FOI release

Freedom of Information request on the regulatory approval on the COVID-19 vaccines (FOI 21/1242)

Published 31 May 2022

FOI 21/1242

8th December 2021

Dear

Thank you for your email to MHRA customer services dated 21st November 2021, where you asked questions on the following under the Freedom of Information (FOI) act:

1. Please supply all safety data, trial and other information provided by Pfizer, Moderna and AstraZeneca which was used by the MHRA in order to approve their covid vaccines for use

2. Please supply copies of the contracts which were agreed upon for these 3 companies to supply their covid vaccines

3. What precise steps do the MHRA take to investigate reported deaths which have occurred from these vaccines and can you provide any details or information resulting from these investigations?

4. Following these investigations are reported deaths removed from the yellow card system if they are found to not be related to the covid vaccines?

5. Using the most recent data following these investigations how many deaths have occurred from the Pfizer, Moderna and AstraZeneca vaccines?

Question 1

This information is available in the public domain already, through the EMA’s clinical database. A link to this is provided below:

https://clinicaldata.ema.europa.eu/web/cdp/home

Question 2

The information concerning the authorisation of the Pfizer and the AstraZeneca vaccines under Regulation 174 are published at the following links:

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/conditions-of-authorisation-for-covid-19-vaccine-astrazeneca

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/conditions-of-authorisation-for-pfizerbiontech-covid-19-vaccine

Contracts with vaccine manufacturers to supply any of the COVID-19 vaccines to the NHS/Department of Health and Social Care, would not fall under the remit of MHRA. As such we would advise that you contact the Department of Health and Social Care at Contact the Department of Health and Social Care - contactus.dh.gov.uk (dhsc.gov.uk)

Question 3

All Yellow Card reports received for COVID-19 vaccines, including those relating to fatalities, are included in the weekly publication. The most up to date publication is available to be viewed here: Coronavirus vaccine - weekly summary of Yellow Card reporting - GOV.UK (www.gov.uk)

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.

Question 4

As mentioned above, for all the fatal reports concerning COVID-19 vaccines, where permission is provided, a follow-up letter is sent to the reporter to request further information, including a copy of the Post Mortem (PM) report and the certified Cause of

Death. Once we receive this follow up information, it may change the classification of the case. In some instances, the reporter may not consider the death to be related to the COVID-19 vaccine. The classification of these cases would therefore be amended within our database and these updates reflected in the following weekly Coronavirus ADR publication.

Please note that the database used to capture information from Yellow Cards is dynamic and therefore numbers are subject to change over time. Due to high reporting volumes the MHRA sometimes receives multiple reports of the same case from different reporters (for example a family member and a healthcare professional both separately reporting the same event concerning the same individual). When these cases are picked up by us through our regular monitoring processes, we have a responsibility to merge these cases into one. There are also instances where assessors reclassify cases to ensure the case is an accurate representation of what has been reported to the MHRA and update cases as new information is received. These instances can account for fluctuation of numbers in the overall Yellow Card data.

Please be reassured that 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.

Question 5

The following figures are the latest numbers of fatal reports received by the MHRA until 1st December 2021. The MHRA has received 634 UK reports of suspected ADRs resulting in a fatal outcome to the Pfizer/BioNTech vaccine, 1138 reports for the AstraZeneca COVID-19 vaccine, 18 for the Moderna COVID-19 vaccine and 32 where the brand of the vaccine as unspecified. The 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 the 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.

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