Freedom of Information request on the COVID-19 vaccination in those with a weakened immune system (FOI 22/693)
Published 22 March 2023
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FOI 22/693
31 May 2022
Dear,
Thank you for your enquiry, in which you asked about COVID-19 vaccination in those with a weakened immune system.
Please note the there is nothing in the current Summaries of Product Characteristics (SPC) that recommends 4th or 5th doses to the vulnerable – but it is in line with the Green Book on Immunisation that the Joint Committee on Vaccinations and Immunisation JCVI can make recommendations outside of the SPC:
“Recommendations on immunisation procedures are based on currently available evidence and experience of best practice. In some circumstances, this advice may differ from that in vaccine manufacturers’ Summaries of Product Characteristics (SPCs). When this occurs, the recommendations in this book (which are based on current expert advice received from the Joint Committee on Vaccination and Immunisation (JCVI)) should be followed.”
Please also refer to: Joint Committee on Vaccination and Immunisation (JCVI) advice on third primary dose vaccination - GOV.UK (www.gov.uk)
“The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event. We ask for any suspicions to be reported, even if the reporter isn’t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse drug reactions (ADRs).
Many suspected ADRs reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that symptoms occurred around the same time as vaccination.”
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: info@mhra.gov.uk
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:
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Yours sincerely
MHRA Customer Experience Centre