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4 June 2021, 12:05
The Pfizer/BioNTech vaccine has been approved for some children in the UK.
The Pfizer vaccine has been approved for children aged 12-15 in the UK, it was confirmed today.
The medicines regulator has said that the Pfizer/BioNTech vaccine is safe and effective and that its benefits outweigh the risks.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it had carried out a "rigorous review" of the vaccine in that age group, and the UK's vaccines committee will not decide whether it will be offered to them.
The vaccine is already approved for people aged 16 and over.
Dr June Raine, chief executive of the MHRA, 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."
"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."