Australians will be offered respiratory “vaccines’ from next year without the usual assessment that ensures they are the most effective available at the best possible price, under the confidential $2bn onshore manufacturing deal the Morrison government struck with Moderna.
The agreement exempts Moderna’s mRNA vaccines from assessment by the Pharmaceutical Benefits Advisory Committee, a government memorandum has revealed. The contract signed with the American pharmaceutical company in 2021 commits successive Australian governments to buying locally produced Moderna vaccines for at least a decade.
The vaccines will be manufactured at a specially built plant at Melbourne’s Monash University, which was opened by the health minister, Mark Butler, and the Victorian premier, Jacinta Allan, last week.
The existing check-and-balance system normally applies to all but the most urgently needed and highly specialised vaccines. Before the plant opened, the federal government issued a regulation – which can be disallowed by the Senate – to enshrine the deal it inherited in law.
The accompanying explanatory memorandum sheds new light on the secretive contract, including its exemption from assessment by the PBAC. Comprised of medical experts, the PBAC 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 memorandum says the Moderna vaccines “will not go through the … PBAC process and therefore will not be listed as designated vaccines on the National Immunisation Program”. PBAC assessment is required for inclusion in the program, now the vehicle for providing vaccines to Australians free of charge.
Under the Moderna deal, the government will pay an undisclosed price for an undisclosed percentage of the up to 100m vaccine doses to be produced at the plant every year. The Moderna mRNA vaccine deal was forged during the Covid-19 emergency but has been extended to cover all respiratory vaccines produced onshore and registered through the TGA – including any for influenza and respiratory syncytial virus, or RSV. The Australian National Audit Office announced last month it would investigate the deal. The switch to an apparently parallel system for Moderna – which has not been publicly explained – has raised red flags in the health sector.
The PBAC has expressed concern about government proposals to change the system more broadly to make it faster and more effective. The committee’s chair, Robyn Ward, wrote to Butler in October warning that moves aimed at speeding up the distribution process “should not come at the expense” of the other objectives, “including fairness, equitable access, and safe and judicious use of medicines”.
