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National Immunisation Program Schedule Update

Sammi:                                 
Good evening everybody and welcome to this evening’s National Immunisation Program Schedule update webinar. My name is Samantha and I will be your host this evening. We are joined by our presenter this evening, Dr Ketaki Sharma and our facilitator, Dr Tim Senior. 
                                              
Before we start, I would like to make an Acknowledgement of Country. We recognise the traditional custodians of the land and sea on which we live and work and we pay our respects to Elders past and present.  
                                               
Okay. I would to formally introduce our presenter for this evening. Dr Ketaki Sharma is a general paediatrician and a Staff Specialist at the National Centre for Immunisation Research and Surveillance. She is part of the New South Wales Immunisation Specialist Service and reviews children who have experienced an adverse event following immunisation. She is also currently undertaking a PhD focussed on optimisation of antenatal vaccination. And our facilitator for this evening, Dr Tim Senior is a GP at Tharawal Aboriginal Corporation in South Western Sydney. Tim is also an RACGP Medical Advisor for the National Faculty of Aboriginal and Torres Strait Islander Health and a senior lecturer in General Practice and Indigenous Health at UWS. So thank you for joining us and welcome Ketaki and Tim. 
 
Tim:                                       
Thank you very much. So, these are the learning outcomes for this evening. So this is what we hope to achieve tonight. So by the end of this online QI and CPD activity, we should be able to be aware of the changes to the National Immunisation Program from the 1st July 2020. We should be able to discuss which additional at risk groups are eligible for funding of vaccines under the National Immunisation Program. We should be aware of New South Wales and National resources that are available to support these changes, and we should be able to discuss the evidence for the changes and the clinical impact. And so I shall hand over to Ketaki to take us through these.  
 
Ketaki:                                  
Thank you both. So I would like to start by acknowledging the following experts who have all contributed slides to tonight’s talk. And if you have seen any of their recent webinars, there might be a little bit of repetition so I apologise for that but I hope that tonight’s presentation is comprehensive in addressing your learning objectives and some of the frequently asked questions that we have already seen. 
                                              
Here we go. So what we will be looking at is firstly just the process by which the National Immunisation Program actually gets updated. A summary of the schedule changes. And then for each of the vaccine preventable diseases, we will take a look at the relevant epidemiology that informed the change, what the schedule change actually is and where relevant some practice points. We will then have a look at a few case studies that incorporate these new schedule changes and I am happy to take questions throughout as well as at the end, and as Sammi mentioned if there is anything that I am unable to answer, I am happy to take it on notice and get back to you offline. 
                                              
So firstly, we will have a look at how the NIP actually gets updated. This is actually a simplified version of the process. So it starts off with the vaccine manufacturer applying for the vaccine to be licenced by the TGA. This is based on vaccine efficacy and safety data from the clinical trials. The manufacturer will then apply to the PBAC to have that vaccine listed officially on the NIP, and as part of that application, they have to include clinical advice from ATAGI. ATAGI is the Australian Technical Advisory Group on Immunisation and it is a panel of immunisation experts. In addition to that clinical trial data, they will consider at a population level safety and effectiveness data. And so that includes things like does this vaccine generate herd immunity in the population. But they also have to consider the epidemiology and the burden of that disease for our population and for subgroups of our population, as well as programmatic aspects. So we all know that the schedule is becoming increasingly complex and crowded, and so it still needs to be practical and implementable. And then it goes to the PBAC for review. And in addition to all these factors we have already discussed, they will have to consider health economics. So is this proposed schedule change cost effective and is it cost effective for the whole population or only for certain subgroups of the population? They also have to consider alternative options. And as you can see with the green arrows, this can happen over multiple iterations and the PBAC can request further information ATAGI. And so only when all of these factors are favourable will a positive recommendation be made and passed on to the Department of Health for the Minister of Health to approve. It then needs to be translated into legislation and then we see a change in the NIP. I think that is just useful to understand and hopefully it explains why the Immunisation Handbook may put a strong recommendation for an individual or a group to be vaccinated but you might not see that recommendation reflected in the NIP funding for that particular group. And it is often because of this cost effectiveness requirement. 
                                              
So, we will have a look at the summary of the schedule changes that have come in. Firstly, there are now two National Immunisation Program schedules. There is the schedule for all non-indigenous people and a schedule for all indigenous people. And this reflects the fact that there are now across several vaccine-preventable diseases, additional vaccines that are available for indigenous people. And in particular for people living in the high risk jurisdictions of Northern Territory, Queensland, South Australia and Western Australia, there are a few extra that we will also have a look at. 
                                              
The vaccines that are affected are listed here including the brands that are NIP funded. So by the meningococcal vaccines, hepatitis A, Hib and both pneumococcal vaccines. And for tonight’s presentation I will just use the words, Prevenar and Pneumovax to make it simple. And I just had a look at that first question. I will get to that, I promise. 
                                              
So this is an overview of all of the changes in one slide. It is a very busy slide, but I will go through each of these changes in more detail. But I thought what was useful about this table is that it gives you an overall view of which patient groups you need to have something triggering in your mind that yes, there is something different to do for this particular category of patient. And the first group is non-indigenous, older, healthy adults who do not have particular risk factors for pneumococcal disease. So previously for that particular group of older adults, they received Pneumovax at 65 years of age. This is no longer recommended, and instead at the age of 70, all healthy, non-indigenous adults are eligible for NIP funded Prevenar 13 and that can be given concurrently with their NIP funded Zostavax. The second group of patients that are effected are people with this specific list of medical at-risk conditions. And the first of those is people with complement defects and that includes people taking this medication, eculizumab which is an anti-complement antibody. Patients who have complement defects have a one thousand to 10 thousand fold increased risk of invasive meningococcal disease. So for that reason, they are receiving fully funded NIP courses of both meningococcal vaccines. 
                                              
The second group is patients with any sort of spleen dysfunction. So functional or anatomical asplenia or hyposplenia. And patients who have asplenia are at increased risk of severe overwhelming infection with encapsulated organisms. So those are bacteria which have a polysaccharide capsule, and that includes pneumococcus, meningococcus and Hib, and so they are now eligible for NIP funded courses of all of these vaccines. 
                                              
And the third medical at-risk group are patients at increased risk of invasive pneumococcal disease. We previously had a very complex system of category A and category B. This has now been replaced with a single list of pneumococcal at-risk conditions all of which are recommended to be vaccinated with both Prevenar and Pneumovax, however only some of these are funded. And we will have a look later at which ones those are. 
                                              
And then the third group of people that will be effected are Aboriginal and Torres Strait Islander people. Firstly, all Aboriginal and Torres Strait Islander infants are now eligible for NIP funded Bexsero starting from two months of age. There is going to be a catch up program which I will explain soon. In the high risk jurisdictions of Northern Territory, Queensland, South Australia and Western Australia, Aboriginal and Torres Strait Islander children already received an additional dose of Prevenar 13 at six months of age and they will now be eligible for two doses of Pneumovax 23 starting from age four. In these jurisdictions, Aboriginal and Torres Strait Islander children already received hepatitis A vaccine at 12 and 18 months and these time points will now change to 18 months and four years. And that is purely logistical in order to facilitate the implementation of the Bexsero program. 
                                              
And then finally, Aboriginal and Torres Strait Islander people aged 50 or older are now eligible for NIP funded doses of both Prevenar 13 followed by two doses of Pneumovax 23. 
                                              
So the rationale for all of these changes is to improve protection and vaccine availability for people with increased risk of pneumococcal, meningococcal and Hib disease. And that increased risk may be a function of their status as an Aboriginal and Torres Strait Islander person, their age or those specific medical conditions listed. 
                                              
So having a closer look at the meningococcal vaccine changes. Firstly as I mentioned, Bexsero is now being introduced for all Aboriginal and Torres Strait Islander children nationally starting at two months of age. The catch up program is going to be in place for children aged up to 23 months and will be in place for three years. So once they have turned 24 months, they are no longer eligible for free catch up doses of Bexsero. So it is really important that within this three year time frame, we try to identify all eligible children and catch them up with meningococcal B.  
                                              
So the second change as mentioned was that both of the meningococcal vaccines are now going to be NIP funded for people with this list of medical conditions. Functional or anatomical asplenia, complement defects and current or future treatment with eculizumab. 
                                              
And this graph is showing us the rates of invasive meningococcal disease over a three year recent period by indigenous status in the blue and non-indigenous in the red, as well as by age. And you can see here that the rate ratio of IMD is sixfold higher in young indigenous infants compared to non-indigenous infants and remains higher in older infants. So that is the rationale for the cost effectiveness being demonstrated in that age group and that cohort specifically. 
                                              
I am just having a look at the questions here. Can they complete a catch up schedule as long as they commence the first dose by 23 months? Yes, once they are officially into the catch up schedule, if they turn 24 months and they still need their second dose, that can be considered to finish their schedule. And for people who have already got pneumococcal 23, do they still need to inject Prevenar 13? I will get to that when I talk about pneumococcal vaccines as well the Pfizer question. 
                                              
So what has not changed with relation to meningococcal vaccines, is the overall handbook recommendations for which risk groups should be vaccinated. So for example, people with HIV or people who have had a stem cell transplant are still strongly recommended to be vaccinated with both meningococcal vaccine types, however they did not meet the cost effectiveness criteria. So it will not be NIP funded. The NIP funded meningococcal ACWY program at 12 months of age and in year 10 will also continue along with the catch up program of MenACWY for people aged up to 19 years of age, and they can get at their GP. 
                                              
So looking at the Bexsero schedule for Aboriginal and Torres Strait Islander children for healthy infants, they will follow a two plus one schedule, or doses at two months, four months and 12 months of age. And for infants with those medical risk conditions, they will receive an extra dose at six months of age. It is important to check their vaccination history and the immunisation register to see if they have already been vaccinated. So in South Australia, there has been a state-based program for all infants since October 2018 and of course people may have been vaccinated on private script. 
                                              
This is the table showing you the Bexsero schedule by age and by presence of at-risk medical conditions. And what you can see here is that an additional dose is only required if you have a medical risk condition and you are under six months of age. So, for people aged six months or older it does not matter if they also have asplenia or some other medical condition, the number of doses is the same. And this is showing you the schedule. So from 12 months of age onwards, it is two doses eight weeks apart regardless of your risk condition. 
                                              
And for people who have one of those at-risk medical conditions for invasive meningococcal disease, they will now require the same number of doses for both meningococcal ACWY and Bexsero, which depends on the age at which they start vaccination. And all of these doses are NIP funded. Furthermore, for people who have ongoing increased risk of invasive meningococcal disease, and that includes most of these patients, because many of these conditions are chronic, they will be eligible for NIP funded booster doses of meningococcal ACWY. The timing of those booster doses depends on the age at which you complete your course of meningococcal ACWY. But if you finish the course at age six or under, you have your first booster dose three years later and then every five years. And if you finish the course at age seven or older, you have your booster doses every five years. And there are no booster doses for Bexsero. 
                                              
So a few practice points about meningococcal vaccines. Bexsero can be safely co-administered with other NIP vaccines and all scheduled vaccines should be administered in one visit if possible. And we know that this can get very tricky, particularly if you are also wanting to include flu vaccine or if it is a 12 month old baby who is also eligible for hepatitis B. So there may be instances that you need to separate into two visits, but from an immune point of view it is safe to administer all scheduled vaccines together in one visit. The issue becomes acceptability for parents, depending on how many needles you are required to give the child. Both Bexsero and Prevenar 13 are associated with a high frequency of injection site reactions, so ideally we would avoid giving these two vaccines in the same limb, however it is not contraindicated. We just need to ensure that there is a minimum 2.5 cm distance between any two vaccines that are co-administered in the same limb. And from age 12 months, we prefer the upper limb for administration of Bexsero or Prevenar in particular. You can have a look at the immunisation handbook vaccine administration section for more information on how to administer multiple vaccines. And please document the limb and site at which each of the doses was given. And for the meningococcal B vaccine, we are still recommending prophylactic paracetamol with each dose of Bexsero for children who are aged under two. And that would ideally be given as a single dose 30 minutes before they get their vaccine, followed by two doses six hours apart after they get the vaccine. 

There is further information available in both the NIP Clinical Advice Fact Sheet and the ATAGI Clinical Advice Statements which are very detailed.

So now I am moving on to the hepatitis A. Hang on, I will just have a look here. Can you please advise, is both Bexsero and Nimenrix for both Aboriginal and Torres Strait Islanders? Yes. So, both the Bexsero and Nimenrix, the doses that I showed you were for people who have a medical risk condition. If you are an Aboriginal or Torres Strait Islander child without one of those specific medical risk conditions, you would have the normal number of doses and so you would only have a single dose of Nimenrix funded at 12 months and you would have the two plus one schedule of Bexsero at two, four and 12 months. I hope that answers that. 

Can Bexsero be given with other vaccines in the same thigh? So ideally you would be giving, for a 12 month old or older, you would ideally be giving the Bexsero in the upper limb, but yes it can be given with another vaccine in the same thigh. So for example in a younger child. Just make sure you leave 2.5 cm between the two vaccines. In terms of side effects of giving them together, you are more likely to see a local reaction with Bexsero compared to some other vaccines, but if you administer it next to Prevenar for example, they might be more likely to have a sore limb on that side. And Men. B at two months. Yes, it is okay to give it at six weeks along with the other two month vaccines and you would still have your next dose of Bexsero at four months. Someone has also asked why is the upper limb preferred? That is purely for mobility of the child. So 12 month olds are often walking or at least crawling and we just want to give them the opportunity to continue, so you do not want them to have a really sore leg. And just to confirm, there is no need to separate Men. B vaccine from other vaccines due to risk of fever. Yes, that is correct. So for the scheduled vaccines it can be co-administered with the two, four, six and 12 month NIP scheduled vaccines. There is some advice in the immunisation handbook that if you wish to minimise the risk of fever with Bexsero and other vaccines, you can electively have a three day window between giving Bexsero and giving other vaccines, however as a general practice for all patients, the risk of doing this is that it is less convenient and you have the risk of potentially losing people to follow up, so they may not come back for those additional vaccines. So that is something that needs to be considered on a case by case basis. And yes, Bexsero can safely be given at the same time as influenza vaccine. 

So I might just continue moving on because there are lots more questions, to hepatitis A. So this is relevant for Aboriginal and Torres Strait Islander children in these high risk areas, Northern Territory, Queensland, South Australia and WA. And this is a logistical change. The only reason this schedule change was made was to facilitate the implementation of the Bexsero program. So instead of having their first dose at 12 months, they will now have it at 18 months and instead of having the second dose at 18 months, they will now have it at four years. These new time points were simply chosen to align with the existing immunisation program. We are not trying to intentionally increase the interval between dose one and dose two. So in the transition period, if you have a child who is under 18 months and they are presenting for catch up for their 12 month vaccines, you do not need to catch them up for the hepatitis A. They can wait until 18 months and have it in the new schedule time point. And for children who have already received their first dose prior to July, they can have their second dose at age four, or opportunistically, any time at least six months after the first dose. 
                                              
And this is just a graph to show you the impact of the hepatitis A program. So it has had a good effect on the incidence of hepatitis A, both in the indigenous and non-indigenous communities. So there has been some herd immunity generated. You can see that we now have good control of hepatitis A and we know that it is an effective vaccine with prolonged antibody persistence after the first dose. So, they do not anticipate an increase in hepatitis A cases as a result of this schedule change. So now for these particular high risk areas, this is what the schedule will look like for healthy indigenous children. They will get four vaccines at age 12 months which now includes the Bexsero, four vaccines at age 18 months which includes that changed time point of hepatitis A and three vaccines at four years of age which include the additional dose of Pneumovax 23 and they would get another one at age nine and the second dose of hepatitis A. 
                                              
So moving onto Hib. There is now NIP funding for Haemophilus Influenzae B (Hib) vaccine for people of all ages with functional or anatomical asplenia, which includes sickle cell disease and other haemoglobinopathies as well as congenital or acquired asplenia, or hyposplenia. A single dose of Hib vaccine is required if the person was not vaccinated in infancy or if they did not complete the correct number of doses in their infant schedule. And booster doses are not required. Hib vaccine is still recommended but not funded for people with haematopoietic stem cell transplants. 
                                              
And now moving onto pneumococcal vaccination. 
 
Tim:                                       
We have just got a question about haemoglobinopathy there. Does thalassaemia count as a haemoglobinopathy for the Hib vaccine? 
 
Ketaki:                                  
Yes, yes, haemoglobinopathy, yes. 
 
Tim:                                       
Thank you. 
 
Ketaki:                                  
No worries. And will people with coeliac disease be eligible for Pneumovax and Prevenar? I will show you, not for Hib, I do not think they fit into those categories, but we will have a look at the pneumococcal table shortly. And why does a month difference in age result in additional Bexsero vaccine? Okay, I will have a look at that at the end. 
                                              
So just looking at pneumococcal disease, when we talk about pneumococcal vaccines, you often hear the term invasive pneumococcal disease, or IPD. And that refers to specifically when the organism is isolated from a site which is normally sterile. So you have to have evidence of meningitis or bacteraemia for it to be considered invasive. And there is a line here that shows you, you can get pneumonia progressing to bacteraemia. You then have invasive pneumococcal disease. But otherwise, if you have mucosal pneumococcal disease, so pneumonia otitis media or sinusitis, that is not considered invasive. 
                                              
So, this is showing you over the past 20 years, the numbers of cases and the rates of invasive pneumococcal disease from the National Notifiable Diseases Surveillance System. And the overall picture you can get from this graph is that the pneumococcal vaccine program has not been great over the past decade. We have actually seen an increase in our overall burden of disease. So, that was the impetus to change the program and improve this. 
                                              
Now you can have a look at the same rates but split up by age category. So you can see that in the recent years about half of the cases, so this bit plus this bit, are at the extremes of age. And people under five years of age, they get vaccinated in the infant program, and people 65+ they were getting vaccinated with the Pneumovax 23. But that means about half of the cases in this age range of five to 64 were not previously eligible for any NIP funded doses of pneumococcal vaccines. And even though they may have been category A and recommended, these were not specifically NIP funded. There was PBS subsidy, but no free NIP doses. So that was a gap. 
                                              
Now just having a look back at the infant pneumococcal schedule. So we had the 7-valent conjugate vaccine introduced in 20-5 followed by the 13-valent in 2011. And you can see that after the introduction of each of these, there was a decline in the vaccine type invasive pneumococcal disease cases. And there was also some herd immunity effect. So this is showing you under two years of age where you see a dramatic effect, and even in over 65 year olds, at those time points there was also some decline in vaccine type cases. 
                                              
So the infant schedule was also updated in 2018 with the doses changed from two, four and six months to two, four and 12 months, and so over the coming years we hope to see the impact of that schedule point change. 
                                              
And now looking at what the schedule will look like for older Australians. Previously non-indigenous Australians received a single dose of Pneumovax at 65, and indigenous Australians received it at 50. There is no recent data but the older data from 2009 suggests that there was not great uptake of this program, so coverage was sub-optimal and we know that this Pneumovax 23 is effective against vaccine type invasive pneumococcal disease. But there was not convincing evidence of its efficacy against vaccine type pneumonia, and there are a number of reasons why that was difficult to estimate. Partly the studies that were done were observational studies in countries that had very different schedules to us, that may not have had infant schedules, and this is in contrast to Prevenar 13 where there is demonstrated efficacy against vaccine type pneumonia. 
                                              
So I will show you that here. This is the CAPITA study which was a randomised placebo controlled trial of Prevenar 13 in preventing vaccine type community acquired pneumonia as well as vaccine type invasive pneumococcal disease. And you can see here that the reduction of invasive pneumococcal disease was 75%, so that was quite good. And to a lesser extent, 45% for vaccine type community acquired pneumonia, invasive or non-invasive. So there is some demonstrated efficacy of this vaccine against pneumonia as well. There are a couple of other differences between Prevenar 13 and Pneumovax 23 that were also taken into account. So, the Prevenar 13 being a conjugant vaccine leads to a long term immune memory response, whereas Pneumovax 23 being a polysaccharide vaccine tended to lead to shorter term protection even though it had more strains. 
                                              
So, the way this change came about was that the company Pfizer which is the company for Prevenar 13, somebody has asked that, applied to replace Pneumovax 23 with Prevenar 13 in older Australians based on the data from that trial. So the PBAC commissioned an independent review and concluded that replacing the dose of Pneumovax 23 with Prevenar 13 was likely to be cost effective in older Australians and that Pneumovax 23 is no longer likely to be cost effective for the whole population at the age of 65. However as I did mention there are obviously additional strains in Pneumovax 23 that are not contained within Prevenar 13. And when you look at invasive Pneumococcal disease in the highest risk groups, so indigenous Australians and people with medical risk conditions, a considerable proportion of those cases where caused by strains that are contained in the 23-valent vaccine but not the 13-valent vaccine. And therefore, they are continuing to offer two doses of the 23-valent vaccine to those high risk groups. 
                                              
I will just have a look at the questions, sorry. Okay. So, invasive pneumococcal disease in indigenous Australians. Previously they were funded to have two doses of Pneumovax 23 starting from age 50 and you can see here the indigenous Australians in recent years is in this red line, so 2011 to 2014. And non-indigenous Australians in this blue line. And the gap has been widening. So obviously the previous program was not effective. 
                                              
And this is showing you from the time period, the breakdown of high risk categories. So firstly by age and by risk category. And people with no risk factors are represented in red. So you can see here that the majority of cases of IPD are occurring in people with some medical risk factor. And the blue is people with chronic conditions, so that is probably the most common. Yellow is immunocompromised. So that is also very significant. But the previous program was very complex with category A and category B, and different recommendations depending on your category and depending on your age. And as I mentioned this was subsidised on the PBS but it was not NIP funded. So it was considered very difficult to navigate and there was feedback that this system was too complex. 
                                              
So the rationale for the pneumococcal schedule changes was that we were seeing a lower than expected reduction in adult cases with the previous schedule. There was a rising gap between indigenous and non-indigenous adults in rates of IPD, and many of those at highest risk were unable to access NIP funded doses. There was also suboptimal coverage in those at greatest risk and the recommendations were very complex and difficult to implement. 
                                              
Someone has asked about the timeframes between Prevenar 13 and Pneumovax 23 and I will show you that on an upcoming slide. And how many doses is Medicare covered over 65? From now on, for healthy adults it will be a single dose of Prevenar 13 only at age 70. If they are in a risk condition, they will be eligible for a single dose of Prevenar 13 followed by two doses of Pneumovax 23. So they will be NIP funded. 
                                              
So this is the new risk condition list for the medical risk factors and also a couple of behavioural risk factors. So you can see down the bottom, smoking and harmful use of alcohol. And what you can see here is a long list of conditions where patients are recommended to be vaccinated with one dose of Prevenar 13 and two doses of Pneumovax 23, however only the age and the boxes here with a tick, are NIP funded. So just as an example, people who have congenital immunodeficiency are NIP funded, but people who are taking immunosuppressive therapy are recommended to be vaccinated, but they did not meet that cost effectiveness criteria for it to be NIP funded. And this is where you can find that list. So the NIP schedule actually refers to this Clinical Advice Statement which in found in that particular document. So I will just have a look and see if a couple of questions have popped up. 
                                              
Why is COPD not included and NIP funded? So, from my understanding, the conditions for which it is not funded, they did not meet the cost effectiveness threshold. So what they would have looked at is specifically the rates of pneumococcal disease in those particular groups of the population and whether it would be cost effective to pay for the vaccine and arrange for it to be delivered for each one of those patients. But the important thing is that people with COPD are still strongly recommended so we would still encourage you to identify and offer it to all of those patients. 
                                              
If someone has had two doses of Pneumovax 23 or more as an older patient, do they need to have Prevenar 13 when they turn 70? Yes. So as long as they have never had a dose of Prevenar 13 and they turn 70, then yes, they should receive Prevenar 13 and that is because of this evidence that it produces a longer duration and superior immune response against those shared strains.                                              
                                              
And if someone has already had Pneumovax at 65, will they be eligible for a further dose of Prevenar 13 at 70? Yes. So, obviously there will be a great number of people now who would have received Pneumovax at 65 and they might be in that in between age. When they get to 70, yes, they will receive a funded dose of Prevenar 13. 
                                              
So I will let you have a look at that list in your own time. It is very complicated so I did not want to read through any more of those cases. So this is what the pneumococcal vaccine schedule will now look like by category. So to start with, the universal childhood schedule applies to all non-indigenous children and indigenous children in the lower risk jurisdictions of ACT, New South Wales, Tasmania and Victoria. And there has been no change to this routine schedule. They will all get three doses of Prevenar 13 at two, four and 12 months. Then for children under 12 months who have a risk condition, whether that is a medical risk factor or if they are an indigenous child in Northern Territory, Queensland, South Australia or WA, they will receive an additional dose of Prevenar 13 at six months of age and they will also be funded to have two doses of Pneumovax 23 starting from a minimum age four and then with a subsequent dose five to 10 years later. Anybody aged over 12 months who has a risk condition is recommended to have a dose of Prevenar 13 at diagnosis followed by two doses of Pneumovax 23. 
                                              
And now we can talk about the time intervals and that was a question that has come up a couple of times. Ideally, Prevenar 13 would be given first followed by Pneumovax 23. Obviously there will be many patients who are category B or who were 65 or for whatever reason have already had Pneumovax 23 and if they are now eligible for Prevenar 13, they should still be given Prevenar 13, but if possible and if they are na├»ve to pneumococcal vaccines, you would give them Prevenar 13 first. Then the recommended duration to wait before giving them Pneumovax 23 is 12 months. But there is a minimal interval of two months and that again has to be determined on a case by case basis. So one example I think would be somebody that you know they are about to go onto immunosuppressive therapy so you would rather vaccinate them sooner than later, because once they start their immunosuppressive they may not mount a good response. So for a patient like that, you might choose to give them Prevenar 13 and then two months later, Pneumovax 23 and then they go onto their immunosuppression. But if possible, the recommended interval is 12 months to maximise your response to both vaccines. Or for younger people, you have to wait until they are at least four years of age, and that is because children under two do not respond well to polysaccharide vaccines, so once they are older they are able to mount an effective immune response. And then the next dose or final dose of Pneumovax 23 will be five to 10 years later. And there is now a recommendation for a lifetime limit of only two doses of Pneumovax 23. Previously there were three doses, so that has been reduced, and that partly because with further doses you have increased risk of injection site reactions and also because of possible concern of immune hyper-responsiveness with multiple doses. So it anybody has any further questions about that, I would be happy to try and elaborate. 
                                              
So the next group is Aboriginal and Torres Strait Islander adults aged 50 or older. They are now eligible to receive a funded dose of Prevenar 13, followed by two doses of Pneumovax 23 following the same intervals that we just discussed. 
                                              
And then finally, for healthy, non-indigenous adults aged 70 or older, they are now eligible for NIP funded Prevenar 13. And the reason it has been moved to 65 to 70 is a couple of reasons, firstly, the rates of invasive pneumococcal disease are much higher in the 70+ age group compared to 65 to 70 in recent years. And secondly, it aligns with the Zostavax time point. So it can be co-administered. And there is also the recognition that none of these vaccines will provide, well their protection is best in the first few years after vaccination so they want to optimise that protection for that older age group. 
                                              
I will just have a look and see if there are any questions. Pneumococcal vaccines can be given with influenza at the same time. Yes, they can. 
                                              
Does 23-valent cover all the organisms covered by 13-valent. No, I do not think so. I do not know off the top of my head all the strains, but for example one of them covers 6A, one of them covers 6B. So I think there are subtle differences, however for most healthy people there are no funded doses of Pneumovax 23 and certainly the most common strains are included in Prevenar 13. 
                                              
Someone has received pneumococcal vaccine as a trial. Do they still need this vaccine in adulthood? That is probably a question that is difficult to answer because we still do say that a lifetime limit of two doses of Pneumovax 23, however all of those people who have risk conditions and they get vaccinated in childhood, by the time they turn 70 we will probably have completely different vaccines and a completely different schedule. So, at the moment hopefully that last slide addressed how many doses a child would need now and there are sort of no plans for re-vaccination later in life. 
                                              
Should we recall indigenous people for Prevenar if they have already had Pneumovax for over 50 years? Yes. So anyone who is now eligible for Prevenar 13 who has not yet had Prevenar 13, should be called back to get it because they will benefit from that additional stimulation of immune memory. 
                                              
So after Pneumovax 23, when 13 can be injected for those who have already had 23? That is a good question. So, somebody who has already had Pneumovax 23 and is now eligible for Prevenar 13, it is recommended to wait 12 months before giving Prevenar 13. A couple of people have asked that. 
                                              
And a 35-year-old diabetic patient received Pneumovax 23. Yes, so that patient we would recommend, so if someone has received one dose of 23, they are actually eligible for another dose of that, and they are also eligible now for Prevenar 13. I would wait 12 months and give them Prevenar 13 and then wait until another five years has passed and then give them the Pneumovax 23. 
                                              
And for non-Caucasian Australians like Indian, Asians, also the same age for Prevenar 13? Yes, so for non-indigenous Asians, the time point is 70 regardless of their ethnicity. 
                                              
Over 70’s catch up for Prevenar 13? Yes. So it is 70 or older. So anybody who is older than 70 is also eligible for a funded dose of 13-valent pneumococcal conjugant vaccine. 
                                              
If a child with high risk did not have the six month Prevenar 13, when can they be given as catch up? So if a high risk child did not get that six month dose, they should just be vaccinated at 12 months of age. The reason that that schedule point was moved was simply to provide protection in the second year of life. So if they get a vaccine dose at 12 months of age, they do not need a fourth dose. As long as they have got a dose in the second year of life, you can consider them up to date. 
                                              
I will just go back to the talk. So, this is a summary now of what the pneumococcal program will look like. So, the routine schedule for healthy infants remains the two plus one schedule at two, four and 12 months of age. For people with medical risk conditions, including older Australians with risk conditions, it is a single dose of Prevenar 13 and two doses of Pneumovax 23. And for older Australians without risk factors, it is a single dose of Prevenar 13 only. 
                                              
So a few practice points. So as I mentioned, there is now a maximum recommended lifetime number of doses of Pneumovax 23 of two doses. However, if someone is unsure of their vaccination history and you think they might have had a Pneumovax 23 or they might have even had two doses in the past but you do not have any documentation, you do not have any evidence, it is still okay to vaccinate them. If it is not documented we cannot assume that they have been covered. And older Australians aged 70+ who have already received Pneumovax 23 should still receive Prevenar 13. The minimum intervals I have already mentioned, but I will just reiterate. Ideally you would give Prevenar 13 first and if you are giving Pneumovax 23 afterwards, it is recommended 12 months but minimum two months and if you are giving - that should be 23 sorry, not 12 – if you are giving 23-valent after, it is a recommended interval of 12 months. 
                                              
And what to expect in future. So, now the NIP funding of Prevenar 13 and Pneumovax 23 of those at greatest risk of disease will hopefully improve compliance because it is simplified a little bit with that single list, and hopefully reduce IPD rates. Hopefully this new schedule will be easier to implement and we are still waiting to see the impact of the infant schedule change in 2018. But pneumococcal epidemiology will be continually monitored. We will need to assess the impact of these changes and inevitably, this will result in changes in the pneumococcal serotypes that we see which is called a replacement phenomenon. And there will be future changes again in the vaccine schedule most likely. 
                                              
So now to have a look at a few case studies. There are a couple of other questions that have popped up. I have a patient over 70 who has had Pneumovax 23 before. Do they still need PCV13 later? Yes. If they have never had a dose of Prevenar 13, and they are 70 or older, yes, they should get it. 
                                              
What about young people without risks? Should they get Prevenar 13? They should, as part of the National Immunisation Program, they should have gotten it as a young infant. I think above five there are no catch up doses, so if they are not in a risk category, they are in that healthy, middle aged group, they do not qualify for additional doses. 
                                              
And, an asplenic patient can get free vaccination under NIP from July 2020. Is that correct? Yes, that is correct. So, asplenic patients now get NIP funded vaccination for meningococcal, pneumococcal and Hib. 
                                              
Okay, so just to go back to the case studies. So the first case study is an Aboriginal child aged 12 months in Queensland who is a healthy child, born at term, up to date with the vaccines so far but has never had influenza vaccine. This is what the schedule will look like for this child. So at their 12 month visit, they will get their standard dose of Prevenar 13. They will get the standard NIP MMR and Nimenrix but they will also get their Bexsero and because we are only just starting it, they will need a second dose eight weeks later, and we recommend that they have their flu vaccine and it is the first time they are getting flu vaccine, so they need two doses one month apart. Then at 18 months of age they are going to get their first dose of hepatitis A whereas previously it would have been here at the 12 month time point. And then we recommend yearly flu vaccines. And at age four they will now qualify for Pneumovax 23 and they will get their second dose of hepatitis A. And at age nine or later, they can get their final dose of Pneumovax 23. So all of these doses are now NIP funded. And in our clinic, we tend to give people catch up schedules or schedules that look like this with the time point across the top and all the vaccines down the side. We find that a little bit more easy for people to get organised. 
                                              
So the second case study is an older, healthy non-indigenous adult. So she is 65. She is not indigenous. She does not have any behavioural risk factors of pneumococcal disease and she also has not had a flu vaccine this year. So this is what her vaccine schedule will look like. She no longer qualifies for Pneumovax 23. We do not give that to healthy adults. And instead we will ask her to come back at the age of 70 to get a single dose of Prevenar 13. And of course, we recommend yearly flu vaccines because she is in a high risk age category, and all of these vaccine doses are NIP funded. 
                                              
Finally, a non-indigenous adult with a medical condition. So, we have a 35-year-old man who had an emergency splenectomy three weeks ago. In terms of his vaccine history, so he is otherwise healthy, no risk factors, non-indigenous, he has had tetanus in hospital once, he has never had a Hib vaccine or meningococcal vaccine. He thinks he might have had one MMR in childhood but cannot remember and has not had a flu vaccine this year. So this is what his schedule would look like. So because he has got asplenia, he now qualifies for all of these vaccines for the encapsulated organisms. Both pneumococcal vaccines. So he will get a dose of Prevenar 13 now and then a year later, he will get his first dose of Pneumovax 23 and then five years after that, he will get his final dose of Pneumovax 23. He gets both types of meningococcal vaccines, so healthy adults would only get one dose of Nimenrix but because he has got asplenia, he qualifies for two doses of Nimenrix, eight weeks apart and everybody who takes Bexsero at this age group gets two doses eight weeks apart. And he qualifies for a single dose of Hib. And remember that meningococcal ACWY, because he has now got no spleen is an ongoing risk, so every five years he will qualify for a booster dose of Nimenrix. But there are no booster doses of Hib. So just a single lifetime dose of Hib and annual influenza vaccine. And then there are a couple of options for the MMR. You could check his serology and if he was immune to all three, you could consider him up to date, you could give him a single dose and then check his serology, or you could just give two doses. And the MMR is funded by New South Wales, but all of these other vaccines are funded by the National Immunisation Program. 
                                              
I am just having a look at some recent questions. Oh yes, I will get to a couple of those. So some resources that are useful are the ATAGI Clinical Advice Statements. They are really detailed, they include some information about the rationale behind all of these changes and they have that great table for pneumococcal risk factors. I would highly recommend looking at those. The Immunisation Handbook which is now available as an App, and Clinical Advice Updates from the National Immunisation Program as well as, this is answering one of the questions, a National Immunisation Catch-up Calculator which is being released this month. There are also fact sheets on the NCIRS website, including FAQs, and if you have not signed up, we recommend that you sign up for the NCIRS Weekly Jab newsletter which is an immunisation newsletter. 
                                              
So, some take home messages. Identify Aboriginal and Torres Strait Islander people within your practice and discuss the need for additional recommended vaccines. Please identify the medically at-risk patients within your practice and discuss the need for additional recommended vaccines. Familiarise yourself and educate practice staff on the planned schedule changes. There are the NIP resources that I mentioned before, but there are also relevant State and Territory resources and schedules. And so for example, New South Wales Health have an excellent schedule as well on their website. Please record all immunisation encounters on the Immunisation Register and ensure that your practice software is up to date and the company will be able to give you further advice. 
                                              
So that is it from me. I will just have another look at the questions. Are we getting a copy of the slides? I am happy to share the slides. 
                                              
A 75-year-old with splenectomy. Yes, they qualify for both ACWY and Bexsero. 
                                             
What do you advise for a healthy 40-year-old who wants to get private pneumococcal vaccination or would you advise against it? That is a really good question. If they are healthy and they have absolutely no risk factors, they would be able to purchase it privately. I do not really have a stance. I guess you just have to have a risk-benefit discussion with the patient. But I do not see why they could not be offered both vaccines, they would just have to pay for them. 
                                              
Any other questions, Tim that you wanted me to answer? 
 
Tim:                                       
Yes I am just looking through. Thank you very much everyone for your questions. It has been really good. I think we got lots of questions early on about the various pneumococcal vaccines and I think we have covered those off in the section about the pneumococcal vaccinations. I am just looking at some of the others. People are concerned about COPD not being cost effective for vaccination, so it is recommended but not on the National Immunisation Program. That has come through a couple of times. Clarification, is MMR not NIP funded for all born after 1966? 
 
Ketaki:                                  
It is. That is a New South Wales thing to my knowledge. I am not aware about in other states, but it is funded in New South Wales. It is not on the NIP though, so it is a different funding structure to my knowledge. 
 
Tim:                                       
Yes, so the NIP is a national immunisation program, so one of the complexities I imagine is the National Immunisation Program that is federally funded and then each State also has immunisation programs that link in with that, too. So MMR was a State one. 
 
Ketaki:                                  
Exactly. And actually, something a lot of people do not know, is the NCIRS website has recommended schedules for adults and infants, and so that actually includes vaccines that are recommended but are not NIP funded. So it would be good to be familiar with the State schedule for your jurisdiction as well as having a look at those NCIRS recommended schedules, and then there are funded NIP schedules. It is incredibly complex. 
 
Tim:                                       
It is complex. Someone is asking if we can clarify examples of functional asplenia? 
 
Ketaki:                                  
Yes. So that would be for example the haemoglobinopathy. So people with something like sickle cell disease or if they have had like a splenic sequestration, haematological conditions that affect the spleen. It is a good question. I think there should probably be a list. I am not sure if there is a list in the handbook, but it basically just anything that is impaired spleen function versus anatomical which is where you might be born without a spleen, or you have had surgery to take out your spleen for example. That is the difference between functional and anatomical. 
 
Tim:                                       
There is a question here that I suspect has gone through all our minds. What strategies do you recommend so the providers do make any mistakes in what looks like a very complex vaccination schedule? 
 
Ketaki:                                  
Yes, so what we do is those tables in the case study I find really useful. And they take a long time so I understand that you know, I have the luxury of being in a specialist immunisation clinic where we have time to sit down and do that. I understand that would be really tricky for providers. Sometimes we suggest that you could contact your local public health unit to try and help you, or particularly complex cases to come up with a schedule. What I would recommend is certainly have printed out the non-indigenous immunisation schedule and the indigenous immunisation schedule. Think about the medical risk factors and then if you can tabulate it with the time points that they need their doses and specific vaccines. Give a copy to the patient as well because it really is a challenge telling someone come back in one month for your next dose of flu, then month later for your Bexsero and then a four months later for your 18 month vaccines. It really is much easier if it is written down like that. But I do understand the logistical difficulties when you have only got you know, a 15 minute appointment and many other things to do. 
 
Tim:                                       
I suspect for many of us, it is going to be by individual patient, just spending some time working out what it is that they require, so rather than by vaccination, but by patient. What does this patient require? And setting out a vaccination plan where possible as part of perhaps a health assessment or medication review or something. I think each of us will come up with our own strategies for that and share them with everyone else, please. 
 
Ketaki:                                  
Yes, and hopefully the Catch-up Calculator will be a useful resource for that as well. 
 
Tim:                                       
I am looking forward to seeing that. So, a 19-year-old girl who gets recurrent pneumonia, asking for pneumococcal vaccine. What would be your position on that? 
 
Ketaki:                                  
So we will go back to that list. It is interesting. So if she has had an episode of confirmed invasive pneumococcal disease, then she would qualify for NIP funded doses, but that means that she needs to really have had that demonstration of bacteraemia. So the reason that that is funded is partly because invasive pneumococcal, having had invasive pneumococcal disease as a young person means perhaps that is masking one of those medical conditions. It is not that the episode itself was a concern, it may be a reflection of something underlying. But if she has had recurrent community acquired pneumonia but does not have any evidence of these chronic respiratory diseases, she would not qualify for NIP funding for doses, but you could still consider offering her on private script. We have certainly seen patients, young adults who have had community acquired pneumonia and they do not have any evidence that it was pneumococcal, let alone invasive, but they have opted to pay for both vaccines. So they are licenced in Australia. They can be given in that way, but they are just not specifically recommended in the high-risk handbook groups. 
 
Tim:                                       
Some of the other questions, with three minutes to go. Sometimes specialists recommend more doses for a patient. Would that be a private script? 
 
Ketaki:                                  
Yes. If they are getting additional doses beyond what is here, but I wonder additional doses they are talking about? I can see the question. Yes, we certainly would not recommend giving additional doses of Pneumovax 23 and really, beyond the doses that have been listed here, I do not see why you would. But it would have to be private script, yes. 
 
Tim:                                       
Yes. So we have got a few questions about the different chronic medical conditions recommended and I think that the lists on your screens now, and I will certainly be going to the ATAGI website and looking up that list and maybe printing it off and having it on my desktop I think. 
 
Ketaki:                                  
Yes. I have not memorised this list myself. 
 
Tim:                                       
And you can see why for most of them, it sort of seems to make sense. But I think I always struggle to memorise that sort of list. Lots of interest in the National Immunisation Catch-up. So people asking, does that mean that the States are now aligned? And just confirming that it will take in these new schedules into account? 
 
Ketaki:                                  
No, I think that the National Immunisation Catch-up Calculator will be for NIP vaccines. I know there is a South Australian Calculator but no, unfortunately I suspect you will have to think separately for your jurisdiction what additional vaccination requirements there are. That might be something I get to you on. When I was last involved in giving feedback for the National Catch-up Calculator is was only looking at NIP vaccines.
 
Tim:                                       
Yes, okay. Which would mean for us in New South Wales, taking a close look at the MMR vaccines as well as the Catch-up Calculator.
 
Ketaki:                                  
Yes, that is right. And so that is why it is worth looking at your own State or Territory health website as well, because you will see what additional things are State-funded. So South Australia for example, that would be Bexsero. Torres Strait Islander children are eligible for Japanese encephalitis in some areas. So there are a lot of additional ones around the country that are quite unique. 
 
Tim:                                       
We have got a couple of questions on vaccinations that we have not particularly talked about because the schedule has not changed. What is your position on a second influenza vaccination in the year? And also, someone is asking about the upper age range for free Gardasil given COVID has affected everyone. 
 
Ketaki:                                  
Okay. So, for the second influenza vaccine, yes, excellent question. There has been a lot in the media about that. But the position at least of the policy team at NCIRS has not changed, which is that there is not sufficient evidence to recommend a second dose of influenza vaccine in the same season, except for a couple of circumstances. One of those is if you are pregnant and in that case the second dose, so say you had a flu vaccine before you got pregnant, you then got pregnant and it is still the same flu vaccine around, we still recommend getting re-vaccinated in that case in order to generate antibody to pass onto the baby. And then the second instance is probably not relevant this year, is travel to the Northern Hemisphere. Other than that, it is not routinely recommended to be re-vaccinated in the same season. There is some evidence that having a repeat dose, I think there is one study that looked at a 12 week interval, it did not show a significant improvement in antibody titers. So at this stage, no we are not recommending routinely giving second doses. 
 
Tim:                                       
And the second dose is not on the schedule either as far as I know. 
 
Ketaki:                                  
That is right, it is certainly not funded on the schedule. And the other one. The age range for free Gardasil is currently 19. Considering the COVID saga. No, is that question because people were not at school and they might have missed it at school? 
 
Tim:                                       
Yes, I think so.
 
Ketaki:                                  
That is a really good question. No I do not think the upper age range has changed. But I think hopefully people would have been able to see their GP – oh maybe they would not have been able to see their GP. That is a great question. I do not know, sorry. There has not been any policy change to account for that. 
 
Tim:                                       
It is a really good question. And on that note, we have hit half past eight. Thank you very much Ketaki, that was excellent and really, really helpful. You will be all getting an evaluation survey when we are finished and Sammi I think you can confirm the webinar will be recorded and whether people will get the slides? 
 
Sammi:                                 
That is correct. So it is recorded. The live recording will be available on the website in a couple of weeks and you will all receive a copy of the presentation with all the hyperlinks and resources tomorrow. 
 
Ketaki:                                  
Thank you. 
 
Sammi:                                 
Wonderful. So I would just like to say a big thank you again to Ketaki and Tim and for everybody that joined us online. We do hope you enjoyed the session and enjoy the rest of your evening.
 
 
 

Other RACGP online events

Originally recorded:

6 July 2020

From 1st July 2020, the National Immunisation Program (NIP) schedule was updated to improve protection against meningococcal, pneumococcal and Haemophilus influenzae disease for certain risk groups. This webinar discusses the changes to the NIP, the rationale for these changes and their clinical impact, and where further information and clinical advice can be sought.
 

Learning outcomes

  1. Be aware of the changes to the National Immunisation Program (NIP) from 1 July 2020
  2. Discuss which additional at risk groups are eligible for funded vaccines under the NIP
  3. Be aware of NSW and National resources that are available to support the changes
  4. Discuss the evidence for the changes and the clinical impact
This event attracts 2 CPD points

This event attracts 2 CPD points

Facilitator

Dr Tim Senior
MBBS, FRACGP

Tim Senior works as a GP at an Aboriginal Community Controlled Health Service in South West Sydney, and is involved in teaching medical students and GP registrars, and is active in policy development and advocacy in Aboriginal and Torres Strait Islander Health. He is an award winning writer on General Practice and Public Health, and is a contributing editor and member of Croakey Health Media. He is active on social media, and was named as one of the top 10 health users of Twitter in Australia.

Presenter

Dr Ketaki Sharma
MBBS, MPH, FRACP

Staff Specialist, National Centre for Immunisation Research and Surveillance

© 2020 The Royal Australian College of General Practitioners (RACGP) ABN 34 000 223 807