FOI release

Freedom of Information request on the safety surveillance for COVID-19 vaccines (FOI 21/975)

Published 17 January 2022

16th September 2021

FOI 21/975

Dear

Thank you for your email dated 19th August 2021, where you asked:

“How many people have died or been injured after taking 1 or 2 doses of the Covid vaccine? Aside from the voluntary yellow card reporting system, what steps are you taking to ensure you are obtaining and recording full and accurate data on this matter?.”

We can confirm that we do not hold this information as we do not collect complete fatality data. We suggest you contact the Office for National Statistics for death statistics, please find below contact details;

Email: info@ons.gov.uk

Reports received through our Yellow Card scheme include some fatality reports and these can be viewed for the COVID vaccines by following the link below: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

When considering the 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, 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.

• It is important to note that when submitting a Yellow Card, reporters may report the time to onset as the time when the first symptoms began, the time at which an admission occurred or a diagnosis. The MHRA consider all ADR reports in our ongoing analysis regardless of time to onset and look at a range of risk windows in our statistical analysis; we never exclude a case.

One of MHRA’s main roles is to continually monitor safety of medicines and vaccines during widespread use, and we have in place a proactive strategy to do this for COVID-19 vaccines. Through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We can then take any necessary action to minimise risks to individuals.

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