This story was first published in digitalhealth.net
MHRA approves Pfizer/BioNTech vaccine in 12- to 15-year-olds
The MHRA 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 the risks.
The regulator said it had carried out a ‘rigorous review’ of the vaccine in adolescents, and the UK's vaccines committee will now decide whether children should get the jab.
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.
The Pfizer vaccine is already approved for use in people aged 16 and over. However, at present, there is no routine vaccination of under 18s against coronavirus 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.”
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