Recombinant zoster vaccine Shingrix will be free for more than four million older Australians under the National Immunisation Program (NIP), but only a narrow group of younger patients who are severely immunocompromised will be eligible.
The federal government announced this week Shingrix, which protects against herpes zoster and post-herpetic neuralgia but has an out-of-pocket cost of about $560 – will replace live vaccine Zostavax on the NIP from 1 November [link here].
A two-dose course will be available for people aged 65 and over, Aboriginal and Torres Strait Islander people aged 50 and over and a select group of high-risk immunocompromised patients aged 18 and older with the following conditions:
- Haemopoietic stem cell transplant
- Solid organ transplant
- Haematological malignancy
- Advanced or untreated HIV
The non-live, recombinant subunit vaccine works by inducing antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity against the herpes zoster virus, according to manufacturer GlaxoSmithKline.
But advocacy groups for patients immunocompromised through taking immune-modifying therapies are hoping the Shingrix access will be widened to include them.
Last month, MS Australia wrote to the PBAC Secretariat [link here] calling for eligibility to be broadened to cover more patients at risk of herpes zoster infection.
“There is a pressing need to consider a wider immunocompromised population over the age of 18, which includes people with MS on certain disease modifying therapies (DMTs),” it said in a submission dated 12 September.
Infectious diseases expert Professor Robert Booy acknowledged the current criteria for immunocompromised patients were “fairly narrow” but stressed the decision to include those groups was based on need, effectiveness and safety.
“They’re at substantially increased risk of shingles and there’s evidence that vaccination is protective in those groups; for example, they did a randomised controlled trial of people with stem cell transplant and a post-hoc analysis of people who had blood cancers,” said Professor Booy, from the University of Sydney.
These studies demonstrated vaccine efficacy of 68.2% and 87.2% respectively.
Further, immunological responses (increases in anti-glycoprotein E antibody levels and glycoprotein E-specific CD4[2+] T cell response) were apparent across patient groups, including autologous hematopoietic stem cell transplant recipients, haematological malignancies, solid tumours and renal transplant recipients.
Professor Booy said further expansion of the program was under review.
“If there is evidence showing that people with particular illnesses are at increased risk, that should be shared. There probably will be wider use of the product in the future to cover more people with immunocompromise,” he told the limbic.
“It’s a major investment and it’s covering a big chunk of the population, especially people who are at high risk, so it is focusing on people who need the vaccine.”
People who have already received a free Zostavax vaccine won’t be able to access the Shingrix vaccine under the NIP in the five years following their Zostavax dose.
The government said the Shingrix program will cost more than $800 million.