Taipei, TAIWAN, June 9, 2022 - Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical company focusing on the development and production of vaccines and biologics, today announced that its COVID-19 vaccine candidate, MVC-COV1901 has shown positive early laboratory results in combination with a novel 200-dose bag primary packaging solution produced for mass vaccination campaigns. The 200-dose bag is developed by INTACT Solutions, a subsidiary of MEDInstill, and is supported and co-funded by Coalition for Epidemic Preparedness Innovations (CEPI). The bag differs substantially and improves upon the conventional glassware used for drug delivery, such as multi-dose vials or single-dose pre-filled syringes.
During the on-going COVID-19 pandemic there were severe shortages of glassware, limiting production and delivery capacities of vaccine manufacturers globally. The 200-dose bag will resolve multiple constraints surrounding mass vaccination campaigns by increasing drug product delivery capacities, increasing cold chain capacities, removing issues of glass fragility in the logistics chain, increasing capabilities for mass vaccinations, reducing cost of goods sold, and greatly reducing environmental footprint and medical waste.
In many developing countries, limitations of existing cold chains provide challenges for COVID-19-vaccine distribution. The 200-dose bag being evaluated by MVC in collaboration with CEPI and INTACT Solutions will address markets where such pharmaceutical cold chains are limited. Currently, the one-month accelerated and real-time storage performance of MVC-COV1901 in the 200-dose bags indicates strong compatibility and a comparable storage performance to that of the same vaccine in pre-filled syringes and multi-dose vials, with a much smaller cold-chain footprint. The results further indicate that the 200-dose bag in combination with MVC-COV1901 may provide superiority to generic glassware for mass vaccination campaigns and in certain conditions where there are cold chain challenges.
Compared to commercially available mRNA vaccines, which require ultra-cold chains, MVC-COV1901 is a protein subunit vaccine that can be stored for over one year at +2-8°C with a better temperature excursion tolerance during transportation. MVC-COV1901 shows excellent thermal stability in current temperature cycling and thermal shock tests, indicating that the vaccine will likely allow for better access and availability in areas with limited cold chain infrastructure.
MEDInstill and INTACT Solutions’ multidose vaccine pouch can contain up to 200 doses of vaccine in a compact packaging. The vaccine is filled using a sterile filling process developed by MEDInstill. A single filling machine can deliver over 1 billion doses per annum. The pouch has an attached dispensing kit that can deliver accurate dosing per subject with additional safety measure ensuring single-use needles. This multidose alternative primary packaging reduces the cold-chain footprint allowing for the possibilities of regional filling hubs for the future. Moreover, the packaging is particularly suitable for rapid mass vaccination campaigns, and may assist significantly with COVID-19 vaccine delivery to low-income regions.
“We are excited to see that our vaccine is working well with the 200-dose bags in early testing. The eventual goal is to see a more rapid deployment of vaccines in larger volumes at a more affordable price point.” said Charles Chen, Chief Executive Officer of MVC. He further stated “The pandemic has shown that deployment of vaccines globally has been slow and that improvements in all aspects of the supply chain is important for the current and future pandemics, the bags will hopefully address the later stages of delivery and packaging of vaccines. We will continue the R&D efforts in collaboration with CEPI and MedInstill in hopes to bring this novel platform to market.”
About Medigen Vaccine Biologics (MVC) Corporation
MVC is a biopharmaceutical company using cell-based technologies for the development of 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 COVID-19 vaccine (MVC-COV1901), enterovirus A71 vaccine (EV-A71), dengue vaccine, and influenza quadrivalent vaccine, which have all entered late clinical stage. Clinical study data of MVC-COV1901 has shown robust safety and promising immunogenicity responses and has as a result obtained Taiwan's EUA approval on July 19, 2021, and Paraguay’s EUA approval on February 14, 2022. 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. MVC will continue to collaborate with international partners to develop promising COVID-19 vaccines and assist the global community in its fight against the ongoing pandemic. 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: 6547.TWO) including with respect to the progress, timing and completion of research, development and clinical trials for MVC's COVID 19 vaccine candidates, MVC-COV1901 and alternative delivery platforms, 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 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.
Director, International Business Development