The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulator, has extended approval of the Pfizer-BioNTech COVID-19 vaccine for use in children aged 12 to 15 years.
This follows a similar approval for the vaccine by the European Medicines Agency and the FDA in the US.
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.
MRHA Chief Executive June Raine 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.”
An important finding from the adolescent study was that no new safety signals were generated. Although the MHRA has approved the vaccine in the adolescent population, it remains 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.
