The UK regulator has approved the use of the Pfizer-BioNTech vaccine in children aged 12-15, saying it is safe and effective in this age group and the benefits outweigh any risks.
The Medicines and Healthcare products Regulatory Agency (MHRA) have approved the Pfizer/BioNTech coronavirus vaccine for children aged 12 to 15-years-old in the UK.
Dr June Raine, MHRA chief executive 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.”
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 to 17.
“We will be guided by the expert advisors and will update in due course.”