WHO/MPP mRNA Technology Transfer Programme
Regional meeting in South-East Asia
Background
Announced on 21 June 2021, WHO and the Medicines Patent Pool established a Technology Transfer Programme for mRNA vaccines in South Africa, in order to build manufacturing capacity in LMICs to produce mRNA vaccines, in an effort to improve health security in LMICs through local and/or regional production of mRNA COVID-19 vaccines, as a primary target. The center for mRNA technology development and transfer comprises Afrigen/Biovac/South African Medical Research Council, South Africa, and will share technology and technical know-how with a network of technology recipients in LMICs. The Programme currently receives funding from European Commission, Belgium, France, Germany, as well as Canada, Norway, the African Union, South Africa and the ELMA foundation.
The mRNA Technology Transfer Programme has four main objectives:
- Establish or enhance sustainable mRNA vaccine manufacturing capacity in regions with no or limited capacity;
- Introduce new technologies in LMICs and promote regional research and development (R&D);
- Strengthen regional biomanufacturing know-how and workforce development;
- Develop regulatory capabilities and workforce to support and accelerate regional approval and distribution of mRNA vaccines;
Objectives of the meeting:
- Promote R&D regional collaboration to advance mRNA product development around diseases of regional importance (e.g. dengue, malaria vivax, HPV, HFMD)
- Share information on new discoveries to help design second-generation mRNA products.
- Review intellectual property issues and regulatory aspects relevant to mRNA vaccines for diseases of regional importance.
Meeting materials
Meeting agenda
List of participants
Presentations
Day 1
mRNA innovations for sustainability: establishing an enabling environment – Petro Terblanche, Afrigen
Clinical trial design and policy expectations for novel dengue vaccines – Annelies Wilder-Smith
Designing a mRNA vaccine against dengue, key considerations – Eugenia Ong, Duke-NUS
Product development plan for a mRNA dengue vaccine – Mainul Ahasan, Incepta
Epidemiology of HFMD in South East Asia and key immunological considerations for vaccine development – Yoke-Fun Chan, Univ. Malaya
Designing a mRNA vaccine against HFMD, key considerations – Justin Chu, National University of Singapore
Epidemiology of malaria vivax in South East Asia and key immunological considerations for vaccine development – Rintis Noviyanti, Eijkman Institute for Molecular Biology
The role of human infection challenge models to advance P. vivax vaccine development – James McCarthy – Wehi Institute
Lessons learned from P.berghei vaccine development: an mRNA vaccine adjuvanted with a NK-cell agonist against liver-stage malaria – Gavin Painter, Wellington Univ. of Victoria
Designing a mRNA vaccine against malaria vivax: key considerations – Herbert Opi, Burnet Institute
Product development plan for a mRNA P.vivax vaccine – Neni Nurainy, PT Bio FarmaShow less Show more
Day 2
R&D capacity in South-East Asia
- Lisa Ng, A*STAR
- Alain Bouckenooghe Hilleman Labs
- Manki Song, IVI
- Kiat Ruxrungtham, Chula VRC
- Amina Larbi, MPP
HPV mRNA therapeutic vaccine – Epidemiology and rationale for HPV therapeutic vaccine development – Kiat Ruxrungtham, Chula VRC
HPV mRNA vaccine design and preliminary insight – Eakachai Prompetchara & Supichcha Saithong, Chula VRC
BMGF strategy to advance mRNA vaccine R&D – Philippe-Alexandre Gilbert, BMGF
Development of novel lipids – Charles de Koning, Wits Univ.
Nucleotide-modification for mRNA vaccines, evidence from in vitro and animal models – Patrick Arbuthnot, Wits Univ.
Review of automated technologies for mRNA production – Martin Friede, WHO & Ike James, MPP
mRNA drugs production from very small to very largescale capacity: when to use batch versus continuous strategies – José Castillo, Université Libre de Bruxelles/Univercells
From: Department of Chemical and Biological Engineering, University of Sheffield
Professor Tuck Seng Wong
Sheffield to lead £7.6 million UK-South East Asia Vaccine Manufacturing Research Hub. The Hub is a consortium of four UK universities (Sheffield, Cambridge, York and Kent) and eleven partners based in South East Asia, covering five countries (Thailand, Malaysia, the Philippines, Vietnam and Indonesia). Prof. Tuck Seng Wong at Sheffield U is the director and Prof. Kiat Ruxrungtham at Chula VRC, and School of Global Health, Faculty of Medicine, Chulalongkorn University is the co-director of this UK-SEA manufacturing research hub. “
From BioNet-Asia
ChulaCov19 BNA159 is a COVID–19 mRNA vaccine developed by Chulalongkorn University and produced by BioNet
- ChulaCov19 mRNA vaccine was found safe and immunogenic for primary immunization in clinical trials in Thailand.
- The Australian trial will evaluate the safety and immunogenicity of a booster dose of ChulaCov19 BNA159 mRNA vaccine in healthy volunteers.
- The collaborators of the trial are Chulalongkorn University, BioNet and Technovalia.
Melbourne, 15th November 2022 – Technovalia, Chulalongkorn University and BioNet today announced that Human Research Ethics Committee (HREC) in Australia approved the phase 2 trial of ChulaCov19 BNA159 mRNA vaccine as a booster dose in adults.
Ethics approval is granted to commence a phase 2 trial after sharing satisfactory results of clinical safety and immunogenicity data of prior phase 1 and 2 studies of ChulaCov19 mRNA vaccine.
Mr. Laurent Dapremont, Chief Executive Officer of Technovalia said: “We are pleased to have received ethics approval for testing the ChulaCov19 mRNA BNA159 vaccine. We have been leading the development of genetically designed innovative vaccines in Australia, starting with clinical trials evaluating a recombinant pertussis vaccine, two DNA COVID vaccines and now a mRNA COVID vaccine.”
The clinical trial will assess the safety and immunogenicity of one single booster dose of ChulaCov19 BNA159 mRNA vaccine in healthy volunteers having previously received vaccination with an approved COVID-19 vaccine. The trial includes several sites in Australia and will commence in November.
Assoc. Prof. Chanchai Sittipunt, MD, Dean of Faculty of Medicine, Chulalongkorn University added: “Our university aims at developing approaches to move society forward. Developed in Thailand, Chulacov19 mRNA vaccine has already shown good safety data and very promising immunogenicity data in Thai phase 1 and phase 2 trials. We are glad to continue its development as a booster vaccine and to sponsor this clinical study in Australia. We believe mRNA vaccines will play an important role to combat current and future pandemics and infectious disease threats.”
ChulaCov19 mRNA vaccine was developed by Professor Kiat Ruxrungtham and his team of Chulalongkorn University Vaccine Research Center (ChulaVRC), Thailand, in collaboration with Professor Drew Weissman of the University of Pennsylvania, USA. the first ChulaCov19 vaccine lot was manufactured in the U.S. and was evaluated in a phase 1 safety trial in Thailand. It was then evaluated in a comparative phase 2 safety and immunogenicity trial in Thai adults and elderly participants who received two primary doses of vaccine. The ChulaCov19 vaccine was compared to an mRNA vaccine licensed in Thailand. The new multi-centre trial in Australia, will evaluate the boosting immunity induced by one dose of ChulaCov19 BNA159 vaccine, produced in Thailand, in adults aged 18 – 64 years.
Dr. Pham Hong Thai, Chief Executive Officer of BioNet, added: “We are very pleased to collaborate with Chulalongkorn University to produce mRNA vaccines against SARS–CoV–2 and to continue our development partnership with Technovalia. We have been collaborating on several vaccines of which three are in clinical trial stage in Australia. This is a key milestone for all our colleagues who worked relentlessly towards the success of this mRNA vaccine project.”
BioNet has established an end-to-end manufacturing platform to produce mRNA vaccines from cell bank to encapsulation in record time. ChulaCov19 BNA159 mRNA vaccine is the fruit of a collaboration between Chulalongkorn University and BioNet. The mRNA technology platform enables the rapid development of new vaccines in 100 days from research to use in human trial. A second-generation mRNA vaccine against Omicron variant and the ancestral strain of SARS-CoV-2 virus is also in development.
About Chulalongkorn University
Chulalongkorn University aims to become a model institute of education, setting the standard as a university of innovations for society and focusing on three social development core principles: preparing future leaders, developing impactful research and innovation, and advocating social sustainability. The university has 20 faculties, 23 colleges and research institutes, more than 3,000 full-time faculty members and over 37,000 students. Recently, Chulalongkorn University was ranked Asia’s No.1 for Global Impact by Times Higher Education (THE) Impact Ranking 2021, which is the global performance scale that assesses universities using the United Nations’ 17 Sustainable Development Goals (SDGs). Chulalongkorn University earned the scores of SDG 3 for Good Health and Well-being and SDG 9 for Industry, Innovation and Infrastructure.
About BioNet
BioNet is a biotech organization sharing expertise and innovation to secure rapid access to vaccines. Located in France and Thailand, BioNet creates genetically designed vaccines and produces Pertagen, the world’s only recombinant pertussis-only vaccine containing genetically inactivated pertussis toxin. BioNet has also established technology platforms to produce DNA and mRNA vaccines with 10 projects in preclinical and clinical studies. BioNet is advancing global research in collaboration with eminent advisors and organizations (The Pasteur Institute, The Bill and Melinda Gates Foundation, PATH, CEPI and IVI). BioNet has developed bio-clusters fostering vaccine self-reliance around the world and for 20 years, BioNet has driven a unique manufacturers alliance deploying 10 billion doses of polio vaccines worldwide.
About Technovalia
Melbourne-based Technovalia is a privately-owned Australian biotech company dedicated to the research and development of innovative vaccines. In partnership with several academic organisations and international companies, Technovalia is investing in the development of new technology platforms that have the potential to significantly improve protection against several infectious diseasesby producing safer, more stable, and more cost-effective vaccines. Technovalia is developing BioNet’s recombinant acellular pertussis-only vaccine Pertagen® in Australia and needle-free COVID-19 DNA-based vaccine Covigen.
For further information, please contact:
Ms Michelle Tat
Marketing Communications
E-mail: info@technovalia.com
