London: United Kingdom’s drug regulator on Friday knowledgeable that it had accredited the COVID-19 vaccine developed by Pfizer and BioNTech to be used on 12 to fifteen year-olds after comparable clearances got within the US and the EU.
Britain’s Medicines and Healthcare merchandise Regulatory Company (MHRA) at the moment introduced this choice following a “rigorous review” of the protection, and effectiveness of the vaccine on 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,” mentioned Dr June Raine, MHRA Chief Government.
“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 accredited to be used in adults and adolescents aged 16 years and above.
Professor Sir Munir Pirmohamed, Chair of the Fee on Human Medicines mentioned: “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 because the administration of the vaccine to youthful individuals in wealthy international locations has garnered criticism from World Well being Organisation (WHO). WHO has urged wealthy international locations to provide pictures to the COVAX initiative.