Therapeutic Goods Administration, Professor John Skerritt and Commodore Eric Young's press conference on 6 May 2021

Read the transcript of Therapeutic Goods Administration, Professor John Skerritt and Commodore Eric Young's press conference on 6 May 2021.

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ERIC YOUNG: Good afternoon ladies and gentlemen. Today I'm joining Professor John Skerritt at the Therapeutic Goods Administration. He will make some remarks shortly and before that, I'll give a short operational update.

This week, we've had a major boost to the vaccine program, as announced by the Minister yesterday, and predominantly that relates to us now increasing the distribution of AstraZeneca vaccine for general practice, and increasing the distribution of the Pfizer vaccine for states and territories to implement the direction from National Cabinet, which predominantly limited the use of the Pfizer vaccine for those under 50. In short, we'll be distributing more vaccines across Australia to protect more Australians. As we enter the next phase of the program, opening up to those 50 and over, while we also ensure our other vulnerable cohorts continue to receive a vaccine as soon as possible. To achieve that, next week we'll be increasing the allocation of AstraZeneca by 270,000 doses. That will allow us to triple the current allocation for our low volume general practices from 50 to 150 doses per week, and to double the allocation for our 1000 medium volume general practices from 100 to 200 doses per week. In addition, we'll see an additional 130,000 doses of the Pfizer vaccine allocated to states and territories, which will double their current allocation.

In terms of the operational update for this week, again, I'd like to do that in three components, starting with supply, talking about the distribution of the vaccine, and then talking about the administering of the vaccine. In terms of supply, the Therapeutic Goods Administration this week conducted sample testing and released 351,000 doses of Pfizer vaccine, which arrived onshore earlier this week, and 736,000 doses of the onshore CSL-produced AstraZeneca vaccine. In terms of distribution, this week, we have more than 550,000 doses of vaccine going to nearly 3000 sites across the country. We've already distributed 287,000 doses of that vaccine and today we have 72,000 doses of that vaccine on the road to more than 570 locations across Australia. In order to implement the changes I talked about earlier, next week we'll see a 157 per cent increase in the vaccines distributed across the country. That will be our biggest week of distribution by far, aiming to have more than 850,000 doses of the vaccine distributed across the country. In terms of the administering of the vaccine, yesterday we had 77,215 doses administered, taking our total now to 2,473,529 doses of vaccine administered. And early analysis of the data indicates that our daily weekly- correction, our average daily administering is now 71,000 for this week, which is up 5000 from last week. General practice administered 49,632 doses of the vaccine from now more than 4600 sites across the country. And this week, we've had additional state and territory Pfizer and AstraZeneca clinics on board, now taking the total sites for vaccine across the country to nearly 5200.

For our vaccine workforce providers, our focus continues to be on those most at risk in our community, those older Australians in our residential aged care facilities. Yesterday we conducted 29 first dose visits to residential aged care facilities, taking our total to 1833 first dose visits, and we conducted 40 second dose visits, taking our total now to 1222 second dose visits. In addition to those most at risk, we continue to ramp up other priority cohorts including the disability sector. We've now conducted 116 first dose visits to disability residential sites and 20 second dose visits.

This week, we continue to be focused on ensuring that all eligible Australians now know how and where to access a vaccine, and predominantly, that's through the Eligibility Checker at This week we've averaged 119,000 visits to that checker each day, with now more than 4 million visits to that site. Every single day though, our focus continues to be on ensuring that all the vaccines that we have are available across the country, when and where required, to protect our most vulnerable Australians.

I'll now hand over to Professor John Skerritt.

JOHN SKERRITT: Thank you, Eric. And good afternoon, everyone. So, the TGA, since the beginning of the rollout in February, has been publishing a weekly safety report. This is together with media releases about new serious adverse events. But our weekly safety report, which is now out on at the website at, does describe the current status regarding adverse event reports and adverse event cases, and I'll just outline some of the main features. I just want to go back a step and remind people that for every thousand doses of either the Pfizer or the AstraZeneca vaccine administered, we receive between six and seven, on average, adverse event reports. Now these are reports where not necessarily cause and effect from vaccines but these are people who have either felt unwell or have presented to a doctor or a hospital after being vaccinated. And overwhelmingly, these reports are of the sorts of things that are associated with any vaccination generally - fever, joint pain, muscle- muscle soreness, tiredness, maybe nausea, and vomiting. And for the two COVID vaccines we have at the moment, these were expected and found in the clinical trials. The adverse events are more common after the first dose of AstraZeneca but they're more common after the second dose of Pfizer globally, recognising that not many Australians have had a second dose of AstraZeneca, and that seems to be the pattern with the global. We also, of course, get reports of people who've had significant medical problems and at the same time, a week or two or three earlier, they've had one or two of the vaccines- either of the vaccines. And they're the cases that we look very closely at for investigation. I'll come back to those. So, we've had a total of just over 15,000 adverse event reports, and that's a significant increase over the types of numbers of adverse event reports that we've had in previous years, but of course, in previous years, we haven't had a program with- of the nature of the COVID vaccine. And we know that these COVID vaccines do, in a number of patients, provide short-lived and not serious adverse events such as the tiredness, the fatigue, the sore arm, the sore muscles and so forth that I talked about. So, what's- so it doesn't mean that the COVID vaccines are less safe than other vaccines.

The other thing that stimulated the reporting, of course, with vaccines being on the front page all the time, has also been deliberate raising of awareness among individuals in the general public. The requirement of health care professionals, whether they're GPs who are administering the vaccine or whether they're state and territory facilities, to report these adverse events to us. And so we've seen a very significant increase and we're actually- it might sound funny but we're actually encouraged by the fact because we want consumers to report adverse events directly to us, whether it's any vaccine or any medicine. And we've had a 60-fold increase in the number of adverse event reports made to us by consumers since- compared to, say, 2020. And so, over 3200 of those adverse events have actually been reported to us by consumers, and again, we see that as a good thing. We want to encourage people to step forward, and of course, we undertake to look at all of them and to dig deeply into the serious and unexpected ones.

There have been more adverse events reported in the last week, so we've had about 2000- 1967 in the week which is actually 26 April to 2 May. Now, there's a bit of a lag for the general adverse events although we jump right in and analyse the serious ones as soon as we get the information. The wait period is obviously to allow us to complete the investigations because often we have to go back to people, to their doctors, to their hospitals. Now, of that just under 2000 adverse event reports, there have been more reported for AstraZeneca than Pfizer, on about a three to one, 2.5 to one ratio, but that actually reflects the relative levels of the two vaccines given in the community. And so, on a per vaccination basis, we're seeing about the same number of adverse event reporting whether you're having AstraZeneca or Pfizer. There's not one vaccine that overall, for all sorts of adverse events, is giving a lot more signals or a lot more reports than the other one.

Now I'll talk about what we call the adverse events of special interest, the serious ones. And so, with Pfizer, globally, a very small but significant number of people have reported anaphylaxis, a severe allergic reaction. Now, in Australia, there were 55 cases reported to 24 April, but only 16, on investigation, were genuine anaphylaxis. Now all those people have recovered. They were often treated with adrenalin by their health care facility. And there's a warning with the vaccines that if you've had this sort of reaction to similar sorts of products or vaccines before, don't get vaccinated with the Pfizer vaccine. And that again is consistent with the global estimated rate. Again, I'd still confirm but it's a comparatively rare event with only 16 cases reported in Australia.

I now want to come to AstraZeneca and blood clots which I know has been the adverse event that's received most media and public and medical attention globally. So during the reporting period, we've received 163 reports of blood clot disorders for people who had had AstraZeneca vaccine a few days or a couple of weeks before hand. And there were 44 reports received, sorry, in the week 19-25 April. We've had 163 overall since the rollout started. Now that might sound like a large number of reports but again you'll remember that sadly blood clotting, including fatal blood clotting is actually quite a common cause of serious illness and death in Australia. We've talked about 50 cases a day being quite serious, and this was before we even had COVID vaccines. It's also responsible for about 10 per cent of the deaths of people who die when they're admitted to hospital, and sadly never get out. So this is a common, serious thing that happens to people for a whole lot of reasons. But in each of those 163 cases, we've dug deeply into looking at cause and effect. And the other thing that distinguishes, of course, this very rare event with the AstraZeneca vaccine is that there's also low platelets and typically an antibody to a particular protein on the platelets so there's a lot of tests that are run with these people.

So, I can report today that we have identified five cases since we last stood up last week, five new cases of clotting and low platelets that we believe are likely to be linked to the AstraZeneca vaccine. Five cases. And they are in a 74-year-old man, 51-year-old woman in Victoria, a 66-year-old man in Queensland, a 64-year-old woman from WA and a 70-year-old man in Tasmania. And you'll notice that all of those people, one just, are over 50, but if you stop back and think about who is now getting the AstraZeneca vaccine, it is only - with a few rare exceptions - it is only people over 50. So it is obvious that future cases will be in the over 50s, and remember the early results globally showed that the prevalence of this rare side effect was much more common in people under 50 but it wasn't unknown in people over 50. So we're not at all surprised with the results we're seeing. If you're only giving a medicine or vaccine to people over 50 that's the only group, you'll see an adverse event.

So that takes the total number of cases to 11. And as of 2 May, which was when the last lot of new cases were reported, we have a couple of possibles coming through, there was about 1.4 million doses. So you can do your mathematics for yourself. And I would say the rates in Australia are very similar to those both publicly and confidentially reported to us in places like Canada, the UK and continental Europe. There are three possible cases of this syndrome but we don't think they're caused, but again we're waiting on some more tests, but at the moment they're appearing to be negative but they're still under investigation.

Now, I want to share some really good news. That might sound funny in the middle of talking about adverse events to a vaccine but I want to share some really good news with you today. And what it is, you'll remember last week we talked about one sad death and five hospitalisations to date. That was a figure as of about the Anzac Day long weekend that we'd reported on and we spoke about last week. And I don't want to talk about individual names and states but I will give some aggregate results. Of those five people who were in hospital with the side effect, the really great news is that four of them have gone home, and of the younger ones who are of working age two of the four, a couple of the older are not working full-time, but they're back at work. And so while they were in hospital and in some cases in intensive care for a day or two, the really good news is that four of the five people have returned home and the other person is doing quite well in hospital. So, we're really excited with that news that only came through today. I would add for the death, I indicated a week ago that we were awaiting the findings of a post-mortem. Now coroners do move at their own speed. They have hearings, they look at medical evidence and then there's often an inquest, and so we don't have an update on any results from a post-mortem from the woman who, sadly, died.

So just to finalise, the adverse event remains very rare, it remains at a frequency that's similar to that reported by other countries using the AstraZeneca vaccine. The evidence from TGA and the advice from ATAGI, the advisors to Government, is that the benefits of this vaccine for the over 50s still very significantly exceed the risks of this vaccine. Remember, that - and sadly, we see that Australia is not immune from community transmission, and we're certainly not immune from cases coming in through hotel quarantine. And remember that the risk of serious illness or death dramatically increases by every 10 years of age once you turn 50. By being vaccinated, we're not only protecting ourselves, but we're also protecting our loved ones, especially the older and more frail loved ones, and those around in our community. We'll now take questions.

QUESTION: Professor, is there anything else that the 11 cases have in common other than having had the AstraZeneca jab? Did they all have underlying conditions or similar underlying conditions?

JOHN SKERRITT: Many of these people had quite serious and significant underlying health conditions, but there was a range of underlying health conditions. So we don't believe there's an a-ha thing, even though this is an area of very active medical research throughout the world. We- and I want to add that people with underlying clotting conditions do not seem to be at risk. So even though clotting conditions are so common, and a lot of people are put on anti-coagulants, for example, if they have a cardiac stent, or other heart surgery, or even non-surgical things to their circulatory system. We don't think they're at added risk. So a lot of these people did have other serious conditions, but there's not a common thread.

QUESTION: Professor, is there anything outstanding or concerning before you related to the new cases that have been reported today? Is it what you expected to see with similar kinds of figures from overseas?

JOHN SKERRITT: The sorts of numbers aligned with what we see overseas. We do report a little bit differently from some- some countries don't publicly report to the level that we do. Other countries do report, but they report both plausible cases as well as likely cases. So the UK numbers, for example, include a mixture of possible cases. And we, in confidence, have seen the- because of individual medical data, we've seen in confidence the actual case data. And some are people who are quite unlikely, and some are almost definite. And so, some of the higher rates that you see from some countries are because they're reporting on a number of reports received, not on the number cases that have been assessed by doctors and scientists, and statisticians.

QUESTION: Of the new cases- apologies if I misunderstood you. The ones that you just ran through, the hospitalisations. Were they the previously reported cases, or are they the new…

JOHN SKERRITT: No, no. So there's been 11 cases reported in total since vaccinations started. There are five new ones. And it's been this period of about a week and a half, because of the timing of reporting. And also because while in some cases we get information within 24-36 hours and can make a decision, sometimes it does take four or five days, especially if a person is in regional Australia to get all the clinical information we need.

QUESTION: So with those new ones, are all those patients in hospital? Can you give as an idea of their condition?

JOHN SKERRITT: So the- so all the new people are currently hospitalised, and that's a mixture of both the seriousness of the presentation, but also the importance of them being closely monitored. So there are treatments, such as intravenous immunoglobulin, that are given in a hospital situation. But as I've said, the really encouraging news is that of the five people who are hospitalised from earlier adverse events, four of them are now at home, and several are at work.

QUESTION: You also mentioned the 16 people who were treated for anaphylaxis in Australia after getting Pfizer. Do you know to breakdown of how many of them experienced that after the first dose? And how many after the second dose?

JOHN SKERRITT: Generally, the anaphylaxis is after the first dose of Pfizer, because it's like an allergic reaction to something new. And the recommendation - or the strict advice I should go, it's more than recommendation - to doctors is don't give a second dose of Pfizer to those people. So those people will either not get a second dose or there'll be offered AstraZeneca.

QUESTION: Is there any change to your advice to the Government based on the latest cases?

JOHN SKERRITT: No, because they are pretty much along the trajectory we expect. If you are only vaccinating people over 50 years of age, if you're doing another million vaccinations- and as we heard, we expect that by night-time today, we'll be up at 2.5 million vaccinations. And so the numbers are increasing and accelerating. So this is a rare adverse event, but we believe it's staying at the expected frequency and at the frequency that we're seeing internationally.

QUESTION: Slightly weird question, but do you expect to see increase in reporting in adverse events for the flu vaccine this year on the back of this kind of very widespread vaccine…

JOHN SKERRITT: It often does trickle through to other medicines and vaccines. And it might sound funny, but we actually think that that's a good thing. We want any patient, any individual, any doctor, any state and territory hospital, public or private, to know that there's a system for adverse event reporting. And the adverse event that you report helps fine tune and improve how medicines and vaccines are used in the community. So adverse event reporting is a really important part of making sure we use medicines and vaccines as well as we possibly can. So we actually encourage it. And if there is more with the flu, so be it. Now in different seasons, different years- because the flu vaccine changes every year, some years there's a lot more adverse event reports from the flu vaccine than others, and it's just the way it's put together.  

QUESTION: Commodore, can you give us an indication how many people have had a second vaccine shot?

ERIC YOUNG: Again, I've been asked numerous times, what I report on each day is what's made public on the website, which is what's agreed by National Cabinet. What I can say is that 2,473,529 people have been given a vaccine dose. Correction, vaccine doses have been given.

QUESTION: Given there's an increased amount of doses being distributed, is there a short-term daily goal of how many vaccines you'd like to administer per day?

ERIC YOUNG: I think both the Prime Minister and the Minister on the record of saying that they're not willing to set any targets at all. What we are focused on is getting the max amount of doses into arms every single day. And what my team's focused on, make sure those vaccines are available across country to do just that.

QUESTION: Is there any indication why National Cabinet won't release the second dose figure, especially as we're nearly passed 2.5 million doses?

ERIC YOUNG: Yeah. So again, I've been asked this a number of times. There's no conspiracy theory. It's very simply a case of from the outset of the pandemic, we're working in really close partnership with states, territories in the Commonwealth. They very carefully agree on what's provided publicly. At the moment, that's what they've agreed on. At some point, they may choose to change that.

QUESTION: When you started in the job, you said you were to fine tune, I guess, a lot of the systems. Can you give us an idea of what sort of things you'd fine tune in terms of logistics or delivery, that kind of thing.

ERIC YOUNG: So it's literally everything, in the time that I've been here. And when I say fine tuning, I must reinforce that there are hundreds of great people doing amazing work every single day, and have been from the outset of the pandemic. It's what's simply- systemically going through every part of the supply chain, finding out how we're doing, understanding where there's lessons to be learnt, dealing with all of our stakeholders. And as I said in my first press conference, focusing on getting a little bit better every single day.

I think we'll close up there, ladies and gents. Thank you very much.


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