Freedom of Information request on clinical trial data for the Pfizer/BioNTech vaccine in children aged 12-15 (FOI 21-678)
Published 13 August 2021
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22nd June 2021 FOI 21/661
Dear
Thank you for your email.
We have carefully reviewed clinical trial data for the Pfizer/BioNTech vaccine in over 2000 children aged 12 to 15 years of age and have concluded that that the benefits of this vaccine outweigh any risk and that it is effective and acceptably safe in this age group. This data has also been reviewed by the independent Commission on Human Medicines (CHM), its COVID-19 vaccine benefit-risk expert working group, as well as the Paediatric Medicines Expert Advisory Group.
No new side effects were identified and the safety data in children was comparable with that seen in young adults. As in the young adult age group, the majority of adverse events were mild to moderate, relating to reactogenicity (e.g. sore arm and tiredness.)
The Commission on Human Medicines (CHM) met on 27 May 2021 to discuss the request to vary the existing authorisation to extend the approval to apply to children aged 12 – 15 years old.
The CHM considered the results of randomised, placebo-controlled clinical trials in over 2000 children aged 12 – 15 years.
The immunogenicity results (showing how well the vaccine works), studied in approximately 200 children, demonstrated similar neutralising antibody levels in adolescents aged 12-15 years compared with the levels in young adults aged 16-25 years.
These results are supported by a very high level of short-term efficacy data in adolescents against symptomatic disease after 2 doses of vaccine 21 days apart.
In participants with no prior evidence of infection there were no cases of COVID-19 in the vaccinated group from 7 days after the second dose compared with 16 cases in the placebo group.
Consistent with what was seen in adults there was evidence that the vaccine provides protection even before the administration of dose 2. There were no cases seen in the vaccine group from 11 days after dose 1 compared to 31 in the placebo group. Prior to day 11 there were 3 cases in the vaccine group and 4 on placebo.
Safety data in children aged 12-15 years is available from one clinical trial. This safety data is supported by the safety data from the clinical trials in individuals aged 16 years and over, together with a large amount of real-world data on the safety of the Pfizer/BioNTech COVID-19 vaccine in individuals aged 16 years and over. This has been closely monitored as the vaccine has been rolled out both in the UK and internationally. This experience has reinforced the conclusion that the benefits of the Pfizer/BioNtech COVID-19 vaccine continue to outweigh any possible side effects.
The Public Assessment Report (Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 - GOV.UK (www.gov.uk)) will be updated to include the data which the CHM looked at to approve this vaccine, this will be available in due course.
You may be interested to know that other regulatory authorities around the world, including the European Medicines Agency (EMA), US FDA and Health Canada, have also approved the use of the vaccine in 12 – 15 year olds
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Yours sincerely
MHRA Customer Service Centre
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