GlaxoSmithKline is launching its non-live shingles vaccine Shingrix in Australia later this year but expects it will be a “few years” before it is included in the National Immunisation Program.
Shingrix was registered by the Therapeutic Goods Administration (TGA) in 2018 for use in adults aged 50 years and older for herpes zoster and postherpetic neuralgia, but was later rejected by the PBAC on cost grounds.
In efficacy trials among people aged over 50 and over 70, Shingrix was found to significantly decrease the incidence of herpes zoster compared to placebo, with 97.2% efficacy in subjects ≥50 years of age and 91.3% efficacy in subjects ≥70 years of age.
The company has not provided a firm date for the vaccine’s release.
“We are currently expecting to return to the Pharmaceutical Benefits Advisory Committee in late 2022 or 2023 for an NIP that could start in 2024,” a spokesperson said.
“Until that time, and despite our disappointment from the PBAC rejection in 2018, we are glad to be able to provide some access in the private market soon.”
Australians are likely to pay between $450-$550 for a two 0.5mL dose course.
Currently the main herpes zoster vaccine available in Australia is the Merck vaccine Zostavax, which contains a live, attenuated varicella-zoster virus. It was included on the National Immunisation Register for 70-79 year olds in November 2016.
However it 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 [see story here].
Since 2016 there have been three fatalities linked with that vaccine, including one patient with inflammatory arthritis, leading the TGA to remind clinicians in December not to administer it to patients with compromised immune systems.
Department of Health advice states that there may be safe doses of immunomodulatory drugs (eg methotrexate ≤0.4 mg/kg/week) and the Australian Immunisation Handbook gives recommendations for the use of zoster vaccine in people on immunosuppressive therapy.
Speaking with the limbic, Dr Peter Wong, a rheumatology senior staff specialist at Westmead Hospital, said there were pros and cons to both vaccines.
Post Shingrix vaccine serological titres showed a much higher level of protection, but it was a “very potent adjuvant” and there was a risk it may flare underlying autoimmune diseases such as rheumatoid arthritis or lupus.
“But GSK are certainly doing studies,” he said.
One study, published in the journal Rheumatology in March, found that 95.6% of participants who reported a pre-existing condition did not experience any exacerbation of their disease after taking Shingrix.