Tag: Kiat Ruxrungtham

May 25, 2024

From: Health Policy Watch / By Petro TerblancheJerome KimRajinder Suri & Padmashree Gehl Sampath, et al.

South Sudan’s Minster of Health, Elizabeth Chuei, receives a COVID-19 vaccine in March 2021, delivered by the WHO co-sponsored COVAX vaccine mechanism.

Sixteen leading scientists and manufacturers involved in vaccine development and production worldwide issue an urgent call for a pandemic accord that can be a ‘win-win for all.’ The full list of authors is available below.

Health misinformation was not invented during COVID-19 but was certainly brought to a higher, more malevolent  and destructive pitch during the pandemic.  That hostile crusade has since been (mis)directed at two landmark agreements, the Pandemic Prevention, Preparedness and Response Agreement (Pandemic Agreement), and amendments to the International Health Regulations (IHR), that are currently being negotiated by WHO’s 194 member states for approval at the World Health Assembly.  

The overarching goal of ensuring that the world will deal more equitably with the next pandemic appears to be elusive as we near the deadline of May 2024 for the close of the negotiations.

Several social media and news outlets have claimed that the WHO is negotiating two instruments that will afford the agency far-reaching powers in case of a future pandemic. 

Member-state led talks

WHO member states negotiate a proposed agreement on pandemic prevention, preparedness and response at the ninth meeting of the Intergovernmental Negotiating Body (INB) in May, 2024.

While the WHO is the global custodian of human health, the WHO is not negotiating these agreements – the 194 member states are.  Aside from being untrue, the false claims undermine the goals of the Pandemic Agreement and its ability to ensure that it remains centered around the key pillars of access, equity, and global health security. 

Moreover, these false claims gainsay the grim facts of the COVID-19 pandemic and the lethal consequences that the lack of equitable access to life-saving medical countermeasures imposed on the greater part of the world’s population.  

The Pandemic Agreement and the IHR amendments do not grant WHO far-reaching powers and do not compel member states to surrender national sovereign rights.  

Rather, they seek to ensure that, by working together, the global community can ensure the health of all. The Pandemic Agreement is an important and empowering step in that direction.

Powerful instrument for for all people

The Pandemic Agreement is a powerful instrument for mankind and, while recognising that the WHO is the internationally-recognised lead agency, it is important to remember that WHO member states initiated these processes, remain the main players in the negotiations, and are themselves, not WHO, responsible for the outcome. The World Health Assembly (WHA), not WHO, decides on the content and adoption of the agreement.

It should be borne in mind that the Pandemic Agreement is NOT written for low- and middle-income countries, but for all countries to secure health security for all peoples – rich and poor. This is critical as pandemics do not stop at country borders, nor put all within a country’s population at similar risk. 

Fostering a value system that emphasises equity, as demonstrated through commitments to equal access to vaccines and therapeutics for all people, no matter who they are or where they live is central to such an outcome.

For this to happen, the agreement we need is one that will ensure access by providing a clear pathway to enable access and equity. 

The world already has several instruments and treaties, such as the flexibilities under the World Trade Organization’s Trade-related Aspects of Intellectual Property (TRIPS), and the COVID-19 Technology Access Pool, now repositioned as H-TAP (Health Technology Access Programme), which have not yet been used to their full potential. 

Implementation roadmap

A doctor providing essential health services to children in a refugee camp in north-west Syria during the COVID-19 pandemic.

The agreement’s success will be measured by how it can provide a better roadmap and enable more effective use of complementary agreements and instruments. We must not just discuss notions of technology access, transfer, production and equitable access but move beyond the words on paper to implementation.

There must be clarity on leadership and the need for one entity to lead and govern the implementation of the entire agreement – where health is the focus. WHO, as the directing and coordinating authority in international health work, should be empowered, and supported to effectively execute its mandate with WHO still being accountable to the WHA. 

But WHO alone cannot protect the world; there are many other essential players – regional health agencies, governments, public and private agencies, funders, civil society organisations, communities, research, development entities, as well as academic and public health institutions. 

Building trust for consensus amongst all these players is complex: it requires a clear view on the barriers to trust.

Moving the needle toward consensus amongst the 194 World Health Assembly states with a few days left to go will require a strong effort to eliminate the fundamental misunderstandings about  the Agreement and bring forth its acceptance. 

Why support a pandemic agreement?

The COVAX initiative spearheaded the distribution of millions of doses of COVID-19 vaccines to dozens of countries, including Barbados [portrayed here]. But excessively large developed country vaccine pre-orders sharply curtailed availability in lower-income countries for months.

Why should we join a movement to ensure that a pandemic agreement is agreed to by all governments and is adopted as soon as possible?

The answer is both simple and profound: in the face of the COVID-19 pandemic, people were often afterthoughts, and some countries used the worst pandemic in a century to further their own geopolitical and domestic political agendas rather than to unite to advance life-saving solutions together, effectively, efficiently, equitably, and justly both globally and within their own country. 

During the pandemic, it was governments (many elected by the people) that chose – or did not choose –to impose lockdowns to quell waves of COVID-19; it was governments that chose – or did not choose – to impose travel restrictions. 

When high-income countries pre-ordered far more vaccine doses than they could ever use, and indeed, millions upon millions of doses were disposed of, rather than being shared with health workers, elderly people, and immune-suppressed patients in lower-income countries when demand was high, it was governments that justified these excesses. 

Act-Accelerator and COVAX partners, including the WHO, which works for its 194 member states, did their best to streamline access to vaccines, diagnostics, and therapeutics. 

But WHO is only as strong as governments of the member states wish it to be – WHO cannot force governments to do anything.

A win-win for all

At present, there are several issues in the agreement still to be resolved. Higher income countries are worried about their autonomy and pharmaceutical corporations based in those, about profits, while lower-income countries in all regions, including those across Africa, are requiring mechanisms that will prevent gross inequities from recurring. 

The pandemic agreement is not designed to be detrimental to the autonomy of nations or the profits of private firms but a win-win for all by preventing gross inequalities in access to vaccines, therapeutics, and diagnostics.

Some of the mechanisms being discussed involve nesting within WHO several time-bound processes that would alert governments when the first signs of a dangerous outbreak are being detected; that would require governments to share information about nascent outbreaks anywhere on the globe; whereby pandemics that threaten all people everywhere result in the equitable sharing of life-saving medical interventions – with industry, researchers, and governments agreeing in advance to a level of essential benefits-sharing that will save lives while fostering scientific innovation.

Researchers at the WHO mRNA hub hosted by Afrigen Biologics in South Africa.

Central role of technology transfer

Paradoxically, ensuring the spread of technical know-how and manufacturing capacity to lower-income countries, which is central to these outcomes, is a strong area of disagreement amongst WHO’s Member States about the Pandemic Agreement, although the WHO has been leading an effort over the past two years to do just this. 

South Africa is at the centre of this shift, and there is real hope that it will change the game for mRNA vaccine production in Africa and the use of other vaccine manufacturing technologies. 

A global pandemic agreement that addresses the issue of technical know-how for manufacturing will ensure that the next time around, the global community is prepared ahead of time to accelerate this shift. Ultimately, when governments agree on principles like sharing and equity, it is ordinary people who benefit. At the same time, in the face of conflict and chaos, it is ordinary people who suffer.

A better path to global equity

To be clear, the Pandemic Agreement will not be enacted in isolation. Other established instruments, especially those that govern intellectual property and trade, will support and continue to co-exist working together to enhance access in a synergistic manner. 

The agreement is a means to better address equity globally and must be owned by all governments.

We urge all of those who are curious about the Pandemic Agreement and its agreement process to learn more and join millions of others around the world to urge all governments to get the job done, to find a way to bequeath to future generations the sort of pandemic agreement which, will ensure a swifter, fairer response for a better healthier world for all. 

Prof Petro Terblanche is managing director of Afrigen Biologics, South Africa, which hosts the WHO’s global mRNA technology vaccine hub.

Dr Jerome Kim is Director General of the International Vaccine Institute, South Korea.

Rajinder Suri is CEO of Developing Countries Vaccine Manufacturers Network, India.

Prof Padmashree Gehl Sampath is CEO of the Africa Pharmaceutical Technology Foundation, Rwanda.

Prof Kiat Ruxrungtham is founder and co-director of the Vaccine Research Center  at Chulalongkorn University, Thailand. 

Frederik Kristensen is managing director of the Regionalized Vaccine Manufacturing Collaborative and Coalition for Epidemic Preparedness Innovation.

Ramon Rao is CEO of Hilleman Laboratories, Singapore, which translates early discovery of vaccines and biologics for infectious diseases into affordable products with global health impact.

Prof Sarah Gilbert is Saïd Professorship of Vaccinology at Oxford University UK, and co-developed the Oxford-AstraZeneca COVID-19 vaccine.

Prof Glenda Gray is president of the South African Medical Research Council South Africa. 

Boitumelo Semete is  CEO of the South Africa Health Products Regulatory Agency, South Africa.

Prof Noni MacDonald is professor of paediatrics (infectious diseases) at Dalhousie University in Canada.

Charles Gore is executive director of the Medicines Patent Pool Switzerland.

Dr Amadou Sall is CEO of the Institute Pasteur Dakar in Senegal and Director of the WHO Collaborating Center for Arboviruses and Viral Hemorrhagic Fever.

Prof Cristina Possas is an infectious diseases expert at the Institute of Technology on Immunobiologicals (Bio-Manguinhos) at Fundação Oswaldo Cruz (Fiocruz) in Brazil.

Dr Simon Agwale is CEO of Innovation Biotech (Nigeria and USA).

Image Credits: Chris Black/WHOUNICEFInternational Rescue CommitteePMO BarbadosKerry Cullinan.

Posted in News | Tags: , ,
April 17, 2024

From: Vaccine Insights

Tuck Seng Wong, Kiat Ruxrungtham

Vaccine security and self-reliance must be a priority for all nations if they are to escape the worst health and economic impacts of future pandemics. For low- and middle-income countries, this is best achieved with a wider regional approach. Existing geopolitical and economic alliances and a strong baseline of biopharmaceutical manufacturing mean that South East Asia is well-positioned to become a global leader in vaccine production. The newly launched UK-South East Asia Vaccine Manufacturing Research Hub will support this ambition by addressing key priorities including technology transfer, IP, standardization, and supply chain.

Vaccine Insights 2024; 3(2), 35–42

DOI: 10.18609/vac.2024.008

December 22, 2023

From https://www.who.int/news-room/events/detail/2023/10/31/default-calendar/who-mpp-regional-mrna-meeting-in-searo-wpro

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:

  1. Establish or enhance sustainable mRNA vaccine manufacturing capacity in regions with no or limited capacity;
  2. Introduce new technologies in LMICs and promote regional research and development (R&D);
  3. Strengthen regional biomanufacturing know-how and workforce development;
  4. Develop regulatory capabilities and workforce to support and accelerate regional approval and distribution of mRNA vaccines;

Objectives of the meeting:

  1. Promote R&D regional collaboration to advance mRNA product development around diseases of regional importance (e.g. dengue, malaria vivax, HPV, HFMD)
  2. Share information on new discoveries to help design second-generation mRNA products.
  3. 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 

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

November 6, 2023

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. “

October 9, 2023

Organized by Chula Vaccine and Research Center (Chula VRC)