FOI release

Freedom of Information request on adverse reactions for the MMR and flu vaccine (FOI 21/877)

Published 20 January 2022

18th August 2021

FOI 21/877

Dear

Thank you for your email dated 23rd July 2021, where you asked for the following information under the FOI act:

I am writing to request the data for the total amount of AVRs per year, for the years 2018-2020 for the MMR vaccine and Flu vaccine.

To address your question about the total number of adverse reactions reported in association with the MMR (measles, mumps, and rubella) and influenza vaccines received via the Yellow Card Scheme, please see the below tables that illustrate a breakdown of the total number of UK spontaneous suspected Yellow Card reports received by the MHRA between 2018-2020 in association with an MMR or influenza vaccine.

The data is divided into three groups; Table 1 contains the total number of adverse drug reaction (ADR) reports following the administration of the MMR vaccine, Table 2 covers the ADR reports following the live attenuated influenza vaccine (LAIV) and Table 3 covers ADR reports following the injectable inactivated influenza vaccines. These are the two main types of flu vaccine administered in the UK; the LAIVs are administered nasally, mostly to children, and the inactivated flu vaccines are typically administered to adults, especially the elderly, via injection. Both are currently on the routine immunisation schedule. It is important to note that the data provided is inclusive of all brands of MMR vaccine, live attenuated influenza vaccine and injectable inactivated influenza vaccine.

Please find attached 9 Drug Analysis Prints (DAPs) for the MMR vaccine, live attenuated influenza vaccine and the injectable inactivated influenza vaccine broken down by year. The prints contain complete information on all the UK spontaneous suspected ADR reports received for each year between 2018 to 2020 for all 3 requested vaccines. Please also find attached a guidance sheet which provides you with further information on how to interpret the prints.

Table 1: Total number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports received by the MHRA in association with the MMR vaccine broken down by year

Year	Total number of Yellow Card reports
2018	398
2019	431
2020	299
Total	1128

Table 2: Total number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports received by the MHRA in association with the live attenuated influenza vaccine (LAIV) broken down by year

Year	Total number of Yellow Card reports	Total number of Adverse Drug Reactions
2018	358	1159
2019	399	1359
2020	197	578
Total	954	3096

Table 3: Total number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports received by the MHRA in association with the inactivated injectable influenza vaccine broken down by year

Year	Total number of Yellow Card reports	Total number of Adverse Drug Reactions
2018	1376	4570
2019	1145	3948
2020	1340	4376
Total	3861	12894

When considering the spontaneous 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. A patient may also experience more than one adverse reaction, and as such, each report may contain more than one suspected reaction reported in association with vaccine use. Therefore, Yellow Card data cannot be used to determine the incidence of a reaction or to compare the side effect profiles of different medicines or vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug or vaccine 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.

As you may already be aware, the MMR vaccine is usually given as part of the UK routine immunisation schedule which is offered to all eligible age groups and rolled out under the National Health Service (NHS). It is important to note that whilst we have provided data for the MMR vaccination, many of the reports will contain multiple other vaccines from the routine vaccination schedule detailed as co-suspect vaccinations as often a number of vaccines will be given to a patient on the same day.

Please be assured that the MHRA and Public Health England work closely together to monitor the quality, safety and effectiveness of all vaccines authorised and used in the UK.

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,

Vigilance and Risk Management of Medicines Division