FOI release

Freedom Information request on the number of hospitalisations due to ADRs to COVID vaccines, number of autopsies of the fatalities reported to the Yellow Card system and the current survival rate of the Delta variant of COVID-19 (FOI 21/832)

Published 27 April 2022

9th August 2021 FOI 21/832 Dear

Thank you for your email dated 20th July 2021, where you asked: “please can you provide:

1) the weekly data for UK / England and Wales of the number of hospitalisations due to adverse reactions to the Coronavirus vaccines since the rollout began, and where this is available going forward? 2) the number of fatalities within 28 days of having a vaccination and where this information is available going forward? 3) the number of autopsies of the 1400 fatalities plus reported to the Yellow Card system 4) the number of investigations undertaken into the above reported fatalities/ and access to individual reports for each of the investigations into the above 1400 plus reported fatalities. 5) the current survival rate of the Delta variant of Covid19.”

Question 1, 2 and 3: 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 and Public Health England for hospitalisation statistics please find below contact details; Email: info@ons.gov.uk Email: enquiries@phe.gov.uk Reports received through our Yellow Card scheme include some fatality reports and these can be viewed by following the link below: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

Question 4: All Yellow Card reports we receive are promptly entered onto the MHRA’s Adverse Drug Reaction (ADR) database so that they are available for a process called signal detection. During signal detection, reports are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of medication or vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern. For the COVID-19 vaccines, we supplement this form of safety monitoring with other epidemiology studies, including data analysis on national vaccine usage, anonymised GP-based electronic healthcare records, and other healthcare data to proactively monitor safety. These combined safety data enable the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally important objective of monitoring will be to quickly rule out risks – in other words, to confirm that the vaccine is not responsible for a suspected side effect and to provide reassurance on its safety. We also take into account the international experience based on data from other countries using the same vaccines. For further information on how we use the data we collect, please view our COVID-19: vaccine surveillance strategy - GOV.UK (www.gov.uk).

As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA to consider whether the medicine or vaccine may have caused the event or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. To ensure the comprehensive assessment of fatal reports, we follow-up all fatalities where permission has been provided to do so for further information.

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. Fatal cases associated with extremely rare blood clots with lowered platelets are described above. 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. Regarding your request to access individual reports, we can confirm that we hold this data however patient information is exempt from release under Section 40 of the FOI Act which protects personal data, the disclosure of which would breach one or more of the data protection principles therefore we cannot provide individual case safety reports. For COVID-19 vaccinations we are proactively publishing details of adverse drug reactions received, including MHRA assessment of the data to provide context. Please note this data is updated weekly. https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

Question 5: We can confirm that we do not hold this information.

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