Medigen Vaccine Biologics Corp (高端疫苗) has applied to the Australian medicines regulator for provisional approval of its COVID-19 vaccine, the pharmaceutical company said in a filing with the Taipei Exchange yesterday.
The company yesterday delivered the necessary documents to the Australian Therapeutic Goods Administration (TGA), but did not say when the regulator would complete its review, the filing showed.
The TGA in November last year gave the Medigen vaccine a provisional determination, the first step to provisional approval, corporate data showed.
Photo: CNA
The step allows for provisional registration of medicines on the basis of preliminary clinical data.
The TGA said it requires comprehensive non-clinical data on safety, quality and compliance with “good manufacturing practice,” the same as for prescription medicine.
The TGA is one of the world’s most credible regulatory authorities as defined by the WHO, Medigen said in the filing.
The COVID-19 vaccines from AstraZeneca PLC, Moderna Inc, Pfizer Inc and BioNTech SE, Johnson & Johnson, and Novavax Inc have obtained provisional approvals from the TGA.
Medigen’s COVID-19 vaccine has been given emergency use authorization in Taiwan and Paraguay, and the company is waiting for a review to be completed in the Kingdom of Eswatini, while New Zealand, Palau, Indonesia, Belize and Thailand exempt travelers who have received the vaccine without requiring strict quarantine measures, it said.
Medigen reported a net loss of NT$140 million (US$4.76 million) in the first quarter, or losses per share of NT$0.66.
First-quarter revenue advanced to NT$326 million from NT$3 million a year earlier, with gross margin of 64 percent.
The company’s operating expenses grew 27.5 percent annually to NT$361 million last quarter due to higher marketing and research spending, company data showed.
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