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The Therapeutic Goods Administration (TGA), part of the Department of Health, has granted provisional determination to Grand Pacific CRO (the Australian sponsor acting on behalf of Medigen Vaccine Biologics Corp) in relation to its COVID-19 vaccine: MVC-COV1901-S-2P-Protein (MVC-COV1901 Vaccine).
This protein-based subunit vaccine will be considered for the active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals aged 18 years of age and older. If approved, a complete course of the MVC-COV1901 Vaccine is likely to be two doses given as an injection 4 weeks apart.
Protein vaccines use a non-infectious component of the coronavirus. This protein is found on the surface of the virus and is manufactured in a laboratory. When the vaccine enters the body, immune cells recognise the vaccine protein as foreign and launch an immune response against it.
The granting of a provisional determination means that the TGA has made a decision that Grand Pacific CRO (on behalf of Medigen Vaccine Biologics Corp) is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG).
Provisional determination is the first step in the provisional registration process. Importantly, registration and supply in Australia will only commence should the vaccine be approved as safe and effective by the TGA.
In making its decision to grant Grand Pacific CRO (on behalf of Medigen Vaccine Biologics Corp) a provisional determination, the TGA considered all eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data and the seriousness of the current COVID-19 pandemic.