FOI release

Freedom of Information request (FOI 22/1130)

Published 17 January 2024

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FOI 22/1130

8th December 2022

Dear

Thank you for your email.

Further information on the need for the vaccination programme has been provided by the UK Health Security Agency:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1097153/UKHSA_12440_polio_leaflet_for_parents_and_carers.pdf

The vaccines listed in the above-linked publication by the UK Health Security Agency, Infanrix Hexa (PLGB 19494/0261), Vaxelis (PLGB 50692/0001 & 2) , Boostrix-IPV (PL 10592/0214) , Revaxis (PL 46602/0006), are all authorised medicines. Further information on each is available from MHRA and the EMA (links provided below):

https://products.mhra.gov.uk/search/?search=PLGB+19494%2F0261&page=1

https://www.ema.europa.eu/en/medicines/human/EPAR/infanrix-hexa       

https://products.mhra.gov.uk/search/?search=vaxelis&page=1                         

https://www.ema.europa.eu/en/medicines/human/EPAR/vaxelis

https://products.mhra.gov.uk/search/?search=PL+10592%2F0214&page=1

https://products.mhra.gov.uk/search/?search=PL+46602%2F0006&page=1

Regarding the specific questions:

  1. Why is a booster required for children aged between 1 and 9? Where is the evidence for this?

We hold no information on this and advise that you contact the UK Health Security Agency concerning this.

  1. Children aged over  3 years and four months would have already been vaccinated four times against polio. The whole point of those vaccines was to deal with outbreak of polio.  Why is a booster necessary?

We hold no information on this and advise that you contact the UK Health Security Agency concerning this.

  1. Where is the proof the vaccine is safe? What tests/research done to support this? When were these tests/research done?

Information is available in the Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs) and Public Assessment Reports (PARs linked above to show how these vaccines are safe.

  1. Has the vaccine been modified to take into account the alleged mutations of the polio strains?

The effectiveness of the vaccines against any new strains of the polio virus is something that the requester should contact the UK Health Security Agency.  

  1. How long does the original vaccine work for?

Vaccine effectiveness can decrease over time. For information on the effectiveness of the polio vaccines being administered, we recommend that you look at the  Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs) and Public Assessment Reports (PARs) we have provided links to above.

  1. Why is a booster vaccine not being offered to adults?

We hold no information on this and we advise that you contact the UK Health Security Agency concerning this.       

  1. What are the adverse reactions/side effects of the vaccine?

The adverse reactions/side effects observed with each vaccine are listed in the SmPC and PIL for each vaccine, that we have provided links to above.

Since February 2022, vaccine-derived polio virus has been detected in sewage in north and east London. Following this, the Joint Committee on Vaccination and Immunisation (JCVI) are advising that children aged 1-9 years old in London are offered a polio vaccine booster dose.

In the UK, IPV is only found in the following combination vaccines, and these are used in the routine immunisation schedule Complete routine immunisation schedule - GOV.UK (www.gov.uk) and IPV booster campaign. Hence, the data provided will refer to the combination vaccines, and not the single-antigen IPV.

  • DTaP/IPV/Hib/HepB (6-in-1 vaccine) – brand names Infanrix hexa or Vaxelis
  • DTaP/IPV vaccine – brand name - brand name Boostrix-IPV
  • Td/IPV vaccine – brand name Revaxis

Polio booster information for parents, is provided here:

Have your polio vaccine now - information for parents - GOV.UK (www.gov.uk)

For each of the above vaccines, the recognised adverse reactions are listed in section 4.8 of Summary of Product Characteristics (SPC) and section 4 of Patient Information leaflets (PIL). You can find links to the SPCs and PILs here:

The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes, including the Yellow Card scheme. This monitoring process involves the collection of information about suspected adverse reactions in patients (through the Yellow Card scheme). As part of our signal detection processes, all adverse reaction reports received by the Yellow Card scheme are individually assessed, and cumulative information is reviewed at regular intervals. If appropriate, regulatory action would be taken if any serious risks were confirmed.

For suspected adverse reactions being reported, the MHRA collects this information and this data is displayed as Analysis Prints. Please find attached the Vaccine Analysis Prints (VAPs) for IPV[1]containing combination vaccines (DTaP/IPV/Hib/HepB, DTaP/IPV, Td/IPV and DTaP/IPV/Hib*). The prints contain information on all the UK spontaneous Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme up to and including 26/10/2022. Please refer to the attached information sheet for guidelines on how to interpret the VAPs.

  • DTaP/IPV/Hib (5-in1-vaccine) was replaced by the 6-in-1 vaccine in 2017.

When viewing the vaccine analysis prints, you should remember that:

  • Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine or vaccine may have caused the adverse reaction. The existence of an adverse reaction report in the print does not necessarily mean that the vaccine has caused the suspected reaction.
  • It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.
  • Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.
  1. Is there a way to test the immune to see what level of protection has been generated by the original vaccine?

We confirm that MHRA holds no information on this. We recommend that you contact the UK Health Security Agency for an answer to this question.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

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