The Pfizer/BioNTech vaccine is already approved for those aged 16 and upwards in the UK and, in line with countries including the UAE, Singapore and the US, the vaccine is now considered "safe and effective" for those aged 12 to 15 years; this is the first Covid-19 vaccine to be approved in the UK for this age group.
There is currently no routine vaccination of under 18s against Covid-19 in the UK. However, following a rigorous review of the Pfizer jab by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK's Joint Committee on Vaccination and Immunisation (JCVI) will now advise the government on whether this age group should be vaccinated as part of the UK rollout.
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."
More than 2,000 children aged 12-15 years were studied as part of the placebo-controlled clinical trials, and 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.