By Deirdre Tynan • 04 June 2021 • 16:38
Pfizer approved for children in the UK aged between 12 and 15.
The UK has approved the Pfizer jab for 12- to 15-year-olds after a review of the safety, quality and effectiveness of the vaccine in that age group.
An extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds has today been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
This follows a rigorous review of the safety, quality and effectiveness of the vaccine in this age group by the MHRA and the Government’s independent advisory body, the Commission on Human Medicines, the government said.
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 said.
“It will now be for the Joint Committee on Vaccination and Immunisation to advise on whether this age group will be vaccinated as part of the deployment programme,” she added.
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. In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25 years. These are extremely positive results.”
The Pfizer/BioNTech COVID-19 vaccine is already approved for use in adults and adolescents aged 16 years and older.
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Deirdre Tynan is an award-winning journalist who enjoys bringing the best in news reporting to Spain’s largest English-language newspaper, Euro Weekly News. She has previously worked at The Mirror, Ireland on Sunday and for news agencies, media outlets and international organisations in America, Europe and Asia. A huge fan of British politics and newspapers, Deirdre is equally fascinated by the political scene in Madrid and Sevilla. She moved to Spain in 2018 and is based in Jaen.
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