UK approves Pfizer Covid vaccine for use in 12-15-year-olds

The UK has approved the use of the Pfizer-BioNTech vaccine in children aged 12-15.

The move follows “a rigorous review of the safety, quality and effectiveness of the vaccine in this age group” the Medicines and Healthcare products Regulatory Agency (MHRA) has said.

Last month first minister Mark Drakeford said children as young as 12 in Wales could be given a Coronavirus vaccination later this year.

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.”

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines said: “Over 2000 children aged 12-15 years were studied as part of the randomised, placebo-controlled clinical trials.”

“There were no cases of COVID-19 from 7 days after the second dose in the vaccinated group, compared with 16 cases in the placebo group.”

“In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25 years. These are extremely positive results.”