FOI release

Freedom of Information request (FOI 22/1092)

Published 17 January 2024

1st December 2022

FOI 22/1092

Dear ,

Thank you for your email dated 3rd November 2022, where you requested the following:

1. The most common side effects of the Pfizer vaccine

2. Latest research findings on impact of Pfizer on child’s enduring health in the months/year post vaccine should delayed side effects arise

Response to question 1

As you are aware, the NHS is offering a COVID-19 vaccine as active immunisation to prevent COVID-19 caused by SARS-CoV-2 in children aged 5 years of age and above. The current recommendation from the Joint Committee on Vaccination and immunisation (JCVI), which advises UK health departments on immunisation, is that children aged 5 to 11 years should be offered the COVID-19 vaccine from Pfizer/BioNTech (brand name Comirnaty). You can find the COVID-19 vaccination guidance for parents of children aged 5 to 11 years here:

https://www.gov.uk/government/publications/covid-19-vaccination-resources-for-children-aged-5-to-11-years/a-guide-for-parents-of-children-aged-5-to-11-years

For Comirnaty, the recognised adverse reactions, including the most common side effects, are listed in section 4.8 of the Summary of Product Characteristics (SPC) and section 4 of the Patient Information leaflet (PIL). You can find links to the SPC and PIL here:

https://www.medicines.org.uk/emc/product/13134/pil

Response to question 2

For all the COVID-19 vaccines deployed in the UK, long-term safety is a safety concern specified in the Risk Management Plans and is subject to ongoing monitoring and investigation in post-authorisation safety studies. Due to the relatively short period of time which has elapsed since the deployment of the vaccines in the UK and abroad, final results from these studies are not yet available. Should any new safety concerns arise from the interim or final results of these studies, the MHRA will act promptly to protect the public health.

On an ongoing basis, the MHRA closely monitors the safety of COVID-19 vaccine exposures in people under 18 years old and in adults. This monitoring process involves the collection of information about suspected adverse reactions in through the Yellow Card scheme. As part of our signal detection processes, all adverse reaction reports received by the Yellow Card scheme are assessed, and cumulative information is reviewed at regular intervals. We also supplement this analysis with information with data from epidemiology studies, anonymised GP-based electronic healthcare records, and other healthcare data, to proactively monitor safety. If appropriate, regulatory action is taken is any new or changing safety concerns are identified.

The MHRA displays Yellow Card data in Vaccine Analysis Prints. Please find attached the VAPs for the Pfizer/BioNTech COVID-19 vaccines authorised in the UK (Comirnaty 10 micrograms/dose, Comirnaty 30 micrograms/dose and Comirnaty Original/Omicron BA.1 15/15 micrograms/dose). The prints contain information on all the UK spontaneous Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme up to and including 22/11/2022. Please refer to the attached information sheet for guidelines on how to interpret the VAPs.

I would also like to take this opportunity to draw your attention to ‘Coronavirus vaccine - summary of Yellow Card reporting. This document contains summaries of several aspects of the COVID-19 vaccine safety data including safety data arising from use in people under 18 years of age.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response and can be addressed to this email address.

Yours sincerely,

FOI Team,

Safety and Surveillance