Assuring implementation of JCVI guidance for vaccinating severely immunosuppressed individuals with a third primary dose
Publication approval reference: C1427
- All GP practices
- PCN-led vaccination sites
- ICS and STP leads
- All CCG accountable officers
- NHS Regional Directors
- NHS Regional Directors of Commissioning
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 who were severely immunosuppressed at the time of their first or second dose.
Eligibility for, and timing of, a third dose vaccination as part of a primary course 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 2 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”
Actions now required
These people are some of the most vulnerable in our society to COVID-19 as they may not mount a full response to vaccination and therefore may be less protected than the wider population. It is vital that we take immediate steps to ensure that they receive the maximum protection from the disease.
We wrote to you on 2 September setting out the next steps for Primary Care Networks. A copy of the letter can be found here. GP practices were asked to identify individuals on their registered list against the eligibility definition provided by JCVI in advance of the provision of searches. Practice level information to identify eligible patients will shortly be made available to support local call and recall, and as next steps:
- NHS Trusts have been asked to identify all patients eligible for a third primary dose within their care and offer a vaccination, at an appropriate time, at the NHS Trust. Where it is not possible for the NHS Trust to offer a vaccine on site, it is expected a consultant letter will be sent directly to the patient, copied to their GP, to support vaccination elsewhere. This action has been requested to ensure all patients can access a vaccination as quickly as possible to ensure maximum protection.
- Practices are asked to ensure they have access to the GP COVID-19 vaccine dashboard. The dashboard is accessed via smartcard and instructions on access and user guides are available here. Any issues in accessing the dashboard should be raised with email@example.com.
- From 4 October, practices should review the indicative practice level list of patients that will be uploaded by NHS Digital to the GP COVID-19 vaccine dashboard. This will support identification of patients via NHS number that national coding data suggest may be eligible for a third primary dose. This is a non-exhaustive list and due to coding and challenges of identifying a complex cohort of patients there may be additional eligible individuals not listed identified by the practice. The full list of eligible individuals is included at Annex A.
- Where they have not already done so, practices should contact patients identified via the GP COVID-19 vaccine dashboard or local searches of their registered list by 11 October and offer a third primary dose through their PCN with consideration to the optimal timing and interaction with any treatment as set out by the JCVI. As per JCVI advice, the third dose should usually be at least 8 weeks after the second dose but with flexibility to adjust the timing so that, where possible, immunosuppression is at a minimum when the vaccine dose is given.
- The third dose should be recorded as a booster dose in the point of care system. Records will be retrospectively amended through a national process to ensure that the third primary dose is accurately recorded as such. This will ensure distinction is made between a third primary dose and a booster dose and that individuals are invited for any subsequent doses should that be recommended.
- Practices that are not delivering the COVID-19 vaccination enhanced service should share a list of eligible patients, based on those identified via the GP COVID-19 vaccine dashboard, with their local commissioner (CCG) by 11 October so alternative provision can be made. This request is necessary for the reasons of public interest.*
*Practices are required to provide information to the local commissioner under the duty of co-operation requirement in their GMS / PMS / APMS contracts.
The Phase 1, 2 and 3 Enhanced Service specifications for general practice COVID-19 vaccinations contain provision for sites to follow JCVI guidance on the vaccination requirements, including dose schedule, for different patient groups. Therefore, no change to this contractual document is required to enable all PCN-groupings, regardless of which ES they have opted into, from administering a third dose as part of a primary course to these patients.
Thank you for your continued efforts in delivering a highly successful vaccination programme and to identify and vaccinate this vulnerable population.
Professor Sir Keith Willett | SRO Vaccine Deployment | NHS England and NHS Improvement
Dr Nikita Kanani | Medical Director for Primary Care | NHS England and NHS Improvement
Annex A – JCVI List of eligible individuals
- 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 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)
- immunosuppression due to HIV/AIDS with a current CD4 count of <200 cells /µl for adults or children > 12 years
- 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 (GHVD)
- Persistent agammaglobulinaemia (IgG <3g/L) due to primary immunodeficiency (e.g. common variable immunodeficiency or secondary to disease / therapy
- 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.
- 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
- 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
- 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.