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UK: Pfizer/BioNTech COVID Shot for 12-15 year-olds Approved

5 Jun, 2021 17:34 IST|Sakshi Post

Following similar approvals in the US and the EU, the UK's pharmaceuticals regulator announced on Friday that it has approved the COVID-19 vaccine created by Pfizer and BioNTech for use in children aged 12 to 15. 

Following a "rigorous examination" of the vaccine's safety and effectiveness in this age group, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom announced this decision today.

"We carefully assessed clinical trial data in children aged 12 to 15 years and determined that the Pfizer/BioNTech COVID-19 vaccine is safe and effective in this age group and that the vaccine's benefits outweigh any risks," stated MHRA Chief Executive Dr. June Raine.

Dr. Raine continued, "We have a rigorous safety surveillance system in place to monitor the safety of all UK-approved COVID-19 vaccinations, and this surveillance will include the 12-to 15-year age group."

The COVID-19 vaccine, developed by Pfizer and BioNTech, is already authorized for use in adults and adolescents aged 16 and above.

The Chair of the Commission on Human Medicines, Professor Sir Munir Pirmohamed, stated: "Randomized, placebo-controlled clinical studies involving almost 2,000 youngsters aged 12 to 15 years were conducted. From 7 days following the second dosage, there were no cases of COVID-19 in the vaccinated group, compared to 16 cases in the placebo group."

The World Health Organization has criticized the provision of vaccination to younger people in rich countries, prompting Pfizer/BioNTech's clearance. The World Health Organization has asked wealthy countries to support the COVAX program.

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