Other safety alerts
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| Australia: Live vaccines: what are the contraindications? |
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The Therapeutic Goods Administration (TGA) announces that 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.
If health professionals 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.
People who are significantly immunocompromised should not receive live vaccines due to the risk of unchecked infection. 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.
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.
Zostavax is contraindicated in people with current or recent severe immunocompromising conditions from a medical condition or treatment. The TGA has published previous safety advisory on this issue.
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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/live-vaccines-what-are-contraindications
In Hong Kong, there are registered pharmaceutical products which are live vaccines, including Zostavax For Vaccine (HK-55419) which is registered by Merck Sharp & Dohme (Asia) Ltd, and Imojev Japanese Encephalitis Vaccine (HK-62787) which is registered by Sanofi Hong Kong Limited. Both products are prescription-only medicines. So far, the Department of Health (DH) has received 6 cases of adverse events following immunisation with Zostavax. The DH has not received any case of adverse events following immunisation related to Imojev.
Related news on the use of Zostavax in immunocompromised patients was previously issued by TGA, and was posted on the Drug Office website since 8 Mar 2017, with the latest update posted on 17 Feb 2022. Letters to inform local healthcare professionals were issued by the DH on 2 Jun 2021. In Dec 2021, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided to keep vigilant on any update from other health authorities on the matter.
The current local product insert of Zostavax and Imojev includes safety advice on the use of the vaccine in patients with immune deficiency and in pregnancy. The risks and precautions associated with the use of live vaccines in immunocompromised patients and in pregnancy are also documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Thursday, May 4, 2023
Issued at HKT 15:00
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