2021/11/22 Medigen is Granted Provisional Determination by Australia's Therapeutic Goods Administration (TGA)

TAIPEI, 22 November 2021 - Medigen Vaccine Biologics Corp (MVC) announced today that the company has been granted Provisional Determination for its COVID-19 vaccine candidate, MVC-COV1901 with the Therapeutic Goods Administration (TGA).
Medigen's MVC-COV1901 is the 6th COVID-19 vaccine candidate which has received the granting of a provisional determination by TGA. The subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 can now be considered by the TGA for COVID-19 vaccinations in Australia. Before any COVID-19 vaccine is approved for use in Australia, it will be subject to the well-established and rigorous assessment and approval processes of the Therapeutic Goods Administration (TGA), part of the Department of Health.
The granting of a provisional determination means the TGA has made a decision that Medigen would be eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG). The provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data. Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the vaccine will be provisionally approved for inclusion in the ARTG.
Charles Chen, Vice Chairman & CEO of MVC said, "TGA is known for their rigorous assessment, monitoring and high standards of pharmaceutical products as a globally recognized Stringent Regulatory Authority (SRA). Medigen is encouraged by receiving a positive provisional determination by the TGA and to be considered eligible for the provisional pathway. In order to introduce our protein-based subunit vaccine to Australia, Medigen and our local partner, Grand Pacific CRO, will do all in our power to start the submission for provisional approval of our COVID-19 vaccine candidate."
About MVC-COV1901
MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax and aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by the U.S. NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). CpG 1018 is developed and produced by Dynavax Technologies. Building upon the S-2P platform, MVC conducted large-scale screenings of various adjuvants and finalized the compositions of MVC-COV1901 vaccine to optimize safety and desired immunogenicity properties. MVC established the production platform of MVC-COV1901 and based on MVC's preclinical and clinical studies, MVC-COV1901 has shown robust safety and promising immunogenicity responses. MVC-COV1901 has been granted emergency use authorization in Taiwan with vaccinations commencing Aug 23, 2021. MVC continues to pursue global regulatory recognition. MVC-COV1901 has been selected by an independent vaccine prioritization advisory group composed of leading global scientists and experts to be included in WHO Solidarity Trial Vaccines.
About Medigen Vaccine Biologics Corp. (MVC)
MVC is a biopharmaceutical company using cell-based technologies to develop novel vaccines and biosimilars. With a goal of national self-sufficiency, MVC also aims to provide vaccines and biopharmaceuticals to meet regional needs and with a desire to help globally against the threats of infectious diseases. MVC's pipeline includes enterovirus EV71 vaccine, dengue vaccine, influenza quadrivalent vaccine which all have entered late clinical stage. MVC's large-scale production facility is state-of-the-art and adherent to international PIC/s GMP requirements.  For more information, visit www.medigenvac.com.
MVC's Forward Looking Statements
This press release contains certain forward-looking statements relating to the business of Medigen Vaccine Biologics Corporation (MVC, TPEx: 65470.TWO) including with respect to the progress, timing and completion of research, development and clinical trials for MVC's COVID 19 vaccine candidate, MVC-COV1901, and the ability to manufacture, market, commercialize and achieve market acceptance thereof. These forward-looking statements are based largely on the current expectations of MVC as applicable, as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, such could be affected by, among other things, uncertainties involved in the development and manufacture of MVC's COVID19 vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, changes in global financial markets and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that such forward-looking statements will in fact be realized. MVC and is providing the information in this press release as the date hereof, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Medigen Contact:
Paul Torkehagen
Director, International Business Development
Investor Relations:

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