* Medicines & Healthcare products Regulatory Agency FOI release FREEDOM OF INFORMATION REQUEST ON THE CIVIL LIABILITY AND IMMUNITY (FOI 21/943) Published 17 January 2022 © Crown

copyright 2022 This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit

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our website page below:

https://www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines#civil-liability-and-immunity

Any further enquiries concerning liability should be sent to the Department of Health and Social Care (DHSC). The Yellow Card scheme is run by the MHRA and is the UK system for collecting

and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. Reports received through our Yellow Card scheme

associated with the COVID-19 vaccines including reports associated with a fatal outcome can be viewed by following the link below:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions. When viewing the data at the link above 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 profile 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. As with any vaccine or medicine,

COVID-19 vaccines require continuous safety monitoring and that the benefits in protecting people against COVID-19 outweigh any side effects or potential risks. This is a process known as

safety monitoring (pharmacovigilance). This ensures that any potential medium and long term safety issues are promptly and adequately evaluated. As part of our signal detection processes,

all adverse reaction reports received are individually assessed and cumulative information reviewed at regular intervals. Be reassured that the MHRA is working in collaboration with partners

in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary. Vaccination is the single most effective way to reduce

deaths and severe illness from COVID-19. Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile

seen in clinical trials. Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a ‘flu-like’ illness, headache, chills, fatigue, nausea,

fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these reactions are not associated with more serious illness and likely reflect an expected, normal immune

response to the vaccines. 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. A high proportion of people vaccinated early in the vaccination campaign were very elderly, and/or had pre-existing medical conditions. Older age and chronic underlying

illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated. It is therefore important that we carefully review these

reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination. Part of our continuous analysis includes an evaluation of natural death rates

over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. Based on age-stratified all-cause mortality in England and Wales taken

from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions of doses of vaccines

administered so far, mostly in the elderly. Usage of the vaccines has increased over the course of the campaigns and as such, so has reporting of fatal events with a temporal association

with vaccination however, this does not indicate a link between vaccination and the fatalities reported. Review of individual reports and patterns of reporting does not suggest the vaccines

played a role in these deaths. The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects.

As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored and benefits and possible risks remain under review. In reference to your query surrounding

conflicts of interest, the declarations of interest of all members of the Commission on Human Medicines (CHM) and the MHRA’s Expert Advisory Groups (EAGs) are published. A link to these is

provided below: https://www.gov.uk/government/publications/human-medicines-regulations-2012-advisory-bodies-annual-report-2019 The MHRA staff conflict of interest policy sets out that staff

are required to declare any interests yearly and cannot hold direct financial interests. The policy states that ‘Staff members cannot hold direct financial interests in the pharmaceutical

and healthcare (medical devices) industries. ‘Newly appointed staff will be required to dispose of such interests before taking up employment with the Agency’. If you have a query about the

information provided, please reply to this email 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 you receive this response and addressed to: [email protected] Due to the ongoing Covid-19 situation, we are not able to accept delivery of any

documents or correspondence by post or courier to any of our offices Please remember to quote the reference number above in any future communications. If you were to remain dissatisfied with

the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not

normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at: Information Commissioner’s

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