The Taiwan-made Medigen COVID-19 vaccine has moved one step closer to a potential rollout in Australia. That comes after Australia’s Therapeutic Goods Administration granted provisional determination to Medigen’s local partner, Grand Pacific CRO Australia.
The administration says provisional determination is the first step in the provisional registration process. Medigen’s partner will have to demonstrate that the vaccine is safe and effective before it can obtain registration and begin supplying doses to Australian authorities.
Medigen’s COVID-19 vaccine has received emergency use authorization in Taiwan. To date, authorities have administered 1.43 million doses of the vaccine to Taiwan’s population.
The Medigen vaccine has not passed a Phase III clinical trial to determine its efficacy. However, Medigen and Taiwan health authorities say the vaccine provokes a strong immune response in recipients. Health authorities say this data suggests that the Medigen vaccine should provide at least as much protection from COVID-19 as the AstraZeneca vaccine.
Medigen is currently carrying out a Phase III clinical trial in Paraguay. In addition, the World Health Organization has selected Medigen as a candidate for its Solidarity Trial Vaccines platform. The platform is designed to “rapidly evaluate the efficacy and safety of promising new candidate vaccines” through large-scale clinical trials.