FOI release

Freedom of Information request on Yellow Card reporting for COVID-19 vaccinations (FOI 21/775)

Published 29 December 2021

27th July 2021

FOI 21/775

Dear

Thank you for your email dated 5th July 2021 where you requested the following:

1. To date, of the 1403 fatalities recorded on the yellow card system, how many of these have the MHRA formally investigated in relation to adverse affects of taking a vaccine, or vaccines?
2. In relation to question 1, of any formal investigations taking place, how many deaths have been found to be as a direct result of taking a vaccine.
3. To date, of the 1,007,253 adverse reactions taking place as a result of vaccine yellow card reporting, please advise how many of these have been formally investigated by the MHRA?
4. Please provide details as to why the MHRA has not undergone formal investigations, if none have been carried out, in relation to the yellow card data as above. If investigations have been undertaken and the results of these investigations show that the vaccines are unsafe, please provide details on these findings.

The MHRA takes all reports of fatal events in patients who have received a COVID-19 vaccine very seriously and every report with a fatal outcome is fully evaluated and kept under continual review. We follow-up reports with a fatal outcome, where permission has been provided to do so, for further information, including post-mortem details if available. All details within a report are thoroughly assessed to consider whether the vaccine may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. The information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the death alongside data available from international sources. This is further considered by the Commission on Human Medicine and its Expert Advisory Groups.

Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or event in the days and weeks after vaccination. A high proportion of people vaccinated early in the vaccination campaign were very elderly, many of whom 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.

Up to the 14th July the MHRA has received 460 UK reports of suspected ADRs to the Pfizer/BioNTech vaccine in which the patient died shortly after vaccination, 999 reports for the COVID-19 Vaccine AstraZeneca, 7 for the COVID-19 Vaccine Moderna and 24 where the brand of vaccine was unspecified. The majority of these reports were in elderly people or people with underlying illness. 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. Our review of individual reports and patterns of reporting does not suggest the vaccine played a role in the deaths reported.

It is important to note that a report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. 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.

In regards to the non-fatal adverse reaction reports you reference - as part of our post-marketing signal detection processes, all adverse reaction reports submitted, by either healthcare professionals, patients and pharmaceutical companies alike, are assessed by one of our signal assessors. Vaccine-event combinations of interest, are further assessed and discussed at length by our team of multidisciplinary specialists, with representatives from different medical backgrounds and professions including scientists, physicians and pharmacists. If any emerging safety concerns or areas where risk minimisation measures could be in place are identified during this routine assessment, appropriate action will be taken. Where the COVID-19 vaccines are concerned, the MHRA is working closely with Public Health England and many other organisations across the UK to facilitate the sharing of post-marketing data and to ensure awareness of safety concerns if any arise. Reports are routinely followed up by the MHRA where additional information is required to aid in the assessment of a case or signal detection activities. The MHRA takes all reports very seriously and every report is fully evaluated by the MHRA and kept under continual review. Findings of any investigations involving COVID-19 vaccinations or any changes in government advice for healthcare professionals or patients is posted in the weekly summary of Yellow Card reporting, which can be found on our website here.

We supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. These combined safety data enables the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. Further information on our strategy for continually monitoring safety of COVID-19 vaccines can be found here:

https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance

We also work closely with our public health partners in reviewing the effectiveness and impact that the vaccines are having to ensure benefits continue to outweigh any possible side effects. In addition, we work with our international counterparts to gather information on the safety of vaccines in other countries. We now have very clear evidence from Public Health England (PHE) that both vaccines are highly effective and are contributing to an 80% reduction in hospitalisations.

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