Freedom of Information request on Incidence of stroke/TIA events in people under 30 years old following the first, second and booster COVID-19 vaccinations (FOI 22/464)
Published 1 June 2022
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FOI 22/464
18th March 2022
Dear
Thank you for your email dated 25th February 2022 where you requested the following information:
• Incidence of stroke/TIA events in people under 30 years old following the first, second and booster COVID-19 vaccinations.
• Incidence of stroke/TIA in under 30 year olds for the year 2015-2020.
As you may be aware, the MHRA operates the Yellow Card scheme 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.
The MHRA is playing an active role in responding to the coronavirus pandemic. In relation to COVID-19 vaccines the MHRA is responsible for monitoring these vaccines on an ongoing basis to ensure their benefits continue to outweigh any risks. This is a requirement for all medicines and vaccines within the UK. We publish a weekly summary of Yellow Card reporting which summarises the information received via the Yellow Card Scheme.
When reviewing all of the data received via the Yellow Card Scheme, it is important to note that just because a Yellow Card has been submitted reporting a suspected adverse reaction to the vaccine, it does not necessarily mean that the vaccine caused the reaction. Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events (including events with a fatal outcome) in the days and weeks after vaccination. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
It is also important to note that Yellow Card data cannot be used to determine the incidence of a reaction. This is because the level of reporting can be influenced by many factors including the seriousness of the ADR, their ease of recognition, the extent of use of a particular drug or vaccine and may be stimulated by promotion and publicity about a drug.
Therefore, in terms of your request, the MHRA can only provide the number of stroke/TIA events that have been reported to the MHRA following vaccination. However, in regard to the breakdown of the data by age, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure. Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it.
We recognise that there is strong interest in this data but consider that it is in the public interest to continue to uphold the Section 22 exemption at this time. This decision involved balancing the public interest in publishing the data now, with the public interest in publishing it at a later date.
The MHRA will be developing a more appropriate route to publication in Summer 2022 and subsequently begin implementing new systems for provision of data across all medical products including vaccines, enabling the MHRA to produce an improved and more suitable format for publishing data in general. This will enable the COVID-19 data collected to be published in such a way as to minimise the risk of misuse and through providing context to the data and clear guidance around what is being presented. This will allow us to mitigate risks we have identified such as undermining the wider Government public health campaign for widespread COVID-19 vaccination and the subsequent risk to public health and safety. Data will be available in the new format by the end of 2022.
The MHRA has undertaken a thorough review into UK cases of an extremely rare and unlikely to occur specific type of blood clot in the brain, known as cerebral venous sinus thrombosis (CVST) occurring together with low levels of platelets (thrombocytopenia) following vaccination with the COVID-19 Vaccine AstraZeneca. It has also considered other blood clotting reports (thromboembolic events) alongside low platelet levels. Based on this evidence thrombosis with thrombocytopenia syndrome (TTS) is listed in the product information as a recognised adverse drug reaction for COVID-19 Vaccine AstraZeneca. This entity encompasses both arterial and venous forms of thromboembolism.
In addition, a recent review identified an association between the first dose of COVID-19 Vaccine AstraZeneca and CVST events without thrombocytopenia. This is also listed in the product information as a recognised adverse drug reaction for COVID-19 Vaccine AstraZeneca. No association with CVST events has been identified for the other vaccines used in the UK immunisation campaign (the mRNA COVID vaccines made by Pfizer/BioNTech and Moderna). No association between COVID-19 vaccination and other types of strokes without thrombocytopenia has been identified following over 140 million doses administered in the UK so far.
Regarding the incidence of stroke/TIA in under 30-year olds for the years 2015-2020, I can confirm this is not information that the MHRA hold. We encourage you to contact the UK Health Security Agency (UKHSA) at enquiries@ukhsa.gov.uk to obtain this data.
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: info@mhra.gov.uk. Please remember to quote the reference number above in any future communications.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division
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