Freedom of Information request on all adverse event (yellow card) reports to date for all vaccines Used in UK, differentiating between inactivated and LAIV flu vaccines? (FOI 22/515)
Published 1 June 2022
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FOI 22/515
15th March 2022
Dear
Thank you for your FOI request dated 4th March 2022, where you asked:
“Please could you send me all adverse event (yellow card) reports to date for all vaccines Used in UK, differentiating between inactivated and LAIV flu vaccines?”
I can confirm that the MHRA collects reports of suspected adverse reactions to medicines and vaccines via the Yellow Card Scheme. The Yellow Card scheme is run by the MHRA and is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. The scheme relies on voluntary reporting of suspected side effects or medical device incidents to be reported by health professionals and the public, including patients, carers and parents.
The purpose of the scheme is to provide an early warning that the safety of a medicine or a medical device may require further investigation. It is important for people to report problems experienced with medicines or medical devices as these are used to identify issues which might not have been previously known about. The MHRA will review the issue and if necessary, take action to minimise risk and maximise benefit to the patients.
Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information. We consider that extracting the adverse reactions data that you have requested will take longer than 24 working hours to complete.
We would be able to provide you with Drug Analysis Prints (DAPs) which include the number of reports of all suspected adverse reactions to a particular medicine or vaccine if you were to narrow your request by, for example, limiting your request to specific vaccines on the schedule.
As your request has been refused under Section 12 of the FOI Act, we cannot answer any part of it however we will be happy to provide a response to any refined request you send in the future. 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.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU