(CMR) The UK has approved the use of the Pfizer COVID-19 vaccine for children 12 to 15, with Britain’s regulator saying on Friday the benefits outweigh any risk for those in this age group.
This latest approval follows a rigorous review of the vaccine's safety, quality, and effectiveness for children, which was carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).
“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,” Dr. June Raine, MHRA’s chief executive, said.
Raine said the UK's comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines would also include this age group.
She noted, “No extension to an authorization 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 program.”
Over 2,000 children aged 12 to 15 were studied as part of the randomized, placebo-controlled clinical trials. Results showed no coronavirus cases from seven days after the second dose in the vaccinated group, compared with 16 cases in the placebo group.