Freedom of Information request (FOI 22/959)
Published 17 January 2024
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25th October 2022
FOI 22/959
Dear
Please accept my apologies for the delay in responding to your email dated 12th September 2022, where you confirmed that your request for 1b data for COVID-19 vaccines associated with inflammatory eye disease specifically, Iritis, Uveitis, Panuveitis, Choroiditis, Chorioretinitis, Retinitis, Optic Neuritis, Scleritis, Orbital Myositis and Retinal Vasculitis.
Further to your request for the specific reactions listed above I can confirm up to and including 28/09/2022 that the MHRA has received 125 UK spontaneous suspected reports associated with COVID-19 Pfizer BioNtech vaccine, 154 reports associated with COVID-19 AstraZeneca, 21 reports associated with COVID-19 Moderna vaccine and none with COVID-19 Novavax vaccine. Please note that under the FOI act, we can only release FOI Category 1b data on these cases which includes the following:
• Aggregated patient age
• Aggregated patient gender (number of males and females)
• Suspect drug/vaccine(s)
• Dose
• Route of administration
• Duration of treatment
• Suspected adverse drug reaction(s)
• Outcome of reaction
• Reaction onset times
• Patient medical history
• Year of receipt
Please find attached the available details of these reports displayed separately for each of the COVID-19 vaccines, presented in table 1, 2 and 3.
When reviewing spontaneous ADR data, it is important to also bear in mind the following points:
• A report of a suspected ADR report does not necessarily mean the medicine or vaccine has caused the event, just that there is a suspicion that it could have been responsible. Many factors have to be taken into account in assessing causal relationships including temporal association and any underlying or undiagnosed illness.
• The number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions to drugs for a number of reasons, as this scheme is associated with an unknown and variable level of under-reporting - i.e. not all reports of suspected ADRs are reported as it is not mandatory for healthcare professionals to report suspected ADRs to the MHRA.
• ADR reporting rates may be influenced by the seriousness of reactions, their ease of recognition, extent of use and promotion and publicity about the medicine or vaccine.
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