Freedom of Information request on the safety and efficacy of the Pfizer COVID-19 vaccine in the paediatric population (FOI 22/654)
Published 27 March 2023
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FOI 22/654
13th May 2022
Dear
Thank you for your email.
Please note that a publicly available version of the PIP is available here: MHRA-100390-PIP01-21-M01 (update) - MHRA and this version was developed such that commercially sensitive details and information with the quality of confidence were omitted and as such certain information is exempted under Sections 41 and Sections 43(1) and 42(2).
S.41. is an absolute exemption and no consideration of the public interest is required, except to state that we would consider the release of this information to be an actionable breach of confidence. S.43. is a qualified exemption and requires a consideration of the public interest. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm of alerting competitors to commercially sensitive details that are present in the unabridged PIP.
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. In terms of clinical assessment of the vaccine in younger children, please refer to the EPAR on the extension of the approval to 5-11 year olds which includes a very full discussion on the safety and efficacy of the vaccine in that age group. Please also refer to the SmPC and Package Leaflet published on the .gov website that are specific to the paediatric vaccine:
SmPC
Package Leaflet:
We understand the significant public interest in the COVID-19 vaccines, including use in children, and would like to highlight that the dose of the paediatric COVID-19 Vaccine Pfizer/BioNTech is lower than that used in adults, and to also highlight that use of the vaccine in the 5-11 year olds is carefully guided by JCVI recommendations and the MHRA product information (referred to above).
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. 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 MHRA’s assessment of the use of the Pfizer/BioNTech vaccine in adolescents is available in Annex 1 of the below-linked Public Assessment Report (PAR):
Furthermore, the study of the safety, immunogenicity, and efficacy of the Pfizer/BioNTech vaccine is published in a peer-reviewed journal, the link to this is also provided below:
https://www.nejm.org/doi/full/10.1056/NEJMoa2107456
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Yours sincerely
MHRA Customer Experience Centre