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for sheep, noting that an overseas manufacturer has been approved while an Australian manufacturer has had its approval withdrawn.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: https://senroberts.com/vaccine-approvals