Speakers: Prof Anthony Lawler, Senator Malcolm Roberts, Speaker 17, Prof Katherine Gibney, Blair Comley, Prof Michael Kidd, Senator Ellie Whiteaker, Speaker 33
Transcript
Senator Malcolm Roberts
>> I'd like to move to a Target TGA and the
Prof Michael Kidd
Just check that Professor Gibney is back online. She is
Senator Malcolm Roberts
>> Okay. Atagi and TGA Sweden's COVID vaccine change. I note the current Australian National Immunization Program recommends only FISA JN1/KP8.1, not New Vacciation, which is approved in Australia. Is this >> That's correct.
Speaker 17
>> Yeah. Um Senator uh currently uh uh FISA is the only uh CO 19 vaccine in Australia available through the national immunization program
Senator Malcolm Roberts
>> but new vex new vex if it is approved
Speaker 17
>> uh it's it's not on it's not available through the national immunization program. So no it's not a part of the program.
Senator Malcolm Roberts
>> It's not a part of the program but is it approved?
Speaker 17
>> Uh I'd have to as in uh approved with the TGA. Yes. >> Uh I'd have to check with the TDA on that.
Prof Anthony Lawler
>> We will we can we can come to you on that uh tonight.
Senator Malcolm Roberts
>> Okay. >> Thank you. Sweden has just changed its vaccine schedule. In a procurement shift, they have removed mRNA COVID vaccines and replaced mRNA co shots with the old way of doing it, proteinbased vaccines, specifically new vexacid. For clarity, mRNA has not been banned. I'm not saying it's been banned, just removed from the schedule. Will you follow suit and drop M mRNA vaccines? If not, what is Sweden getting wrong? Why do you disagree?
Speaker 17
>> Um, Senator, just going back to your previous question, I've got more available information at hand. Uh, the vaccine that you're referring to in Australia is referred to as Novivvax. Um, and it is actually approved uh by the TGA uh but isn't available. the company made an independent uh decision uh not to continue ma manufacturing uh that that vaccine uh that has regulatory approval. So we unable to get stock of it. So that's why it's not in Australia.
Senator Malcolm Roberts
>> Thank you very much. Miss Dr. Pete, can you tell me why? If you know, I don't 100% expect you to know, but uh do you know why they are not selling it here?
Speaker 17
>> Look, that's an individual decision for
Senator Malcolm Roberts
So, what's Sweden getting wrong? >> Going back to my second question. U
Prof Anthony Lawler
look, I'm I'm I'm happy to um refer to to Dr. Dr. G, Professor Gibney, I should say, on the um individual decisions and recommendations around what's contained in in Australia's um immunization um recommendations and schedule. But we've had the conversation previously, Senator, around the fact that uh different decisions are made in different countries and they're based on issues such as demography, epidemiology, and the and the emerging disease patterns. We we also um are not in the position of questioning or um making judgments about other countries um uh clinical decisions, but um I don't know, Professor Gibney, if there's anything
Prof Katherine Gibney
Yeah, I mean I I don't think it'll be there's no sort of reason for us to comment on um Sweden's decision about which vaccine they purchase. Um we're happy with the mRNA vaccine that we have available for CO. Um and don't have any plans to request another company to come in and try and provide an alternative vaccine. >> We have a we have a vaccine available.
Senator Malcolm Roberts
With due respect, I think this issue is is fairly serious. When a country that led the way in many ways on the correct response to CO um changes its mind, I would ask I would surely expect you to ask questions why then find out why.
Prof Katherine Gibney
>> We certainly review um policy updates from other national immunization technical advisory groups. Um and we routinely do that. Um but for there's a whole range of reasons why a comp where why a country might choose one vaccine over another. Uh and that does not need necessarily need to um initiate a change in Australia. In this case it it would not initiate a change.
Senator Malcolm Roberts
>> Well I would have thought I would have thought in the interest of protecting the people of Australia that if a country like Sweden changes its mind that you would inquire why and either say this is why we are not changing our mind but this is why we are changing our mind. Could you take that on notice please because I think the question deserves a a better answer in writing.
Prof Katherine Gibney
>> Certainly we can
Senator Malcolm Roberts
>> thank you professor.
Prof Anthony Lawler
>> So s I just my colleague Mr. stand has to say but I I would just highlight that I know that there are different um positions and views on on some of the actions and public health measures that were undertaken during co but I think it's fairly well recognized around around the world that our our both our vaccination rates and the extent to which that vaccination led to a reduction in uh mortality and morbidity is such that I take your point that Sweden is an example to many countries so is Australia's vaccine responsive an example to many countries in terms of a successful vaccine roll out and management of the challenges that co presented. So I I'm not sure that we need to necessarily be looking to other countries as an example. The um the regulatory decisions that we take and the scientific approach that it provides and the national immunization program all serve Australia well.
Senator Malcolm Roberts
>> Well, if if that's the case and you don't want to do it and Professor Gibney does it, that that's fine. Um, but surely you need to justify yourself with references because Sweden has has the attention of many people around the
Prof Anthony Lawler
>> Uh, yes, I I think that that's probably true, but unless there's actually a specific I mean when you say with references, I I think it's actually um quite clear and we've provided evidence previously around the success of the vaccine roll out in Australia and and where we have uh performed in terms of um in terms of mortality by population. um around the world we performed very well. Um as we've um highlighted previously, the the risk benefit uh profile at a population level of the vaccines that we've both approved and recommended um remain overwhelmingly positive. And I'm not convinced that a case has been made as to why we should conform to the practices of another
Senator Malcolm Roberts
>> I'm not saying you should conform. >> Well, I'm saying why don't you check? Surely if I were in your position, I'd be checking and saying they've got it wrong. Here's why. They've got it right.
Prof Anthony Lawler
>> But by that suggestion, I think, Senator, what you're suggesting is that we should review the vaccination decisions of 190 other countries and work out that ours is the best. I think I've highlighted previously that we make our own sovereign decisions that we undertake um appropriate review and the regulatory decisions that we make and professor Gibney and the other members of Atagi provide their scientific expertise in in those decisions and and they're they're solid decisions.
Senator Malcolm Roberts
>> Do I really need to remind you what your what your predecessor, Professor Scarret, said to me when I asked him if they'd done testing on the co shots here? He said, "No, Senator, we relied upon the FDA in America." At that time, the FDA had previously announced that they did no testing and relied entirely on FISA, which which killed Senator,
Prof Anthony Lawler
>> if I if I may, I'm I'm I'm more than happy to have a conversation again around the process that we undertake and that reliance is not simply accepting the decisions of other regulators and that we have a very we comment on on Professor Scarit's discussion. whole basis of our vaccine
Blair Comley
answer your question one thing Senator >> the the press law has talked about us not necessarily exhaustively looking at every country when they make a different decision on something but it is true we engage very actively internationally with um regulatory peers to understand trends and a whole range of things in fact professor law is Lawler is chair of an international organization of regulators so that we share information about the emerging trends. So I think I'd just put that in the context that we we are not blind to what happens internationally. Um we can certainly uh potentially engage with our Swedish colleagues but we do scan the international environment on a very regular basis.
Senator Malcolm Roberts
>> Right. And that's all I'm asking for
Speaker 33
>> on notice. Um Senator, sorry Nick Henderson, first assistant secretary medicine regulation division. Um I just want to clarify um in relation to Nova um vid. Um it's only the original strain that is registered. So it's not the the most recent strains of CO 19 that are on the ARTG.
Senator Malcolm Roberts
>> Thank you. It's appreciated.
Senator Ellie Whiteaker
>> One final question, Senator Roberts, I'll have to rotate.