FOI release

Freedom of Information request on the death numbers from adverse reactions, were these wrongly submitted or proven to not be caused by the vaccine administration? (FOI 21/1225)

Published 31 May 2022

FOI 21/1225

15th December 2021

Dear,

Thank you for your FOI request and email enquiry, both dated 15th November 2021, where you have commented on and requested the following information:

1. Deaths have been lowered from previous weeks. Up to the 3rd November 2021 there were 1,243,998 adverse reactions and 1738 deaths reported. Were these wrongly submitted or proven to not be caused by the vaccine administration?

2. Who is acting upon and following up these deaths and adverse reactions?

3. Does this mean that those figures above are the actual ones reported and have currently been classed as being correct?

4. Why does this website and its contents never get mentioned on mainstream media and why do various social media site class this website as “SPAM” when people try to post its contents?

It may be useful to provide some background on the Yellow Card scheme to help answer your first two questions. As you are aware, the Yellow Card scheme is the UK system for collecting suspected side effects from healthcare professionals and patients and is used to monitor the safety profile of all medicines. The MHRA collects reports of suspected Adverse Drug Reactions (ADR) via the Yellow Card scheme and enters them onto a specialised database which allows us to process and analyse reports rapidly.

To maintain the accuracy of the reports we receive, a team of scientific and medical assessors evaluate reports as part of our routine signal detection work. When new ADRs or a change in frequency/characteristics of an ADR are identified, reports are followed up for completeness and for further information as part of quality assurance.

It is important to note that 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 for further information including details of any post-mortem findings.

With regards to your first question, there are a number of reasons why the reported figures relating to the COVID-19 vaccines might change from week to week, including the number of reports where the patient has sadly passed away. Whilst newly reported cases may be received in the week since the previous summary, the number of cases overall may decrease, due to the merging of reports which, on investigation relate to the same patients. When the number of merged cases exceeds the number of newly reported cases, this leads to a decrease in the total number of cases.

Regarding question 3, the MHRA are committed to transparency and as you are aware, we are publishing a weekly summary of Yellow Card reporting which is available here. As this is updated weekly, I can confirm that data within this report is correct for the stated period. The latest report covers the period 9 December 2020 to 1 December 2021. It should be noted that the nature of Yellow Card reporting means that ADRs are not always proven side effects, only that the reporter has a suspicion it may have been caused by the vaccine. Some events may have occurred coincidently, regardless of vaccination meaning the data held on the database is dynamic and subject to change over time as follow up information is received.

In response to your question about mainstream media and social media, it is not within the MHRA’s remit to comment on decisions made by other organisations. We suggest you contact them directly, as they will be best placed to answer any questions you may have.

However, it should be noted that the leaflets provided to UK recipients of the COVID-19 vaccines contain information on how suspected side effects can be reported to the MHRA and encourages reporting of any side effects through the Yellow Card scheme. Information on Yellow Card reporting has been included in NHS training materials, as well as the materials available to individuals both before and after vaccination.

The MHRA have also optimised website search functionality and worked with media outlets to encourage them to carry messages about reporting of side effects. In addition, we have run social media campaigns informing healthcare professionals and members of the public that reporting to the Coronavirus Yellow Card reporting site will enable the MHRA to rapidly identify new and emerging side effects. We have also issued a Drug Safety Update, a press release, and the general public have also been encouraged to report any suspected side effects to the vaccine to the MHRA via a Yellow Card in recent televised press briefings. Since the launch of the national immunisation campaign the Yellow Card scheme has benefited from an increased spotlight and as such the MHRA has also seen an increase in reports received for non COVID-19 related drugs and vaccines

Concerning your comments surrounding informed consent, all patients consenting to COVID-19 vaccination are provided with a patient information leaflet (PIL), which includes information on what the vaccine is used for, what patient’s need to know before receiving the vaccine, how the vaccine is given, and any possible side effects that may be experienced. This document and the Summary of Product Characteristics (SPC) for healthcare professionals are available on the Yellow Card Coronavirus website (https://coronavirus-yellowcard.mhra.gov.uk/productinformation) which is available to all patients, doctors and pharmacists.

I hope that you will find this information useful.

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