Contents

• Immediate action required
• Annex A – JCVI List of eligible individuals

Classification: Official
Publication approval reference: C1428

To:

• All NHS trust and foundation trust chief executives
• All NHS trust and foundation trust medical directors

CC:

• CCG accountable officers
• ICS leads
• PCN-led vaccination sites
• Regional Directors
• Regional Directors of Commissioning

Dear colleague

On 1 September the Joint Committee on Vaccination and Immunisation (JCVI) published guidance on third doses of COVID-19 vaccinations for individuals aged 12 years and over with severe immunosuppression.

We wrote to you on 2 September setting out the immediate actions required. A copy of the letter can be found here.

Eligibility for, and timing of, a third dose vaccination are based on an individual with severe immunosuppression’s clinical needs, informed by the timing of their specific therapeutic interventions and personal care plan. The JCVI guidance states:

“The specialist involved should advise on whether the patient fulfils the eligibility criteria and on the timing of any third primary dose. In general, vaccines administered during periods of minimum immunosuppression (where possible) are more likely to generate better immune responses. The third primary dose should ideally be given at least 8 weeks after the second dose, with special attention paid to current or planned immunosuppressive therapies guided by the following principles:

• where possible, the third primary dose should be delayed until two weeks after the period of immunosuppression, in addition to the time period for clearance of the therapeutic agent

• if not possible, consideration should be given to vaccination during a treatment ‘holiday’ or at a nadir of immunosuppression between doses of treatment”

Immediate action required

To ensure all patients who fall within scope of the JCVI guidance for severe immunosuppression (see Annex A) are offered a third dose vaccination, all NHS trusts now need to confirm the following action has been taken:

• Consultants have verified all patients identified as eligible for a third primary dose within their care.
• All eligible patients have been contacted and the optimal timing for administering a third dose has been provided, and where appropriate discussed.
• All eligible patients have been offered a vaccination by the NHS trust. These events should be recorded as a booster dose in the point of care system while the point of care system is updated centrally.
• In the unlikely event trusts are unable to offer vaccination on site, or where a patient has requested alternative access, a consultant letter has been sent to the patient and copied to their GP, to support vaccination elsewhere.

You will be asked by your regional team to confirm in writing that the above actions have been taken by 11 October.

Professor Sir Keith Willett | SRO Vaccine Deployment | NHS England and NHS Improvement

Professor Stephen Powis | National Medical Director | NHS England and NHS Improvement

Dr Keith Ridge CBE | Chief Pharmaceutical Officer for England

Annex A – JCVI List of eligible individuals

1. Individuals with primary or acquired immunodeficiency states at the time of vaccination due to conditions including:
   1. acute and chronic leukaemias, and clinically aggressive lymphomas (including Hodgkin’s lymphoma) who were under treatment or within 12 months of achieving cure
   2. Individuals under follow up for a 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)
   3. immunosuppression due to HIV/AIDS with a current CD4 count of <200 cells /µl for adults or children > 12 years
   4. Primary or acquired cellular and combined immune deficiencies – those with lymphopaenia (<1,000 lymphocytes/ul) or with a functional lymphocyte disorder.
   5. 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
   6. Those who had received a stem cell transplant more than 24 months ago but had ongoing immunosuppression or graft versus host disease (GHVD)
   7. Persistent agammaglobulinaemia (IgG <3g/L) due to primary immunodeficiency (e.g. common variable immunodeficiency or secondary to disease / therapy
2.  Individuals on immunosuppressive or immunomodulating therapy at the time of vaccination including:
   1. those who were receiving or had received immunosuppressive therapy for a solid organ transplant in the previous 6 months.
   2. 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)
   3. 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:
   1. high dose corticosteroids (equivalent to ≥ 20mg prednisolone per day) for more than 10 days in the previous month
   2. long term moderate dose corticosteroids (equivalent to ≥10mg prednisolone per day for more than 4 weeks) in the previous 3 months
   3. 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
   4. 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 month before vaccination
5. Individuals who had received brief immunosuppression (≤40mg prednisolone per day) for an acute episode (e.g. asthma / COPD / COVID-19) and individuals on replacement corticosteroids for adrenal insufficiency are not considered severely immunosuppressed sufficient to have prevented response to the primary vaccination.