Taipei, TAIWAN, Aug 29, 2023 - In a significant move towards equitable global vaccine distribution, Medigen Vaccine Biologics Corp. (MVC, TPEx 6547.TWO) announces an out-licensing agreement with the World Health Organization's COVID-19 Technology Access Pool (C-TAP) initiative and its implementation partner Medicines Patent Pool (MPP). Through the C-TAP initiative, MVC will out-license its COVID-19 vaccine, its technology and critical know-how and provide training to licensees, fostering widespread availability and accessibility of life-saving vaccination technology worldwide.
The COVID-19 Technology Access Pool (C-TAP) was launched in May 2020 by the WHO and the Government of Costa Rica, with the support of 44 Member States, UN Development Programme, Unitaid, UNAIDS, and implementation partners such as the Medicines Patent Pool (MPP). C-TAP was welcomed by the Member States in the 2021 “Local Production Resolution,” formally establishing a mechanism to facilitate sustainable access to quality-assured, safe, effective and affordable medicines and other health technologies. Furthermore, C-TAP has played an important part in raising awareness of the role of technology and knowledge sharing and access-oriented voluntary licensing.
Commitment to sharing technologies during the COVID-19 Public Health Emergency (PHE) has been disappointing. Despite this, two public health R&D Institutes such as the Spanish National Research Council (CSIC) and the US National Institute of Health (NIH) decided to share their key COVID-19 technologies with C-TAP. The license provided by CSIC is already in use by manufacturers such as Biotech Africa to develop their diagnostic technology, and the US NIH licenses have been core to facilitating MVC’s out-licensing as the first private vaccine manufacturer to share its vaccine via C-TAP. These licenses are global, transparent, and non-exclusive to all manufacturers and accessible on the C-TAP website.
The MVC and C-TAP out-licensing collaboration seeks to address the pressing issue of vaccine disparities across the globe by sharing expertise and intellectual property to enhance vaccine production capabilities, in particular in low and middle-income countries (LMICs). By joining hands with C-TAP and MPP, MVC reinforces its commitment to promoting health equity and ensuring that no one is left behind.
With MVC’s proven track record of vaccine innovation and dedication to public health, MVC aims to empower nations with the necessary tools to manufacture high-quality vaccines locally. By encouraging technology transfer and knowledge sharing, the out-licensing aims to accelerate the scale-up of vaccine production and ultimately save lives.
The ambition to right the wrongs caused by hoarding technology during the COVID-19 pandemic is further encouraged in today’s announcement by the WHO of three new licensing agreements to the C-TAP initiative, made possible via the Medicines Patent Pool (MPP). The three additional licensees clearly demonstrate that the concept and mechanism established via C-TAP works:
- Medigen Vaccine Biologics Corp, the first private manufacturer, is offering its vaccine, which has been used in more than 3 million administrations across seven countries. It is the first time that a vaccine manufacturer is using the WHO voluntary patent and know-how access model, seeking a win-win solution for the WHO, the manufacturer, recipients of the technology and most importantly, patients in need around the world. The agreement will facilitate technology transfer of IP, proprietary know-how and staff training, ensuring a holistic approach and transfer of vaccine production capabilities.
- CSIC, in addition to a prior technology made available through C-TAP, is sharing a second license for two COVID-19 vaccine candidates. The agreement includes plant visits and training, direct assistance and ongoing consultation, including quality and regulatory questions.
- The University of Chile is sharing its technology for a COVID-19 assay for the quantification of neutralizing antibodies.
The three technology holders are providing patent licenses through a WHO C-TAP/MPP license, including the transfer of know-how, materials, and clinical data needed for regulatory approvals in different countries.
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said, “COVID-19 is here to stay, and the world will continue to need tools to prevent it, test for it and treat it,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Through C-TAP, WHO and our partners are committed to making those tools accessible to everyone, everywhere. I am grateful to the leadership shown by those license holders who have contributed technology.
Charles Gore, Executive Director of the Medicines Patent Pool (MPP), said, “Access to essential medicines and health technologies needs to remain a top priority on the global health agenda. We congratulate Medigen Vaccine Biologics Corp, CSIC and the University of Chile for licensing their products to MPP and hope it will send an important message to other originators around the world to enter into further licence agreements under the auspices of C-TAP.”
Dr. Charles Chen, CEO of Medigen Vaccine Biologics Corp. (MVC), said, "We believe that the most effective response to a pandemic must be rooted in solidarity, cooperation, and collective global effort. By joining the C-TAP initiative, we are providing equitable access to our vaccine technology. It underscores our commitment to ensuring that vaccines reach all corners of the globe, leaving no one behind. This is not just about COVID-19," Charles continued. "It is about setting a precedent for future global health challenges. By demonstrating our commitment to open science and cooperative strategies, we hope to inspire other organizations to follow suit. To all those that trusted, participated, collaborated and supported us, thank you! For without you, we could not make this C-TAP initiative possible.”
An evolved model for technology sharing will soon be announced by the WHO based on the significant learning achieved since the launch of C-TAP. Its ambition will continue to be embedded in equity of access to health technologies.
Access the licence agreements on the MPP website:
- Medigen: Vaccine MVC-COV1901
- CSIC: MVA-S(3P) (Vaccine Candidate)
- University of Chile: Technology that detects the presence of neutralising antibodies against SARS-CoV-2
Access the press release issued by MPP
Access the press release issued by WHO
About C-TAP
Launched in 2020 by the WHO Director-General and the President of Costa Rica and supported by 45 Member States, its ambition is to facilitate timely, equitable, and affordable access to COVID-19 health products by boosting their production and supply through transparent, public health-oriented, non-exclusive and broad licensing agreements. The C-TAP platform provides a global one-stop-shop for developers of COVID-19 therapeutics, diagnostics, vaccines and other priority health technologies to share knowledge and data, with the possibility to license intellectual property through public health-driven, voluntary, non-exclusive and transparent licences. By pooling technologies, developers of COVID-19 health products can boost manufacturing capacity in all regions and expand access to life-saving tools. The WHO Technology Access Pool is supported by UNDP, UNAIDS, Unitaid and implementing partners such as the Medicines Patent Pool and the Open COVID Pledge.
About MPP
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with 18 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, three oral antiviral treatments for COVID-19 and 15 COVID-19 technologies. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation and SDC. More information at https://medicinespatentpool.org/ and follow MPP on Twitter, LinkedIn and YouTube.
About Medigen Vaccine Biologics Corp (MVC)
MVC is a biopharmaceutical company using cell-based technologies for the development of vaccines and biosimilars. MVC has developed and manufactured the first SARS-CoV-2 vaccine in Taiwan with emergency use approval granted in 2021. MVC has two additional vaccines that have received authorization in 2023: EV-71 against Hand-Foot-and-Mouth-Disease (HFMD) and quadrivalent influenza vaccine (QIV) entering the National Immunization Program of Taiwan. 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 will continue to collaborate with international partners to develop promising vaccines. MVC’s large-scale production facility is state-of-the-art and adherent to international PIC/s GMP requirements. For more information, please visit https://www.medigenvac.com/en/ and follow MVC on LinkedIn.
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 vaccine candidates 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 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 disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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