Medicines

Action needed on immune therapy patients and shingles vaccine


A TGA committee has urged the regulator to take steps to prevent any further more incidents of immunocompromised patients being given zoster vaccine by mistake.

The live virus vaccine is contraindicated in patients taking immune therapies such as biologics and most DMARDs, in whom it may cause severe, disseminated, life threatening herpes zoster infection.

But despite warnings following a fatality from the zoster vaccine contraindication last year, the TGA’s Advisory Committee on Vaccines says it is continuing to receive reports of immunocompromised patients being given the vaccine.

Since April 2017 there have been five notified incidents, two of which resulted in serious life-threatening adverse events. These incidents occurred after an alert was issued in March 2017 over the death of an immunocompromised man who was given zoster vaccine by a doctor.

The committee said it wanted to see more campaigns to remind doctors about the risk of zoster vaccine in immunocompromised patients, including ‘pop-up’ alerts in prescribing software as well as patient education activities.

The Advisory Committee on Vaccines also noted that there may need to be a revision of what the ‘safe’ dose of methotrexate is with regards to vaccination with zoster vaccine.

Current Department of Health advice is that there may be safe doses of immunomodulatory drugs (eg methotrextate ≤0.4 mg/kg/week).

Zoster vaccine is licensed for prevention of herpes zoster (shingles) in people aged 50 years and older, and since 2016 has been available free for people between the age of 70 to 79.

It is contraindicated in people on current or recent high-dose immunosuppressive therapy, including anti-TNF drugs such as etanercept, and other therapies such as rituximab, anakinra, and abatacept. Zoster vaccine is also contraindicated for patients taking cancer treatments such as tacrolimus, cyclosporine, and cyclophosphamide.

The contraindications also cover people with haematological or generalised malignancies (including people not on treatment).

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