Freedom of Information request on the authorisation of the Pfizer COVID-19 vaccine (FOI 22/439)
Published 27 March 2023
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FOI 22/439
10th May 2022
Dear
Thank you for your email.
Please find below answers to the questions you raise below.
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
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1043378/Summary_of_Product_Characteristics_for_COVID-19Vaccine_Pfizer_BioNTech_10_micrograms.pdf](https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1143553/SPC_COMIRNATY_10mcg_5_to_11_years.pdf)
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):
[https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine#further-information](https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine#further-information
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
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. Nearly 5 million 12 – 15 year olds in the USA have now received the vaccine, of whom 3.5 million have received both doses CDC COVID Data Tracker . In Canada, 1.5 million 12 – 17 year olds have received the vaccine
COVID-19 vaccination coverage in Canada - Canada.ca”
1) I am requesting to know why the MHRA have authorised the Pfizer covid 19 vaccine for children with out proper safety studies ?
Safety studies are detailed in the PARs (provided)
This is a totally new experimental treatment and even the JVCI was against the roll out of this treatment for children as the vaccine risks are higher than the benefits and children are not affected by covid.
Deployment follows JCVI recommendations (linked in our response)
2) I am also requesting copies of all the literature you have on which you based your decision regarding these vaccines for children ?
(Especially the long term safety studies)
The PAR for the Pfizer/BioNTech vaccine is a 74 page document specifically written for members of the public to understand the basis of our approval. Pages 52 – 74 address the extension of the indication to include subjects aged 12 to 15 years and the content of the PAR describes the studies that were submitted in detail. The EMA has also produced an 140 page EPAR for this vaccine. Please note as a vaccine for a new disease that emerged in 2019 it is not possible to have the results of long term studies, this explains why there is follow-up of Clinical Trial participants and detailed surveillance of vaccine safety in a real-world setting. . The independent experts (the members) of the Expert Working Groups and Commission on Human Medicines (CHM) are experts in their fields, and in order to effectively discharge their duties members regularly consult the scientific literature. The CHM advises ministers on the safety, efficacy and quality of medicinal products and vaccines.
3) I am requesting copies of the MHRA protocol for authorisation of any new experimental treatment ?
(For example does the MHRA have to follow strict protocols whereby adult studies have to be fully completed) Before offering treatment to children ?
Please note that conditional MAs are granted by both the MHRA and the EMA for the Covid-19 vaccines as we both have legislation that allows the approval of products as soon as sufficient data become available to demonstrate that the medicine’s benefits outweigh its risks. Both MHRA and EMA have published details of when such authorisations are appropriate:
4) What systems have the MHRA put in place to monitor serious rare side effects from the experimental Covid 19 vaccine in children ?
We also have a proactive pharmacovigilance strategy in place for the COVID-19 vaccines which includes specific monitoring of suspected adverse events in those under 18 years old and gathering information from international experience in these age groups too. Over 5 million doses of COVID-19 vaccine have been given to under 18 year olds in the UK, and so far no new safety concerns have been identified in this population. You can read more about the safety data for the COVID-10 vaccines gathered in children and adolescents here Coronavirus vaccine - weekly summary of Yellow Card reporting - GOV.UK (www.gov.uk)
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Yours sincerely
MHRA Customer Experience Centre