FOI release

Freedom of Information request on deaths following influenza vaccinations (FOI 21/781)

Published 29 December 2021

29th July 2021

FOI 21/781

Dear

Thank you for your email dated 7th July 2021, where you asked for the following information under the FOI act:

From 2014-2019 how many influenza vaccinations were given per year in the UK? How many Yellow Card reports were created for these vaccines each year and how many were fatal?

In response to your first question about how many influenza vaccinations were given per year in the UK, the MHRA do not collect this information. Please contact Public Health England directly as they should be able to provide you with this:

https://www.gov.uk/government/organisations/public-health-england

Regarding your second question about how many Yellow Card reports were created for these vaccines each year and how many were fatal, please see the below tables that illustrate a breakdown of the total number of UK spontaneous suspected Yellow Card reports the MHRA received for each year between 2014-2019 in association with an influenza vaccine. The data is divided into two groups; Table 1 contains adverse drug reaction (ADR) reports following the administration of the live attenuated influenza vaccine (LAIV). Table 2 covers ADR reports following the injectable inactivated flu vaccines. These are the two main types of flu vaccines 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.

Table 1: 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 and those with a fatal outcome

Year	Total number of Yellow Card reports	Total number of fatal reports
2014	416	0
2015	463	2
2016	289	2
2017	372	1

Table 2: 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 and those with a fatal outcome

Year	Total number of Yellow Card reports	Total number of fatal reports
2014	517	6
2015	612	4
2016	571	5
2017	803	4
2018	1376	4
2019	1145	11
Total	5024	34

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. 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 with any serious suspected ADRs, all reports with a fatal outcome are fully evaluated by the MHRA, including an assessment of post-mortem details if available, to consider whether the vaccine (or medicine) may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. Any emerging evidence relating to possible risks associated with vaccines and medicines, would be carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed, and communicated with the public. These cases should be considered alongside the fact that in the UK alone, millions of people have received these vaccines over many years.

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