sore arm or tiredness. – PA