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Shingles Vaccines

A petition I received fromChange.org calling on GlaxoSmithKline (GSK) to supply their shingles vaccine in Australia where it is already approved for the PBS.

"Pharma giant GSX: Make live-saving shingles vaccine Shingrix available in Australia

3,626 have signed Cathleen Morrison’s petition. Let’s get to 5,000!

Sign now with a click

Shingles is a viral infection that causes a painful blistering rash that can last for months and usually affects older people , especially those with weakened immune systems. I’m an immuno-compromised cancer patient and I’m at high risk of getting shingles . The pharmaceutical giant, GSK (Glaxo Smith Kline) is refusing to make the vaccine for small markets like Australia where their profit margin is low.

I’m calling on the global pharmaceutical company to make Shingrix, the hugely effective shingles vaccine available to Australians now. The company has a duty to make at least a small number of vaccine doses available to those most at risk, in all countries.

Currently, we have the Zostavax vaccine available which is only 51% effective in preventing the disease in my age group, as opposed to Shingrix, which has a 90% protection rate. Only recently, an immuno-compromised person died after receiving the Zostavac vaccine. I am afraid for my health and possibly my life but I shouldn’t be - GSK must make the vaccine available here.

Shingrix was already approved for PBS in Australia last year. GSK claims to not have enough supply of the vaccine to meet the global demand. It appears they have made a comfortable commercial decision to supply countries like the USA where profit margins are high. It’s unfair for people like me to be missing out on this life-saving vaccine.

Please sign and share the petition calling on GSK to distribute the Shingrix vaccine more equitably across the world.

Sign now with a click

Visit petition page

At Change.org, we believe in the voice of everyday people. Is there something that you want to change?"

No real surprise regarding GSK’s disgusting behaviour as I have previously posted in Choice Community and Product Review.

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They do supply to Australia and it is available. It appears that the person who lodged the petition didn’t see their medical professional:

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How do you know the lack of supply in Oz is because the makers refuse to supply it?

There isn’t much information available about Shingrix in Oz but a number of sources say it is registered for use, those and others say it is not yet available here due to a global shortness of supply.

This US article supports the global shortage view.

So far in its Shingrix rollout, GSK has focused mostly on the lucrative U.S. market, although it has also won approvals in Canada, Europe, Japan and China. GSK execs have said they expect production for the vaccine to jump in 2024, when a new bioreactor is expected to come online. The company is also pushing to make incremental supply gains until then.

Since the product is a guaranteed earner I find it odd that GSK would not be doing their utmost to produce it and sell it around the world. But the claim that big pharma is holding back (for reasons left to the imagination) sells more clicks.

I find the change.org user’s custom of presenting a one-sided view with little or no explanation of the situation and trying to promote dog-piles on large organisations with little evidence, in order to drum up their own business, to be unfair and not really in line with the stated aim of giving a voice to the little man.

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GSK’s list of vaccines they sell in Australia.

https://au.gsk.com/en-au/products/our-prescription-medicines-and-vaccines/

No Shingrix listed.

I seriously doubt that the author of the petition would not have checked thoroughly before starting a petition to GSK.

And based on my personal experience, GSK could not care less about Australia.

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Unless it has changed since September, I ask my GP every visit if Shingrix is available and the answer has been no. I had Zostravax a few years ago and it has always been ‘the plan’ by myself and the GP to have Shingrix when it is available. It is not now nor has been a financial issue - just ‘inability to obtain’.

I have not asked nor do I expect anyone outside GSK may factually know why it has not been available. There may be stories, but will they be factual? The profit motive meets the pub test. Manufacturing ability? It has been ‘on the market’ for a few years so somewhat less re the pub test, but still could be vis a vis the ability to rake in the dollars in the US.

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If they have only just getting enough to supply the US how will a petition make any difference to getting some in Oz? The internet outrage industry sometimes does some good but too often it is just a waste of time.

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Interesting that it hasn’t made it onto the Government’s medicine shortage list:

There are other vaccinations in critical shortage, but Shingrix (varicella-zoster virus glycoprotein e recombinant adjuvanted vaccine) isn’t listed.

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From January 2019, sponsors are required to report all shortages of reportable medicines. The TGA then mandatorily publishes information about all shortages that have a critical patient impact (see Browse shortages below). Information about medium or low impact shortages may also be published where the sponsors agree to it or if the TGA determines that it is in the interest of public health (to view choose ‘display ALL medicines shortages’ on the Browse shortages page).

Perhaps it fails one of the tests for publication.

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It also appears to be recommended only for specific groups within the community. Qld health has the following. Assume similar for the other states and territories.


http://conditions.health.qld.gov.au/HealthCondition/condition/14/217/127/shingles-herpes-zoster

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Those guidelines are long standing. Note also that is about Zostravax (about 50% effective), not Shingrix (about 90% effective) although should apply to either. nb. Zostravax is readily available.

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The Shingrix vaccination has been approved for use in Australia by the TGA and the TGA recommended it be included on the PBS. However, it is still not available on the PBS - medicare subsidised medications. You find the 2018 report of the PBS decision here:
https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2018-11/files/varicella-zoster-virus-recombinant-vaccine-psd-november-2018.pdf. The cost-benefit analysis seems to be the sticking point. Therefore, it is likely that the cost on a private script may be too much for those at risk to pay for a private script.

However, there is another vaccine available Zostavax that has been in use for many years and is free to those who qualify. This difference is that the Shingrix does not use live virus.

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Which is part of why Zostavax much less effective than Shingrix. I am all for the most effective remedies being available but I don’t know that jumping up and down will help get Shingrix here any quicker.

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It probably won’t. It’s much the same with any medication or medical gadget. I want to be able to use the Freestyle Libre Sensor under a subsidy to help maintain my diabetes. Its available to use at a price ($200/month give or take) The TGA eventually approved it for Type1 diabetics but only under certain circumstances. I’m a type2 but insulin dependent, so I suppose those with the purse strings think we T2s are undeserving (must be our own fault, right?). Abbott pharma claims to be still working with the TGA to get it approved for others but… no sign of that at all. Why would they bother when they can get us spending money we can’t afford just to keep on track…

Its probably about the money, one way or another.

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Thanks to OP for bringing up this topic. Looking on the web I found thatit it is not yet available in Australia but should be released in autumn.
See this article taken from ‘Pharmainfocus’

"Shingrix comes back to Aust
Posted 9 November 2020
GSK is bringing its blockbuster shingles vaccine Shingrix to Australia for the first time in 2021 but it will not be looking for funded access on the National Immunisation Program - Shingrix will only be available on private script.
GSK confirmed to Pharma in Focus that the vaccine will be available as early as Autumn 2021 after soaring global demand and a PBAC knockback denied Australians access to the vaccine for the past two years.
Shingrix was registered by the TGA in 2018 but was rejected by the PBAC later that year, prompting a strong response from GSK about valuing vaccines.
“This meant that we lost out on the opportunity to put Australia among the first group of countries to receive supply,” said a GSK spokesperson.
"Early and preferential recommendations and the unprecedented demand that followed in the US, Canada, Germany and Japan has required us to focus our supplies for those countries to ensure recommendations could be implemented in full.
"Now, as supply capacity increases, we are able to expand access into new countries, including Australia.
“We are excited to confirm that plans are underway to make Shingrix available in the private market in Australia. We expect the first Australians may be immunised with Shingrix as early as autumn 2021.”
The government has a $98 million contract with Seqirus to supply its older and less effective Zostavax to the NIP which has run since October 2016. Initially inked for three years at $61.5 million, the contract was most recently extended in July.
Globally, Shingrix reached blockbuster status but sales slumped in the third quarter of 2020 to 374 million UK pounds, down 30 per cent on the same quarter for 2019. GSK attributed the slump to the impact of Covid but the lower demand is likely to have freed up supply for the Australian market."
https://www.pharmainfocus.com.au/news.asp?newsid=17217

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I telephoned GSK 2 years ago. They were very helpful on line. As with some COVID vaccines, two shots are required and there was a shortage in the US back then. Am sure it will get here. That was their intention. At least have Zostavax in the meantime. It has dropped in price.

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I have been chasing the Shingrix vaccine since 2017.

I have rung and emailed GSK - and they have told me that it is not available in Australia despite it being approved for Australia.

A specialist has recommended it for my husband. I have asked doctors in Australia (GPs and specialists) about prescribing it for my husband and myself.
But we have not been able to get a prescription for it in Australia, despite it having been approved for use in Australia.

Does anyone know of how a doctor in Australia can prescribe Shingrix?
Does anyone know of a pharmacy that dispenses Shingrix?

This Qld Health webpage mentions the old Zostavaxc vaccine only. No mention at all of the Shingrix vaccine. Ditto for the federal health website and other states’ health websites

Zostavax does not work very well in older people.
Zostavax is not recommended for immuno-compromised people.

Shingrix works well in older people.
Shingrix is safer.

Australian scientists played a large part in the development of Shingrix.

In Australia it is ‘older’ people who need protection from shingles because it wasn’t until 2005 that Australia chickenpox vaccine became free for babies and children under the National Immunisation Program (NIP).

Information about Shingrix:
15 July 2015 presentation document (PDF) by Tony Cunningham (when he worked at Westmead, Sydney) is a good introduction to the differences between the old Zostavax and the new Shingrix.

March 2018 article about effectiveness of Shingrix
https://www.westmeadinstitute.org.au/news-and-events/2018/new-study-reveals-why-the-latest-shingles-vaccine

2 July 2018 Therapeutic Goods Administration (TGA) approval 1531132870290 for SHINGRIX recombinant Varicella Zoster Virus glycoprotein E antigen 50 micrograms powder and suspension for suspension for injection vial

Shingrix is in the Australian Register of Therapeutic Goods (ARTG); it has ARTG ID: 289257

3 July 2018 Healthcare Professional Media Release “Singrix approved in Australia for the prevention of shingles and post herpetic neuralgia in adults aged 50 and over” GSK announced that TGA has approved Shingrix, a vaccine for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN) in adults aged 50 years or older. (store at 2 to 8 degrees Celsius, do not freeze, protect from light). Recombinant Varicella Zoster Virus glycoprotein E antigen.

2019 WA Health brochure titled “Useful information following vaccination” mentions Shingrix https://www.healthywa.health.wa.gov.au/-/media/Files/Corporate/general-documents/Immunisation/PDF/Usefulinformationfollowingvaccination.pdf

NPS Medicinewise website

Herpes zoster vaccination in Australia: what’s available and who benefits?

Herpes zoster vaccine is freely available to at-risk Australians, but many are not vaccinated.

says “There is a new herpes zoster recombinant subunit adjuvanted vaccine (HZ/su, Shingrix). It is not a live vaccine and requires a two-dose schedule with approximately 2–6 months between doses. The vaccine was registered in Australia in 2017 for people aged 50 years and above. However, it is not yet available for use.”
… and goes on to say " In 2018, an application by the manufacturer to include the HZ/su vaccine on the National Immunisation Program was unsuccessful due to uncertainty regarding cost-effectiveness."
… and “The [Shingrix] recombinant vaccine is more efficacious and more reactogenic than the live vaccine [Zostavax]. In clinical trials, it provided 97% protection against herpes zoster for 50–59 year olds and 91% for those aged over 70 years.”
… and goes on to explain the past trials that showed Shingrix to be safe and effective for immuno-compromised people.

Is a campaign needed to get Shingrix approved by the National Immunisation Program (NIP) for Australians too old to have been vaccinated against chicken pox as children; and also anyone else who missed out on protection from shingles caused by varicella virus (for example cannot have live virus Zostavax for medical reasons, or too old for Zostavax to have sufficient effectiveness)???

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Is there any hard data on the numbers of Australians this may benefit?
What might the costs of delivery be?
What is the quantum/cost to the community of the poor health outcomes of not having access?

A campaign may be very worthwhile. Knowing what is being asked and why there is no local supply (at full cost or subsidised) may help frame the argument.

Also perhaps more likely to elicit a definitive response as to why Shingrix is not available?

Start with ABS figures on people born before chicken pox vaccine added to National Immunisation Program in 2005.

Numbers are not hard to calculate

  1. Number of Australians who did not get vaccinated to protect from chicken pox

    • vaccination didn’t exist when they were kids
    • vaccination was contraindicated when they were kids
    • they weren’t in Australia as kids (even today UK doesn’t protect its children from chicken pox)
  2. plus Australians who did get vaccine protection against chicken pox as a child - but were in the minority where it did not work

Having had chicken pox is what sets someone up as a candidate for shingles (chicken pox disease does not protect).

Shingrix is safe for
someone who has not had chicken pox
someone who has had chicken pox
someone who has had the old Zostavax vaccine
someone who has had one or more bouts of shingles (the advice is to wait six months after the last bout of shingles to start the shingrix vaccine (2 needles).

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The govt has a view.

https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_Shingles.pdf.aspx

The data and reporting is telling us that it is the over 70’s who are at risk. Hence the current targeted program. For those under 70 years a death rate of 0.1 per million equates to 2-3 deaths annually, which may explain why mass immunisation of those under 70 has not been prioritised.

What about those who have already had the government sponsored free vaccinations or through their GP? Apparently nobody knows.

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A 2016 publication does not address a vaccination that was approved in 2018 for use in Australia.

Counting deaths from shingles does not count the true cost.
The cost of treating shingles is much greater.
The cost of treating post-herpetic neuralgia (PHN) has to be included too.
As well as medical costs there are the losses to productivity when PHN causes inability to work.
Shingles can begin at any age in people who have previously had chicken pox. A family member was under 30 when first attack of shingles occurred.

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