2 December 2021; Oslo and Taipei: The Coalition for Epidemic Preparedness Innovations (CEPI) and Medigen Vaccine Biologics Corp. (MVC) will co-fund a clinical trial of heterologous and fractional booster doses – or 'mix-and-match' booster – combinations of MVC's COVID-19 vaccine, known as MVC-COV1901, with other COVID-19 vaccines. CEPI will provide up to $2.3m in co-funding, with MVC funding the remaining cost of the clinical trial.
In clinical studies and real-world vaccinations to date, a two-dose regimen of MVC-COV1901 has demonstrated a good safety profile and induces strong immunogenicity[1]. The new clinical trial will assess the safety and immunogenicity of a third full or fractional dose of MVC-COV1901 in people previously immunized with a primary regimen of MVC-COV1901 or vaccines developed by AstraZeneca or Moderna. This will be the first mix-and-match booster study to include MVC-COV1901, a vaccine that can be manufactured at scale and has a profile which potentially makes it suitable for broad distribution, particularly in low- and middle-income countries (LMICs). Data on mix-and-match combinations of vaccines, including full and fractional booster doses, are urgently needed to contribute to the design of more flexible vaccination strategies and mitigate against shortages of vaccine at times of uncertain or fluctuating supplies. All of the data will be made available open source to inform policy makers and regulatory authorities' recommendations on the use of COVID-19 vaccines.
The clinical trial will be conducted at trial sites in Taiwan and will be sponsored by MVC. Up to 960 adult and elderly participants will be enrolled into the trial and randomized to receive either a homologous vaccine booster regimen or a mix-and-match combination of a full or fractional booster shot of MVC-COV1901 following a primary regimen of either AstraZeneca or Moderna vaccines. Trial participants will be followed up for six months to gather data about the durability of immune responses. The first interim results are expected to be available in the first quarter of 2022.
Dr Richard Hatchett, CEO of CEPI, said:
"As we strive to stay one step ahead of COVID-19, mix-and-match combinations of vaccines could play an increasingly important role in controlling the virus – particularly in many LMICs where supplies of vaccine are unstable. This CEPI-supported trial will generate valuable data on combinations of vaccines which have not been evaluated before, potentially providing additional flexibility to vaccination campaigns and contributing to equitable access to vaccines."
Charles Chen, CEO of MVC, said:
"The data gathered from these trials will allow us to further understand and evaluate the performance of MVC-COV1901 in combination with other vaccines as we work towards keeping people safe and protected against COVID-19. We are committed to providing and supporting the global population to access safe, effective and well-tolerated vaccines. We are honoured to collaborate with CEPI to further develop scientific data for the benefit of the world in our effort to counter waning immunity and to keep pace with an evolving virus."
Expanding access to COVID-19 vaccines by filling R&D gaps
This is the fourth programme to be funded in response to a CEPI Call for Proposals launched in January 2021 which aims to address current gaps in our clinical knowledge of vaccine performance both now and in the long term, in order to expand access to COVID-19 vaccines as part of the global vaccination rollout. Examples of such gaps include assessment of the safety and effectiveness of COVID-19 vaccines in pregnant women, infants and children, and immunocompromised populations, as well as studies on booster doses, length of vaccine efficacy, mix-and-match strategies, and dosing intervals. In response to this Call for Proposals, CEPI is also funding a study of COVID-19 vaccines in immunosuppressed and transplant patients, a project to expand access to BBIBP-CoV in Africa and a clinical trial of mix-and-match combinations of vaccines in Pakistan. In addition, CEPI has previously announced funding to support a mix-and-match study led by the University of Oxford
This work forms part of CEPI's next 5-year plan, published in March 2021, which aims to reduce or even eliminate the future risk of pandemics and epidemics. As part of this plan CEPI is working to strengthen our defences against COVID-19 and reduce the risk of future coronavirus pandemics, by optimizing our current vaccines, addressing variants of concern, developing next-generation COVID-19 vaccines, and initiating the development of broadly protective or universal coronavirus vaccines.
About CEPI
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI's work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).
During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access. These programmes leverage the rapid response platforms developed by CEPI's partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.
CEPI's 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at http://www.endpandemics.cepi.net.
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About 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 studies. MVC's large-scale production facility is state-of-the-art and adherent to international PIC/s GMP requirements. For information on MVC-COV1901 please visit the product specific website. For more information on MVC, 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 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.
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