Safety Advisory – Zostavax Vaccine

The Therapeutic Goods Administration (TGA) is advising health professionals that Zostavax vaccine should not be used in people whose immune system is weakened by certain medical conditions or medicines.

This is because of the risk of disseminated varicella-zoster virus infection with the vaccine virus, which can cause serious illness and death.

Zostavax is a live, attenuated varicella-zoster virus vaccine that is used to prevent shingles in patients aged 50 years and older, and prevention of nerve pain associated with the virus in patients aged 60 years and older.

The TGA issued safety advisories in March 2017 and July 2020 following two reports of fatal disseminated vaccine strain varicella-zoster virus infection.

The TGA has received a report of a new case involving this adverse event in a patient on immunosuppressive medicine.

The patient, who at the time of vaccination was taking prednisolone (steroid medication) and had also recently been taking checkpoint inhibitors (medication that modulates the immune system), died a few weeks after receiving Zostavax. Although this adverse event can occur in immuno-competent patients, the risk increases with the degree of immuno-suppression.

The most common adverse events following Zostavax are reactions at the site of injection, such as redness, pain and swelling. Serious reactions, such as the disseminated varicella-zoster virus infection reported in this advisory, are very rare.

The latest case demonstrates the importance of careful pre-screening and a risk-based assessment prior to Zostavax administration.

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