Australian Novavax trial participants remain unrecognised by vaccine register
Australians who participated in clinical trials of the Novavax Covid vaccine are being told their vaccinations cannot currently be recognised on Australia’s immunisation register.
Hundreds of Australians took part in clinical trials for the Novavax jab last year, hoping to help the world chart a way out of the pandemic.
But the participants have since faced significant uncertainty over their vaccination status, unsure whether their doses would be recognised by Australia.
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The Australian Immunisation Register (AIR) does not currently recognise vaccines administered to the Novavax trial participants. That is because only vaccines approved by the Therapeutic Goods Administration and available for use in Australia can be added to the register.
“At this time, this is the AstraZeneca Vaxzevria, Pfizer Cominarty and Moderna Spikevax vaccines,” a spokesperson said.
The health department says if Novavax is approved for use in Australia, individuals administered with the vaccine “will have their details recorded on the AIR”. Asked whether that included trial participants, a spokesperson confirmed that it eventually would.
The Australian government has ordered 51m doses of the Novavax vaccine, but repeated delays mean deliveries are not expected until next year.
The timeline for approval also remains unclear. The US company has lagged well behind others like Pfizer and Johnson & Johnson in seeking regulatory authorisation.
Last month, Novavax delayed its timeline for seeking authorisation from the US Food and Drug Administration. The company had previously said
it would seek emergency-use authorisation from the FDA in the third quarter of 2021. That has now changed to the fourth quarter.
Despite the US delays, Novavax has filed for regulatory authorisation in India, Indonesia and the Philippines.
The company’s executives told investors they may prioritise vaccines to low-income countries to meet critical unmet demand for first doses, according to Reuters.
Novavax also told Reuters it was on track to file for regulatory approval in the UK in September, before following suit in Australia and Canada “within weeks”.
That could leave Novavax trial participants waiting months before the TGA grants its own authorisation and their vaccines are recognised on the immunisation register.
It’s not the only problem experienced by those seeking to have their vaccines recognised in Australia, ahead of a mooted vaccine passport system and conditional easing of restrictions.
The Guardian has continued to receive reports of Australians receiving their vaccine but it not being reflected on the AIR, often due to poor data entry by vaccine providers.
Those with mixed doses of Pfizer and AstraZeneca also cannot currently be recognised as fully vaccinated against Covid-19, even if they were acting on medical advice by switching vaccines between first and second doses.
Those vaccinated overseas with vaccines not currently recognised by Australia are also unable to have their doses recognised.