FOI release

Freedom of Information request on suspected adverse drug reaction (ADR) reports received for the AstraZeneca COVID-19 vaccine (FOI 21-489)

Published 13 August 2021

3rd June 2021 FOI 21/489

Dear

Thank you for your email dated 6th May 2021, where you asked:

“Of the cases and deaths reported in ‘Table 5: Number of UK suspected thrombo-embolic events with concurrent thrombocytopenia ADR reports received for the COVID-19 Vaccine AstraZeneca by patient age up to and including 28 April 2021’ of your report ‘Coronavirus vaccine - weekly summary of Yellow Card reporting’ for data up to and including 28th April, please provide the number of cases and deaths that relate to vaccines administered before March 31st 2021.”

With regards to your request for date specific UK suspected adverse drug reaction (ADR) reports of thrombo-embolic events with concurrent thrombocytopenia along with breakdown of these reports by age group and fatal outcome, this information is due to published in the near future. As such, we have determined that this information is exempt under Section 22 of the of the Freedom of Information Act. Section 22 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from publishing the number of deaths per age group by date. However, we consider that the public interest will be better served by releasing the information when it is in its complete form, rather than the Agency releasing an incomplete version of the data prematurely.

As with any major new vaccination campaign, the MHRA always develops a proactive vigilance strategy. 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.

Please be reassured that the MHRA takes all reports of adverse reactions with the utmost seriousness, including those reporting fatal events in patients who have received a COVID-19 vaccine. Where these events are reported to us, we follow up to find out full details of the events and the cause of death and, where applicable, further information of any post-mortem findings. Once received, we look at each individual adverse drug report to individually assess each case, together with additional sources of evidence, by a team of safety experts. Additionally, 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 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. We also monitor deaths rates over time and the information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the death.

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. Furthermore, we also take into account the international experience based on data from other countries using the same vaccines. We also receive independent advice from the Commission on Human Medicines (CHM) which is responsible to advise on the impact of any safety issues including fatal cases on the balance of risks and benefits of COVID-19 vaccines. For further information on the CHM please follow this link:

https://www.gov.uk/government/organisations/commission-on-human-medicines/about

On the basis of this ongoing review, the advice remains that the benefits of the vaccine outweigh the risks in the majority of people. Patient safety is our highest priority and vaccines are the best way to protect people from COVID-19. Everyone should continue to get their vaccination when asked to do so unless specifically advised otherwise.

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