Freedom of Information request (FOI 22/895)
Published 17 January 2024
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FOI 22/895
6th September 2022
Dear
Thank you for your enquiry under the Freedom of Information Act (FOIA) dated 12 August 2022, where you requested information on the 6-in-1 vaccines, including information on the ingredients.
The MHRA continually monitors the safety profile of all vaccines licensed in the UK. This monitoring process involves the collection of information about suspected adverse reactions in patients (through the Yellow Card scheme) and assessment of any new suspicions of harmful effects. The Yellow Card scheme captures reports of suspected side effects from all users including patients and healthcare professionals alike. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects. Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.
In the UK, two of the 6-in-1 vaccines commonly used are Infanrix Hexa and Vaxelis. The ingredients included in these vaccines are listed in Sections 2 and 6.1 of the Summary of Product Characteristics (SPC) (word files attached), the same list of ingredients is also present in section 6 of each of the package leaflets, or patient information leaflet (PIL) (pdf files attached). In terms of side effects, these are listed in section 4 of the package leaflets. You can also find the link the SPCs and PILs for Infanrix Hexa and Vaxelis here;
Infanrix Hexa: https://www.medicines.org.uk/emc/product/2586/pil
Vaxelis: https://www.medicines.org.uk/emc/product/12264/pil
You have mentioned Enfield NHS as the healthcare provider for your baby, therefore, please do contact them directly if you wish to which 6-in-1 vaccine they are currently using.
The 6-in-1 vaccine was introduced in 2017 in order to include the hepatitis B vaccination in line with World Health Assembly recommendations, More information on this can be found here; https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1048675/Hexavalent-information-for-HCP-Jan22.pdf
We have also provided the below webpages for further reading.
A guide to immunisations for babies born on or after 1 January 2020 - GOV.UK (www.gov.uk)
| [6-in-1 Vaccine | Vaccine Knowledge (ox.ac.uk)](https://www.gov.uk/government/publications/a-guide-to-immunisations-for-babies-up-to-13-months-of-age) |
We 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
Medicines and Healthcare products Regulatory Agency