Australia Inks $2 Billion Deal Allowing Moderna mRNA Vaccines to Bypass ‘Key Step’ in Safety Process

The Australian government signed a confidential $2 billion manufacturing deal with Moderna that exempts the company’s vaccines from key regulatory processes.

by Brenda Baletti, Ph.D.

The Australian government under former Prime Minister Scott Morrison signed a confidential $2 billion manufacturing deal with Moderna that exempts the company’s vaccines from key regulatory processes, The Guardian reported.

Under the deal, Moderna’s mRNA vaccines produced at its recently constructed Australian facility do not have to undergo an assessment by the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC is an independent advisory committee that recommends medications and vaccines for Australia’s Pharmaceutical Benefits Scheme — the program that provides 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 also commits the Australian government to buy Moderna vaccines produced in Australia for at least 10 years.

The Guardian spoke with several public health experts who said they were concerned that a parallel system was being created for Moderna and about more general attempts to speed up the regulatory system. Experts emphasized that the PBAC stage was crucial to providing high-quality and affordable vaccines.

However, Health Minister Mark Butler was supportive of the new process. 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 construction on the new facility began.

Butler and Victorian Premier Jacinta Allan opened the facility earlier this month. At the opening celebration, 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.”

Before the plant opened earlier this month 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 PBAC 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 because the existing checks-and-balances system that subjects drugs and vaccines to that review applies to all “but the most urgently needed and highly specialised vaccines.”

Moderna’s new facility can produce up to 100 million vaccines per year. 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 government’s $2 billion deal with Moderna. Local rival manufacturer CSL Seqirus alleges that it offered to make vaccines for a much lower price, but lost out to Moderna.

Moderna told The Guardian that the new assessment process for its vaccines was meant to speed up the existing process, which is 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.