FOI release

Freedom of Information request on deaths following AstraZeneca COVID-19 vaccination (FOI 21/660)

Published 29 December 2021

9th July 2021

FOI 21/660

Dear

Thank you for your email to MHRA customer services dated 13th June 2021, where you asked questions relating to the AstraZeneca vaccine. Please see our response to the requested information below.

• How many people have died within 28 days of receiving the AstraZeneca vaccination?
• How many people have been hospitalised within 28 days of receiving the AstraZeneca vaccination?

The MHRA does not hold information relating to the number of fatalities or hospitalisations within 28 days of receiving the AstraZeneca vaccination. The Office for National Statistics release a Monthly Mortality Analysis dataset, in which the number of deaths involving COVID-19 (including adverse reactions to the COVID-19 vaccination) can be found:

https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/datasets/monthlymortalityanalysisenglandandwales

I would advise you to contact the Office for National Statistics in order to obtain further information.

The MHRA collect reports of suspected side effects to the COVID-19 vaccines including those with a fatal outcome. The MHRA has received 936 UK reports of suspected ADRs to the COVID-19 Vaccine AstraZeneca in which the patient died shortly after vaccination. The majority of these reports were in elderly people or people with underlying illness. Usage of the vaccines has increased rapidly 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 the deaths. Further information on these reports can be found in our weekly summary of Yellow Card reporting. Reports received via the Yellow Card scheme can be reported at any time after a suspected side effect has occurred. Additionally, the time frame from when the patient received the vaccine to experiencing a suspected side effect is not always provided by the reporter. We review and publish all death reports regardless of the time to onset from receiving a medicine or vaccine.

• How many people have been disabled or permanently incapacitated by the AstraZeneca vaccination?

The MHRA is unable to comment on the number of people left disabled or incapacitated as a result of a covid-19 vaccination as the Yellow Card reports do not detail functionality outcomes for patients, particularly in the medium to long term to be able to assess the level of disability for any patient that might have been experienced adverse events following COVID-19 vaccination. It is important to note that a report of an adverse drug reaction (ADR) does not necessarily mean that it was caused by the drug or vaccines. Other factors such as the underlying disease or other medicines may contribute to suspected adverse reactions. Any functionality outcomes for such patients evolve over time and depend on multiple factors such as type of adverse event that occurred, patient’s age and underlying conditions.

• How many serious yellow card submissions has there been for the AstraZeneca vaccine?

As of 23rd June 2011, 211,339 Yellow Cards have been reported for the COVID-19 Vaccine AstraZeneca. It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence ADR reporting.

For all COVID-19 vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness. A range of other isolated or series of reports of non-fatal, serious suspected ADRs have been reported. These all remain under continual review. There are currently no indications of specific patterns or rates of reporting that would suggest the vaccine has played a role.

Within the weekly summary of Yellow Card reporting reference above, the Vaccine Analysis Print (Annex 1) contains a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for the COVID-19 Vaccine AstraZeneca. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies.

• Have any MHRA internal reports recommended not using the AstraZeneca vaccine or suspending its use?

The MHRA’s role is to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to do this. The MHRA has been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at the population level.

All Yellow Card reports we receive are promptly entered onto the MHRA database so that they are available for review. Further information on how the MHRA monitors the safety of medicines and vaccines can be found here. 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.

The main objective of the safety monitoring process is to identify any new risks that may emerge as the vaccines are used. Such risks could include a new side effect, an apparent change in the nature of a known side effect, identification of factors that increase the chances of having a side effect, batch-related problems or issues related to inappropriate use of the vaccines.

If a new risk is confirmed, this will be fed into a continuous evaluation by the MHRA of the balance of benefits of a vaccine versus risks. The MHRA will consult the Commission on Human Medicines (CHM) and its Expert Groups and, if deemed necessary, regulatory action would be taken to minimise risk and support safe use of a given vaccine (e.g. adding warnings to the product information, sending out communications to healthcare professionals and patients, restricting its use). This would also be communicated to DHSC, PHE, devolved Governments and public health partners in the devolved nations to inform any decisions regarding the immunisation programme.

For further information on how we use the data we collect, please view our COVID-19: vaccine surveillance strategy - GOV.UK (www.gov.uk).

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division