Novavax files for provisional approval of COVID-19 vaccine in Australia


Novavax Inc. NVAX, -1.19% said Friday it has filed for provisional approval of its COVID-19 vaccine in Australia. “The company’s application to the TGA marks the first complete application for provisional approval of a protein-based COVID-19 vaccine in Australia,” the company said in a statement. The move comes just days after Novavax filed for approval of the vaccine in the U.K. with the completion of a rolling submission to the U.K. Medicines and Healthcare products Regulatory Agency. The submission was based on late-stage data from about 45,000 patients that the company said showed high efficacy and well-tolerated safety, including against variants of Covid-19. The company is planning to submit filings to other regulators in key markets, including Europe, Canada, New Zealand and the World Health Organization, as well as other markets around the world. In the U.S., Novavax expects to submit the complete package to the FDA by year-end. Shares were down 0.7% premarket, but have gained 35% in the year to date, while the S&P 500 SPX, +0.19% has gained 22%.

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