Freedom of Information requeston the adverse drug reaction (ADR) reports the MHRA have received in association with diphtheria, tetanus, pertussis and polio (dTaP/IPV) childhood vaccine.(FOI 21/1146)
Published 26 May 2022
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FOI 21/1146
15th November 2021
Dear
Thank you for your FOI request dated 18th October 2021, where you requested data on the adverse drug reaction (ADR) reports the MHRA have received in association with diphtheria, tetanus, pertussis and polio (dTaP/IPV) childhood vaccine.
When considering the spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:
• A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms or events occur after use of a vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including 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 reviewed at regular intervals.
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.
As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://www.medicines.org.uk/emc/ for details on the possible side effects of the vaccine.
I can confirm that the MHRA has received 2,089 spontaneous UK suspected ADR reports with administration of the dTaP/IPV vaccine up to and including 28/10/2021 (data extracted on 29/10/2021). Please see the attached Drug Analysis Print (DAP) for a breakdown of the reported reactions and refer to the enclosed information sheet for guidelines on how to interpret the DAP.
It is important to note that in the UK, the dTaP/IPV vaccine is given alongside other vaccines as part of the routine childhood immunisation schedule. Details of the current UK immunisation schedule can be found here:
https://www.gov.uk/government/publications/the-complete-routine-immunisation-schedule
In response to your question as to how long your daughter is likely to protected from the diseases covered by this vaccine (diptheria, tetanus, pertussis and polio), please note that the Green Book on Immunisation against infectious disease chapter on tetanus recommends that the first booster should be given 3 years after completion of the primary course (which your daughter will have already received). https://www.gov.uk/government/publications/tetanus-the-green-book-chapter-30
These recommendations are made by the UK Health Security Agency (formerly Public Health England) on the basis of surveillance of these diseases. Details of the routine childhood immunisation schedule can be found here:
Routine childhood immunisations schedule from June 2020 (publishing.service.gov.uk)
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,
Vigilance and Risk Management of Medicines Division