FOI release

Freedom of Information request on the adverse reactions relating to all vaccines from 2016 (FOI 21/883)

Published 20 January 2022

1st September 2021

FOI 21/883

Dear

Thank you for your email to MHRA customer services dated 3rd August 2021, where you requested the following:

1. What steps has the MHRA taken to ensure that the reactions figures and fatal outcome figures are accurate and reliable? For example, are all reports routinely followed-up to ensure accuracy and reliability?

2. For the following years (2016, 2017, 2018, 2019, 2020, 2021) how many reactions and fatal outcome reports has the MHRA received for all vaccines i.e. how many in 2016, how many in 2017 etc?
3. For the following years (2016, 2017, 2018, 2019, 2020, 2021) how many reactions and fatal outcome reports has the MHRA received for influenza vaccines i.e. how many in 2016, how many in 2017 etc?

In regard to your first question, each week all signals (a drug-reaction combination) in the adverse drug reaction (ADR) database are statistically analysed to help identify potential signals of concern. These recognised signals are then assessed by a team of physicians, pharmacists, and scientists with expertise in assessing the benefits and risks of medicines. Assessors review individual reports and evaluate if a suspect vaccine (or drug) may have caused the reported reactions and consider factors including the patient’s medical history or concomitant medicines. In order to ensure accuracy of the data collected, cases are reviewed by assessors and recoded when necessary to capture accurate adverse drug reaction data. Serious cases (including fatalities) are followed up with the reporter to gather further information on the suspected adverse drug reaction. This helps to ensure reliability of our data and minimises false data entries. Weekly Covid and non-Covid signal meetings consisting of physicians, pharmacists, and scientists are carried out to discuss the reviewed signals and possible risks associated with a drug or vaccine. If you would like to find out more details on how the MHRA monitors the safety of medicines, you can find a summary here.

Further to your request, please see table 1 below which provides a breakdown of the total number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports received for any vaccine between 01/01/2016 – 31/05/2021 and the number of fatal reports. Please note the table below excludes reports received for the COVID-19 vaccines as further information is provided on these vaccines in the weekly summary of Yellow Card reporting which can be found here COVID-19 vaccines summary of Yellow Card reporting.

As you will be aware, the COVID-19 vaccines have been given to millions of people in the UK and we have worked to ensure that people know to report suspected side effects to the Yellow Card scheme. In addition to social media campaigns, we have issued a Drug Safety Update, a press release, and run social media campaigns informing healthcare professionals and members of the public that reporting to the Coronavirus Yellow Card reporting site help will enable the MHRA to rapidly identify new and emerging side effects. Vaccination materials have also signposted individual to the Coronavirus Yellow Card reporting site.

Table 1: Total number of UK spontaneous suspected ADR reports received for all vaccines (excluding COVID-19 vaccines) per year.

Year	Total reports	Fatal reports
2016	3394	22
2017	3880	19
2018	3926	25
2019	3360	23
2020	2739	14
Up to and including 31/05/2021	2055	8

Tables 2 and 3 provides a breakdown of the total number of UK spontaneous suspected ADR reports received for influenza vaccines between 01/01/2016 – 31/05/2021 and the number of fatal reports per year. The data is divided into two groups; table 2 contains adverse drug reaction (ADR) reports following the administration of the live attenuated influenza vaccines (LAIVs). Table 3 covers ADR reports following the inactivated flu vaccines. These are the main two flu vaccine groups; the LAIVs are mostly given to children, and the inactivated flu vaccines are typically administered to adults, especially the elderly.

Table 2: Total number of UK spontaneous suspected ADR reports received following the administration of the live attenuated influenza vaccines (LAIVs) per year.

Year	Total reports	Fatal reports
2016	289	2
2017	372	1
2018	358	0
2019	399	0
2020	197	2
Up to and including 31/05/2021	452	0

Table 3: Total number of UK spontaneous suspected ADR reports received following administration of the inactivated influenza vaccines per year.

Year	Total reports	Fatal reports
2016	571	5
2017	803	4
2018	1376	4
2019	1145	11
2020	1340	6
Up to and including 31/05/2021	362	1

Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. It is therefore important that we carefully review these reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination.

Please be aware underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines.

When considering spontaneous 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 vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. 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 or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine or vaccine, and may be stimulated by promotion and publicity. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

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