The Pfizer/BioNTech Covid-19 vaccine has been approved for use for 12 to 15-year-olds, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
The MHRA said the decision follows a “rigorous review” of safety and effectiveness in that age group.
The vaccine is already approved for use in adults and adolescents aged 16 years and above.
More than 2,000 children aged 12 to 15 were studied as part of the randomised, placebo-controlled clinical trials.
There were no cases of the virus from seven 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.
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.
Dr June Raine, MHRA Chief Executive said: “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.”
The Government’s independent advisory body, the Commission on Human Medicines (CHM), also reviewed the safety, effectiveness and quality of the vaccine for use in the age group.
The chairman of the Commission on Human Medicines Professor Sir Munir Pirmohamed said. “We have concluded that based on the data we have seen on the quality, effectiveness and safety of the vaccine, its benefits do outweigh any risk.
“The MHRA will continue to scrutinise all of the suspected side effects data received through the rigorous surveillance programme in place through the Yellow Card scheme and other safety surveillance measures for all of the Covid-19 vaccines used in the UK.”
He said the results were “extremely positive results.”
A Department of Health spokeswoman said: “The government has asked the independent experts at the Joint Committee on Vaccination and Immunisation (JCVI) to advise whether routine vaccination should be offered to younger people aged 12 to 17.
“We will be guided by the expert advisors and will update in due course.”
