Thanks to a confidential $2 billion manufacturing contract, Moderna mRNA vaccines made at a new Australian facility are exempt from a key regulatory process, The Guardian has discovered.
Doses produced at a newly-opened, specially built plant at Melbourne’s Monash University do not have to be assessed by the Pharmaceutical Benefits Advisory Committee (PBAC). This independent advisory group recommends medications and vaccines for the Pharmaceutical Benefits Scheme, under which Australians receive government-subsidized medications.
PBAC’s assessment is “a key step in ensuring government-purchased vaccines are confirmed as the safest and best quality for their required task, at a reasonable price,” The Guardian wrote.
The contract, signed in 2021 under former Prime Minister Scott Morrison also commits the Australian government to buy Moderna vaccines produced in Australia for at least ten years.
Several public health experts expressed concerns to the The Guardian that a parallel system was being created for Moderna amidst more general attempts to speed up the regulatory system.
Regardless, Health Minister Mark Butler supports the arrangement. He said “specific approval processes have been negotiated for domestically manufactured mRNA vaccines” to prepare for future pandemics.
Moderna and the Australian government agreed to establish a domestic mRNA production facility in Melbourne, where Moderna planned to produce new “mRNA vaccines against respiratory viruses, including COVID-19, seasonal influenza, respiratory syncytial virus (RSV), and other potential respiratory viruses, pending licensure,” the company announced in 2022 when the partnership was finalized and facility construction began.
Butler and Victorian Premier Jacinta Allan opened the facility on December 4. At the opening, Butler said, “COVID taught us how important it is to have the capability to manufacture the latest vaccines here in Australia.”
Allan touted the factory’s ability to bring new jobs to the state of Victoria. “This is exactly what economic growth looks like: more investment, more jobs and more opportunity for all," Butler said.
Before the plant opened, the federal government issued a new regulation that would codify the deal signed by the previous prime minister into law. However, the Senate can override the law.
The deal was signed during the COVID-19 pandemic emergency period but was later expanded to cover all respiratory vaccines produced in Australia and registered through the Therapeutic Goods Administration (TGA), Australia’s equivalent of the U.S. Food and Drug Administration.
The Moderna vaccines’ exemption from PBAC review appeared in a memorandum, recently obtained by The Guardian, accompanying the regulation. Without this review, vaccines can’t be included in the National Immunisation Program, which provides free vaccines to Australians, according to the memo.
The Guardian reported that the decision to exempt Moderna’s vaccines from undergoing PBAC review is unusual it applies to all “but the most urgently needed and highly specialised vaccines.”
Moderna’s new facility can produce up to 100 million vaccines annually. Under the deal, the government is committed to paying an undisclosed price for an undisclosed amount of those vaccines.
The Australian National Audit Office announced last month that it would investigate the $2 billion deal. Local rival manufacturer CSL Seqirus alleges that it offered to make vaccines for a much lower price, but lost to Moderna.
Moderna told The Guardian that the new assessment process for its vaccines was meant to speed up the typical process which they find too slow. The company also said that PBAC didn’t review every single new drug or vaccine produced.
“All products manufactured under Moderna’s partnership are subject to the same rigorous standards of quality, safety and efficacy as other vaccines,” the Moderna spokesperson said.
The vaccines must be registered with the TGA and assessed by the Australian Technical Advisory Group on Immunisation. Moderna said its vaccines would then also be assessed through a different independent Health Technology Assessment that followed PBAC guidelines.
