NVAX Stock – Novavax COVID vaccine could be months away
Novavax is in the late stages of its clinical trial program and data from its British phase 3 study released last month showed 100 per cent protection against severe disease and 96.4 per cent effectiveness against mild and moderate illness in the original coronavirus strain, and 86.4 per cent effectiveness against the UK variant.
The company has also completed dosing participants in an Australian trial. However, the vaccine does not yet have approvals anywhere in the world, and Australia will not be the first jurisdiction where the company will seek regulatory approval.
“Novavax expects to file for regulatory authorisation with the Medicines and Healthcare products Regulatory Agency in the UK first. This will be followed by the US in the second quarter of the year, followed by other countries,” the spokesman said. The business hopes to file US approvals by June.
The vaccine is protein-based and could in theory be made in Australia. Home-grown vaccine maker CSL has said it would consider its capacity to make Novavax’s product, but only after it has completed all doses of the AstraZeneca vaccine.
The government has said it continues to monitor both vaccine product and manufacturing options for Australia, but has only inked formal dose agreements with Pfizer, AstraZeneca and Novavax. It has not signed any deals with US vaccine powerhouse Moderna.
The only other candidate which has started the process towards local TGA registration is Johnson & Johnson’s one-shot vaccine, which was granted a “provisional determination” by the local health regulator last November to fast-track any future approval.
“As we move forward with clinical development, we continue to work closely with the Therapeutic Goods Administration (TGA), to facilitate provisional registration on the Australian Register of Therapeutic Goods, so our vaccine can be made available in the future to Australians if proven safe and effective,” a spokesperson for Johnson & Johnson’s pharmaceuticals arm Janssen said.
The company says it’s open to discussions with governments around the world for future supplies.
However, no formal agreements with the government are in place for Australia.
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Emma reports on healthcare companies for The Age and Sydney Morning Herald. She is based in Melbourne.