Last reviewed 4 June 2021
Following a rigorous review of the safety, quality and effectiveness of the vaccine in this age group, an extension has been authorised to the current UK approval of the Pfizer/BioNTech Covid-19 vaccine to allow its use in 12 to 15 year-olds.
The Medicines and Healthcare products Regulatory Agency (MHRA) said that it had carefully reviewed clinical trial data in children in this age group and has concluded that the vaccine is safe and effective in this age group and that the benefits outweigh any risk.
MHRA Chief Executive, Dr June Raine, said: “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.”
The Pfizer/BioNTech COVID-19 vaccine is already approved for use in adults and adolescents aged 16 years and above.
No new side effects were identified and the safety data in children was comparable with that seen in young adults, Dr Raine made clear. As in young adults, the majority of adverse events were mild to moderate and relating to reactogenicity, such as a sore arm or tiredness.
Details of the regulatory approval of Pfizer/BioNTech vaccine can be found here .
Professor Sir Munir Pirmohamed, Chairman of the Commission on Human Medicines, said: “Over 2000 children aged 12 to 15 years were studied as part of the randomised, placebo-controlled clinical trials. There were no cases of Covid-19 from seven days after the second dose in the vaccinated group, compared with 16 cases in the placebo group”.