Department of Health

TGA safety warning for Zostavax® vaccine in immunocompromised patients

Health advisory

Advisory number:
Date issued:
23 Sep 2020
Issued by:
Dr Annaliese van Diemen, Deputy Chief Health Officer (Communicable Disease)
Issued to:
Health professionals and consumers

Key messages

  • The Therapeutic Goods Administration (TGA) is advising against giving Zostavax® (shingles vaccine) to people with compromised immune function due to the potential for rare adverse events including death.
  • This recommendation follows the recent death of a person in Australia who received Zostavax® while on low doses of immunosuppressive medicine.
  • While TGA’s investigation found that Zostavax® was used in line with existing recommendations, the potential exists for this very rare adverse event. Careful pre-screening and a risk-based assessment prior to Zostavax® administration is therefore essential.
  • If uncertain about a person’s level of immunocompromise and whether vaccination is safe, do not vaccinate. Seek expert advice from their treating physician or a medical immunisation expert.
  • Seek urgent medical advice for people who are immunocompromised and who inadvertently receive Zostavax® vaccine.
  • Zostavax® is available on the National Immunisation Program for people aged 70 - 79 years.

What is the issue?

The TGA has previously advised that Zostavax® should not be used in people with compromised immune function, as it is associated with a risk of mild to serious complications (including death) from infection with the vaccine virus.

The vaccine contains live attenuated varicella-zoster virus. The amount of virus in the zoster vaccine is approximately 14 times greater than in varicella (chickenpox) vaccines.

As with other live viral vaccines, zoster vaccine is generally contraindicated in people who are immunocompromised due to disease or medication. Haematologic malignancy and metastatic cancer are absolute contraindications. Recommendations for people who are immunocompromised due to other conditions or medications are complex. The decision to vaccinate should be deferred until specialist advice has been sought.

Consumers and health professionals are advised that the TGA has received a report of a new case involving this adverse event in a patient on low doses of immunosuppressive medicine.

The patient, who at the time of vaccination was taking hydroxychloroquine and a low dose of prednisolone to treat arthritis, died three weeks after receiving Zostavax. The TGA investigation found that Zostavax was used in line with existing recommendations. However, it is important for health professionals to be mindful of the potential for this very rare adverse event.

Who is at risk?

Zoster vaccine contains live attenuated varicella-zoster virus. It is therefore contraindicated in pregnant women and people with current or recent severe immunocompromising conditions which include, but are not limited to individuals who:

  • are receiving high-dose systemic immunosuppressive therapy, such as chemotherapy, radiation therapy or oral corticosteroids (≥20 mg per day of prednisone equivalent dose for ≥14 days)
  • are receiving biologic or targeted synthetic disease-modifying anti-rheumatic drugs (bDMARDs or tsDMARDs)
  • have malignant conditions of the reticuloendothelial system (such as lymphoma, leukaemia or Hodgkin disease, even if they are not receiving active treatment)
  • have AIDS or symptomatic HIV infection
  • have similar immunocompromising conditions due to a disease or treatment.

Zoster vaccine is contraindicated in people who have had anaphylaxis after a previous dose of any varicella-zoster virus (VZV) containing vaccine and anaphylaxis after any component of a VZV-containing vaccine.


Health professionals are reminded that, on rare occasions, disseminated varicella-zoster virus (Oka vaccine strain) infection can occur in patients following administration of Zostavax vaccine. This case has demonstrated that this can occur in patients who are on low dose immunomodulation and demonstrates the importance of careful pre-screening and a risk-based assessment prior to Zostavax administration. If necessary, this could include medical specialist consultation and potentially screening for pre-existing antibody to varicella-zoster virus. The Australian Immunisation Handbook contains the current guidance on screening.

If a recent Zostavax recipient is suspected of having disseminated varicella-zoster virus infection the health professional should:

  • conduct appropriate diagnostic testing early
  • where appropriate, initiate acyclovir empirically while awaiting test results
  • where feasible, cease immunosuppression.
  • Notify SAEFVIC -Victorian Vaccine Safety Service immediately: Telephone 1300 882 924 (option one).

The Australian Immunisation Handbook contains information about Zostavax administration in special populations, including patients who are immunocompromised or have medical conditions that place them at risk of immunocompromise. Additionally, information can also be obtained from the National Centre for Immunisation Research and Surveillance.


Always check the patient records for medical contraindications. If contraindicated, do not administer Zostavax. If unsure use the Zostavax® screening for contraindications GP Decision Aid

Check the patient’s record for prior documentation of Zostavax administration not reported to the AIR. If previously given, do not administer another dose, report the documented dose to the Australian Immunisation Register.

More information

Clinical information

TGA safety advisory Zostavax® vaccine

National Centre for Immunisation Research and surveillance (NCIRS) Zoster fact sheets

Zostavax® screening for contraindications GP Decision Aid

SAEFVIC Victorian vaccine safety service -Telephone 1300 882 924 (option one)

Australian Immunisation Handbook - Zoster (herpes zoster)

Australian Immunisation Handbook - recommendations for use of Zoster vaccine in people on immunosuppressive treatment

Consumer information

Better Health Channel - Shingles


For more information please contact the Immunisation section at the Department of Health and Human Services on email

Reviewed 24 September 2020


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