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04/06/2021
Pfizer/BioNTech Covid-19 Vaccine Approved For 12 To 15-Year-Olds
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.
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.
"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 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.
"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."
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