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TGA not expecting Novavax quality data until September

Asked whether the department of health had a view on this stage about how Novavax doses would be used, a spokesman said Australia’s Technical Advisory Group on Immunisation would advise the health minister on the “medical administration” of vaccines, including priority age groups for products.

In an investor call this week, Novavax chief executive Stan Erck said the company saw its product as an important booster tool, both in and outside the United States.

“There’s going to be a need for booster reload. There’s a need for boosting, and I think that’s pretty well accepted in the industry. The studies that are going on right now are going to show how our vaccine is effective at boosting and has a safety profile that’s favourable.”

Novavax has no operations in Australia so is partnering with Sydney business Biocelect to lodge documents for regulatory approval of its vaccine.

“Timing of approval is still the subject of ongoing interactions with the regulatory authorities; however, Novavax and Biocelect are working towards having final submissions sometime in Q3 2021,” a spokesman for the companies said.

Novavax’s Nasdaq-listed shares are up 60 per cent year-to-date.

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