FOI release

Freedom of Information request on Yellow Card reporting published on 13th May 2021 (FOI 21-508)

Published 13 August 2021

10th June 2021 FOI 21/508

Dear

Thank you for your email to MHRA customer services dated 13th May 2021, where you asked questions relating to an extract from the summary of Yellow Card reporting published on 13th May 2021. Please see our response to the requested information below, and please note that we have grouped a couple of questions together as they share the same response from the MHRA.

• What review and checking of a suspected death report is carried out by the MHRA before it publicly reports a patient died from a suspected ADR and is published on the MHRA website? Has the process of review been similarly applied to other MHRA reports for other non-Covid vaccines?

All Yellow Card reports received for COVID-19 vaccines, including those relating to fatalities, are included in the weekly publication.

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 countriesusing 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.

• What is the definition of “shortly after vaccination” used by MHRA? Where did this definition come from, and has it been similarly applied to other MHRA reports for other non-Covid vaccines?

‘Shortly after the vaccination’ typically signifies within 28 days of receiving the COVID-19 vaccine. The duration of up to 28 days aligns with other government data on COVID-19 fatalities in the UK. 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 reports of suspected ADRs in which the patient died (whether or not shortly after vaccination) have been received for the three Covid vaccinations (or where the vaccine was unknown)?

• How many reports of death (as defined above) have been received in total by MHRA as of 13th May 2021? Please provide this information as against each vaccine, and also where the vaccine is unknown.

The following figures are the latest numbers of fatal reports received by the MHRA until 26th May 2021. The MHRA has received 396 UK reports of suspected ADRs resulting in a fatal outcome to the Pfizer/BioNTech vaccine, 831 reports for the AstraZeneca COVID-19 Vaccine, 4 for the Moderna COVID-19 Vaccine and 22 where the brand of the vaccine was unspecified. This information is available here.

It is important to note that Yellow Card reports are not proof of a side effect occurring due to a vaccine but a suspicion by the reporter that the vaccine may have caused the side effect. Some events may have happened naturally, regardless of vaccination. For example, sometimes, these events can be part of the condition being treated rather than being caused by the vaccine. This is particularly the case when millions of people are vaccinated.

As the data in the prints do not necessarily refer to proven side effects, you should refer to the product information for these details on possible side effects of each COVID-19 vaccine, which can be found on the Yellow Card coronavirus website here. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the prints alone.

• How many reports of death have been not counted (either rejected, removed, pending or otherwise not officially counted) and for what reason? Please provide this information as against each vaccine and also where the vaccine is unknown.

As in the response to question one, all Yellow Card reports received for COVID-19 vaccines, including those relating to fatalities, are included in the weekly publication. We do not reject any fatal reports from being included in our data available online.

• For the period of 9th December 2021 to 5th May 2021, 1143 deaths were reported on the MHRA website. How many reports were either pending or in a backlog, as they had not been reviewed as of 13th May 2021? Please provide this information as against each vaccine and also where the vaccine is unknown.

We publish the summary of Yellow Card reporting each week, and thus, the number of reports is updated with each publication. We publish the data we collect alongside appropriate context in terms of the number of doses of vaccine administered and our assessment of that data. The next publication due for release will cover all reports received up to and including 2nd June 2021.

Given this, we have determined that this request is exempt under Section 22 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. 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.

• For the 1143 deaths reported, what was the actual date of death for each report?

The MHRA is committed to maintaining patient and reporter confidentiality and therefore are unable to provide the date of death for each report.

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 this response’s date and can be addressed to this email address.

Yours sincerely,

FOI Team, Vigilance and Risk Management of Medicines Division