Using COVID-19 vaccines in patients taking immunosuppressive medicines

David Erskine, Senior Medicine Information Pharmacist, London Medicines Information Services, Specialist Pharmacy ServicePublished Last updated See all updates

National advice and considerations on the use of this vaccine in patients taking immunosuppressive medicines

Use in immunosuppression

Immunosuppressed people, due to disease or treatment are an ‘at-risk’ group (previous termed ‘clinically extremely vulnerable’) and should be vaccinated against COVID-19 as stated by UK Health Security Agency (UKHSA – formerly known as PHE) Immunisation Against Infectious Disease (The Green Book)

Adults and children aged 5 and over who are household contacts of people with immunosuppression are also considered to be a higher priority for vaccination.

There are no groups of potentially immunosuppressed patients that should be excluded from receiving the vaccine based on their treatment or disease alone according to Patient Group Directions (PGD) for:

PGD for Comirnaty® 30micrograms/dose COVID-19 mRNA vaccine

PGD for COVID-19 Comirnaty® 10micrograms/dose mRNA vaccine

PGD for COVID-19 mRNA vaccine BNT162b2 (Pfizer/BioNTech)

PGD for COVID-19 vaccine AstraZeneca, (ChAdOx1-S [recombinant])

PGD for Spikevax (formerly COVID-19 Vaccine Moderna)

Priority vaccination groups

The Green Book suggests priority vaccination for anyone taking the following medicines:

  • immunosuppressive chemotherapy (i.e. regimens containing any “traditional” chemotherapy)
  • immunosuppressive therapy following a solid organ transplant
  • immunosuppressive or immunomodulating biological therapies such as anti-TNF monoclonal antibodies, alemtuzumab, rituximab, ofatumumab
  • protein kinase inhibitors such as imatinib, erlotinib, everolimus
  • poly-ADP ribose polymerase (PARP) inhibitors such as niraparib, olaparib, rucaparib
  • long-term immunosuppressive medicines for systemic lupus erythematosus, rheumatoid arthritis or psoriasis
  • systemic corticosteroids for more than a month at a dose equivalent to prednisolone 20mg daily (any age)
  • a steroid sparing medicine such as cyclophosphamide or mycophenolate

Household contacts

Adults and children aged 5 and over who are household contacts of people with immunosuppression are also considered to be a higher priority for vaccination

Third primary COVID-19 vaccine dose

Patients who are immunosuppressed due to underlying health conditions or medical treatment may not mount a full immune response to primary COVID-19 vaccination.  The Green Book suggests that these patients should be offered a third primary vaccination.

Individuals whose immunosuppression started at least 2 weeks after the second dose of vaccine do not require an additional dose.

Timing of administration

The third dose should be given ideally at least 8 weeks after the second dose. The decision on timing of the third dose should be taken by the specialist involved in the care of the patient. In general, vaccines administered during periods of minimum immunosuppression are more likely to generate better responses.

The Green Book provides the criteria for patients who are eligible for a third primary vaccine dose.

Further advice on particular patient groups

Scheduled to begin immunosuppressive therapy

Vaccination should be considered by people who are about to receive planned immunosuppressive therapy, according to The Green Book)

  • ideally vaccinate at least two weeks before immunosuppressive therapy
  • where possible, the 2-dose schedule should be completed prior to commencing immunosuppression.
  • the second dose can be offered at the recommended minimum for that vaccine (three or four weeks from the first dose)

Immunosuppressive chemotherapy

The UK Chemotherapy Board Organisations has issued the following guidance on COVID-19 vaccine for patients receiving systemic anti-cancer therapy (SACT) including monoclonal antibodies:

  • all patients receiving SACT should be considered for vaccination
  • if relevant, vaccination should be timed to coincide with when blood counts have maximally recovered but avoided on same day as chemotherapy.
  • thrombocytopenia may be a minor consideration due to the need for an intramuscular injection – a platelet count of >20×109/L would be preferable.
  • ideally vaccination should be delayed in patients with neutropenia who are unwell until the neutrophil count has recovered to >1 x109 /L and are well again.
  • patients with chronic neutropenia should be vaccinated without delay.

It also states that medicines given by bladder instillation, such as BCG, mitomycin or gemcitabine, do not impact on timing of vaccination.

Corticosteroids (oral, intra-articular, intra-muscular or intravenous)

The British Society of Rheumatology and the Arthritis and Musculoskeletal Alliance (ARMA) agree that the benefits and risks should be discussed with the patient to arrive at a shared decision:

  • it is safe to have the COVID-19 vaccine alongside steroid exposure, but the patient may not mount such a good immune response.
  • do not delay vaccination for someone who is taking, has received or is soon to receive steroids in any form.
  • additional steroids required to control inflammatory disease, may take priority, as a disease flare can also worsen the risk from COVID-19.
  • it may be appropriate to delay a non-essential steroid injection, as part of a shared decision, so that the response to the vaccine is more effective.

Corticosteroid scenario

  • For example, a patient who is on an elective waiting list for a steroid injection of up to 80mg methylprednisolone or 80mg triamcinolone, should be offered COVID-19 vaccine as a priority especially if the prevalence of COVID-19 is high. In this scenario, the steroid injection should be deferred by 2 weeks after the COVID-19 vaccine, to enable the patient to mount the best response to the vaccine.

Rituximab

For rheumatology indications

The British Society of Rheumatology (BSR) advise that:

  • the COVID-19 vaccine course should be given four weeks or more before rituximab, where clinically possible.
  • a sub-optimal response to COVID-19 vaccines may be produced, especially for people within six months of the last dose of rituximab, or those who must have maintenance treatment due to their underlying clinical condition.
  • BSR acknowledge that there is no evidence to suggest how long after rituximab a patient should delay vaccination with a COVID-19 vaccine, but consensus suggests this should ideally be 4-8 weeks after rituximab.
  • the decision to defer a COVID-19 vaccine may be dependent on the prevalence of COVID-19 and should be agreed with the patient.
  • consider using alternative therapies to rituximab, due to the potential of a sub-optimal response to COVID-19 vaccination. This should be on a case-by-case basis, balancing the need for rituximab and the suitability of alternative therapies for the relevant clinical situation.

For oncology indications

According to UK Chemotherapy Board Organisations:

  • patients receiving monoclonal antibodies including rituximab should be considered for vaccination.
  • there are no issues in relation to timing of vaccination when it is being used as a monotherapy provided blood counts are within acceptable range.
  • when used in combination with cytotoxic chemotherapy, vaccination should coincide with when blood counts have maximally recovered but avoided on same day as chemotherapy.

Multiple sclerosis

The MS Society Medical Advisers have issued a consensus statement on COVID-19 vaccine for patients receiving MS treatments

(updated 14 Jan 2022)

Their advice is as follows:

There is no reason to believe that glatiramer acetate, teriflunomide, dimethyl fumarate, beta interferons, and natalizumab reduce the efficacy of the vaccines.

  • ocrelizumab there may be a sub-optimal response so it may be beneficial to delay the first course of this medicine in order to get the vaccine first. However there is thought to be limited benefit in delaying the second or third course in order to increase vaccine effectiveness. Where possible someone waiting for ocrelizumab treatment should have 2 doses of vaccine 3- 4 weeks apart. Patients who have recently had a course of ocrelizumab should ideally wait at least 12 weeks before having the vaccination. They also advise this approach for patients receiving rituximab for MS.
  • fingolomid, ozanimod or siponimod may also reduce the vaccine response but in general it is felt that it would not be advisable to stop treatment in order to increase the immune response.
  • alemtuzumab may reduce the vaccine response so it is recommended that vaccination should be delayed for 3 months after an alemtuzumab infusion. A second course of alemtuzumab can be delayed to support scheduling of COVID-19 vaccination but this increases the risk of disease recurrence.
  • cladrabine may reduce the vaccine response so it is recommended that vaccination should be delayed for 3 months after a course of cladrabine. A second course of cladrabine can be delayed by up to 4 weeks to support scheduling of COVID-19 vaccination.

If ocrelizumab, fingolimod, alemtuzumab, or cladribine are being started for the first time it might be preferable to wait until the vaccination course is complete if this is considered clinically appropriate.

Further information on Covid-19 primary vaccination

Dosing information COVID-19 primary vaccination

Dose scheduling, actions when the intervals are longer than or less than recommended, and use of alternative brands for second doses

Change history

  1. Added revised guidance from MS Society on recommended scheduling of vaccination in light of MS treatments
  1. Updated to reflect Green Book recommendations on vaccination of children aged 5 to 11 years
  1. Updated link to latest version of UK Chemotherapy Board Guidance on COVID-19 vaccine for patients receiving Systemic Anti-Cancer Therapy (published 15 Dec 2021))
  1. Formatting change.
  1. Resources checked and information remains correct.
  1. Updated according to Green Book terminology from 'clinically extremely vulnerable' to 'at-risk'. Included children aged 12 and over as household contacts for higher priority vaccination. Updated link for Moderna (Spikevax) PGD.
  1. Resources checked and information remains correct.
  1. Updated with information from Green Book about immunosuppressed patients and 3rd primary vaccine dose.
  1. Updated with new link to Comirnaty PGD
  1. Resources checked and information remains correct.
  1. Resources checked and information remains correct.
  1. Added advice from MS Medical Advisers on vaccination in patients being treated with immunomodulating treatments for multiple sclerosis
  2. Added further advice from BSR on timing of vaccination after a dose of rituximab
  1. Added updated advice from National Chemotherapy Boards on vaccination in patients with neutropenia
  2. Added updated advice from National Chemotherapy Boards on vaccination in patients receiving bladder instillations
  1. Added revised advice from Green Book regarding vaccination regimen in patients scheduled to start immunosuppressive medicines. Added advice from BSR/ARMA on vaccination in patients taking corticosteroids
  2. Published