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Summary
Health professionals are reminded that live vaccines should not be given to people who are significantly immunocompromised or pregnant. This is particularly the case for the herpes zoster vaccine – Zostavax – and the Japanese encephalitis vaccine – Imojev – as incorrect use continues to be reported. While not all reports of inadvertent use are associated with an adverse event, this safety alert provides a timely reminder to healthcare professionals considering live vaccinations for patients.
What should health professionals do
If you are uncertain about the degree of immunocompromise in a patient, do not give them a live vaccine and seek specialist advice. Detailed information to manage these patients, including tools to assess the severity of immunocompromise, are available from the Australian Immunisation Handbook.[1]
Background
There are several live vaccines available in Australia, including:
- BCG (bacille Calmette–Guérin) vaccine
- one of the Japanese encephalitis vaccines – Imojev
- MMR (measles-mumps-rubella)
- MMRV (measles-mumps-rubella-varicella)
- oral rotavirus vaccine
- oral typhoid vaccine
- smallpox vaccines against monkeypox (Jynneos, ACAM2000)
- varicella vaccine
- yellow fever vaccine
- one of the zoster vaccines – Zostavax
For most of these vaccines, the virus (or bacteria for BCG and typhoid vaccines) has been weakened (attenuated). This means when it is introduced into the body in the form of a vaccine, it induces an immune response without being able to cause the disease. However, live vaccines are contraindicated in certain patients where the risk of adverse events including vaccine-related infection is higher.
Guidance on the use of these vaccines is available in the Australian Immunisation Handbook.[1] Clinical recommendations for vaccination against monkeypox are available from the Australian Technical Advisory Group on Immunisation (ATAGI).[2]
General contraindications for live vaccines
People who are significantly immunocompromised should not receive live vaccines due to the risk of unchecked infection. However, people with HIV who are mildly immunocompromised can receive MMR (measles-mumps-rubella), varicella and zoster vaccines with further advice from their doctor. For more information, see Vaccination for people who are immunocompromised in the Australian Immunisation Handbook.
People who are immunocompromised include those who:
- are receiving high-dose immunosuppressive therapy, including biologic or targeted synthetic disease-modifying anti-rheumatic drugs (bDMARDs or tsDMARDs) or oral corticosteroids (≥20 mg per day of prednisolone equivalent dose)
- are receiving chemotherapy or radiation
- have malignancies related to the immune system such as lymphoma, leukaemia or Hodgkin disease, even if they are not receiving active treatment
- have AIDS or symptomatic HIV
- have similar immunocompromising conditions due to a disease or treatment
In general, pregnant women should not receive live vaccines and should be advised not to become pregnant within 28 days of receiving a live vaccine. See Table. Vaccines that are contraindicated in pregnancy: live attenuated vaccines in Vaccination for women who are planning pregnancy, pregnant or breastfeeding.
As with all vaccines, live vaccines are contraindicated in anyone who has had a severe allergic reaction to a previous dose of the same vaccine or from a different vaccine containing a component of the live vaccine, such as albumin.
Herpes zoster vaccines
There are two vaccines available to prevent herpes zoster (and its complications) in people aged 50 years and above:
- Zostavax, a live attenuated vaccine given as a single dose
- Shingrix, a subunit non-live vaccine given as two doses.
Updated guidelines from ATAGI now recommend that Shingrix is preferentially used over Zostavax in immunocompetent adults.
Zostavax is contraindicated in people with current or recent severe immunocompromising conditions from a medical condition or treatment. The Therapeutic Goods Administration (TGA) has published previous safety advisory on this issue.[3]
The Australian Immunisation Handbook provides a screening tool – Live shingles vaccine (Zostavax) screening for contraindications – to assess whether it is safe to give a patient Zostavax or delay administration. The tool lists a series of questions to guide providers and patients with these decisions.
Go to the ATAGI recommendations and the Australian Immunisation Handbook[1] to find out more about herpes zoster vaccination.
Japanese encephalitis vaccines
Japanese encephalitis vaccines are routinely used for laboratory workers who may be exposed to the virus, people who live or work on the outer islands of Torres Strait, and travellers spending a month or more in endemic areas during the Japanese encephalitis transmission season.
There are two vaccines to prevent Japanese encephalitis:
- Imojev, a live attenuated vaccine given as a single dose
- JEspect (also known as Ixiaro), a non-live vaccine given as two doses
Imojev, the live vaccine, should not be given to children under 9 months of age and is contraindicated in immunocompromised individuals and women who are pregnant or breastfeeding.
Go to the Australian Immunisation Handbook[1] to find out more about Japanese encephalitis vaccination.
Reference
| [1] | Australian Immunisation Handbook, Australian Government Department of Health and Aged Care, Canberra, 2022. |
|---|---|
| [2] | Australian Technical Advisory Group on Immunisation (ATAGI) – Updated ATAGI Clinical guidance on vaccination against monkeypox (MPOX). Version 4.0 Issue date: 12 December 2022. |
| [3] | TGA Safety advisory - Careful assessment and screening for immunocompromise essential before administration of Zostavax. February 2022 |
| [4] | Australian Technical Advisory Group on Immunisation (ATAGI) – Clinical advice. Statement on the clinical use of zoster vaccines in adults in Australia. Version 2.1 Issue date: 26 April 2022. |
What to report? You don't need to be certain, just suspicious!
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle ▼ in PI and CMI documents – this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
To report a suspected side effect or for more information about reporting, go to our ‘Report problem or side effect’ webpage or contact the TGA's Pharmacovigilance Branch ADR.Reports@health.gov.au.
Disclaimer
Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.
© Commonwealth of Australia 2022
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to tga.copyright@tga.gov.au.
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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance Branch at ADR.Reports@health.gov.au.
Medicines Safety Update is written by staff from the Pharmacovigilance Branch.
Editor: Ms Tahli Fenner
Deputy Editor: Dr Fiona Mackinnon
Contributors: Dr Grant Pegg