by Charlotte Kilpatrick | Oct 24, 2024 | Global Health |
In October 2024 the International Finance Facility for Immunisation (IFFIm) priced a US$1 billion, 3-year fixed-rate bond to fund “critical vaccine research and immunisation programmes”. This is IFFIm’s largest single benchmark transaction in the primary market since its inaugural benchmark in 2006, with proceeds supporting Gavi and CEPI. The bond will mature on 29th October 2027 and carries a semi-annual coupon of 4.125% and a semi-annual re-offer yield of 4.222%.
“The success of this bond highlights the ongoing strength of IFFIm’s model, which leverages sovereign support and strong financial structuring to offer investment opportunities that make a positive impact on children’s health.”
The order book was IFFIm’s largest to date, exceeding US$4 billion. The bond drew interest from a diverse group of investors with geographic spread.
Support for vaccine programmes
IFFIm is an “important flexible tool” for organisations like Gavi; since 2006 it has provided Gavi with US$5.8 billion in financing, one sixth of its overall budget. It has been “critical” in enabling Gavi’s recent emergency responses as well as routine immunisation and health system resilience efforts. Dr Sania Nishtar, CEO of Gavi, reflected that IFFIm has been a “groundbreaking and indispensable tool”.
“Today’s bond issue provides us with vital flexibility in our mission to protect millions of children from preventable diseases and to protect our world from the threat of future pandemics.”
As Gavi nears the end of the 2021-2025 strategic period and prepares for the next phase, IFFIm states that the bond issue will play a “pivotal role” in supporting life-saving programmes.
IFFIm has also provided approximately US$272 million in past financing to CEPI in support of the research and development of new vaccines. Dr Richard Hatchett, CEO of CEPI, acknowledged the “serious threat to global health security” presented by epidemics and pandemics. He commented that these can be “mitigated through investment in vaccine R&D and manufacturing”.
“The IFFIm financing mechanism enables CEPI to access the critical funding it needs to accelerate the development of vaccines against emerging infectious disease threats, for the benefit of all.”
Offering opportunities
IFFIm Board Chair Ken Lay believes that the latest issue “highlights IFFIm’s unparalleled strengths”; it is “backed by sovereign donors, driven by a vital global mission, and structured to maximise impact”.
“IFFIm’s bonds continue to offer investors compelling opportunities to earn competitive returns with good secondary market liquidity and assured use of proceeds.”
Jorge Familiar, Vice President and Treasurer, World Bank commented that capital markets are a “powerful tool for connecting private investment with global public goods”.
“As IFFIm’s Treasury Manager, the World Bank is pleased to support IFFIm in accessing capital markets to provide a long-term and flexible funding source to Gavi to accelerate access to vaccines and vaccine development.”
Head of SSA and EMEA IG Syndicate, BofA Securities Adrien de Naurois congratulated the IFFIm team on a successful return to the USD market.
“Today’s transaction, the first USD benchmark in two years, is a clear demonstration of IFFIm’s loyal and diverse investor base, attracted by the importance of its mission to deliver immunisation programmes to those most vulnerable via the ongoing work of Gavi.”
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by Charlotte Kilpatrick | Oct 23, 2024 | Technology |
The National Institute for Health and Care Research (NIHR) announced in October 2024 that the first Phase III randomised trial of an investigational mRNA norovirus vaccine is opening across the UK. The trial seeks to evaluate the efficacy and safety of mRNA-1403 and is sponsored by Moderna. It will be conducted across 39 sites in the country, including 27 NHS primary and secondary care sites. Investigators hope to recruit 2,500 participants between late October and early 2025.
Norovirus
Norovirus, or the “winter vomiting bug”, is a viral illness; it is the “most common cause” of acute gastroenteritis globally. Symptoms include acute onset diarrhoea and vomiting, but there is evidence to suggest that norovirus infection is associated with intestinal inflammation and malnutrition and could cause long-term morbidity. WHO estimates that 685 million cases of norovirus are seen each year, including 200 million cases in children under 5.
“The burden of norovirus is significant; norovirus causes an estimated 200,000 deaths per year, including 50,000 child deaths, primarily impacting low-income countries. Norovirus has been estimated to cost $60 billion globally as a result of healthcare costs and economic losses.”
There are no licensed norovirus vaccines in use.
The trial
Participants in the trial will be randomly assigned to two groups. One group will receive the investigational vaccine, and the other groups will receive a placebo. While anyone who is aged 18 or older and meets the inclusion criteria is eligible for the trial, researchers are seeking participants aged 60 and older. This age group is “generally more likely to be severely affected by norovirus”. Thus, a successful vaccine would be of greatest benefit to them.
The trial is part of the 10-year partnership between Moderna and the UK Health Security Agency (UKHSA) on behalf of the UK Government. It is supported by the UK Vaccine Innovation Pathway (VIP) and the NIHR, which are working together to accelerate vaccine trials in the UK. The NIHR Research Delivery Network (RDN) is working with the devolved administrations to accelerate the roll-out of “key” vaccine studies. These efforts include the NIHR’s flagship recruitment tool: Be Part of Research.
Be Part of Research is an online service that connects people to health and care research across the UK. Anyone over the age of 18 can register for an account, indicating the areas of research that they are interested in. They are then sent information about suitable studies.
Advancing healthcare
The UK Chief Investigator, Dr Patrick, is a GP in Dorset and Research Director at the NIHR’s South West Regional Research Delivery Network. Dr Moore commented that the UK is “really pleased to be able to play an important role” in finding a vaccine for this “highly contagious disease”.
“Outbreaks of norovirus have huge consequences, both on our health systems and our economy. This innovative trial is crucial in helping us advance healthcare.”
NIHR Chief Executive and Chief Scientific Advisor to the Department of Health and Social Care, Professor Lucy Chappell, hopes that the vaccine could “make a difference to lives of many – especially our most vulnerable citizens”.
“Leveraging the UK’s expertise in vaccine development, the DHSC through the NIHR and Moderna are delivering this large-scale trial at pace, so that people across the UK and the world can benefit sooner.”
Health and Social Care Secretary Wes Streeting described the trial as a “huge vote of confidence in the UK’s life sciences sector”. It could also allow a “shift” away from sickness towards prevention, which would reduce pressure on the NHS and keep people healthier in the colder months. Moderna’s Chief Development Officer Dr Melanie Ivarsson is “delighted” to bring the trial to the UK.
“By advancing our investigational mRNA norovirus vaccine into a pivotal Phase III trial, we are one step closer to potentially providing a new tool to prevent infection from this highly contagious virus, which places a significant burden on health systems globally.”
Sarah Collins, Commercial Director at UKHSA, reflected that norovirus “isn’t just a nasty tummy bug – it can have serious consequences” including “disruption” to health services and education settings.
“It’s fantastic to see the first trial of its kind get underway as a result of UKHSA’s strategic 10-year partnership with Moderna, which aims to enhance investment in scientific research and vaccine development to enable a rapid response to future pandemics and other infectious diseases.”
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by Charlotte Kilpatrick | Oct 16, 2024 | Global Health |
In October 2024, parliamentarians from across the world met at the UNITE Global Summit in Berlin to sign a statement in support of the WHO Pandemic Agreement. The statement was described by WHO as a “significant commitment” to “strengthen pandemic preparedness, response, and equitable access to health”. The Summit was held in collaboration with the World Health Summit (WHS), drawing global parliamentarians, civil society leaders, and health experts to “translate discussions into actionable policy priorities”.
Building trust for a healthier world
The World Health Summit 2024 was held under the theme “building trust for a healthier world”, focussing on inspiring “innovative solutions for better health and well-being for all”. The UNITE Global Summit agenda reflected key topics highlighted during WHS, divided into four pillars:
- Human rights and equitable access to health
- Global health architecture and security
- Strengthening of healthcare systems
- Sustainable financing for health
Support for the Pandemic Agreement
The Pandemic Agreement is under negotiation by WHO Member States as an attempt to address the “gaps” exposed by the COVID-19 pandemic and the threats presented by mpox and other disease outbreaks. It also seeks to “strengthen global collaboration pandemic prevention, preparedness, and response”.
A critical moment during the summit was the signing of the Global Parliamentary Statement in Support of the Pandemic Agreement, which demonstrated the importance of parliamentarians in “ensuring global health security and safeguarding populations against future pandemics”. The statement emphasised their commitment to ensuring that “all countries, regardless of resources, have access to the tools, capacities, resources, and healthcare required” during a pandemic.
Dr Ricardo Baptista Leite, President of UNITE, commented that parliamentarians are the “voice of the people” and carry a “crucial responsibility in safeguarding public health”.
“The WHO Pandemic Agreement represents a historic opportunity to prevent pandemics and strengthen our global preparedness and response capabilities. By signing this statement, we are not only showing our support for the agreement but also pledging to ensure that its principles of equity, solidarity, and global cooperation are fully realised in every nation.”
WHO Director-General Dr Tedros Adhanom Ghebreyesus welcomed the support for the “once-in-a-generation opportunity to build a stronger, fairer, and more prepared global health system”.
“By signing this statement, parliamentarians from around the world are showing their commitment to protecting lives from future pandemics and ensuring equitable access to vaccines, treatments, diagnostics, and other health tools for every country, particularly those with fewer resources.”
Key commitments
The Global Parliamentary Statement emphasises four “key commitments”:
- Equity at the core – ensuring equitable access to pandemic-related health tools based on public health need for everyone, especially countries with fewer resources
- Global solidarity – strengthening international cooperation to build resilient health systems that can prevent and respond to pandemics
- Legislative action – advocating for the ratification and implementation of the Pandemic Agreement within national legislatures, as appropriate
- Combating misinformation – providing communities with evidence-based health information to counter the spread of harmful misinformation
Dr Baptista Leite reflected that “the challenges we face today demand a global response”.
“No single country can prevent or combat pandemics alone. The WHO Pandemic Agreement is an essential step forward in ensuring that every nation has the tools, resources, and capabilities to respond to future health threats.”
More work to be done
WHO states that the Pandemic Agreement “needs to continue to garner broad international support”. Within the latest commitment, parliamentarians are to work with WHO and other international organisations to ensure the Pandemic Agreement is implemented in a way that “benefits all countries”, particularly those with “limited resources”.
“The statement signed in Berlin is expected to act as a catalyst for global parliamentary action, fostering collaboration and solidarity among nations.”
Join us at the Congress in Barcelona this month for a keynote discussion on “strengthening global preparedness and building resilient health systems” with experts from the field, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Oct 10, 2024 | Global Health |
In October 2024, WHO announced an agreement with the International Monetary Fund (IMF) and the World Bank Group (WBG) on “broad principles for cooperation on pandemic preparedness”. The cooperation is intended to enable scaling up of support to countries to prevent, detect, and respond to public health threats through the IMF’s Resilience and Sustainably Trust (RST), WBG’s financial and technical support, and WHO’s technical expertise and in-country capabilities. The organisations will “leverage their experience to enhance pandemic preparedness”, working on the “synergies and complementarity” of each institution’s in-country analysis and operations.
Principles of coordination
Under the Broad Principles of Coordination:
- WHO and the WBG will continue to lead on health-related development policies and, with other multilateral development banks and The Pandemic Fund, on specific project investments for pandemic preparedness. RST financing will not be earmarked for specific projects.
- Pandemic preparedness policy reform measures supported by RSF arrangements will be informed by existing data, analytics, and operational engagement of WHO, the WBG, and country authorities.
- Pandemic preparedness reforms will build on each institution’s area of expertise. RSF programmes will focus on macro-critical policy reforms within the IMF’s expertise and complement the work carried out by the WBG and WHO to maximise both the financial resources and technical expertise available to countries. RSF Reform measures can include policy actions aimed at enhancing the readiness of finance and health systems to respond effectively to future health emergencies.
The cooperation will enable all three institutions to better serve countries’ efforts on pandemic preparedness.
Working for a safer world
Kristalina Georgieva, Managing Director of the IMF commented that the “stepped-up collaboration” will help the organisations to “complement and leverage each other’s expertise” to support members’ pandemic preparedness and resilience efforts.
“The IMF’s Resilience and Sustainability Trust allows eligible member countries to access affordable, long-term financing to address structural challenges that threaten their macroeconomic stability.”
WHO Director-General Dr Tedros Adhanom Ghebreyesus reflected on the need for “new sources of financing to bolster health systems”, making them “more able to prevent and detect” health threats and to “respond and withstand them when they strike”.
“WHO is proud to be working with the IMF and the World Bank to unlock financing from the Resilience and Sustainability Trust, and support countries to put it to work for a safe world.”
World Bank Group President Ajay Banga suggested that the “deepened collaboration” will focus efforts to help countries prepare for and respond to health threats.
“We must aggressively be planning and preparing for the next global health crisis, so that when the battle comes – and we know it will – we will have the health workforce that can be rapidly deployed in the face of a crisis, laboratories that can quickly ramp up testing, and surge capacity that can be called upon to respond.”
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by Charlotte Kilpatrick | Oct 7, 2024 | Global Health |
WHO Africa reported in October 2024 that the Democratic Republic of the Congo (DRC) has started a vaccination campaign as part of outbreak control efforts against mpox. The vaccination drive has launched in the eastern North Kivu province and will prioritise health workers and frontline responders, contacts of confirmed cases, contacts of those contacts, and other at-risk groups. It will later be implemented in 11 of the most affected health zones in Equateur, North Kivu, Sankiri, South Kivu, Sud-Ubangi, and Tshopo provinces.
Addressing the emergency
The Democratic Republic of the Congo (DRC) has reported more than 30,000 suspected and laboratory-confirmed cases and 990 deaths since the start of 2024. These numbers account for 90% of the cases reported from 15 countries in the African region this year. WHO recommends that vaccination should form part of a “comprehensive response” involving enhanced surveillance, community engagement, and case management. It is working with partners and the national authorities to “scale up and reinforce all the key control measures”.
In preparation for the mpox vaccination campaign, WHO has supported national health authorities in training health workers, enhancing vaccine delivery systems and infrastructure, and community engagement. There are also efforts to “reinforce measures to identify and address” vaccine misinformation and disinformation, responding with increased access to accurate information.
Delivering doses to affected areas
Noting that mpox vaccines are “currently in short supply, especially in Africa”, WHO is encouraging global collaboration to get doses to the people who need them most. In September, WHO prequalified MVA-BN for mpox, which is “expected to facilitate timely and increased access”. It is also working with partners like Gavi and UNICEF to establish a distribution mechanism for donated doses and direct procurements. DRC has received 265,000 doses of MVA-BN, donated by the European Commission’s Health Emergency Preparedness and Response Authority, Gavi, and the United States Government.
WHO Regional Director for Africa, Dr Matshidiso Moeti, expressed gratitude to these partners for their donations.
“As we rally efforts to stop the mpox outbreak, the rollout of the vaccine marks an important step in limiting the spread of the virus and ensuring the safety of families and communities.”
Dr Moeti commented that WHO is “working closely with the national authorities to effectively deliver the vaccines to those who need them most”. Africa CDC also recognised the collaborative effort, which “underscores the collective global commitment” to controlling the outbreak in Africa. H.E. Dr Jean Kaseya, Africa CDC Director General, commended the DRC’s “swift action” in launching the campaign, which “showcases the strength of its public health leadership”.
“By prioritising vulnerable populations, including frontline health workers and those most at risk, the country is taking critical steps to contain the outbreak. Africa CDC remains committed to working closely with the DRC to ensure vaccines reach those who need them the most, while also working to strengthen health systems to prevent future outbreaks. Our top priority is to secure safe and effective vaccines for children in the next phase of vaccination.”
Mpox vaccination will be a key area of high-level discussions at the Congress in Washington next April, including on a keynote panel that will consider the “role of vaccines in a changing world”. Get your tickets to join us for these conversations, and don’t forget to subscribe to weekly vaccine updates here.
by Charlotte Kilpatrick | Oct 7, 2024 | Global Health |
A week after the declaration of a Marburg outbreak in Rwanda in September 2024, Sabin Vaccine Institute announced that it is providing doses of its investigational Marburg vaccine to support the outbreak response. An initial shipment of approximately 700 doses will be used in a trial involving frontline workers, including healthcare professionals, who have been the “hardest hit” by this outbreak. Sabin and the Rwanda Biomedical Centre have entered a clinical trial agreement for a Phase II rapid response open label study, which will be conducted at six trial sites in Rwanda. Sabin also plans to supply additional vaccines, pending a request from Rwandan officials and authorisation from BARDA.
Responding to the outbreak
The outbreak was declared on 27th September 2024, and by 6th October it had caused 12 deaths. Many cases are among health workers in two facilities in Kigali, but there are more cases spread across other districts. Sabin has been “working directly” with Rwandan officials and partners to support the response. There are no licensed vaccines or treatments for Marburg, but Sabin’s single-dose vaccine is in Phase II trials in Uganda and Kenya, with no safety concerns reported to date. The vaccine is based on the ChAd3 platform and results from Phase I clinical trials and nonclinical studies suggest that it is safe and elicits “rapid” and “robust” immune responses.
Commenting on the support from Sabin, Rwanda’s Minister of Health Dr Sabin Nsanzimana reflected that “in emergency situations, the success of clinical trials relies on quick, strategic global partnerships” that combine “expertise, resources, and innovation”.
“Today, a week after this Marburg outbreak was first confirmed, we are receiving doses of the Sabin Vaccine Institute’s Marburg vaccine candidate to protect our health workers and other high-risk groups, and also advance scientific tools which will ensure this virus can be effectively controlled now and in the future.”
Lightning speed
Sabin’s Chief Executive Officer Amy Finan described the team’s “lightning speed” in responding to the Rwandan government’s request for assistance, preparing shipments, finalising protocols, and securing regulatory and legal approvals.
“This swift emergency response demonstrates that a dedicated, collaborative group of individuals and organisations can achieve remarkable results when united by a common cause: to contain a lethal disease outbreak and prevent further loss of life.”
ReiThera, Sabin’s manufacturing partner, has produced the drug substance and filled and finished doses for shipment. CEO Stefano Colloca stated that the ReiThera team believes in the “transformative power of global collaboration to advance science and create lasting impact”.
“Our partnership with Sabin highlights our shared commitment to developing a life-saving vaccine against Marburg disease with a mutual goal: to save lives and ensure that even the most vulnerable communities around the world have access to vital and equitable protection.”
Sabin’s vaccine progress
Sabin plans to launch a Phase II trial of the Marburg candidate in the United States next year, as it looks forward to interim results from the trial in Uganda and Kenya. The development programme is supported by BARDA, which has committed $235 million for advancing vaccine research and development against Sudan ebolavirus and Marburg virus diseases.
To join discussions about safety and effectiveness evaluations of vaccines deployed in emergency situations, get your tickets to the Congress in Barcelona this month. Don’t forget to subscribe to our weekly newsletters for vaccine updates.
by Charlotte Kilpatrick | Oct 3, 2024 | Global Health |
WHO announced in October 2024 that it is launching the Global Strategic Preparedness, Readiness, and Response Plan (SPRP) to tackle dengue and other Aedes-borne arboviruses. The Plan is intended to reduce the burden of disease, suffering, and deaths from dengue and other Aedes-borne arboviral diseases, like Zika and chikungunya, by “fostering a global coordinated response”. It presents priority actions to control transmission and offers recommendations to affected countries across various sectors. With five “key components”, the Plan is to be implemented over one year until September 2025, demanding US$ 55 million.
“The SPRP is a call to action for all stakeholders – from government agencies and health-care providers to communities and individuals – to join forces in the fight against dengue and other Aedes-borne arboviruses, through innovation, new technologies, and improved vector control strategies.”
Turning the tide
In the foreword by WHO Director-General Dr Tedros Adhanom Ghebreyesus we learn that dengue has “afflicted humanity for centuries, and possibly longer”; the first report of a clinically compatible case is recorded in a Chinese medical encyclopaedia in 992. From a much more contemporary perspective, dengue has spread “rapidly” in the past 20 years, enabled by “increased global travel and the effects of climate change”. Between 2000 and 2019, WHO documented a “tenfold surge” in reported cases, to 5.2 million. Since then, the surge has continued; over 12.3 million cases were reported by the end of August 2024.
The global prevalence and effects of arboviruses like dengue are a “significant threat to public health”, particularly in tropical areas where they are endemic. Addressing this threat demands a “concerted, strategic, and informed response”, which the Director-General hopes to achieve with the SPRP, a “comprehensive plan” to outline ways of controlling Aedes-borne arbovirus transmission in affected countries.
“Our multifaceted approach emphasises integrated surveillance, laboratory diagnosis, vector control, community engagement, clinical management, and research and development.”
This approach should reduce the burden of disease, save lives, and minimise the socioeconomic consequences of these diseases. Furthermore, the Plan includes measures for “safe programming” to ensure interventions are “secure and do not exacerbate the risk” for those who are already vulnerable to disease or those involved in responding to the crisis. Dr Tedros states that prevention and control is a “shared responsibility”.
“Together, we can turn the tide against this disease, protect vulnerable populations, and pave the way for a healthier future.”
Understanding the threat
Dengue is a challenge across all of WHO’s regions, endemic in more than 100 countries. Various factors, such as unplanned urbanisation and the effects of climate change, fuel the spread of dengue and other Aedes-borne arboviruses, such as Zika and chikungunya, putting more than four billion people at risk. The growing threat must be addressed with a “robust and dynamic strategy” that accounts for the current global epidemiological landscape. This is complicated by the “still developing” global surveillance system.
Transmission drivers like the effects of climate change and population growth can explain the increase of these infections in some areas, but they also point to the need for a multisectoral approach to prevent and respond to outbreaks.
The Plan
The Plan is intended to “reduce the burden of disease and deaths from dengue and other Aedes-borne arbovirus diseases in all affected WHO regions”. The strategic objective is “to accelerate progress in preventing and controlling dengue and other Aedes-borne arboviral disease outbreaks worldwide”, with the following specific objectives:
- Strengthen global multisectoral coordination and collaboration among stakeholders and partners in preparedness, response, and resilience to dengue and other Aedes-borne arbovirus diseases
- Enhance the capacity of Member States in early detection, reporting, confirmation, and response to outbreaks of dengue and other Aedes-borne arboviruses
- Strengthen the capacity of Member States to implement effective vaccination and integrated vector management strategies for mitigating the transmission of dengue and other Aedes-borne arboviruses
The SPRP combines strategic interventions tailored to local contexts and leverages inter-stakeholder synergies to “confront the challenges” posed by these diseases and move closer to controlling them. The following “interconnected pillars” are included in the multidisciplinary approach:
- Leadership, coordination, planning, monitoring, and prevention of sexual misconduct
- Risk communication and community engagement (RCCE) and infodemic management
- Surveillance, case investigation, and contact tracing
- Travel, trade, and points of entry surveillance and control
- Laboratory and diagnostics
- Integrated vector management and WASH & IPC
- Clinical management and therapeutics
- Operational support and logistics
- Essential health services and systems
- Vaccination
- Research, innovation, and evidence
The 5Cs
The SPRP aligns with WHO’s 2023 Framework for Health Emergency Prevention, Preparedness, Response, and Resilience (HEPR) with a focus on five “core health emergency components”:
- Collaborative surveillance
- Strong national integrated disease, threat, and vulnerability surveillance,
- Effective diagnostics and laboratory capacity for pathogen and genomic surveillance
- Collaborative approaches for event detection, risk assessment, and response monitoring
- Community protection
- Community engagement, risk communication, and infodemic management
- Population and environmental public health interventions
- Multisectoral action for social and economic protection
- Access to countermeasures
- Fast tracked research and development
- Scalable manufacturing platforms
- Coordinated supply chains and emergency
- Emergency coordination
- Strengthened workforce capacity for health emergencies
- Strengthening health emergency preparedness, readiness, and resilience
- Health emergency alert and response coordination
- Safe and scalable care
- Scalable clinical care during emergencies
- Protection of health workers and patients
- Maintenance of essential health services
How do you think the SPRP can be effectively translated into specific contexts and implemented sustainably?
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by Charlotte Kilpatrick | Oct 3, 2024 | Infection |
Since this article was published, Politico has reported that the previously suspected cases in Hamburg tested negative for Marburg virus with a PCR test and will be monitored throughout the incubation period of up to 21 days.
“There was no danger to fellow passengers on the train or in the plane at any time.”
(more…)
by Charlotte Kilpatrick | Sep 30, 2024 | Global Health |
Gavi announced two major funding updates at the United Nations General Assembly High-level week 2024, revealing that it is making progress in its fundraising efforts for the upcoming strategic period. The first of these updates is that the European Commission has pledged funding for the first two years of Gavi 6.0, complementing “strong support” from Team Europe and contributing to Gavi’s goal of helping to protect 500 million more children around the world. Gavi also announced an expanded collaboration with the United States International Development Finance Corporation (DFC), focussed on donor liquidity.
European support
The President of the European Commission, Ursula von der Leyen, addressed a crowd at the Global Citizen Festival on Saturday 28th September, revealing a funding pledge of €260 million for 2026-2027 and promising more to follow. The funds will support Gavi’s 2030 ambition of providing protection to 500 million more children, strengthening immunisation systems, and boosting global health security by “increasing readiness to respond to disease outbreaks”.
Added to the money pledged so far by the United States, France, Spain, and others in June 2024, this pledge takes Gavi’s total for the next strategic period to US$2.7 billion. The target is at least US$9 billion, which would enable Gavi to protect more children against more diseases, faster, and protect the world from outbreaks of disease when they occur. The €260 million pledge is for the first two years of Gavi’s upcoming strategic cycle, which coincide with the last two years of the EU’s 2021-2027 Multiannual Financial Framework (MFF). The European Commission is expected to remain committed to a “high level of ambition in supporting Gavi” as it prepares for the next MFF.
President von der Leyen reflected that “a healthier world is a better world”, with vaccination “one of our best chances for this”.
“Right now, millions of children are still at risk. We must continue to support vaccination around the world to save lives. So today I am proud to pledge 260 million euros for Gavi, the Vaccine Alliance. And more will come.”
DFC collaboration
The DFC and Gavi will expand their partnership with a focus on donor liquidity. This builds on support established during COVID-19, with the US$1 billion Rapid Financing Facility allowing Gavi to access funds quickly in the event of new donor pledges for pandemic response or routine immunisation. The mechanism is also central to Gavi’s Day Zero Financing Facility.
Nisha Biswal, DFC Deputy CEO, recognised that “global health security is economic and national security”. DFC invests in healthcare services, supply chains, and technology to strengthen pandemic preparedness and health system resilience, including over US$3 billion in health-related projects to enable over 50 million patients access healthcare.
“With the new Surge Financing Initiative, the expanded Gavi liquidity facility, and investments in regional manufacturing, we will be able to do far more to expand access to life-saving healthcare products, especially during health emergencies.”
Still on track
Dr Sania Nishtar, CEO of Gavi, expressed gratitude to the European Commission, recognising President von der Leyen’s “leadership in advancing global health outcomes” and DFC.
“Thanks to the European Commission and DFC, we remain on track to meet our target of protecting people, communities, even our entire world through immunisation.”
For more on global health investments at the Congress in Barcelona next month, get your tickets to join us here. Don’t forget to subscribe to our weekly newsletters for the latest vaccine news.
by Charlotte Kilpatrick | Sep 30, 2024 | Infection |
In September 2024, WHO’s Regional Office for Africa announced that Rwandan health authorities are “intensifying outbreak control efforts” after detecting Marburg virus disease in the country for the first time. 26 cases have been confirmed in seven of the country’s districts, and six deaths have been reported. The health authorities are implementing “comprehensive response measures” and an investigation to determine the origin of the outbreak. WHO states that it is supporting these efforts with expertise and tools.
Cases reported and response triggered
26 cases have been reported; 20 are in isolation and receiving treatment, and six deaths have been recorded. 161 contacts of the reported cases have been identified so far and are being monitored. The Ministry of Health, Rwanda, posted a video on social media with a caption reassuring viewers that “people can continue with their daily activities” and “should not panic” as the “hotspots of the disease” have been identified.
WHO is “mobilising” expertise and outbreak response tools to “reinforce the control measures” that are being rolled out. A consignment of clinical care and infection prevention and control supplies will be delivered from the WHO Emergency Response Hub in Nairobi, Kenya, to Kigali in the next few days. Efforts are also underway to “reinforce collaborative cross-border measures for readiness and response” in countries that neighbour Rwanda.
WHO Regional Director for Africa, Dr Matshidiso Moeti, explained that the critical outbreak response aspects are being put in motion “rapidly” to “halt the spread of this virus swiftly and effectively”.
“With the country’s already robust public health emergency response system, WHO is collaborating closely with the national authorities to provide the needed support to further enhance the ongoing efforts.”
Marburg
Marburg virus disease is a “highly virulent” member of the filoviridae family and causes haemorrhagic fever. It has a fatality ratio of up to 88%, with symptoms progressing rapidly after infection. The virus is transmitted to humans from fruit bats and spread among people through direct contact with the bodily fluids of infected people, surfaces, and materials.
The disease was first recognised after large outbreaks in Germany and Serbia in 1967, associated with laboratory research involving African green monkeys from Uganda. Outbreaks and cases have been reported sporadically since then, and efforts have been made to develop effective medical countermeasures. However, there is no licensed vaccine against Marburg virus disease.
A confluence of infectious disease
The Marburg outbreak will increase pressure on the Rwandan health system, which is already fighting its mpox outbreak, declared on 27th July 2024. In September 2024, Dr Jean Kaseya, Director-General of Africa CDC, reported that Rwanda had begun an mpox vaccine campaign after receipt of 1,000 doses. The campaign targeted districts bordering the Democratic Republic of the Congo, the epicentre of the current PHEIC. How will the health services respond effectively to both infectious disease threats, and will there be similarities or ‘doubling up’ in their strategies?
For the latest infectious disease and vaccine news, don’t forget to subscribe to our weekly newsletters here. To participate in important discussions about vaccine development in outbreak situations, join your colleagues at the Congress in Barcelona next month.
by Charlotte Kilpatrick | Sep 25, 2024 | Global Health |
At the United Nations General Assembly High-Level Week in September 2024, CEPI launched a new Biosecurity Strategy to bolster global health security and emphasise its commitment to addressing emerging epidemic threats. The strategy draws on the latest technologies and encourages international collaboration to mitigate the risks presented by emerging pathogens. This is a “significant step” in the “evolution” of CEPI, positioning it as a “though leader in the rapidly developing fields of biosafety and biosecurity”. Chair of CEPI’s Board, Professor Jane Halton, positioned the 100 Days Mission at the centre of this strategy and highlighted the significance of “security and equity” in this effort.
“To underpin that strategy, and to ensure the world can achieve the 100 Days Mission goal safely and securely, we need a robust, collaborative approach to maximising the benefits of new technologies and reducing their potential threats to human health.”
Remaining vigilant and stepping up
Dr Richard Hatchett, CEO of CEPI, writes in the foreword of the importance of remaining “vigilant” and being able to respond quickly to infectious disease outbreaks in an era of “heightened epidemic and pandemic risk”. He reflects that COVID-19 demonstrated the “devastating global consequences” of a pandemic and, through the “persistent controversy” over the origins of the pandemic, heightened awareness of the risk of accidental release and deliberate misuse of science.
“Most risk created by advances in the biological sciences derives from the fungibility of the tools designed to solve specific problems. The tools that will solve a pressing problem are empowering – but there is no intrinsic limit to their application.”
Dr Hatchett acknowledges the problem of “dual use” in the way that biologists tackle problems. However, he warns against imposing limits on scientists, suggesting that this could present “practical challenges” and “impede our progress towards legitimate and worthy goals”, among which is the 100 Days Mission.
“Global scientific participation is critical to the success of the 100 Days Mission and will enable vaccine research, development, and manufacturing to take place in communities that need it, led by those who will benefit from it, and informed by the priorities of the vulnerable communities that are disproportionately impacted by epidemics and pandemics.”
To address the risk of accidents or misuse, Dr Hatchett highlights the importance of mechanisms to “ensure that the highest, most current standards of biosecurity and biosafety are practiced and maintained”. CEPI’s “highly diverse” research portfolio includes more than 50 countries, each with “highly variable” oversight practices. The need for a biosecurity strategy is directed by a recognition that “as a steward of global funds, no matter where those funds are deployed, we have a critical responsibility to ensure that the research we fund does not lead to the next accident or deliberate incident”.
‘Beyond this threshold obligation, CEPI also has an opportunity to step-up as a thought leader in this emerging area.”
In developing the strategy, CEPI engaged more than 150 entities in the global health and security ecosystems in a consultative process and sought advice from a Biosecurity Strategy Group. Although technological capabilities will evolve and “boundaries blur between disciplines”, the strategy anticipates that “traditional approaches” may prove “inadequate” in the face of emerging threats. Thus, stakeholders must collaborate and develop mechanisms to encourage responsible use, supported by CEPI.
Biosafety and biosecurity
The strategy acknowledges the evolution of the terms biosafety and biosecurity, comparing the WHO (2024) definition of biosecurity with FAO’s (2007) understanding of the term. CEPI’s biosecurity and biosafety priorities must align with its mission to accelerate vaccine development towards the 100 Days Mission. The strategy outlines how an “innovative approach…frontloaded towards preparedness”, can enable the safe and secure delivery of this goal.
Top vulnerabilities
Several biosecurity and biosafety vulnerabilities are identified and considered relevant to the strategy:
- Variable biosafety and biosecurity oversight, risk identification, and management practices among life science funders for research involving high consequence pathogens, including CEPI.
- Substantial variations in biosafety and biosecurity policies, regulations, practices, and competencies where CEPI-funded research takes place, and insufficient health and security collaboration.
- The intersection between biosecurity and equity is insufficiently recognised, which threatens progress towards the 100 Days Mission and future responses to epidemic and pandemic threats.
- Emerging biotechnology and converging technologies present dynamic and evolving biosecurity risks that threaten 100 Days Mission progress.
- The world is insufficiently harnessing technological innovation to reduce safety and security vulnerabilities of the 100 Days Mission.
Focus and priorities
CEPI’s biosecurity focus is to “protect society from epidemic and pandemic threats, with an emphasis on preventing accidental and deliberate misuse of pathogens associated with CEPI-sponsored research”. The strategy therefore addresses global biosecurity vulnerabilities to accelerate current strategic goals with the following priorities:
- Strengthen biosafety and biosecurity risk identification, mitigation, and oversight by CEPI and encourage similar efforts by other life science research funders.
- Enhance global biosafety and biosecurity capabilities of CEPI partners for achieving the 100 Days Mission safely and securely and promote health-security partnerships.
- Drive biosecurity and biosafety in support of equity.
- Monitor and reduce emerging biotechnology and converging technology risks across CEPI’s vaccine research, development, and manufacturing portfolio.
- Accelerate biosafety and biosecurity innovation for vaccine research, development, and manufacturing.
More to come
An implementation plan of activities, goals, and timelines will follow the strategy. It will explore how priorities can be integrated into the wider mission and mandate in three major categories:
- Catalysing strategic partnerships and coalitions
- Advocacy and coordination
- Supporting biosafety and biosecurity capabilities development
Director General of Africa CDC, Dr Jean Kaseya, expressed enthusiasm at the strategy launch and its support of Africa CDC’s efforts.
“With a focus on laboratory systems strengthening, training and infrastructure development, and reducing risks of artificial intelligence and other innovations, the strategy is informed by vulnerabilities across a wide range of resource settings and will help galvanise global progress toward safely and securely achieving the 100 Days Mission.”
Trevor Smith, Deputy Director at Global Affairs Canada and member of the CEPI Biosecurity Strategy Group, welcomed the focus on “effective collaboration between the health and security sectors”.
“The strategy articulates an ambitious vision for reducing vulnerabilities and strengthening global health security.”
For insights from senior representatives of CEPI at the Congress in Barcelona next month, get your tickets to join us here. Don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 23, 2024 | Global Health |
In September 2024, WHO described “significant progress” on government-led negotiations on a pandemic agreement after another round of discussions. These discussions took place at the 11th meeting of the Intergovernmental Negotiating Body (INB) between 9th and 20th September in Geneva. Further discussions are scheduled from 4th November.
The pandemic agreement is an effort by WHO Member States to strengthen pandemic prevention, preparedness, and response. The intention to negotiate this agreement was established in December 2021. In June 2024, governments made “concrete commitments” to complete negotiations within a year at the latest.
Collective commitment
WHO Director-General, Dr Tedros Adhanom Ghebreyesus, commented that the “collective commitment” shown in the efforts to reach an agreement is a necessary response to the threat of viruses with pandemic potential.
“The next pandemic will not wait for us, whether from a flu virus like H5N1, another coronavirus, or another family of viruses we don’t yet know about. But all the ingredients are in place to meet the objective of countries to negotiate a generational pandemic agreement. The world needs hope that it is still possible for countries to find common solutions to common problems. You provide that hope.”
Ambassador Anne-Claire Amprou, INB Bureau Co-chair of France, also identified the “visible commitment” shown by governments in the negotiations.
“There was a clear recognition from all countries that we must agree on a way forward to work better, together, to protect their citizens from future pandemics… The constructive contributions by INB relevant stakeholders were incredibly valuable. Together, we must sustain this progress during the coming months to realise our shared goal to forge a pandemic agreement that guides future global responses to pandemics.”
Head of Pandemics at FOUR PAWS, a global animal welfare organisation, Nina Jamal, centred a One Health approach in the “growing urgency” for an effective Pandemic Agreement.
“We thank the Bureau for transparency towards relevant stakeholders, increased openness and constructive proposals by Member States, promoting successful negotiations. We are looking forward to further progress on the substance of the pandemic agreement and improved dialogue among member states to arrive at a meaningful, effective result.”
Michelle Childs, Policy Advocacy Director for the Drugs for Neglected Diseases initiative (DNDi) welcomed the sharing of draft texts and daily briefings.
“These help to improve the ability of stakeholders to follow and input and counter misinformation about what is actually being discussed. We encourage further steps to enhance transparency, including making stakeholder interventions publicly available.”
INB Co-chair from South Africa, Ms Precious Matsoso, suggested that there had been progress on various areas of the draft agreement, from research and development to sharing of benefits such as vaccines. After almost three years, countries are “now focused on the remaining and most critical elements” of the agreement.
“At the heart of the negotiations is recognition that collaboration among countries will ensure the world will not be left vulnerable in the face of future pandemics, while each and every country will maintain their sovereignty and control over national health decision-making.”
For more on efforts to reach an agreement and how the vaccine industry can align itself with this, join us at the Congress in Barcelona next month, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 20, 2024 | Global Health |
In September 2024, the European Medicines Agency (EMA) announced its recommendation to extend the indication of the smallpox and mpox vaccine Imvanex to adolescents from 12 to 17 years of age. Imvanex, Bavarian Nordic’s MVA-BN, is authorised in the EU for the protection of adults against smallpox, mpox, and disease caused by the vaccinia virus. The Committee for Medicinal Product for Human Use (CHMP) based this recommendation on interim results from a study comparing the effects of the vaccine in adolescents and adults.
Data-led expansion
Interim results indicate that the immune response in adolescents was comparable to adults, from which the authorities have inferred that the vaccine will “provide similar protection in adolescents to that expected in adults”. The safety profile was also comparable with no additional risk identified. EMA has requested the marketing authorisation holder to submit the results of this study by 30th May 2025 to further characterise the safety information for adolescents.
Although this is the first approval of MVA-BN as a smallpox,mpox vaccine for adolescents, Bavarian Nordic notes that a recombinant version of MVA-BN (Mvabea) received EMA approval in 2020 as part of a prime-boost regimen for the prevention of disease caused by Ebola virus in individuals aged 1 and older. This approval was based on studies involving more than 3,300 individuals, including over 800 children and adolescents aged 1-17 in Africa.
Implications for the response
EMA states that this assessment has “important implications” for the global mpox response. As EMA is the regulatory agency of record for the WHO prequalification of the vaccine earlier this month, the CHMP assessment constitutes the basis for WHO prequalification approval to “facilitate timely and increased access” in communities that need it most. The EMA’s assessment has also previously been considered by the DRC’s national regulatory authority for fast-track approval.
President and CEO of Bavarian Nordic, Paul Chaplin, applauded EMA for the “expedited” review and decision.
“This represents an important milestone in our efforts to make our vaccine available for all populations and will help improve access for some of the most vulnerable individuals mostly impacted by the ongoing mpox outbreak in Africa.”
For insights into the regulatory processes behind access to vaccines, including from senior representatives of EMA, join us at the Congress in Barcelona next month. Don’t forget to subscribe to our weekly newsletters for the latest vaccines news.
by Charlotte Kilpatrick | Sep 20, 2024 | Global Health |
In September 2024, Africa CDC offered congratulations to the Governments of Japan and the Democratic Republic of the Congo (DRC) for their agreement on the donation of Lc16 mpox vaccines and specialised inoculation needles. At a signing ceremony in Kinshasa, the two governments marked a “significant milestone” in their cooperation. These vaccines are a “critical boost” to DRC’s mpox response; Lc16 is the only mpox vaccine currently approved for children.
Lc16
The vaccine is derived from the Lister strain of vaccinia and contrasts to the replication-deficient vaccines like Modified Vaccine Ankara (MVA) by retaining most of vaccinia genome and being able to replicate at the site of inoculation. It is administered as a single dose through the scarification method, which involves scratching the skin before applying the vaccine solution. Studies in children suggested that the vaccine was safe and well tolerated, leading to licensure. However, the duration of immunity remains unclear.
Another tool for the fight
Africa CDC states that this donation comes “at a pivotal time” in DRC’s fight against the regional mpox outbreak. Since the declaration of a PHECS in August 2024, a “more coordinated international response” has evolved. Central to this response is vaccination, which is complicated by Africa’s “limited access to critical countermeasures”.
Director General of Africa CDC, H.E. Dr Jean Kaseya, is “deeply appreciative” of the ‘” of the “generous donation” of mpox vaccines and specialised vaccine needles to the DRC.
“This timely assistance will significantly bolster our ongoing efforts to contain the outbreak, and I am confident that this partnership will help mitigate the public health threat posed by mpox, not only in the DRC but across the continent.”
Japan’s Senior Deputy Minister for Foreign Affairs, Takeshi Akahori notes the increasing number of cases in the DRC and other countries, commenting that Japan is “monitoring the situation closely” with WHO.
“I hope that these vaccines and needles will contribute meaningfully to the fight against mpox.”
Join us at the Congress in Barcelona next month to engage with public health experts on current health threats and how vaccines can contribute to our response, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 18, 2024 | Global Health |
The Global Fund to Fight AIDS, Tuberculosis, and Malaria (the Global Fund) announced in September 2024 that it is responding to a request from the government of the Democratic Republic of the Congo (DRC) for support in its mpox response. The Global Fund will provide US$9.5 million towards the emergency response in six of the highest transmission provinces (Equateur, Sud-Ubangui, Sankuru, Tshopo, Sud-Kivu, and Nord-Kivu) as well as Kinshasa, which is home to 17 million people.
DRC is fighting the world’s largest mpox epidemic, reporting 5,160 confirmed cases and 25 deaths since the beginning of the year. However, as testing capacity and availability are limited, the number of suspected cases could be up to five times the number of laboratory-confirmed cases. As the epidemiology of mpox evolves in “complex ways”, implications for prevention, preparedness, and response efforts also evolve. Furthermore, mpox is “increasingly being associated with HIV”, which heightens the risk of transmission, illness, and death. Thus, investment in mpox efforts helps to strengthen work on HIV, and vice versa.
Global Fund support
The support offered by the Global Fund contributes to specific priority areas on the government’s National Preparedness and Response plan:
- Enhancing disease surveillance systems with an emphasis on strengthening early warning capabilities and alert and response systems to detect, monitor, and respond to mpox and other disease outbreaks.
- Strengthening laboratory systems and diagnostics to increase case detection and stop the spread.
- Conducting risk communication and community mobilisation and engagement through the network of community health workers and community actors who are deployed for HIV, TB, and malaria prevention and awareness.
- Implementing infection prevention and control measures to protect health workers, including at the community level.
- Reinforcing country-level coordination, planning, and support for emergency response and operations.
- Strengthening the capacity of health facilities to provide primary care services and support future emergencies.
The support also complements the current collaboration between DRC’s ministry of health, Africa CDC, WHO, humanitarian organisations, and other key partners on efforts to “address the severe challenges to the public health system” in the east of the country, where the epidemic is “converging with risks of other infectious diseases”. The Global Fund has already contributed support in moving available stocks of personal protective equipment to the most affected provinces.
Today’s fight for tomorrow’s resilience
Dr Roger Kamba, Minister of Health and Social Welfare for the DRC recalled the “proven track record” of infectious disease control in the partnerships with the Global Fund and other health partners.
“Over the past two decades, the number of AIDS-related deaths and new HIV infections in DRC have reduced by more than 60%, through coordination and collaboration across all out partners.”
Dr Kamba is “determined to continue to work in the same manner for a strong response to mpox”.
“The fight against the current mpox epidemic is a top priority for our ministry, especially through the reinforcement of the community response. It is essential to recognise that by acting now, we are not only fighting mpox but also investing in the resilience and health security of tomorrow.”
Executive Director of the Global Fund, Peter Sands, reflected that people who live in “areas of conflict and crises” often encounter “significant barriers to accessing health services”.
“When a disease outbreak occurs in these places, the challenges are compounded. Strong systems of trusted community health workers, health educators, and other local responders are essential for stopping disease spread.”
Mark Edington, Head of Grant Management at the Global Fund, emphasised the importance of swift action in disease outbreak situations.
“Immediate intervention is crucial to strengthen systems for health and improve disease detection, surveillance, and response mechanisms, aiming to prevent further deterioration in health outcomes, particularly for women, children, and internally displaced persons.”
The Global Fund encourages other affected countries to assess their mpox needs and the consider the possibility of repurposing existing Global Fund investments.
To contribute to important discussions about effective allocation of funds for emergency responses and ensuring more resilient health systems, join us at the Congress in Barcelona next month. Don’t forget to subscribe to our newsletters here for the latest vaccine and global health news.
by Charlotte Kilpatrick | Sep 18, 2024 | Global Health |
In September 2024, Gavi and Bavarian Nordic announced an advance purchase agreement (APA) to secure 500,000 doses of MVA-BN mpox vaccine to be supplied to countries in Africa that are affected by the mpox outbreak. The doses are funded by Gavi’s First Response Fund and are for delivery in 2024. Bavarian Nordic will be ready to supply the vaccine doses after a supply agreement has been signed with UNICEF, which will deliver the doses.
The First Response Fund
Gavi’s First Response Fund was established in June 2024 to “make cash rapidly available” for the purchase of vaccines in health emergencies. It is available to Gavi-eligible countries in the early days of a pandemic or major health emergency. The Fund pre-positions up to US$500 million of surge financing for vaccine procurement ‘at risk’, which means funds are used to secure doses and “Gavi’s place in the queue” while manufacturers complete the final steps of regulatory approval and manufacturing scale-up.
Dr Sania Nishtar, Gavi’s CEO, commented that the First Response Fund was designed in collaboration with donors and partners “specifically to provide rapid early funding for emergencies such as mpox”.
“Using it today to fund the first direct transaction for vaccines in support of equitable access and the global response, just over a month since mpox was declared a public health emergency, takes us a long way towards our goal of protecting those most at risk.”
Dr Nishtar thanked donors for enabling Gavi to “act rapidly” by committing funds before an emergency occurred.
“We are committed to working with affected governments and our partners to turn these vaccines into vaccinations as quickly and effectively as possible and, over time, to build a global vaccine stockpile if sufficient funding is secured for Gavi’s work through 2030.”
Paul Chaplin, President and CEO of Bavarian Nordic, is pleased to sign the agreement and “strengthen our commitment to support Gavi and other global health partners” who demonstrate “strong leadership”.
“The doses secured through this agreement will significantly increase the availability of mpox vaccines for African countries, and we are pleased that Gavi has selected our MVA-BN vaccine, which has proven highly effective during the global mpox outbreak in 2022.”
For the latest on vaccine collaborations to ensure equitable access, get your tickets to join us at the Congress in Barcelona next month, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 17, 2024 | Global Health |
The first round of an emergency polio vaccination campaign in the Gaza Strip reached around 560,000 children under ten between 1st and 12th September 2024. WHO reported that the campaign delivered novel oral polio vaccine type 2 (nOPV2) to 558,963 children after the identification of circulating variant poliovirus type 2 (cVDPV2) in July and August 2024. The effort used an “extensive network” of teams, providing vaccinations at selected fixed sites. Mobile and transit teams engaged families living in shelter homes, tents, and camps for the displaced, and community workers raised awareness.
Efforts continue
The initial campaign target was 640,000 children, which WHO suggests may have been an over-estimate in the absence of an accurate survey and population displacement. The campaign used 473 teams, including 230 mobile teams, and 143 vaccination sites in central Gaza. This was followed by 91 fixed sites and 384 mobile teams in southern Gaza. The campaign concluded in northern Gaza, with 127 teams at fixed sites and 104 mobile teams. Each of the three phases was conducted under an “area-specific humanitarian pause” of nine hours daily, agreed to guarantee the safety of communities and health workers and ensure vaccination targets could be achieved.
749 social mobilisers engaged communities, encouraged families to vaccinate their children, and addressed concerns. Trained monitoring teams were deployed during the campaign to oversee the efforts, and a further 65 independent monitors will now cross-check the proportion of children vaccinated in the Gaza Strip to independently assess the level of coverage achieved in this first round. These monitors will need “safe, unimpeded access” to households, markets, transit points, and health facilities to check that children have purple dye on their little fingers, signifying vaccination.
The second round of the campaign is expected to follow in four weeks, providing a second dose of nOPV2. WHO, UNICEF, and UNRWA hope to reach enough children and stop further transmission, calling for another round of humanitarian pauses with “unimpeded access” to children in areas that require special coordination. The organisations highlight the need for a “long-lasting ceasefire” so that families can “begin to heal and rebuild their lives”.
Public engagement
WHO recognises the “traditionally positive health seeking behaviour among the Palestinian people” as critical to the success of the first round. Families reportedly “flocked” to health facilities to ensure that their children received vaccinations. This positive reaction was complemented by an “impactful campaign to raise awareness and mobilise the public”.
Dr Richard Peeperkorn, WHO Representative for the occupied Palestinian territory (oPt), commented on the “incredible resilience” of helath and community workers who carried out the campaign at “unprecedented scale and speed under the toughest conditions in Gaza”. Additionally, “swift action” from the Global Polio Eradication Initiative, from initial detection to campaign launch, “speaks to the effectiveness of the polio programme”.
“In areas where humanitarian pauses took place, the campaign brought not just vaccines, but moments of calm. As we prepare for the next round in four weeks, we’re hopeful these pauses will hold, because this campaign has clearly shown the world what’s possible when peace is given a chance.”
Jean Gough, UNICEF Special Representative in the State of Palestine emphasised the importance of carrying out the “ambitious campaign…quickly, safely, and effectively”. This will protect children in the Gaza Strip and neighbouring countries from “life-altering poliovirus”.
“The progress made in this first round is encouraging, but the job is far from done. We are poised to finish the task and call on all involved to ensure we can do so in the next round in four weeks’ time, for the sake of children everywhere.”
For insights into effective emergency vaccination campaign delivery and strategies to encourage uptake, get your tickets to the Congress in Barcelona next month, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 17, 2024 | Technology |
Albert Einstein College of Medicine announced receipt of a five-year grant worth $14 million a year from the National Institute of Allergy and Infectious Diseases (NIAID). The grant is part of NIAID’s ReVAMPP (Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness) Network. The funding will enable participation in a national effort to develop “plug-and-play” vaccines and antibody-based therapies against various emerging viruses. Albert Einstein College of Medicine will lead a consortium, called PROVIDENT (Prepositioning Optimised Strategies for Vaccines and Immunotherapies Against Diverse Emerging Infectious Threats).
PROVIDENT
The PROVIDENT consortium links 13 teams from academia, government, and industry on four projects to:
- Discover and analyse virus-host interactions and the molecular mechanisms involved in viral disease
- Design proteins to elicit antiviral immune responses and then evaluate and optimise those responses
- Create “road maps” for quick development of RNA vaccines against microbes with pandemic potential
- Map the antibody response observed in people infected with viruses for use in vaccine and therapeutic design
The project builds on NIAID’s 2021 Pandemic Preparedness Plan, which “leverages its broad research portfolio, long-standing expertise in product development, capacity to engage both domestic and international partners, and flexible infrastructure”. The plan addresses both “priority pathogens” and “prototype pathogens”.
Prototype pathogens will be PROVIDENT’s focus; these are “representative viruses” in families with potential to cause “significant human disease”. The research will concentrate on three virus families:
- Nairoviruses – transmitted by ticks
- Hantaviruses – borne by rodents and other small mammals
- Paramyxoviruses – borne by bats and other mammals
A sprint strategy
Dr Kartik Chandran, principal investigator on the grant, professor of microbiology and immunology, Gertrude and David Feinson Chair in Medicine, and Harold and Muriel Block Faculty Scholar in Virology, reflected on the importance of pandemic preparedness as revealed during COVID-19.
“One of the key lessons from the COVID pandemic is that having existing research on a viral family allows scientists to develop vaccines and therapeutics for a particular virus much more quickly. In our project, we plan to create a base of critical knowledge about a group of similar viruses and then – should a related ‘virus X’ pose a health threat – develop specific countermeasures as quickly as possible to save as many lives as possible.”
Dr Chandran explained that the researchers will select and study one or two prototype viruses from each family, developing countermeasures that will work against “as many viruses within that family as possible”.
“That strategy of quickly responding to an emerging virus with an approach and tools that have already been developed is what we mean by ‘plug and play’. A part of PROVIDENT’s strategy will be to carry out ‘sprints’ in which countermeasures that are developed for the prototype pathogens will be tested against other viruses in the same family to see how well they work and to improve them.”
The approach enabled faster development during the COVID-19 pandemic, and Dr Chandran emphasised the importance of coordinating efforts to “increase our odds of mounting a timely and effective response”. Dr Eva Mittler, research assistant professor and leader of a PROVIDENT component, warned that “we don’t know what virus will cause the next pandemic”.
“Recent outbreaks of mpox, Nipah virus, and Eastern equine encephalitis, among other viral infections, underscore the need for an even broader preparedness programme.”
To join your colleagues at the Congress in Barcelona next month and share perspectives on pandemic preparedness and innovative vaccine development, get your tickets now. Don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 13, 2024 | Therapeutic |
King’s College London shared in September 2024 that an mRNA cancer immunotherapy (mRNA-4359), targeted for patients with lung cancer, melanoma, and other solid tumours, has shown promise in a Phase I trial. The first-in-human study of the therapy involved 19 patients with advanced stage cancers and found that the immunotherapy prompted an immune response against cancer and was well tolerated. Although this was a small study, the researchers are encouraged that their results support further investigations.
Potential in trial
The Phase I trial was designed to test the safety and tolerability of the immunotherapy, with secondary and tertiary objectives exploring the radiographic and immunological responses. 8 out of 16 patients whose responses could be evaluated demonstrated that tumour size did not increase, and no new tumours appeared.
The immunotherapy also activated the immune system in patients, generating immune cells that could recognise two proteins of interest: PD-L1 and IDO1. In some patients the immunotherapy increased levels of “important immune cells that can kill cancer cells” and reduced levels of other immune cells that inhibit the immune system’s response. The researchers acknowledge that their study was small and focussed on safety and finding an optimal dose. However, they continue to recruit patients with melanoma and lung cancer.
An important first step
UK Chief Investigator of the trial is Dr Debashis Sarker, Clinical Reader in Experimental Oncology in the School of Cancer and Pharmaceutical Sciences and consultant in medical oncology at Guy’s and St Thomas’ NHS Foundation Trust. Dr Sarker described the study as in “important first step in hopefully developing a new treatment for patients with advanced cancers”.
“We have shown that the therapy is well tolerated without serious side effects and can stimulate the body’s immune system in a way that could help to treat cancer more effectively. However, as this study has only involved a small number of patients to date, it’s too early to say how effective this could be for people with advanced stage cancer.”
The trial is continuing recruitment of patients in a “huge international effort” across the UK, USA, Spain, and Australia. Dr Kyle Holen, Senior Vice President and Head of Development, Therapeutics and Oncology, Moderna, is “encouraged” by the results. They demonstrate “potential to elicit strong antigen-specific T-cell responses while maintaining a manageable safety profile”.
“This novel approach could be a key component in shifting the tumour microenvironment towards a more immune-permissive state, offering potential hope for patients with advanced solid tumours.”
Professor Tariq Enver, Director of the Cancer Research UK City of London Centre, congratulated the team for “taking us a step closer to personalised cancer vaccines”.
“Through his role supporting training at our centre, Debashis continues to inspire the next generation of clinician scientists to drive life-saving breakthroughs in biological cancer therapies.”
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by Charlotte Kilpatrick | Sep 12, 2024 | Global Health |
Bavarian Nordic issued an update on its supply and manufacturing activities in support of mpox response efforts in September 2024. The company manufacturers the approved non-replicating smallpox and mpox vaccine MVA-BN (marketed as JYNNEOS, IMVAMUNE, and IMVANEX). The company statement describes “intensified” collaboration with global stakeholders in response to the declaration of mpox as a PHECS by Africa CDC and a PHEIC by WHO.
Progress so far
Through donations from the European Commission, the United States government, and Bavarian Nordic, initial doses of MVA-BN have been delivered to the Democratic Republic of the Congo (DRC), the epicentre of the mpox outbreak. Further donations have been pledged by other countries. However, UNICEF and Africa CDC have suggested that vaccines will be needed to protect up to 1 million people in high-risk areas of DRC, with up to 10-12 million doses required through 2025.
Bavarian Nordic “is committed to ensuring equitable access to its mpox vaccine”. It has therefore prioritised the production of MVA-BN for the rest of the year to ensure up to 2 million doses by year-end. This means that some existing orders for 2024 will be delayed to 2025 to provide “greater flexibility” to meet “additional urgent and imminent needs”. The new supply contracts include multi-year agreements with countries, including those who have pledged vaccines for Africa. Additionally, Bavarian Nordic has responded to UNICEF’s emergency tender and is participating in discussions with other organisations and individual governments around the globe.
Up to 13 million doses
By focussing “full capacity to address the current public health emergency”, Bavarian Nordic hopes to supply up to 13 million MVA-BN doses by the end of 2025. This includes 2 million in 2024. Although this may be sufficient to meet the current and near future demand, Bavarian Nordic is exploring “additional levers” to expand capacity. This includes possibly transferring manufacturing to other companies.
“Based on these early, but highly constructive discussions, together with further planned improvements in the manufacturing process, Bavarian Nordic has identified another 50 million doses that, pending regulatory approvals and demand, could be supplied during the next 12-18 months.”
President and CEO of Bavarian Nordic, Paul Chaplin, stated that the company is “working closely with all governments and organisations to support the international efforts to combat the latest public health emergency”. Mr Chaplin highlighted that Bavarian Nordic will “support all requests for vaccine and have already secured agreements to the UNICEF tender that will hopefully secure more access to MVA-BN globally”.
“We remain committed to the equitable access either through prioritising our own capacity, accelerating planned improvements in the manufacturing process and by exploring ways to further expand capacity through partnerships around the globe. Once again Bavarian Nordic, through innovation and our commitment to improving and saving lives has stepped forward as an important part of the international community’s response to the current public health emergency.”
We will hear more from Bavarian Nordic on their contributions to the mpox response at the Congress in Washington next April; get your tickets to join us there and don’t forget to subscribe to our weekly newsletters here.
