Medigen Vaccine Biologics Announces Launch of Its COVID-19 Vaccine MVC-COV1901 Adjuvanted with Dynavax's CpG 1018 Adjuvant

Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical company focusing on the development and production of vaccines and biologics, and Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the rollout of its COVID-19 vaccine, MVC-COV1901. Approximately 600,000 people are anticipated to receive the Medigen vaccine this week.

Charles Chen, Chief Executive Officer at Medigen commented, "Medigen is honored to be able to serve the people of Taiwan, China and participate in the global response to this pandemic. We were grateful to have received emergency use authorization from the Taiwan, China FDA and greatly appreciate the time and effort of both the TFDA staff and the experts that participated in the risk and benefit analysis meeting. It is heartening to see a productive outcome from the dedicated effort from the team at Medigen."

Ryan Spencer, Chief Executive Officer of Dynavax commented, "We are pleased that Medigen's vaccine is now available for the people of Taiwan, China. We are very excited for this first, of hopefully multiple, EUAs and approvals for COVID-19 vaccines that include CpG 1018 adjuvant. Considering the limitations of current vaccines and the global vaccine shortage, we believe adjuvanted vaccines can contribute significantly to current vaccination efforts."

In July, MVC received Taiwan, China Emergency Use Authorization and approval for inclusion in Taiwan, China's COVID-19 vaccine immunization program, MVC-COV1901. MVC COVID-19 vaccine is indicated for adults over 20 years old and is administered in two doses 28 days apart for prevention of COVID-19. The Advisory Committee recommended that MVC should submit safety monitoring report monthly during the declared EUA period and should submit a vaccine effectiveness report within one year after obtaining EUA approval.

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). MVC-COV1901 vaccine's Phase 1 and 3,815-participant Phase 2 clinical study data has shown robust safety and promising immunogenicity responses and as a result obtained Taiwan, China's EUA approval on July 19th, 2021. MVC will continue to collaborate with international partners for phase 3 clinical trial development and assist the global community in its fight against the COVID-19 pandemic.  

About Medigen Vaccine Biologics Corporation (MVC)

MVC is a biopharmaceutical company using cell-based technologies to develop novel vaccines and biosimilars. MVC's pipeline includes EV71 vaccine, dengue vaccine, quadrivalent influenza vaccine and COVID-19 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.

About CpG 1018 Adjuvant 

CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 adjuvant provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.

About Dynavax 

Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis, and universal influenza.