Welcome to tonight’s webinar, Introducing Zostavax to the National Immunisation Program. This is the final webinar in the immunisation series for this year. My name is Penny and I am your host for this evening. Tonight I am joined by your facilitator, Dr Tim Senior and presenter Dr Vicky Sheppeard. Those of you who have joined us previously for webinars probably know Tim and Vicky quite well by now. Before we begin I would like to make an acknowledgement to country. We recognise the traditional custodians of the land and sea on which we live and work. A big welcome back and introduction to some people but mostly welcome back to Dr Tim Senior who is our facilitator for this evening. Originally trained in the UK, Tim is a GP working at Tharawal Aboriginal Corporation in southwestern Sydney, in between lecturing at UWS and acting as the medical advisor for the National Faculty of Aboriginal and Torres Strait Islander Health here at the RACGP. Thank you for joining us tonight Tim and welcome back.
Thank you very much, it’s lovely to be with you all.
And also a big welcome back to Dr Vicky Sheppard. Vicky is a public health physician who has been working for NSW Health since 1999. Her current role is Director of Communicable Diseases Branch Health Protection NSW. This role includes overseeing surveillance of notifiable diseases in NSW, coordinating communicable disease control activities, oversight of immunisation programmes including delivery of the school-based adolescent vaccination programme and representing NSW on Communicable Disease Network Australia. Previously, Vicky managed Health Protection Services in the Nepean Blue Mountains and Western Sydney Local Health Districts from 2008 to 2013. Welcome to Vicky. Welcome back Vicky.
Thank you Penny.
Now I am now going to hand over to Tim and Vicky to take you through the webinar and Tim will talk you through the learning outcomes first of all.
Yep, so this is, as you’ll be familiar with, this just sets out what it is we are going to cover tonight. So at the end of this event this evening we hope that you will be able to use the new herpes zoster vaccine under the National Immunisation Program Guidelines. We are going to identify who the suitable patients are and we’re going to refer to relevant guides, websites and information so you are able to track down extra information should you need it from reliable sources. We are going to talk about how we report our vaccinations to the Australian Immunisation Register and we are also going to do a quick think about the cold chain and making sure that vaccine storage ensures the vaccines are safe and efficacious.
So this is a slide about shingles, which you will probably be all familiar with. You will recognise it from the picture there. You’d all pick that as being shingles with a localised rash often vesicular in nature following a dermatomal distribution and its reactivation through the nerve root and some special occasions where it affects a particular dermatome, so affecting the ear or in the eye. We also get systemic symptoms and complications are really important from the point of view of the immunisation as well. So these can be locally where the rash is coming out but also immunocompromise can be more disseminated in the body. One of the important complications is post-herpetic neuralgia where you get really nasty neuropathic pain that persists for more than three months, up to 120 days. It is more common in older people and it is a severe pain and severe rash in the acute phase and it impacts quite a bit on people’s quality of life and we’ll see some statistics later on about how that impacts both on patients but also on the health system as well and it can be really difficult to treat. So just quickly, if you do see patients with post-herpetic neuralgia then in the initial phase of shingles, treatment with antivirals can be useful and simple and more complex analgesia to help, try and help settle down the neuralgia.
Now we’ll just go into a bit of the epidemiology of shingles and the main reason for this is that it has informed through the vaccination program funded for and I think there’s some really important information here that you’ll be able to relate to your patients to give the context for the vaccination.
So this slide is taken from a pretty important paper in 2009 and it’s looking at the experience of Australians with shingles and post-herpetic neuralgia and it’s mainly taken from BEACH data, which is of course, general practice data and there is some information here from the Pharmaceutical Benefits Scheme on prescribing of antivirals. So what we can see here is that in all the age groups there’s a fairly close correlation between the data that’s extracted from BEACH and the data from the Pharmaceutical Benefits Scheme so that gives us some confidence that we’re estimating what the epidemiology is reasonably well and of course you’re aware, certainly in New South Wales, it’s not a notifiable condition so we don’t have the same level of information on zoster as we do on other conditions.
So as we expect the incidence increases through the age groups so the dark and the light bars are both estimating incidence of herpes zoster and reaching a peak in the 70 to 79 year old age group, which is similar to the incidence per 1,000 persons in people above 80.
The important thing to note here is the light bars, the white bars, and that’s estimating post-herpetic neuralgia based on BEACH data, and you can see that it’s actually a pretty low rate in people under 60. It does increase once you get to 60 to 69 years of age but really jumps up in the over 70s and this is one of the important decisions about bringing in this National Immunisation Program because it’s the post-herpetic neuralgia that is causing a lot of the morbidity and this is the importance of focusing on this age group.
So we also know that people over about 35 about 97% have evidence of prior varicella vaccination, prior varicella infection, beg your pardon, and you know overall we’re getting about 60,000 new cases of herpes zoster annually in Australia, so it’s about 10 per 1,000 people and the cumulative life risk is somewhere between 20% and 30%. So around almost a third of the population will develop shingles at some time in their life and that risk is significantly greater once you’re over 60. About a quarter of patients with zoster develop complications and the post-herpetic neuralgia incidence increases from about 11% in people in their fifties up to about 20% of people who get shingles in their 80s.
The next slide is just a bit more about hospitalisation rates and again I think this really underlines the higher morbidity in the older age groups. So this is national hospitalisation rates and in the younger age groups, which are the blue, red and green bars calling younger people under 70, the hospitalisation rates, the population rates are relatively low but jump up significantly once people reach in the 70s and obviously even much higher for people in their 80s.
Tim mentioned the morbidity of post-herpetic neuralgia. This is data from a Canadian study but I think quite relevant to Australia. There is not a comparable Australian data that we can use but what this is showing here is for people with post-herpetic neuralgia the impact on their activities of daily living, the people who aren’t able to function normally in these different domains that monitor their functionality. So really high rates, particularly of pain and discomfort affecting their ability to function out to 90 days, remaining high out to six months after the onset of post-herpetic neuralgia.
So and you know, what’s the reason that post-herpetic neuralgia is more of a feature in the elderly? It’s thought to be the flagging T cell immunity increasing the risk of herpes zoster and then once herpes zoster manifests then the risk of post-herpetic neuralgia is much higher in these age groups. And then we also know that the available treatments for post-herpetic neuralgia have a lower efficacy and a poor side effect profile particularly as our patients age and have more comorbidities.
So the vaccine that we’re going to be focusing on tonight is Zostavax. It’s the only herpes zoster vaccine that is licenced in Australia or anywhere. So it’s a live attenuated vaccine and it’s the same strain as the vaccine that’s in the varicella vaccine that you’re familiar with that we’ve been using for children and adolescents but it’s very important to note that there’s 14 times more virus in this preparation than there is in the varicella vaccine and the reason for that is the importance of boosting T cell immunity. Most of these patients will have antibodies to varicella if we chose to measure them, which is not recommended routinely but more than 97% of people will have antibodies but in this age group that’s not preventive of developing zoster. The vaccine is licenced for adults 50 years and over at the moment a single dose, and it’s administered subcutaneously in the deltoid region. The contraindications are really important and we’ll go into more detail in later slides but very important to assess patients for significant primary acquired immunodeficiency and also of course anaphylaxis to any component.
Tim I don’t know if you wanted to make any comment about the administration here.
Yeah, I think it’s worth noting that it’s subcutaneous in the deltoid region. I have just seen someone earlier who had a particular question asked for a 60 year old lady who never had chickenpox, will you give Zostavax or varicella vaccine as a second booster and I think this makes it clear that for a 60 year old person it’s actually highly unlikely that they’ve never had chickenpox. It’s likely that they had had it, even if they didn’t remember, and it’s important we’re wanting to boost older people’s T cell immunity so you would use Zostavax rather than varicella vaccine.
So we’re just going to look at some of the evidence in the next few slides behind what Zostavax can do and really focus on particularly the patients over 70 but the studies of Zostavax, which a number of papers arising from these studies, they’re call The Shingles Prevention Study. It was a randomised double-blind placebo-controlled efficacy study of Zostavax and almost 40,000 people ages over 60 years of age were involved, including more than 9,000 cases and controls over 70 years of age. So a very substantial cohort there to test this vaccine.
So these slides demonstrate, there’s a group in red who received placebo and a group in blue who received Zostavax and on the left is the cumulative incidence of post-herpetic neuralgia and herpes zoster on the right. So the incidence of zoster and this figure here is for people, the whole cohort, is reduced by about 50% and I think that’s really important information because patients who receive this vaccine will still develop shingles. So it will reduce their risk but reduce their risk by 50% but what’s very substantially reduced is the risk of post-herpetic neuralgia. So it’s reduced down from about a cumulative incidence of 0.7 over five years down to 0.5. So this is the really important information. So it’s about a 66% reduction in post-herpetic neuralgia over this follow-up period.
So this is just summarising the points from that slide. Again, from this cohort, the shingles prevention study, so the herpes zoster incidence reduction was high in the 50 to 59 year olds, 70% reduction and in fact your 70 and over patients can only expect about a 40% reduction in the risk of shingles. So when they’re vaccinated it’s important that they know that they may still develop shingles but the real benefit of the vaccine for them is in this reduction of post-herpetic neuralgia, which is similar for both the 60 year age group and the 70 year age group of 66-67%. I don’t now Tim if you wanted to comment about that efficacy.
No I think it’s really, I think it’s worth just re-emphasising that what we’re preventing with the vaccine is particularly the complications of post-herpetic neuralgia and the morbidity associated with that. We’re not necessarily preventing the onset of shingles but the real big impact that we can have with this is the prevention of the post-herpetic neuralgia and the morbidity associated with that and so people’s ability to function and ability to stay out of hospital and be more pain-free.
So the next question is, you know, how long does the protection from Zostavax last? And this slide combines data from a few studies. So the shingles prevention study but also some other studies that have been done and monitoring efficacy over time. So this is showing us that certainly in the first four years there’s that 66% figure that we talked about, reduction in post-herpetic neuralgia and that’s persisting reasonably well to seven years. The protection against herpes zoster is reduced even in that second time period and then it looks as if there’s again a substantial drop off in protection against both herpes zoster and post-herpetic neuralgia after seven to 10 years. So this is something that we need to keep a close eye on in Australia and we’ll talk a bit more about that later whether subsequent doses might be required.
These study, the shingles prevention study and others have also looked at the safety of Zostavax and in these placebo-controlled studies there was no difference in serious adverse events compared with placebo. There is this phenomenon of a varicella-like rash at the injection site, so little vesicles but that’s a very rare complication but we’ve got another slide about local reactions and we need to talk about those. But importantly high fever is not more common in vaccine recipients but there is about a 6% rate of systemic symptoms such as headache and fatigue. So you would need to alert your patients that that might be something they could experience in the days after vaccination.
And just a reminder here about our New South Wales Immunisation Specialist Service, which is a phone support that we have for suspected adverse events or other complex immunisation questions. So that 1800 number is available throughout New South Wales if you wish to discuss what you suspect might be a serious adverse event or have questions about complex, vaccine complex patients. Of course any reporting of adverse events still goes either to the TGA or through your Public Health Unit.
So this slide that we’re looking at now is looking at the local adverse events, so the injection site adverse events taken from a randomised control trial reported separately, and again we have a placebo group as well as the herpes zoster vaccine group, the Zostavax group. And just wanting to point out the erythema, swelling and pain that is an increased risk particularly of erythema and swelling, so it’s important to alert your patients that they may expect some local reaction but you note that most of those are mild to moderate and any severe effects of local reaction are rare.
So Tim did you want to talk about the SmartVax at all?
So this is a new app. I’m not sure if this is, so it’s an app that allows SMS and smartphone technology to look at, monitor vaccine safety in real time and links up with practice software and can send SMSs afterwards to the patient to see if they’ve had an adverse reaction. The patient just clicks yes or no on their phone and where there is a reaction that can be flagged in the GP’s software and sometimes I think it can go to the local health authority. So it’s in real time. I haven’t tried this out yet though it sounds very interesting to me and I think Vicky are New South Wales Health promoting this or trialling this as well?
Well yes we’ve, it’s been developed by a GP in Western Australia and quite a lot of practices in Western Australia are using it and it sounds a very positive initiative so we have started discussions about making it available in New South Wales. So I thought it might be worthwhile just introducing the idea tonight but public health units may be in touch with GPs about getting this installed on their software and it seems to be a good additional service to offer patients but it’s also part of a national initiative to have real time innovation and pick up any safety signals in relation to vaccines.
Yeah and certainly that would be a really interesting way of gathering systematic information rather than just ad hoc. So that’s definitely watch this space and see if you can get involved in that if you’re interested.
Mmm. Yep. So, you know, other questions your patients might have is what, so we’ve got these randomised control trials, which show that the vaccine is safe and effective but, you know, what’s been the real world use of Zostavax and particularly in this older age cohort? So in the USA there’s been over 25 million doses distributed in the past decade. We understand that the uptake is so because of course it’s not a funded vaccine there but they have observed in practice similar vaccine effectiveness as what was observed in the randomised control trials. And the UK is a little bit similar to Australia in that it’s funding a program for 70 to 79 year olds. It’s structured a little bit differently than our program in Australia. They’re not doing the whole cohort at the one time but nevertheless that’s the eligibility and that’s been going for a few years now. They’re getting reasonable uptake but we don’t have any data back yet on any effectiveness but once again there have been no concerns about vaccine safety with the exception of one person who was improperly vaccinated and we might talk about that a little bit later on.
And just on vaccine safety a question comes through about SmartVax. If it’s flagged in the medical software who is responsible for the reaction, would the GP be responsible to contact the patient to manage the reaction? So I think not all reactions would need to be managed. The difficulty is I suppose that we’re going out seeking whether patients have had a reaction, whereas if it wasn’t for the SMS message they may not actually seek help if it wasn’t so bad but I suspect either a GP or one of the practice nurses or a system would have to be developed in the practice to follow those up and see if any management was needed or if there was any reporting that was required that. So I think it would have to be in practice systems for following that, they couldn’t just be ignored. I think that’s a good point.
Yeah, that’s right. It’s meant to be part of patient management of the practice so that’s right Tim.