Today the Therapeutic Goods Administration has confirmed that Tasmania has recorded its first case of thrombosis with thrombocytopenia that's likely linked to vaccination of a person with the AstraZeneca COVID-19 vaccine.
The Tasmanian health department this week has convened an expert alert advisory panel to review the case.
The person is a 70 year old man who reported symptoms seven days after they received the vaccine and is currently in hospital and remains in a stable condition.
The Department of Health notified the case to the Therapeutic Goods Administration for assessment this week including to determine whether the case was linked to the vaccination.
As part of the assessment by the TGA, today they have confirmed that this case and four other cases in other states have been assessed as it’s likely to be linked to the vaccination with the AstraZeneca vaccine.
It’s is a rare, newly described condition and it has been recognised as being linked at this stage to the AstraZeneca vaccine and Australian immunisation experts report that the overall rate of this rare syndrome is around about six cases we expect to see for every million or so doses of vaccine that are delivered to people.
It's important that people understand that this blood clot syndrome is very different from other common blood clots which include quite relatively common or more common conditions such as deep vein thrombosis or DBTS and even conditions where people get blocked arteries.
These conditions don't appear to be caused by the AstraZeneca vaccine. They're much more common and caused by other risk factors and other factors in people aged over 70 years of age.
The benefits of AstraZeneca vaccine outweigh the risks and these rare risks that are associated with the vaccine and this is because the lower risk of the syndrome is in people over 50. It reduces as a person gets older over 50 but for people over 50 as they get older the risk of severe outcomes from COVID becomes much greater so it's important that we understand that the risk of the complication of it’s associated with AstraZeneca over the age of 50 is far outweighed by the benefit of receiving the vaccine to prevent against a person having a severe outcome from COVID.
It's very important that any person now who's received their first AstraZeneca vaccine without any serious side effects can very confidently be given a second dose regardless of age and the current national advice is that THE Pfizer vaccine continues to remain the preferred vaccine for people under the age of 50 and that's because for people under the age of 50 AstraZeneca is recognised as causing more cases of it than people over 50 years of age.
Adverse events and serious reactions after any vaccination can be common and are reported to the Tasmanian Department of Health and they're referred for assessment as part of national ongoing vaccine safety surveillance processes to the TGA and that's to ensure that all vaccines including the COVID vaccine remains safe.
People who have received any COVID vaccine, it's important that they're aware of the common side effects. Common side effects associated with COVID vaccination can be quite similar to other vaccines and they include things such as fever, sore muscles, tiredness and a headache and these mild symptoms usually start within 24 hours of the vaccination and they usually only last one or two days. These side effects can be expected and they're not of concern at all unless they are severe or they persist for longer than a couple of days. If they become severe and persist for longer, we'd recommend any person who experiences these side effects sees their GP or a doctor reports of it’s are quite different they have occurred later between usually four days after a vaccine or up to 20 days and they generally are quite severe often requiring someone to see a doctor urgently or to be hospitalised. These can include serious symptoms such as a severe headache, blurred vision, chest pain, severe shortness of breath, severe stomach pain and severe leg swelling and that's because of the symptoms of a blood clot forming. This condition is not just associated with blood clots forming but also a risk of bleeding and that means that it's important that people also look for a rash. That can be a rash that includes bleeding or bruising or even little pinpoint spots of blood underneath the skin. If anyone experiences any of these symptoms more severe symptoms and are persistent following a vaccination they should urgently seek medical condition.
We will continue to monitor the latest international national and local data as this as the vaccine continues to roll out across the country and across Tasmania and we'll provide updates as soon as they become available.
I really want to stress that vaccination remains the best way for us all to protect ourselves against severe illness and death from COVID and it's a core part of our pandemic response as important as any other element of what we're doing within health to manage and respond against the pandemic. So I encourage every Tasmanian to have a COVID vaccination. The COVID vaccine that's important and recommended for their characteristics, their age, their role and it's important that they receive that to protect themselves their family and their community.
Thank you. I’ll now hand it over to Dale Webster, the Commander of the Tasmanian Vaccination Emergency Operations.
Thanks so much. I want to just outline the process by which Tasmania is monitoring adverse events following immunisation. So that process starts with the informed consent and it is a for those that have been vaccinated will realize it's quite a long form and it's deliberately long so that there's information contained in there and you actually do go through and have a discussion with your immuniser around the questions; second part of our adverse event process is the time that you spent in the clinic after your vaccination.
This is a period of observation so that we can make sure that those immediate reactions such as anaphylaxis don't occur in that window or if they do, you're still on site with nurses and medical staff who can actually react to that happening. Also in a number of our clinics, and randomly in a number of GP clinics, we have a process by which people sign into or log into a system called the AusVaxSafety system. That's a random sampling where people are surveyed a few days after through to a few weeks after they've had their vaccine so that we can monitor the types of symptoms that are standard across the population and can confidently say they're the standard ones. And as Dr McKeown said, there are standard treatments like take Panadol; those sorts of things.
The other thing we do is all of our health professionals across the state both in the private sector and the public sector are aware of the reporting processes so they report adverse events through to the Public Health unit here in Hobart and each of those is followed up within so we've got the maximum amount of information before we share that with the TGA so that they can actually feed that into the national system.
Those processes have been in place for a number of years around all types of vaccinations and we've redoubled our efforts during this vaccine rollout to make sure that our health professionals are following the processes that we require them to follow.
At this point I’ll take questions.
You've gone into a great level of detail there as to how these vaccines are being monitored, but just to sort of simplify I guess, if the public are worried that authorities aren't keeping an eye on this, or they they're a little bit anxious to how carefully the city is being monitored, what would your reassuring message to those people be? A reassuring message would be that we're collecting this information and the reason we're having this press conference today is to make sure the public have the full picture of the adverse events. So it's about full disclosure to the public firstly, but secondly reassurance that we are monitoring each of the adverse events reported so that we can see any patterns and those sorts of things that's how we get the national picture, and as Dr McKeown outlined, that so we get the international picture. So we would say to the public we are getting the information; we're gathering it; we're making sure it feeds into how we respond to particular adversities this may have been impossible before.
I might have missed it, but how many adverse events have we experienced in Tasmania? How severe? So the severity of them is the main (reason) most of ours are low range so the things that we would normally expect the rate at the moment is about eight adverse events per thousand doses but most of those, the vast majority are those, that we would expect to see things like after the second Pfizer dose. Five to eight percent of people get flu-like symptoms. For a number of vaccines; people get a sore arm; certainly a small number of people get sore arm after a vaccine. So those are the sorts of things that are being reported and we're monitoring those.
There's nothing in this severity? None of this severity, until this one.
Will this - let me know if this is a better question for Ms Morgan-Wicks - you would have been expecting potentially to have a case or cases of this based on the incidence rate; will this change anything about the vaccine rollout. The way it's being monitored and so on, or you're going to continue with the system you've got? We're going to continue with the system we've got. Across Australia we've delivered 2.47 million doses so far and the system is at the Adverse Event Following Immunisation Reporting System is operating so that we can actually monitor it and the TGA is actually putting that data out now on a weekly basis on Thursdays.
So just to clarify, when you say that there have been adverse reactions per 1,000 doses, are you saying that just all up there has been eight adverse reactions in Tasmania? I just need to wrap my head …? Per thousand doses so we've delivered 84 000 so that would be … can’t do the maths (laughter).
I’ll just check for questions on this particular case is Dr McKeown the best person to direct these to? Yes, yes.
Will just check, you might be able to tell me this case that we've had the diagnosis of TTS is definite and the link to the AstraZenica vaccine that's still considered likely that's not completely sure, but it is considered likely that it's linked to that? It's considered likely there is a causal link.
Will there be an extra process now where that link is set in stone? Is there any additional work or does it remain does likely remain the final diagnosis if you like? Likely will remain the final.
(inaudible question) I could comment on that a little. A new condition such as TTS is often our knowledge increases about it and our ability to be more clear about what the condition is and even if there are sub-conditions within a recognised syndrome - a pattern of sort of symptoms and the way a person might present - we often find out more information over time and that can allow more certainty around being clear about the diagnosis of the condition and very clear about whether or not we can say there's causation or not, so that will evolve with time.
Can you say which hospital this person's in and whereabouts in the state they're from? No, I can't at this stage. Any further information that might enable the person to be identified, I’m not prepared to share at this stage.
Can you say which hospital? It would be very difficult to identify someone just based on being over 70 and a particular one of three hospitals? No, sure, look in the interests of patient confidentiality and obviously because of the sensitivities around this case, we're not going to provide any further information in respect of him.
Could you tell us whether this condition occurred after the first or the second dose of AstraZeneca? After the first dose and that's what we're most commonly seeing is in the rare occasions when it does occur occurs after the first dose. So the message is if anyone has received their first AstraZeneca dose they're due for a second they can safely receive that and if you're over 50 the benefit of receiving AstraZeneca outweighs any risk of TTS. Consent Is very important and informed consent when that vaccine is part of that vaccination process that's undertaken with the health professional including a doctor or a general practitioner as part of that vaccination.
And just because you - sorry, you spoke a little bit earlier when you gave this message; if someone feels that they are having a more severe the normal reaction what should they do? So if anyone does experience severe or prolonged symptoms after a vaccination, they should seek urgent medical care.
And just to be clear here, it can be fatal? It can be fatal and certainly we do have quite good treatments now in Australia and we're certainly seeing that most people with the condition are recovering and that's quite encouraging. But it is serious and severe. It does need to be picked up early so that's why it's important if anybody has concerns about severe or prolonged symptoms that could suggest something like TTS they should seek urgent care as this gives them the best chance of an outcome.
Are you expecting this particular individual to recover? He certainly - you know - remains in a stable condition now and we would be very hopeful and expect his condition to improve/
Did this person have any underlying medical conditions or any pre-existing conditions that would be relevant to this? I’m not going to provide any further personal information or medical information.
Is it okay for me to speak to Dr Melody just about TTS itself and then perhaps to Ms Morgan-Wicks about (inaudible). So we might get you first if you could just say your name and position title and then also say the full description out loud so we know how to say it. Sure, so my name is Dr Shannon Melody. I’m a specialist medical advisor working in the Tasmanian Vaccination Emergency Operations Centre and I oversee the adversary surveillance for Tasmania. And your second question: so thrombosis with thrombocytopenia syndrome, so clotting.
And what I suppose, what does this illness actually cause? What does it do to a body? It depends on how it presents, so what we see and as the name implies; we see this coupling of both clotting and low platelets and it's a bit like an immune – if the immune system is in overdrive so you see clots form and the symptoms present. The symptoms depend on where the clot is, so as Dr McKeown outlined, if you're seeing if someone's presenting with severe headaches or blood vision, that relates to the thought that's being located in the venous system or the of the brain if someone's short of breath who has chest pains that relates to the clot being located within the arteries and veins of the lung and so it presents variably but as outlined what's very different as compared to normal side effects that we expect after any vaccine including COVID vaccines is that it's later and it's more severe so it's not something that someone would shrug off normally it's something that would alert you to see
Is it difficult to treat? It's a newly described condition so the world is learning about this as we go. The treatment itself is fairly straightforward though it's about uh moderating the immune system so providing something called intravenous immunoglobulin which is a drip in the arm and a medication that's received for a number of days and it's also about making sure that you treat the clot as well with a medication that's suitable to do so. So it's usually appropriately managed on a ward in the hospital.
Would you be able to give us an update on the current vaccine rollout in Tasmania; I suppose including a breakdown of where we're at in terms of doses for the state rollout and the one that's been overseen by the federal government? Yeah, so certainly we're probably reaching close to 85,000 doses delivered in Tasmania today, so we're at 84,500 last evening and out of those doses some 45,000-odd estimated AstraZeneca. So certainly at tomorrow's update we'll be providing that weekly review, but that's where we're at, at the moment.
And just to clarify, this case isn't going to - or I’ll rephrase that - is this case going to have any change on the rollout of our vaccine program? So in terms of our reporting of the case today it is showing that our system is actually working in terms of the very thorough and strict protocols that we have in relation to adverse event reporting. The review that's actually being undertaken by the team that's led by Dr Shannon Melody and then the reporting through to the TGA who are receiving all of the reports nationwide, assessing those reports and reporting on a weekly basis and that's the report that's come out this morning from the TGA in terms of the impact on our program. We've got very - we've had a hugely positive response to the opening up of the program to over 50s and I think that's coming from the many, many people that are seeing in terms of the consequence and severe consequence of COVID that the benefit of the AstraZeneca vaccine far outweighs that severe consequence if they contract COVID.
Yeah, I guess rephrasing it another way: if people are wondering or if they're concerned that there's going to be changes or disruption to being able to access the vaccine now? If there are uncertainties as to what the future of AstraZeneca is, you're saying it's still there; still go and get it? Yes and as the commonwealth have confirmed in their press conferences today, and with the release of the TGA report, there's no other further recommended change to the vaccination rollout but there is certainly the continued reporting in relation to adverse events. And the most important message is that if you do receive the AstraZenica vaccine that you are alert to these potential for symptoms and to not ignore them and to seek treatment straight away.
Are you seeing, or the people who are dispensing the vaccines, are you seeing any evidence of any increased vaccine hesitancy as a result of - I suppose - the reporting and the knowledge around some of the adverse outcomes? We haven't seen any increase in terms of hesitancy probably in the conversations that are already occurring at the hubs. I think when a person walks into a vaccination clinic or shows up to their GP they're indicating that commitment to be vaccinated and to protect themselves against COVID, but certainly we do and I’ve been wandering around some of our vaccination clinics there are conversations. We make sure and take informed consent really seriously and so that if there are any questions really encourage people to talk to their own GP or to talk to the immuniser when they come to their appointment.
And is the uptake of the vaccine from the over 50s, is that the rate that you'd be expecting? I think we're actually positively surprised particularly with the opening up on Monday of the number of calls and the attempts to actually book appointments through and we've been responding to that increased demand by opening up further clinics.
So what's the status of the vaccine rollout at the moment? Who's getting a vaccine at the moment and I guess what's happening with it at the moment? I’m a bit out of the loop it appears. I’ve just been on the election. I absolutely understand and we've got probably three phases that are really operating at the moment so we're we've nearly finished in terms of our 1a so we expect that the commonwealth will finish the aged care residences in Tasmania in coming days. You know a couple of weeks certainly we have finished 1a from our priority healthcare worker perspective and quarantine and border protection we've gone well into 1b which had opened up in the main with the over 70s and now we've brought in part of 2a which is the over 50 population and really encouraging anyone that is over 50 to make an appointment and become vaccinated and to make sure that they consider their informed consent on the commonwealth's 1a rollout.
They've almost finished with aged care obviously or something that you're overseeing but what has the commonwealth told you in terms of how they're going with vaccinating people in disability care and their carers? Well certainly the state has indicated that we are assisting the commonwealth in terms of the rollout with disability and certainly that has two aspects so with our disability workers and we've been outbound calling to make appointments for our disability workers for vaccination and also assisting with the mobile residents for disabilities so for people that are able to get out and to reach for example at community centre that we're going to create clinics to assist them with vaccination.
Just for the sake of completeness, I did email through a question before about a post that was on social media regarding vaccines at the LGH and that they had 300 and if you just wanted one to rock in. Is social media a good source of information for people who are looking to vaccines and where should they be looking if not? So i think many people would comment on the pros and cons of social media at times certainly that's not an authorised social media post from the Department of Health. I haven't actually seen the actual post. It's been described to me and it's certainly not the case that we have 300 vaccines available for people to rock up and get. We've got phasing that applies particularly to the availability of vaccine of the Pfizer vaccine and noting that that is preferred for our under 50 environment but certainly there are booking appointments and spots that are available and I think someone might have just been trying and share that information.
So for people looking for accurate information on how they can access vaccines, is their GPa their best point of contact? So their GP or our coronavirus website at coronavirus.tas.gov.au and if you head there you can actually book online as well in a couple of minutes and just talk to each other potentially.