Freedom of Information request on the iDAP data relating to Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and the COVID-19 vaccine (FOI 21-798)
Published 27 April 2022
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4th August 2021 FOI 21/798
Dear
Thank you for your email dated 19th July 2021, where you requested iDAP data relating to Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and the COVID-19 vaccine. The MHRA has been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at the population level. The MHRA has received a total of 15 reports of SJS and TEN in relation to COVID-19 vaccines up to and including 14th July 2021. In your correspondence you referred to 16 cases in the iDAP, please note that due to the dynamic nature of the Yellow Card data these figures may change as new cases are received, and as duplicate cases are identified and managed by merging of case details into one case, which is why there is a reduction of 1 case. Of these 15 reports, 10 correspond to SJS alone and 5 to SJS and TEN. 12 of these reports were reported to us by healthcare professionals including hospital doctors, pharmacists and general practitioners. 6 of the reports were in relation to the AstraZeneca vaccine, 5 in relation to Pfizer and 1 for Moderna. Please note, SJS and TEN are diagnosed based on a number of diagnostic criteria such as skin biopsy, mucosal involvement and percentage area of skin involved. Not all cases reporting SJS or TEN meet these criteria. Furthermore, patients are sometimes exposed to concomitant medication known to cause SJS/TEN and robust assessment is therefore difficult. With regards to your request for a further breakdown of SJS reports including details of first/second dose, onset of reactions, details of other drugs and prior history of SJS/TEN, we can confirm that we do hold this information however 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 there is strong interest in seeing this data and accept it should not be withheld however wish to publish this information alongside appropriate context and assessment. 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.
Yours sincerely, FOI Team, Vigilance and Risk Management of Medicines Division