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Severe immunosuppression at the time of vaccination is defined using the guidance and timings stated below.
1. Individuals with primary or acquired immunodeficiency states at the time of vaccination due to conditions including:
acute and chronic leukaemias, and clinically aggressive lymphomas (including Hodgkin’s lymphoma) who were under treatment or within 12 months of achieving cure
individuals under follow up for chronic lymphoproliferative disorders including haematological malignancies such as indolent lymphoma, chronic lymphoid leukaemia, myeloma, Waldenstrom’s macroglobulinemia and other plasma cell dyscrasias (note: this list is not exhaustive)
immunosuppression due to HIV/AIDS with a current CD4 count of <200 cells/µl for adults or children
primary or acquired cellular and combined immune deficiencies – those with lymphopaenia (<1,000 lymphocytes/ul) or with a functional lymphocyte disorder
those who had received an allogeneic (cells from a donor) or an autologous (using their own cells) stem cell transplant in the previous 24 months
those who had received a stem cell transplant more than 24 months ago but had ongoing immunosuppression or graft versus host disease (GVHD)
persistent agammaglobulinaemia (IgG < 3g/L) due to primary immunodeficiency (for example, common variable immunodeficiency) or secondary to disease/therapy
2. Individuals on immunosuppressive or immunomodulating therapy at the time of vaccination including:
those who were receiving or had received immunosuppressive therapy for a solid organ transplant in the previous 6 months
those who were receiving or had received in the previous 3 months targeted therapy for autoimmune disease, such as JAK inhibitors or biologic immune modulators including B-cell targeted therapies (including rituximab but in this case the recipient would be considered immunosuppressed for a 6-month period), T-cell co-stimulation modulators, monoclonal tumour necrosis factor inhibitors (TNFi), soluble TNF receptors, interleukin (IL)-6 receptor inhibitors, IL-17 inhibitors, IL 12/23 inhibitors, IL 23 inhibitors (note: this list is not exhaustive)
those who were receiving or had received in the previous 6 months immunosuppressive chemotherapy or radiotherapy for any indication
3. Individuals with chronic immune-mediated inflammatory disease who were receiving or had received immunosuppressive therapy prior to vaccination including:
high-dose corticosteroids (equivalent to ≥ 20mg prednisolone per day) for more than 10 days in the previous month
long-term moderate dose corticosteroids (equivalent to ≥10mg prednisolone per day for more than 4 weeks) in the previous 3 months
non-biological oral immune modulating drugs, such as methotrexate >20mg per week (oral and subcutaneous), azathioprine >3.0mg/kg/day, 6-mercaptopurine >1.5mg/kg/day, mycophenolate >1g/day in the previous 3 months
certain combination therapies at individual doses lower than above, including those on ≥7.5mg prednisolone per day in combination with other immunosuppressants (other than hydroxychloroquine or sulfasalazine) and those receiving methotrexate (any dose) with leflunomide in the previous 3 months
4. Individuals who had received high-dose steroids (equivalent to >40mg prednisolone per day for more than a week) for any reason in the month before vaccination.
