The UK regulator on Friday approved the Pfizer-BioNTech vaccine for 12 to 15 year-olds in the country.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it had given the approval after “carefully reviewing clinical trial data”. The European Medicines Agency(EMA) and US Food and Drug Administration(FDA) had earlier given the go-ahead for the vaccines to be administered to adolescents.
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”, she added.
“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,” Dr. Raine said.
Britain has vaccinated over 62 million citizens with at least one dose so far consisting mainly of AstraZeneca and Pfizer-BioNTech vaccines after its vaccination drive began in December.
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