FOI release

Freedom of Information request on adverse reactions following the COVID-19 vaccinations (FOI 21/1018)

Published 25 February 2022

30th September 2021

FOI 21/1018

Dear

Thank you for your FOI request dated 4th September 2021, where you requested the following information:

• In total, in South Oxfordshire, how many 1) deaths and 2) adverse reactions have been recorded/reported, after vaccination?

• From 1st January 2021 to 4th September 2021: in the Reading area (please stipulate all localities included) how many deaths (with no co-morbidities) have been attributed to COVID -19 alone (not just with COVID- 19 recorded as a contributory factor). Additionally, please supply the same information for South Oxfordshire.

When considering the spontaneous Adverse Drug Reaction (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 and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, 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.

Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

All of the data provided below relates to UK spontaneous suspected Adverse Drug Reaction (ADR) reports concerning COVID-19 vaccines received directly by the MHRA (not via pharmaceutical companies). Data provided includes COVID-19 vaccine ADR reports from the geographical area covered by the NHS Oxfordshire Clinical Commissioning Group (CCG) up to and including 13/09/2021. Please note that the accuracy of the data relies on the postcode being provided by the reporter. Where reporters have only provided an email address and not a postal address these reports will not be included in the numbers provided below.

Table 1: Direct UK spontaneous suspected ADR reports for COVID-19 vaccines received from NHS Oxfordshire CCG up to and including 13/09/2021.

COVID-19 Vaccine	Number of Yellow Card Reports	Total Number of ADRs reported	Number of Yellow Card Reports with Fatal Outcome
AstraZeneca	3383	17386	10
Moderna	180	1017	0
Pfizer/ BioNTech	1384	5751	12
Brand unspecified	14	61	0

We have in place a proactive strategy to monitor the safety of the COVID-19 vaccines, and 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. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects. Part of our monitoring role includes reviewing reports (Yellow Cards) of suspected side effects. Data are now available on the impact of the vaccination campaign in reducing infections and illness in the UK.

With regards to your request for fatality data associated with COVID-19 alone in the Reading and South Oxfordshire areas, we can confirm that the MHRA do not hold this information. Public Health England produce the following summary, https://coronavirus.data.gov.uk/details/deaths, so may be able to help you further regarding a specific area breakdown of this information.

I hope that you will find this information useful.

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