FOI release

Freedom of Information request on Yellow Card reports of Covid-19 vaccine side-effects (FOI-21-004)

Published 24 March 2021

In response to your request for information about adverse drug reactions (ADR) to Covid-19 vaccines, I can confirm that the MHRA does hold this data.

We will publish details of all suspected reactions reported in association with available COVID-19 vaccines in the near future, along with our assessment of the data on a regular basis. This is to provide transparent and clear information about the ongoing benefit and risk assessment of available vaccines.

As we plan to publish the data in the near future including narrative assessment of the data and any issues identified, 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 exempt from earlier disclosure.

We are pleased there is strong interest in seeing this important data; we consider that this is best met by publishing the finalised data with an analysis to aid its interpretation.

As above, we expect that this will be published in the near future and when it is, we will send you the link to both the data and our assessment.

In answer to your 5th question - The total number of reports received by MHRA from the start of the pandemic to 22 January 2021 and involving lateral flow devices was 38. This number is not specific to a particular manufacturer.

The number of reports is accurate at the time they were taken from our database, and minor changes in the numbers can occur if the reporter of the incident gives us more details later.

Please note that a report of an adverse incident does not mean the testing device caused the incident. Moreover, the information we hold on our database is not a full picture of all the device-related incidents that happened during this period, it is just a snapshot.

Therefore, our data should not be used to make a judgement on the safety of this type of testing devices (lateral flow antigen tests) or how likely it is to be involved in an adverse incident when using this type of device.

The reason for reporting can be just a suspicion that an incident was caused by a device or the way in which it was being used. Reports might be related to events which resulted in no injury, minor injury or a death or serious deterioration in health or the potential for these events. It is not compulsory for healthcare professionals and members of the public to report incidents directly to MHRA, but we strongly encourage this.

MHRA continues to monitor the safety and performance of all medical devices and encourages patients to report any adverse incidents. For COVID-19 testing devices, these can be reported via the Pandemic Yellow Card Portal at https://coronavirus-yellowcard.mhra.gov.uk.

If you have a query about the information provided, please reply to this email.

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 you receive this response and addressed to: [email protected].

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

Kind regards,

Pharmacovigilance Service Team

Vigilance and Risk Management of Medicines Division

Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Email: [email protected] Stay connected: mhra.gov.uk/stayconnected