London: United Kingdom's drug regulator on Friday informed that it had approved the COVID-19 vaccine developed by Pfizer and BioNTech for use on 12 to 15 year-olds after similar clearances were given in the US and the EU.
Britain's Medicines and Healthcare products Regulatory Agency (MHRA) today announced this decision following a "rigorous review" of the safety, and effectiveness of the vaccine in this age group.
"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," said Dr June Raine, MHRA Chief Executive.
"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," Dr Raine added.
The Pfizer/BioNTech COVID-19 vaccine is already approved for use in adults and adolescents aged 16 years and above.
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines said: "Over 2,000 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."
This approval of Pfizer/BioNTech comes as the administration of the vaccine to younger people in rich countries has garnered criticism from World Health Organisation (WHO). WHO has urged rich countries to give shots to the COVAX initiative.