TAIPEI, 27 October 2021 - Medigen Vaccine Biologics Corp (MVC) vaccine candidate, MVC-COV1901, has been recommended by an independent vaccine prioritisation advisory group to be included in the World Health Organisation (WHO) Solidarity Trial Vaccines (STv). Following the review of around 20 candidate vaccines by the external advisory group, MVC's vaccine was selected as one of two to be included in the global trial.
The announcement by WHO, comes after the approval from WHO Ethics Review Committee and relevant regulatory authorities and ethics committees of Colombia, Mali and Philippines granted approval for the study to progress. Each clinical site and respective national principal investigators and research teams have begun recruiting volunteers to join the trial.
This is an international, randomized clinical trial platform designed to rapidly evaluate the efficacy and safety of promising new candidate vaccines contributing to the creation of a larger portfolio of vaccines needed to protect people from COVID-19 around the world.
MVC began developing its own vaccine in February of 2020 with the hopes of bringing forth a solution capable of helping in part end the devastating pandemic. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax and aluminum hydroxide.
"We are extremely grateful that we have been selected to be part of the WHO International Solidarity Trial Vaccines against COVID-19. We have been working to design a vaccine that has mild side effects and actively protects the public from the adverse effects of the virus. Seeing promising results thus far, we hope that the international trial conducted by WHO and participating countries will assist to curb the escalation of cases," said Charles Chen, Vice Chairman & CEO, Medigen Vaccine Biologics Corp.
With the battle against the pandemic still on an incline, the need for effective vaccines is still in high demand and MVC believes it has the capacity, infrastructure, and expertise to contribute towards achieving global protection.
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). 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, Phase 1 and Phase 2 clinical study data, MVC-COV1901 has shown robust safety and promising immunogenicity responses and as a result applied and was granted EUA in Taiwan and continue to pursue global regulatory recognition.
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.
WHO Media inquiries
mediainquiries@who.int
Medigen Contact:
Paul Torkehagen
Director, International Business Development
paul@medigenvac.com
Investor Relations:
ir@medigenvac.com