FOI release

Freedom of Information request (FOI 22/951)

Published 17 January 2024

19th November 2022

FOI 22/951

Dear

Thank you for your email dated 2nd September 2022, where you requested the following:

1. Copy of scientific evidence held by MHRA confirming that a “virus” is the causal agent of Poliomyelitis [Polio], and

Response to Q.1.

Data and information confirming that polio viruses are the causal agent of poliomyelitis are easily accessible by other means. Similarly to the sentiments expressed in the response below, there is an abundance of information and data about the classification of Polio viruses, as well as, substantiative data to assign these viruses to the cause of poliomyelitis. Section 21 of the FOIA (Information reasonably accessible to the applicant by other means) has been applied to both questions 1 and 2. .

We trust that you will find the below (referenced) resource / informative and of use.

[Pinkbook: Poliomyelitis

CDC](https://www.cdc.gov/vaccines/pubs/pinkbook/polio.html)

1. Copy of scientific evidence held by MHRA confirming that Poliomyelitis [Polio] is “infectious”,

Response to Q.2

Data and information confirming that polio viruses are contagious are easily accessible by other means. We have included some websites below for guidance, and there is also an abundance of scientific literature on the topic of epidemiology that represent evidence of polio virus transmission and infection.

Poliomyelitis (polio) (who.int)

GPEI – Global Polio Eradication Initiative

Disease factsheet about poliomyelitis (europa.eu)

1. Full list of knon[SIC] adverse reactions to the “inactivated polio vaccine” [I P V], to enable parents to make informed decisions.

Response to Q.3

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 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:

• Infanrix Hexa (DTaP/IPV/Hib/HepB)

• Vaxelis (DTaP/IPV/Hib/HepB)

• Boostrix-IPV (DTaP/IPV)

• Revaxis (Td/IPV)

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-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.

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 Teams,

Safety and Surveillance

Healthcare, Quality and Access