Australia’s COVID-19 vaccine rollout has suffered yet another blow, with 51 million ordered doses of the Novavax jab not expected to arrive until 2022.
The Guardian reports lingering supply chain issues have constrained production of the vaccine, impacting the Therapeutic Goods Administration’s (TGA) approval process.
Speaking at a comittee meeting on Friday, TGA deputy secretary John Skerritt said those constraints meant the organisation is yet to run its full slate of safety tests and trials.
The TGA granted the Novavax jab a provisional determination in January, which the TGA describes as a “transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.”
A Novavax spokesperson said the firm has been providing clinical and non-clinical data to the organisation since that point.
“Timing of approval is still the subject of ongoing interactions with the regulatory authorities, however Novavax are working towards having final submissions sometime in Q3 2021,” the spokesperson said.
“Novavax are actively working to ensure [the vaccine] is made available as quickly and safely as possible to Australians, ensuring that we fully address all safety, efficacy and quality elements required for regulatory submissions.”
The push-back marks a radical change of plans for the shot, which initially formed a part of Australia’s three-pronged vaccine strategy, and which the Health Department originally stated could arrive “as early as the first half of 2021”.
Supply chain issues, flagged in April, delayed the Novavax timeline back to the third quarter of 2021, with Health Department secretary Brendan Murphy suggesting the jabs could arrive in August.
Now, the federal government’s current vaccine ‘horizons’ document no longer suggests Novavax doses will come online any time this year.
As the Novavax constraints became apparent, Australia’s vaccine program was also forced to reconcile with high demand for the Pfizer vaccine, and shifting health advice around the AstraZeneca jab, both of which constrained the nation’s ability to get shots into arms.
Australian health authorities have turned their focus to securing additional doses of Pfizer and launching a new deal for Moderna vaccine doses, which are slated to reach primary care clinics in September.
The latest delay means the Novavax vaccine, if approved, will form part of Australia’s planned booster shot program, designed to provide vaccinated Australians with further protection against new and emerging strains of the virus.