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The Therapeutic Goods Administration said it granted provisional determination to the Anglo-Swedish drugmaker last week for its antibody cocktail, EVUSHELD, the first protective shot other than vaccines against COVID-19.
The regulator said the provisional determination is the first step in the process, adding that it now expects AstraZeneca (NASDAQ:AZN) to submit an application for provisional registration shortly.
The determination of the antibody-based therapy, which is already under real-time review in Europe and pending emergency approval in the United States, comes as Australia boosts its vaccination rates, recently launching booster shots, amid easing curbs.
The cocktail, which has proven to work as a preventative shot in the non-infected, was also shown to save lives and prevent severe disease when given as treatment within a week of first symptoms.
