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MHRA approves Pfizer-BioNTech vaccine for 12-15-year-olds

The UK health regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) has extended approval of the Pfizer-BioNTech COVID-19 vaccine for use in children aged 12 to 15 years. This follows a similar approval by the European Medicines Agency and FDA in the US.

According to the manufacturer, in March 2021, the vaccine was studied in a Phase III trial in 2260 adolescents, aged 12 to 15. In the trial, there were 18 confirmed positive COVID-19 cases in the placebo group but none in those given the vaccine. Furthermore, among those vaccinated, the neutralising antibody titre response was high (geometric mean titre, GMT = 1239.5) in a subset of participants one month after the second dose and higher than the response generated in 16 to 25 year olds (GMT = 705.1) in an earlier study.

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According to June Raine, MHRA chief executive, “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.”

Importantly, there were no new safety signals generated in the adolescent study and while the UK regulator has approved the vaccine, it is the responsibility of the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether this age group will be vaccinated as part of the deployment programme.