FOI release

Freedom of Information request on the fatalities and the COVID-19 vaccinations (FOI 22/648)

Published 21 December 2023

FOI 22/648

21st July 2022

Dear

Thank you for your email of 21 April 2022 where you requested:

Could you please send me the details of the investigations into all of these 2,075 fatalities that my MP has assured me you have carried out showing that there is no link to these fatalities and the vaccines.

Please accept our apologies for the delay in responding to your request.

The COVID-19 vaccines used in the UK vaccination programme were approved following a rigorous review of the safety, quality and effectiveness of the vaccines by the MHRA and the Government’s independent advisory body, the Commission on Human Medicines (CHM). The MHRA and CHM concluded that the COVID-19 vaccines were safe and effective and that the benefits of the vaccines outweigh any risk.

However, no medicine or vaccine is completely risk-free and hence the MHRA continually monitors the safety of the COVID 19 vaccines through a comprehensive safety monitoring strategy the details of which has been published online: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance

This four-strand monitoring strategy is proactive (not simply responsive) and based on a wide range of information sources, with a dedicated team of scientists continually reviewing all of the information to look for safety issues or any unexpected, rare events.

One of the information sources examined is reports received through the Yellow Card Scheme which the MHRA operates on behalf of the Commission on Human Medicines (CHM). The scheme collects and monitors information on suspected safety concerns or incidents involving vaccines, medicines, medical devices, and e-cigarettes. The scheme relies on voluntary reporting of suspected adverse incidents by healthcare professionals and members of the public (patients, users, or carers). The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation.

In order to provide transparent information on the Yellow Card reports received on the COVID 19 vaccines, the MHRA regularly publishes a report summarising the suspected adverse reactions (ADR) reported via the Yellow Card scheme: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions.

In this report you will find details of our assessment of Yellow Card reports where a fatal outcome has been reported following a COVID-19 vaccine. Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events, sadly including deaths in the days and weeks after vaccination. Usage of the COVID-19 vaccines has increased over the course of the vaccine campaigns and as such, so has reporting of fatal events with a temporal association with vaccination. However, an ADR report associated with a fatal outcome does not mean that the vaccine caused the death of the individual.

The MHRA evaluate reports of suspected side effects as soon as they are received to consider whether the vaccine may be linked to the events reported, or whether the events were likely to be coincidental. We routinely follow up all Yellow Card reports of fatalities, where permission has been provided to do so, for further information to aid our assessment of the report. However, the role of the MHRA is to consider safety evidence as a whole and its impact on the balance of benefits and risks of a medicinal product at the population level. Information collected through follow up of individual reports forms part of that evidence, but the MHRA is not in a position to draw conclusions upon whether there is a link between the vaccine and a patient’s death in individual reports.

Furthermore, details of individual reports are subject to exemption under Section 41 of the FOI Act (Information provided in confidence). Therefore we are not able to provide details of individual reports of fatalities.

Use of s41 (information provided in confidence):

Below, we have outlined why we consider that the use of s41 is appropriate here.

S41(a) the information must be provided by a third party

Members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA through the Yellow Card Scheme.

S41 (b) -to be met, disclosure of the withheld information must constitute an actionable breach of confidence. A breach will be actionable if:

1.The information has the necessary quality of confidence.

• As the data requested concerns information about an individuals health (medical information), we consider that it has the necessary quality of confidence. It is not otherwise accessible in the format requested and is more than trivial.

2.The information has the necessary quality of confidence and was communicated in circumstances importing an obligation of confidence.

• It should be noted that an action of breach can be maintained where the individual is deceased, such as action by a family member or representative. As outlined in our Privacy Policy, the MHRA will not share the identity of anyone submitting a Yellow Card report with any person outside the MHRA without their explicit consent, unless we are required or permitted to do so by law. The Policy also states that we may receive requests for Yellow Card report data under the Freedom of Information Act. While we are legally obliged to provide some of the requested information, we only provide high-level summary information with all person-identifiable data excluded. Regarding the COVID-19 vaccines specifically, this high-level summary is provided within our weekly summary of Yellow Card reporting which we directed you to above.

3.Unauthorised disclosure would cause a specific detriment to either the party which provided it or any other party; and

4.Although section 41 is an absolute exemption, the law of confidence contains its own built in public interest test with one defence to an action being that disclosure is in the public interest.

Detriment may be assumed where the information concerns the individual’s personal or private life. It is quite clear that the Yellow Card information does form the basis of a breach of confidence. A detriment is not required to be tangible – the mere fact of an invasion into the individual’s private or home life is sufficient. Disclosure would be contrary to the individual’s reasonable expectation of maintaining confidentiality in respect of his/her personal information, such as medical information.

Yellow Card reports are constantly reviewed and may contribute to the identification of, in this case, the individual submitting the report.

Notwithstanding, we consider that disclosure of this information would not be in the public interest for the following reasons.

The MHRA has been working proactively to encourage members of the public or health professionals across the UK to immediately alert us to any concerns they have without a formal diagnosis using the Yellow Card scheme. The information and data provided to us by these third parties are shared in confidence and, as above, are personal data. Sharing the information and data received with the complainant would not reflect the commitments in MHRA’s confidentiality agreements, potential safety signals which would be of detriment both to the application of the Agency’s regulatory function and public health more widely.

As this is personal data in relation to an individuals’ health, this would be of detriment to the individual through their representatives and may damage the engagement with the scheme.

We have carefully considered whether the law of confidence would be breached, and whether, notwithstanding this, there is sufficient public interest in disclosure. We consider that disclosure of

this information is not in the public interestand, therefore, do not consider any such breach defensible.

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