Questions Raised with APVMA on mRNA Vaccine Approvals

During the recent estimates, I raised several questions regarding the approval and use of mRNA vaccines by the Australian Pesticides and Veterinary Medicines Authority (APVMA). I inquired if the APVMA has authorised any mRNA vaccines. Mr Hansen confirmed that, as of now, no such vaccines have been approved. To ensure thoroughness, Dr Maria Trainer, joined the discussion. She reiterated that no permits or authorisations for mRNA vaccines have been issued, although she stated that there is a general permit for small-scale research (Permit 7250) that might cover such activities.

I questioned whether the New South Wales Department of Primary Industries had acted with APVMA’s consent in importing, testing, and manufacturing an mRNA vaccine for border disease. Dr Trainer clarified that while no specific permits were issued, research could legally occur under the general permit. For clarity, I asked for confirmation on whether the Elizabeth Macarthur Institute holds such a permit and was told that this would be provided to us on notice.

I also addressed concerns about the development of mRNA vaccines for lumpy skin disease and foot-and-mouth disease by the Elizabeth Macarthur Institute. Dr Trainer confirmed that no applications for these vaccines have been received, with Mr Hansen adding that notifications about genetic material for vaccines would likely fall under the jurisdiction of the Department of Agriculture, Fisheries and Forestry (DAFF) and Biosecurity.

Lastly, I raised the issue of foot rot vaccines for sheep, noting that an overseas manufacturer has been approved while an Australian manufacturer has had its approval withdrawn. The overseas vaccine is more expensive and less effective.

I urged the government to commit to a process that ensures the availability of the more effective and affordable Australian-made vaccine for our sheep farmers. Senator Chisholm agreed to take this on notice, and Mr Hansen expressed openness to discussions with the Australian manufacturer for product registration.

Transcript

Senator ROBERTS: Let’s go to my first and most important set of questions. At previous estimates, I have asked if an mRNA vaccine has been approved by your agency, and the response was, ‘No it hasn’t.’ So let me first update, has the APVMA authorised for use any mRNA vaccines? 

Mr Hansen: I understand the answer is still no, but if we are going to go down a line of questions on registration of vaccines, do you want me to get an expert to the table? 

Senator ROBERTS: Yes, if you like. That’ll make it quick. 

Mr Hansen: Excellent. It will be Dr Maria Trainer, but, as far as I’m aware, the answer is still no to that. 

Senator ROBERTS: Thank you. The New South Wales department of primary industries has imported, tested and now manufactured an mRNA vaccine for border disease for New South Wales at the Elizabeth Macarthur Institute. Was that action taken with the consent of the APVMA? 

Dr Trainer: We have not issued any permits or authorised any messenger or any vaccines in Australia anywhere, but we do have a general permit for small-scale research, permit 7250, that potentially would allow for the research being conducted. 

Senator ROBERTS: You don’t know if they are doing research, but they could legally be doing research under a permit? 

Dr Trainer: Yes. 

Senator ROBERTS: Could you take that on notice to provide whether or not the Elizabeth Macarthur Institute has such a permit? 

Mr Hansen: Provided they met the criteria around the small scale, and that’s spelt out under the permit, then we wouldn’t be informed about it. But that’s something we can certainly make an inquiry about. 

Senator ROBERTS: Thank you, and could let us know on notice, please. The Elizabeth Macarthur Institute has also declared they are developing mRNA vaccines for lumpy skin disease and foot-and-mouth disease. Have they applied for or advised you of their handling of this incredibly dangerous genetic material? 

Dr Trainer: At this point in time, we’ve received no applications to register or authorise any messenger RNA vaccines. 

Senator ROBERTS: So you haven’t heard from them? 

Mr Hansen: No, not on that, and I’m not sure that we would be the people that they would notify about bringing in the genetic material for the vaccine. That would be more likely DAF and biosecurity. 

Senator ROBERTS: Okay. I was told when looking into this matter that once we have foot-and-mouth disease and lumpy skin disease material in Australia, we can risk our disease-free status. Is it a true statement that if the Elizabeth Macarthur Institute mishandles this material and one animal is infected with foot and mouth, Australia will lose our disease-free status and the $20 billion a year this brings in? 

Mr Hansen: That’s well and truly in the domain of DAF and biosecurity. 

Mr Lowe: That’s an outcome 2 question. 

Mr Fennessy: I can tell you that some of the work we may have done in the past is done offshore, so not in Australia. We might work with overseas labs. But it doesn’t come into Australia unless there is a biosecurity permit, and there haven’t been any permits allowed for that. 

Senator ROBERTS: Who should we put a question on notice to in regard to that? 

Mr Fennessy: To the department. 

Senator ROBERTS: I’ll get on to something quickly. I’ll put most of it in a letter to the minister on a question on notice. There’s also foot rot for sheep. I’m advised that an overseas manufacturer has been given approval and the previous Australian manufacturer has not had its approval withdrawn. The overseas manufactured vaccine is more expensive for sheep farmers based on the need to more frequently apply it plus the cost. It is less effective, and the locally made, therefore, is more effective, cheaper and of higher value than the foreign made. We also have a declaration from a veterinarian that the local product is far more effective. Minister, is your government prepared to commit to a process—I’ve condensed a lot of things into this, and I will put it in detail in a question on notice—whereby it identifies or quantifies the need for this Australian manufactured vaccine and work on foot rot with the relevant parties to ensure the availability of this vaccine for Australian sheep farmers? 

Senator Chisholm: I’ll take that on notice. 

Mr Hansen: I can provide one more sentence to that, which is that the Australian-made vaccine had an emergency permit because there was no other registered product available in the market. The moment that there became a registered product that had actually come through the front door and had met all the safety criteria, the criteria for an emergency use permit no longer met. We would love the producer of that Australian-made product to come back through the front door for registration as a product, and we’re open to conversations with them on that when they are interested. 

Senator ROBERTS: So would veterinarians and so would farmers. They would love that Australian manufacturer to come back. I must say, Chair, Mr Hansen’s comments have been exactly as you said: precise, succinct and direct. I love your forthcoming and forthrightness. 

Senator Chisholm: You were the problem!  

CHAIR: You got the MR tick of approval, so you’re on a roll here. Thank you very much, Senator Roberts.