Shingles jab wins wider TGA approval

4 minute read

There's a new weapon in the fight to protect highly immunocompromised patients from shingles but it comes at a cost.

Doctors have another weapon in their war chest to protect immunocompromised patients aged over 18 who are at increased risk of shingles.

But those who want the newly TGA-approved Shingrix vaccine will have to fund it themselves, at a cost of up to $600.

The TGA’s new indication builds on Shingrix’s existing approval for Australian adults aged 50 years and over for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN). Shingrix is a non-live, recombinant Varicella Zoster Virus adjuvanted vaccine given intramuscularly in two doses.

GSK Australia applied to PBAC for the vaccine to be listed on National Immunisation Program in 2018 but was unsuccessful. A GSK spokesperson said the company had not ruled out making another application.

“We believe there is strong evidence underpinning the community health benefits of wider access to Shingrix. We note that other comparable countries have been able to provide subsidised access to Shingrix and we hope that Australia can avoid being left behind in the future. 

“Until that time, we are glad to be able to provide some access in the private market now so that some Australians can begin to benefit now without further delay.”

The TGA approval applies to in people aged 18 years and over who are at increased risk of shingles, including those who are immune deficient or immunosuppressed, due to a disease and/or therapy, may be at increased risk of shingles. 

This includes patients with solid tumours, haematological malignancies, HIV infection, autologous hematopoietic stem cell transplant recipients, and renal transplant patients on chronic immunosuppressive treatment.

Professor Tony Cunningham, infectious disease physician, clinical virologist and co-director of the Centre for Virus Research at the Westmead Institute for Medical Research, welcomed the TGA’s decision to make the vaccine more widely available to people at increased risk.

“This is a nasty disease in immunocompromised people,” he said. “I think it’s extremely good news and the trials have borne out how effective it [Shingrix] is.”

People with a recent immunosuppressive condition may have a higher risk of shingles than the general population, according to a systematic review assessing risk factors for shingles infection published in the journal Open Forum Infectious Diseases in 2020.

Another article, published in The Journal of Infectious Diseases in 2018, analysed data from 240,000 older adults with more than eight years of follow-up. The researchers found that a diagnosis of cancer was associated with about a 40% higher risk of developing shingles compared to those without cancer. The risk was substantially greater among those with haematological cancers compared to those with solid organ cancers. For both types of cancer, risks were highest in the first year following diagnosis, decreasing thereafter.  

“Shingrix doesn’t lose efficacy – we’re up to seven to eight years and the modelling suggests it could go to 15,” Professor Cunningham said.

He said that while there were antivirals to treat shingles infections, these must be taken within three days of symptoms, and they do not prevent the ongoing pain that can accompany the virus. 

“Prevention is better than cure,” he said. 

“Shingles can be very painful and is often described as burning, shooting or stabbing pain. This acute pain can last for two to four weeks, with some people potentially experiencing complications and chronic pain for months,” said Professor Cunningham. 

“People who are at increased risk of shingles, due to underlying conditions or treatments, are significantly more likely to experience severe disease and hospitalisation than the general population. For these patients, vaccines can play an important role in helping reduce the impact of the infection.”

The GSK spokesperson said Australians were likely to pay between $250-300 per dose for a two-dose course of Shingrix. 

Open Forum Infectious Diseases 2020, online 9 January

The Journal of Infectious Diseases 2018, online 13 December

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