The Health Security Initiative for the Indo-Pacific is supporting a whole-of-system approach to ensure new products get to those who need them.
A mid-term review of the Centre's support for Product Development Partnerships (PDPs) was recently completed. The review found continued evidence that the PDP model represents value for money.
Between 1995 and 2005 only 13 new drugs were developed to respond to neglected tropical diseases (NTDs), with communicable diseases disproportionately affecting populations living in poverty.
By 2017, there were 109 active research and development projects for NTDs. PDPs are responsible for almost a fifth of the total funded research and development for these diseases.
PDPs are non-profit entities that bring together the public and private sectors to research, develop and support access to new products that target diseases disproportionately affecting those in resource-poor settings.
While PDPs have increased development of new drugs, diagnostic tests, vector control tools and vaccines, there are a number of steps needed to get these products to those who need them and barriers that need to be overcome. This is called this the ‘product development to uptake pathway’ (Figure 1).
Recognising that new products were faltering along this pathway and not reaching the market, the Health Security Initiative (HSI) has funded a series of initiatives from product development right through to product access that are addressing these barriers.
At the product development stage, the HSI’s PDP Fund is supporting the following four PDPs over five years: Medicines for Malaria Venture (MMV), TB Alliance, Foundation for Innovative New Diagnostics (FIND) and the Innovative Vector Control Consortium (IVCC). It is also funding the Coalition for Epidemic Preparedness Innovations (CEPI) to support its core work in vaccine development for emerging infectious diseases for three years to December 2022.
In order to ensure the safety, quality and efficacy of new products before they are approved for use, HSI established the Regulatory Strengthening Program (RSP) in partnership with the Therapeutic Goods Administration (TGA). The RSP works with national regulatory authorities to strengthen the regulatory processes for medicines and medical devices in Laos, Cambodia, Indonesia, Myanmar, PNG and Vietnam, including strengthening the registration of new medical products including those developed by PDPs.
At the same time, the HSI funds the Asia Pacific Leaders Malaria Alliance (APLMA) which is working with partner governments at a policy level for country-level roll-out of new products and facilitates connections between PDPs, regulatory agencies and national malaria control programs.
As part of gaining WHO approvals for products to be included in their guidance and recommended product lists, products are tested in different contexts. The HSI funds operational research projects in countries across the Indo-Pacific which are improving country research capacity, and in some cases informing product effectiveness in country specific contexts. For example, IVCC’s NATNAT project will test vector control tools in PNG.
DFAT is also funding Gavi, the Vaccine Alliance, and the Global Fund. Both are mechanisms that pool donor funding to combat diseases, including the global procurement of products for use by country disease control and prevention programs.
Before products make it to the market, health workers need to be trained in how to use them and communities need to be aware of and understand the products in order to create demand. While the HSI is not directly supporting these activities for new products, it is equipping health workers with knowledge and skills in areas such as surveillance and infection prevention control and communities in detecting and responding to emerging infectious disease outbreaks – capacities which could also support the roll-out of new products.
The HSI supports the Tupaia program which has established a system – mSupply - to manage stocks and monitor use of medical products. mSupply is being rolled out in several countries in the Pacific and will help improve efficient product distribution and availability.
There is active collaboration and communication between these HSI-funded initiatives which has resulted in demonstrable added value. For example, the MMV-developed antimalarial tafenoquine was approved by the Thai Food and Drug Administration in 72% of the usual priority product time frame and the product was registered 2 months earlier than usual practice due to the RSP (TGA) setting up a system to share its drug assessment reports with the Thai FDA. APLMA helped to facilitate the process.
While the HSI is working across the product development to uptake pathway, there are many remaining barriers to access that require global and regional cooperation. Efforts to overcome these barriers have largely been fragmented. The HSI is engaging in global, regional and bilateral mechanisms to help to address these barriers.
Rapid and accurate diagnostic testing for the virus that causes COVID-19 (SARS-CoV-2) is central to controlling the global COVID-19 pandemic. However, the pandemic has placed an unprecedented global demand on laboratory supplies. There are critical shortages of some of these supplies, particularly COVID-19 testing cartridges for the Cepheid GeneXpert® testing platform.
Many Pacific island countries are entirely dependent on GeneXpert testing to provide in-country capacity to test for COVID-19. These countries would otherwise be reliant on shipping specimens internationally, with the inherent delays. With the reduction in commercial flights since the beginning of the pandemic, international shipping is less reliable than normal. Crucially, rapid result turnaround time is the cornerstone of effective isolation and contact tracing in containing the spread of infectious disease.
Specimen pooling is a strategy where a laboratory combines the specimens from multiple people into a single tube for testing, in order to conserve limited testing resources. If the pool is positive, specimens for individuals are then retested separately, to determine which sample is positive. This is a commonly used technique in some laboratories, but it is not currently authorised by the manufacturer for GeneXpert, and therefore if used, it becomes an “in-house diagnostic” and must be supported by an evaluation to show it is valid.
Recognising the potential value of specimen pooling for GeneXpert, in June 2020, the Pacific Community’s (SPC) Public Health Division (PHD) along with the Pacific Islands Society for Pathology (PISP) drafted advice for Pacific island countries on how specimen pooling might be employed for GeneXpert, however, no evaluations had been published to support the use of the technique. The Indo-Pacific Centre for Health Security commissioned an evaluation of this technique to confirm its validity, through an existing partnership with the Doherty Institute. The evaluation was led by Associate Professor Maryza Graham and Professor Deborah Williamson.
The evidence provided by the Doherty Institute study is expected to enable countries in other regions around the world to undertake pooled specimen testing for COVID-19 using GeneXpert, thus increasing their testing capacity and reducing the number of cartridges used.
This work was published in the journal Diagnostic Microbiology and Infectious Disease online on 15 October 2020. Other authors have since also published similar evaluations and findings.
Banner photo: Nicole Isles and Associate Professor Maryza Graham at work in the Microbiological Diagnostic Unit Public Health Laboratory in Melbourne.
Story photo: Dr Eka Buadromo from The Pacific Community's Public Health Unit providing remote technical support to Pacific island countries.
What is your new role and why did you choose to be involved?
My new role is working part time as a project officer, with the Pacific Paravet Training Project. I chose to be in this role because coming from Papua New Guinea where there is a current shortage of veterinarians, I recognise the role para-veterinarians and animal health officers play in delivering animal health services in communities, especially in terms of biosecurity and livestock disease and production.
My honours research at Charles Sturt University was focused on documenting the veterinary services in PNG, and the research indicated that the only training para-veterinarians have is on-the-job, and the Pacific Paravet Training Project aims to support sustainable capacity building of para-veterinarians to a globally acceptable standard, thus resulting in the increased standards of animal health services.
How do you hope your work will help the community?
Capacity building is an important aspect in the delivery of veterinary services and the goal of the project is to support sustainable capacity building for the training of national paravets to internationally acceptable animal health standards.
Para-veterinarians provide a majority of animal health services and require consistent training in disease detection and surveillance, animal health diagnostics, antimicrobial stewardship and food safety which are all important in maintaining both animal and public health. Hopefully through the training para-veterinarians will have the ability to provide quality animal health services and, as such, improve the standards of animal health in PNG and the Pacific region.
How can we support more women to enter in the health security workforce in our region?
I will be the first woman from my country to graduate and work as a veterinarian and my study was supported by DFAT through the Australian Awards Scholarship. We need to make veterinary science a priority and support more women and men to study Veterinary Science through more scholarship opportunities. By financially supporting projects like the Pacific Paravet Project, it also contributes to supporting accessible and sustainable training for more women and men.
We need consistent training of our animal health and para-veterinarians and other staff that all contribute to animal health services. In addition to providing training, we need to be able to create employment opportunities through long term funded projects or collaborations with other important stakeholders.
Learn more about the Pacific Paravet Training Project delivered by the Graham Centre at Charles Sturt University.
Kiribati Ministry of Health, along with help from an Australian infection prevention control (IPC) adviser were able to trial new training and processes during an outbreak of measles, a fortuitous test run ahead of preparing for potential COVID-19 outbreaks in the Pacific nation. Following a review of their health security needs in 2017, the Kiribati Government requested support to strengthen infection prevention and control (IPC) in their health facilities. The island nation of 110,000 people has four hospitals, 37 health centres and 72 clinics. This led to the recruitment of Louise (Lou) Carrington through the Indo-Pacific Centre for Health Security to work with the Kiribati Health Ministry as an IPC specialist based at the main referral hospital, Tungaru Central Hospital, between October 2019 and March 2020. In a small team along with two nursing officers, Lou helped to develop a comprehensive IPC program.
Through auditing, surveillance and education, IPC practices were improved across the hospital with the team reporting a 26% improvement in hand hygiene. Lou also helped establish an IPC professional support network between the Kiribati and Fiji nursing teams. This has proven a great resource for sharing locally relevant IPC knowledge between Pacific neighbours. During Lou’s deployment, a small measles outbreak tested the new IPC procedures. In late December, a coalition of assistance including the Kiribati Ministry of Health, World Health Organisation and UNICEF was quickly brought together to address a small number of cases connected to a large outbreak in neighbouring Samoa.
On Christmas Day, Lou joined the Ministry of Health and other partners to set up a measles triage and screening site at the hospital. She ensured the screening processes incorporated IPC best practice. “It was a good dress rehearsal for COVID-19 because the Ministry of Health needed to establish an emergency operations centre, review point of entry and screening processes, coordinate the allocation of health resources, establish screening and contact tracing procedures whilst ensuring education and a staff health and public vaccination campaigns were delivered. The response included repurposing an eight-bed private ward into a measles isolation ward. Lou worked with the team to provide education and IPC infrastructure in the newly designated isolation ward. By late January, the risk of measles spreading among the community returned to low levels and the ward returned to normal operations.
However, the threat of COVID-19 was already making itself felt and the emergency operations quickly shifted focus to this new disease threat in early March. “There wasn’t much break. The Kiribati health team just had to kick off again,” she said.
Lou helped the staff to audit and prepare personal protective equipment such as donning and doffing procedures and the proper fitting of N95 masks. To date, there have been no COVID-19 cases in Kiribati but the swift response by the Kiribati Government and the hard work of the health staff, including the IPC team mean they are ready to respond if needed. Lou returned to Australia in March this year. She has continued her advisory and mentoring role to the d Kiribati IPC program throughout the pandemic remotely.
Drawing on her experience from Kiribati, Lou is now assisting another small Pacific Island nation, Nauru, to prepare for COVID-19 cases. Lou will provide the Health Ministry with additional help and advice in IPC make sure Nauru is also ready to tackle COVID-19 if needed.
Banner Photo: Lou Carrington working with Principal Nursing Officer Toata and Senior Nursing Officer Atata in Tungaru Central Hospital. Story Photo: Lou Carrington with hospital staff.
Australia is working with nurses in the Pacific region to better prepare them to face the coming COVID-19 health challenges.
After seeing how other countries adapted their health workforce to respond to the COVID-19 pandemic, Pacific nursing leaders identified that some nurses would be required to retrain so that they could fill critical care positions.
The Pacific Community (SPC), with funding assistance from the Indo-Pacific Centre for Health Security, launched a package of COVID-19 response activities in June that included lab strengthening, infection prevention and control support, and nurse training.
Critical care is the first area of training being delivered to 114 nurses from 17 Pacific Island countries and territories by Australian online training provider Medcast. This training will increase the number of nurses who can act in a surge capacity to work in intensive care wards if COVID-19 cases increase.
Project Coordinator for Clinical Services Programs at SPC’s Public Health Division, Mabel Taoi says, “This training is a short course that will prepare nurses who don’t usually work in intensive care to prepare themselves for critical care work in intensive care units as we have a shortage of specialised intensive care nurses.”
By mid-August, 79 nurses had completed the online coursework including Shivashna Chand who works in the cardiac coronary unit at the Colonial War Memorial Hospital (CWMH) in Suva. “This training has increased my knowledge in cardiac nursing while at the same time I have upgraded my knowledge in intensive care,” she says. “During this pandemic, it was important for us to expand our knowledge, especially during COVID-19 so that we can save lives and safeguard our own.” Nurses from American Samoa, Cook Islands, the Commonwealth of the Northern Mariana Islands, Fiji, Federated States of Micronesia, Republic of Marshall Islands, Kiribati, Palau, Nauru, Niue, Papua New Guinea, Samoa, Solomon Islands, Tonga, Tuvalu, Tokelau and Vanuatu have enrolled in the course.
During the pandemic, it is important for nurses to have the capacity to respond and keep building their skills. The second area of training under the package supports the placement of 32 nurses in one-year postgraduate certificates in critical care with the Australian College of Nursing, boosting the emergency care capacity of the Pacific.
SPC is a key regional organisation in the Pacific and has been a crucial delivery partner during COVID-19. Australia’s support to SPC’s Public Health Division contributes to the long-term health security and stability in the Pacific region.
Photo Banner: Pacific nurses gather at the inaugural Pacific Heads of Nursing meeting in Suva, February 2020. Story Photo: Shivashna Chand, nurse, Fiji.
Australia will provide $80 million to the COVAX Facility Advance Market Commitment (COVAX AMC) to improve access to safe, effective and affordable COVID-19 vaccines for 92 countries in our region and around the world.
Countries eligible for vaccines from the COVAX AMC in the Pacific include Papua New Guinea, Solomon Islands, Vanuatu, Fiji, Samoa, Tonga, Tuvalu, Kiribati, the Republic of the Marshall Islands and the Federated States of Micronesia. Southeast Asian eligible countries are Indonesia, Timor-Leste, Cambodia, Laos, Myanmar, the Philippines and Vietnam.
In joining this unique collaboration, Australia will help to make sure that all countries have an opportunity to get access to a safe vaccine, not just those that can afford to purchase or manufacture one themselves. In making this investment, Australia joins AMC donors such as United Kingdom, Canada, Italy, Norway and New Zealand.
The COVAX AMC is part of the wider COVAX Facility set up by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organization. The COVAX Facility will enable rapid and equitable access to vaccines for countries by pooling demand and purchasing power.
Eighty higher-income countries, including Australia, have submitted Expressions of Interest to participate in the COVAX Facility to gain access to vaccines for their domestic populations. These countries would finance their allocation of vaccines from their own public finance budgets. Together with the 92 countries supported by the COVAX AMC, this group of 172 countries represents more than 70% of the world’s population.
During the first phase, the COVAX Facility aims to secure 2 billion doses, enabling vaccination of 20% of country populations, initially targeting health care workers and vulnerable groups. By adopting this strategy the COVAX Facility hopes to end the acute phase of the pandemic by 2021.
Further doses will then be made available based on country need, vulnerability and COVID-19 threat. The COVAX Facility will also maintain a buffer of doses for emergency and humanitarian use, including dealing with severe outbreaks before they spiral out of control. CEPI is a global partnership launched in 2017 to develop vaccines against emerging infectious disease threats.
CEPI is leading the COVAX Facility’s research and development work, which aims to develop at least three safe and effective vaccines for countries participating in the COVAX Facility. The COVAX Facility will draw on existing CEPI’s agreements with the developers and manufacturers of nine potential vaccine candidates. Negotiations are already underway with a number of additional manufacturers not receiving R&D support from CEPI to procure their vaccines if they are successful.
Australia has long-standing investments in international medical research and development, in recognition of the importance of pandemic preparedness, including to CEPI. Funding from the Indo-Pacific Centre for Health Security has supported CEPI’s development pipeline since 2018, and provided an extra injection of $7.5 million of funding announced earlier this year.
This is because the health security of our region requires us to work together. Australia is investing in the COVAX Facility because our region’s recovery needs everyone to be safe from COVID-19.
A new project funded by the Indo-Pacific Centre for Health Security will enable 12 Pacific Island nations to combat outbreaks of mosquito-borne diseases and improve the health of people in the region by strengthening vector surveillance and control programs.
Professor Tom Burkot of the Australian Institute of Tropical Health and Medicine (AITHM) at James Cook University, and project leader of Pacific Mosiquto Surveillance Strenghtening for Impact (PacMOSSI) says the main focus will be on the Aedes mosquitos. These mosquitos carry the dengue, zika and chikungunya viruses because there have been more frequent and intense outbreaks of these diseases in Pacific Island countries in recent years.
The project will help Pacific Island countries to do more systematic mosquito surveillance and control, based on best-practice recommendations from the World Health Organization, a directing partner for the project.
Professor Burkot says the reason why vector surveillance is so important is because with malaria and dengue alone, there are 800 million human cases each year and control can be ‘more complicated than rocket science’.
The many species of virus-carrying mosquito evolve constantly and adapt their behaviour to beat interventions, for example, some species have become resistant to insecticides. An effective intervention for one species may not work with others. “What we’re trying to do is arm the countries so that they can monitor the mosquito populations more proactively, so they can anticipate what is going to happen when they put in an intervention and allow them to get a step ahead of the mosquitoes or at least respond much more quickly than they have been doing,” he explains.
Professor Burkot and co-lead Dr Tanya Russell, an AITHM Research Fellow, will collaborate with scientists from a dozen institutions. Partners include the Papua New Guinea Institute of Medical Research, Queensland Institute of Medical Research Berghofer, the Universities of Queensland and New South Wales, Australian Red Cross, Burnet Institute, Beyond Essential Systems, Australian Defence Force Malaria and Infectious Diseases Institute, The Pacific Community and the Asia Pacific Malaria Elimination Network.
Dr Russell says: “What is unique is the strength of the collaboration we’ve been able to put together combining the strengths of our partners in Australia and regionally.”
The consortium intends to work to roll out a regional program across 12 countries, including Papua New Guinea, Fiji, Solomon Islands, Samoa and Tonga. The project has several components.
The researchers will do an online assessment of the capacity, strengths and weaknesses of each Pacific nation’s existing surveillance and control programs. The project was initially delayed because of COVID-19 delayed but the research team are now beginning to sign a memorandums of understanding with the ministries of health in each country, and working with them on building practical strategic plans to make the best use of existing staff and facilities.
The project team will use online platforms for capacity building for vector surveillance officers. The project team will create a complete set of 11 training modules on different aspects of vector surveillance. Countries will be able to pick the modules they need.
Another component is software development and management, so countries can collect and easily visualise data on aspects such as the number of cases, pharmaceutical supplies and which insecticides local mosquitoes are resistant to and which work.
Professor Burkot says controlling the vector-borne diseases is really challenging. “But the control measures work. If you look at malaria, it has been reduced by around 40% over the last 15 years.”
He believes countries have a better chance of being effective against other mosquito-borne diseases if they have the right tools at their disposal and are monitoring the right things. “With dengue in particular we have always been very reactive. We want to change the dynamics and allow countries to be more proactive,” he says.
“The ultimate beneficiaries of the project will be the people of the countries involved, particularly women and children as they are most vulnerable to outbreaks,” according to Dr Russell.
Photo caption: Dr Ian Norton looking at dengue information at the Good Samaritan hospital in Guadalcanal, Solomon Islands. Dengue Taskforce, 2013. Photo credit: Lou Anderson, DFAT.
The Global Health Security Agenda (GHSA) has reaffirmed the need for timely and transparent international cooperation a to stop the devastating public health, social and economic effects of the COVID-19 pandemic. A statement released by the GHSA Steering Group, of which Australia is a member, has pledged to place the highest priority on combatting the spread of COVID-19.
Australia joined the GHSA at its inception in 2014 and has been actively working with members in accelerating political and multi-sectoral support to reach the GHSA2024 target of more than 100 countries with strengthened health security capacities.
The GHSA is a multilateral initiative of nearly 70 countries, international organizations, civil society, and private sector partners working together to keep the world safe from infectious disease threats. It brings together a range of sectors including health, agriculture, finance, and defence to build countries’ capacities to prevent, detect, and respond to disease threats. Australia specifically participates in the Sustainable Financing Gap, Antimicrobial Resistance and Biosecurity and Biosafety Action Packages.
Read the full statement released on 22 July 2020 at the GHSA website.