by Charlotte Kilpatrick | Oct 21, 2024 | Global Health |
In October 2024 WHO certified Egypt as malaria-free after a “nearly 100-year effort” by the government and people to end the disease. WHO described this as a “significant public health milestone” for the country’s more than 100 million inhabitants. Egypt is the third country to receive this certification in the WHO Eastern Mediterranean Region, following the United Arab Emirates and Morocco.
Across the globe, 44 countries and 1 territory have achieved this status by proving beyond reasonable doubt that the chain of indigenous malaria transmission by Anopheles mosquitoes has been interrupted nationwide for at least the previous three consecutive years. A country must also demonstrate its capacity to prevent the re-establishment of transmission.
Malaria becomes history
WHO states that malaria has been traced back as far as 4000 BCE in Egypt; there is genetic evidence of the disease in Tutankhamun and other ancient Egyptian mummies. More recently, efforts to reduce human-mosquito contact began in the 1920s with the prohibition of rice cultivation and agricultural crops near homes. With much of the population living along the banks of the Nile River and malaria prevalence “as high as 40%”, malaria was designated as a notifiable disease in 1930.
By 1942, malaria cases in Egypt exceeded 3 million due to population displacement caused by the Second World War, the disruption of medical supplies and services, and the invasion of Anopheles arabiensis, which is a “highly efficient mosquito vector”. Egypt responded to the outbreak by establishing 16 treatment divisions and recruiting more than 4000 health workers. The Aswan Dam, completed in 1969, brought an additional risk of malaria as standing water provides a mosquito breeding ground. Thus, Egypt worked with Sudan to launch a “rigorous” vector control and public health surveillance project.
By 2001, malaria was “firmly under control”, encouraging the Ministry of Health and Population to work on preventing the re-establishment of local malaria transmission. Egypt “rapidly” contained a small outbreak in the Aswan Governorate in 2014. The recent certification recognises continued efforts and initiatives including the free provision of malaria diagnosis and treatment to the population, regardless of legal status, and health professionals’ training to detect and screen for malaria. The country also has “strong” cross-border partnerships with neighbours like Sudan, which have been “instrumental”.
The beginning of a new phase
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, congratulated Egypt on its achievement.
“Malaria is as old as Egyptian civilisation itself, but the disease that plagued pharaohs now belongs to its history and not its future. This certification of Egypt as malaria-free is truly historic, and a testament to the commitment of the people and government of Egypt to rid themselves of this ancient scourge.”
Dr Tedros hopes that this will be an “inspiration to other countries in the region”, showing “what’s possible with the right resources and the right tools”. Deputy Prime Minister of Egypt H.E. Dr Khaled Abdel Ghaffar commented that the certification is “not the end of the journey but the beginning of a new phase”.
“We must now work tirelessly and vigilantly to sustain our achievement through maintaining the highest standard for surveillance, diagnosis and treatment, integrated vector management, and sustaining our effective and rapid response to imported cases. Our continued multisectoral efforts will be critical to preserving Egypt’s malaria-free status.”
Dr Abdel Ghaffar reaffirmed that the country will “continue with determination and strong will”. WHO Regional Director for the Eastern Mediterranean Dr Hanan Balkhy emphasised that the success is “not just a victory for public health but a sign of hope for the entire world”, including other endemic countries in the region.
“This achievement is the result of sustained, robust surveillance investments in a strong, integrated health system, where community engagement and partnerships have enabled progress. Furthermore, collaboration and support to endemic countries, such as Sudan, remain a priority.”
For insights into the latest malaria vaccine development progress, join us at the Congress in Barcelona next week. Don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Oct 14, 2024 | Global Health |
Phase II trials of a “promising” human vaccine candidate against Rift Valley fever are beginning in Kenya with CEPI support. CEPI reported in October 2024 that this is the “most advanced stage of testing” for a human Rift Valley fever vaccine in an “outbreak-prone area”. Scientists at the University of Oxford and the Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme are leading the trial with $3.7 million funding from CEPI.
Rift Valley fever
First identified in Kenya’s Rift Valley, Rift Valley fever is usually found in people after direct contact with infected animals or bites from infected mosquitoes. Most infected people experience “mild disease”, but a small proportion develop the “severe haemorrhagic form”, with a risk of blindness, convulsions, encephalitis, and bleeding. In these cases, mortality rates can reach 50%.
Rift Valley fever has been detected across “much of Africa” and in the Middle East. It is mosquito-borne, which makes it “climate sensitive”. There is therefore a risk of outbreaks spreading to new areas or increasing in frequency or size. There are Rift Valley fever vaccines for animals, but no currently available or licensed vaccines for human use; the disease is a priority disease for R&D for WHO and CEPI.
ChAdOx1 RVF in trial
The vaccine, known as ChAdOx1 RVF, is based on the University of Oxford’s ChAdOx1 vaccine platform. It has shown positive results in healthy adults in the UK, meeting “many of the optimal product characteristics” of a WHO target product profile. It is one of three Rift Valley fever candidates in CEPI’s portfolio. 240 healthy adults will participate in the research, following local trial approvals.
Funding for the trial comes under CEPI’s strategic partnership with the University to accelerate the development of globally accessible vaccines against outbreak pathogens. Both organisations are “committed to enabling access to any vaccine outputs developed through this partnership”, including developing a target product profile suitable for low- and middle-income countries (LMICs), assessing the need for technology transfer, and priority supply to LMICs at an affordable price.
Professor George Warimwe, Principal Investigator of the trail and Deputy Executive Director of the KEMRI-Wellcome Trust Research programme, reflected that “nearly 100 years” after the disease was identified, there are “still no approved vaccines or treatments”.
“This vaccine trial brings us closer to addressing the rising frequency of outbreaks.”
Dr Richard Hatchett, CEO of CEPI, commented that Rift Valley fever “disproportionately affects the lives and livelihoods of vulnerable pastoral communities”, causing human fatalities and livestock losses.
“Investing in the promising human ChAdOx1 RVF vaccine diversifies CEPI’s portfolio and gives us a greater chance at protecting vulnerable populations against this worrisome threat that may become more prevalent with climate change.”
Director General of Africa CDC, H.E. Dr Jean Kaseya, agreed that the disease “leads to livestock losses and human fatalities, thus impoverishing communities who largely depend on livestock for their livelihood”.
“The launch of a Phase II clinical trial of a Rift Valley fever vaccine candidate in an endemic country is a crucial milestone in our efforts to control this disease. Africa CDC is proud to support this initiative that not only prioritises the health of our people but also demonstrates the continent’s growing leadership in advancing clinical research.”
Dr Kaseya stated that the ChAdOx1 RVF vaccine “offers hope to vulnerable populations” who are “disproportionately affected by the growing impact of climate change”.
Join us at the Congress in Barcelona later this month to explore efforts to address the growing challenges of climate change and infectious disease with vaccine development and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Oct 14, 2024 | Technology |
SK bioscience announced in October 2024 that it has signed an agreement to acquire a stake in Fina Biosolutions (FinaBio) with a $3 million investment. SK bioscience becomes FinaBio’s first and sole strategic investor with a goal of improving the immunogenicity and productivity of conjugate vaccines. This announcement is another example of SK bioscience’s investment in global companies to “create synergies in business” after recently completing the acquisition of a controlling stake in IDT Biologika. The company states that it is securing its “competitiveness” through strategic investments in “promising companies with exceptional technology” and M&As to “lay the foundation for a great leap forward into a leading global company”.
FinaBio’s technology
Founded in 2006, FinaBio seeks to “help emerging market vaccine manufacturers learn to make affordable protein polysaccharide conjugates for vaccines”. It is now a “premier provider” of laboratory and consulting services, specialising in the research and development of conjugate vaccines for pneumoniae, meningococcal, typhoid, and other diseases. One of FinaBio’s key assets is FinaXpress, a proprietary E. coli expression system, that can produce proteins not previously made in the bacteria, like the carrier protein CRM197. FinaBio has expanded access to this protein, marketed as EcoCRM.
FinaBio is also developing a next-generation conjugation technology that is site-specific and targets the desired location for antigen binding. This is intended to boost immunogenicity and productivity. Supplying conjugation technology and carrier proteins to various global biotech companies and institutions, FinaBio continues to expand its business units.
A conjugate collaboration
SK bioscience will use FinaBio’s CRM197 technology in its efforts to “secure the high effectiveness of diverse conjugate vaccines while increasing profitability through high-yield processes”. CEO and President of SK bioscience Jaeyong Ahn is “delighted to continue developing partnerships with global firms that have next-generation vaccine technology”.
“Through our mid- to long-term collaboration with FinaBio, we will advance the vaccines we are developing to the next level and strengthen our competitiveness for global market expansion.”
Dr Andrew Lees, Founder and CEO of FinaBio, apprecitaes SK’s “confidence” in the organisation and support of accelerated global commercialisation of EcoCRM.
“Combined with our efficient conjugation technology, this will enable the development of the next generation conjugate vaccines. It will also allow us to continue our mission of promoting affordable vaccines.”
We look forward to welcoming FinaBio back to the exhibition floor at the Congress in Barcelona later this month; get your tickets to connect with their team there 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.”
For insights into pandemic preparedness initiatives at the Congress in Barcelona this month get your tickets here, and don’t forget to subscribe to our weekly newsletters here!
by Charlotte Kilpatrick | Oct 10, 2024 | Global Health |
The African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) announced in October 2024 that Wellcome is granting US$12,301,075 to “support the strengthening and harmonisation of regulatory systems and the operationalisation” of the African Medicines Agency (AMA). The grant will help to drive efforts to “overcome regulatory capacity challenges” to improve access to essential medical products and technologies.
The African Medicines Regulatory Harmonisation (AMRH) initiative has been “pivotal” at creating a “cohesive regulatory environment” for the pharmaceutical sector across Africa since 2009. It focuses on using Regional Economic Communities (RECs) to ensure that African populations have access to high-quality, safe, and effective medical products and health technologies. Wellcome’s grant will be used in alignment with AMRH’s vision of “overcoming barriers” like “limited human and institutional capacity, fragmented regulatory processes, and inconsistent technical standards”.
AMA
AMA’s vision is that “African people have access to essential medical products and technologies”; it hopes to achieve this through the mission: “provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa”. The funding is expected to accelerate efforts to create a “unified and efficient” regulatory framework. The partnership between Wellcome and AUDA-NEPAD is a “major advancement in the pursuit of a robust and harmonised regulatory environment” with positive effects for health outcomes in Africa.
Efficient, connected, fair
Symerre Grey-Johnson Director for Human Capital and Institutional Development at AUDA-NEPAD, stated that the “generous support” from Wellcome is a “crucial endorsement of our mission”.
“With the African Medicines Regulatory Harmonisation (AMRH) intiative laying the groundwork for the African Medicines Agency (AMA), this grant will empower us to address significant regulatory challenges and enhance access to essential medical products for millions of Africans.”
Mr Grey-Johnson believes that the collaboration will “solidify the foundation of the AMA” and ensure a “robust and harmonised” regulatory environment across the continent. Dr Sally Nicholas, Wellcome’s Head of Health Systems and Environment, recognised the AMA’s “crucial role” in creating a “more efficient, connected, and fair regulatory system” in Africa.
“Strengthening regulatory systems is fundamental to improving healthcare outcomes for Africa. By supporting innovative partnerships, initiatives, and solutions to help coordinate effectively operationalise the AMA, we can ensure equitable access to much-needed vaccines, treatments, and interventions for those with the greatest need.”
At the Congress in Barcelona this month we look forward to learning about an AMA pilot with MSD in the Supply and Logistics track; get your tickets to join us there and don’t forget to subscribe to our weekly newsletters 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 | Technology |
In October 2024, SK bioscience announced the successful completion of its acquisition of a controlling stake in IDT Biologika. This follows the announcement in June 2024 that SK bioscience intended to acquire 60% of IDT Biologika’s shares from the Klocke Group to “leap forward into global markets”. Since the signing of the sale and purchase agreement, SK bioscience has finalised the acquisition after obtaining the necessary approvals. The companies have established a plan for a post-merger integration (PMI) process of around 100 days. This will improve both companies’ “management effectiveness” and “encourage systematic integration for business growth”.
Building foundations
During the PMI, the companies will “build a foundation” for the growth of IDT Biologika through a series of projects. The first element seeks to maximise the utilisation rate of IDT Biologika’s manufacturing facilities and new capacities for drug substance (DS) and drug product (DP) for major projects with global pharmaceutical companies. SK bioscience also hopes to create a framework to expand existing contracts and win further projects for clinical trials and late-stage cell and gene therapy (CGT) projects. Alongside this, the portfolio of available cell lines will be expanded to address new customers, and the development of recombinant vaccines will be advanced.
SK biosciences will invest in high-growth businesses such as pre-filled syringes (PFS), recombinant vaccines, and CGT. This encompasses oncolytic virus (OV), adeno-associated virus (AAV), and lentivirus (LV). The company will also transfer technology and production to IDT Biologika for main products such as flu, shingles, chickenpox, and typhoid vaccines.
To “ensure synergies”, executives from both the Klocke Group and SK bioscience will serve on IDT Biologika’s Advisory Board. The Board will ensure “independent management while carrying out cultural integration”. Dr Ulrich Valley, CEO of IDT Biologika, is “convinced” that the milestone will “contribute to future growth and to our vision of a leading CDMO”.
“This global strategic cooperation is an important driver for our innovative strength, competitiveness, and sustainable success, built on a foundation of trust and common goals.”
Dr Valley is “certain” that Sk bioscience and IDT Biologika can “achieve great things together by combining our competences and capabilities”. President and CEO of SK bioscience, Jaeyong Ahn, commented that the with the successful completion of the acquisition, the two companies “now unite one family”.
“The capabilities and technologies of the two companies are expected to generate significant synergies, and we will accelerate our global expansion.”
We look forward to hearing from IDT Biologika on how to successfully scaling up for vaccine and CGT manufacturing at the Congress in Barcelona this month. Get your tickets to join us there, and don’t forget to subscribe to our newsletters for the latest vaccine news.
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 27, 2024 | Global Health |
WHO and TikTok announced a year-long collaboration to provide “reliable, science-based health information” in September 2024. The partnership seeks to address the challenges of misinformation and disinformation on digital channels by “promoting evidence-based content and encouraging positive health dialogues”. TikTok is a social platform where users create and share short-form videos.
The Fides network, a “network of healthcare influencers” who seek to share “good health content” and tackle misinformation, was launched in 2020. It has over 800 creators with a reach of 150 million people on various platforms. Network creators across the globe will be joining TikTok to create and promote evidence-based content. TikTok is also making a $3 million donation to support WHO’s work on “destigmatising mental health conditions and creating an informed, empathetic, and supportive online community”.
Social channels as a source
WHO recognises that social media platforms are important sources of information that can influence health-related behaviours and decisions. It states that one in four young adults seeks news content on social media platforms such as TikTok. However, these digital channels are increasingly allowing the distribution of misinformation and “malinformation”. Thus, the collaboration will “expand efforts” on several health topics, making science-based information “relatable and digestible”, and offering support for influencers through TikTok’s creator training programmes.
WHO’s Chief Scientist Dr Jeremy Farrar hopes that the collaboration will prove to be an “inflection point in how platforms can be more socially responsible”.
“The intersection of health and technology presents an opportunity to reach people of all ages, where they are, when they want to access. By working with TikTok and others, we are helping people access credible information and engage in scientific discourse that collectively helps shape a healthier future for all.”
Dr Alain Labrique, WHO’s Director of Digital Health and Innovation, reflected that “creators who understand their audience’s needs have a unique opportunity to bridge the gap between science and everyday life”.
“This is where WHO can step in to support influencers in delivering evidence-based information, ensuring that health conversations on platforms like TikTok are both impactful and informed.”
TikTok’s Global Head of Trust and Safety, Outreach and Partnerships, Valiant Richey, commented on the importance of TikTok’s commitment to providing “reliable information”.
“We are delighted to be partnering with the World Health Organisation’s Fides network of healthcare content creators to further strengthen this commitment by bringing engaging and authoritative mental well-being content to our community.”
Creators leading the field
Dr Timothy Tiutan has created a community of almost 2 million followers on social media and hopes that the initiative will enable creators to “empower communities to live healthier lives”.
“The network tackles global health challenges in an era where access to health information has dramatically evolved. WHO Fides is a driving force in shaping a healthier, more informed global community for the future.”
Avisha NessAiver specialises in translating research into accessible language and has worked with Fides and the UN as part of “Team Halo”. His content has reached over 100 million views on various platforms.
“The Fides network is the catalyst transforming isolated scientists and health experts into a powerful collective force, armed with shared knowledge and strategies to effectively combat the spread of health misinformation.”
Do you think this initiative will be an effective way of engaging social media users in reliable information? Or will the partnership ruffle feathers online and in the lab?
To discuss the importance of effective communication and translating the latest research into accessible content with your colleagues at the Congress in Barcelona next month, get your tickets here, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 26, 2024 | Global Health |
A $4.2 million Programme Project Grant renewal from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) in September 2024 will fund efforts by researchers at Weill Cornell Medicine to develop a cytomegalovirus (CMV) vaccine. The vaccine is intended to prevent the transmission of cytomegalovirus from mother to baby during pregnancy. The grant could be extended for five years and $20.4 million to enable research to accelerate the vaccine’s development.
Protecting the foetus
Cytomegalovirus (CMV) is the most common congenital infection worldwide, but Dr Sallie Permar, chair of the Department of Paediatrics at Weill Cornell Medicine, hopes to find a vaccine that prevents transmission of the virus to the developing foetus. Around 1 in 200 babies is born with CMV, with one-quarter of them experiencing long-lasting effects such as hearing loss, microcephaly, developmental delays, and seizures. Dr Permar compares the effects to those recognised in the Zika epidemic, commenting that CMV “affects ten times as many infants”.
“If we could eliminate this terrible congenital infection, we would give more babies the chance to achieve their full potential in life.”
A model of transmission
More than half of all adults live with CMV, but if it is acquired for the first time during pregnancy, the mother has a 30% to 40% chance of passing the virus to her baby. As it is “challenging” to design a clinical trial large enough to assess the effectiveness of a CMV vaccine to protect the foetus, Dr Permar has created a collaborative network. With researchers at the University of California Davis Primate Centre, Tulane University, and Oregon Health Sciences University (OSHU) and Primate Centre, Dr Permar has developed a non-human primate model of congenital CMV transmission to test vaccines.
“This work requires a cadre of multidisciplinary virologists, immunologists, pathologists, physicians, and veterinary scientists who all care deeply about eliminating this devastating childhood infection through vaccination.”
Tackling “immune-evading tactics”
Dr Permar states that CMV has “multiple strategies” for evading host immunity; the virus conceals itself in a person’s cells and producing factors to catch host antibodies, disable common killer T cells, and cause confusion for the antiviral immune response. With the latest grant renewal, the researchers will explore approaches for “thwarting these viral immune-evading tactics”.
The team will use weakened viruses and some of the virus’ own protein factors as antigens to induce the production of antibodies against “CMV’s evasive manoeuvres”. They hope to have a prototype for a vaccine in five years, at which point they could advise the industry on vaccines that are currently in clinical trials.
For insights into maternal vaccine challenges and strategies at the Congress in Barcelona next month, get your tickets to join us here, and don’t forget to subscribe to our newsletters for regular vaccine news.
by Charlotte Kilpatrick | Sep 26, 2024 | Global Health |
In September 2024 Africa CDC and IAVI announced the signing of a Memorandum of Understanding (MoU) to enhance the continent’s capacity to fight disease, pandemic readiness, and supply resilience. This will involve expanding capabilities for locally driven research, development, manufacturing, and supply of priority vaccines and antibodies as well as strengthening Africa CDC-led initiatives. The partnership will combine IAVI’s “expertise in vaccine and antibody development and access” and the “extensive network and Africa CDC”.
Initiatives under the MoU
The MoU is intended to tackle pressing public health challenges and promote long-term health security. Some of the key initiatives under the MoU include:
- Supporting the development of vaccines and antibodies for regional health priorities (like Lassa fever and HIV)
- Fostering a sustainable supply and demand ecosystem for priority products in the region (including monoclonal antibodies)
- Strengthening African research and development capacity
- Exploring regional stockpile strategies for licensed and investigational products to ensure rapid responses during health crises
The MoU exemplifies the “action-oriented partnerships” that Africa CDC’s New Public Health Order demands as the organisation drives its vision for “redefining global health architecture” and ensuring that Africa and the world are better prepared for future health threats. IAVI recognises the support of funders and partners, including Wellcome, CEPI, the European and Developing Countries Clinical Trials Partnership (EDCTP), the United States Agency for International Development (USAID) and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) through the Accelerate the Development of Vaccines and New Technologies to Combat the AIDS Epidemic (ADVANCE) programme.
Dr Mark Feinberg, IAVI President and CEO, described the cooperation as a “key step” in IAVI’s mission to “improve global access to biomedical innovations and safeguard public health”.
“It goes beyond R&D; it’s about creating a vibrant health innovation ecosystem that meets current and future needs across Africa.”
We look forward to welcoming senior representatives of IAVI back to the Congress in Barcelona next month to learn more about the various efforts and initiatives they are enabling in pursuit of global health goals. Get your tickets to join us there and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 23, 2024 | Technology |
Vicebio announced $100 million Series B financing and the initiation of a Phase I clinical study of RSV/hMPV bivalent vaccine in September 2024. The financing is led by TCGX with investment from Goldman Sachs Alternatives, Avoro Ventures, and venBio, with participation from UniQuest and founding investor Medicxi. The funding will support and accelerate the development of vaccines based on Molecular Clamp technology, discovered at The University of Queensland.
Molecular Clamp technology
Vicebio’s next-generation vaccines for respiratory viruses are based on the proprietary Molecular Clamp technology from The University of Queensland. This technology “uniquely stabilises” viral glycoproteins in their immunogenic prefusion conformation, which is “crucial for eliciting strong protective immune responses”. The approach enables the production of “highly effective” vaccines that are easy to manufacture and can be available in ready-to-use prefilled syringes.
The technology has applications for a range of viruses, including respiratory syncytial virus (RSV), human metapneumovirus (hMPV), parainfluenza virus, influenza, and coronaviruses. This has been confirmed by “promising” preclinical and clinical studies.
Vicebio has recently initiated a Phase I clinical trial of VXB-241, a bivalent vaccine that targets both RSV and hMPV. These viruses cause a “significant burden of disease” in elderly patients and those with weakened immune systems. There is no commercially available vaccine for RSV and hMPV. The initial clinical readouts of the study are expected mid 2025.
Cutting-edge science
Dr Emmanuel Hanon, Chief Executive Officer of Vicebio, expressed enthusiasm for the latest interest.
“The support from these high-calibre investors underscores the robust data package we have generated for VXB-241, highlighting the significant potential of our proprietary Molecular Clamp technology to develop next-generation vaccines against respiratory viruses.”
Managing Partner at TCGX, Cariad Chester, emphasised TCGX’s dedication to supporting the “translation of cutting-edge science into transformative medicines”.
“We are thrilled to partner with Vicebio. This is a highly experienced team with a breakthrough technology to address a critical public health need. Vicebio has a unique capability to advance vaccine products that simultaneously provide robust immune responses against multiple respiratory pathogens.”
Cariad Chester will be included on the Vicebio Board of Directors and looks forward to working with the team to “bring these important vaccines to the market”. Dr Giovanni Mariggi, Chair of Vicebio and Partner at Medicxi, identified the “significant progress” Vicebio has made in developing the Molecular Clamp platform and advancing VXB-241 with “unmatched vaccine coverage”.
“We are pleased to welcome TCGX, Goldman Sachs, Avoro Ventures, and venBio to the syndicate to support the fight against life-threatening respiratory viral infections.”
For the latest vaccine technology insights at the Congress in Barcelona next month, get your tickets to join us here, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Sep 18, 2024 | Technology |
PharmaJet announced in September 2024 that it has entered a long-term license and supply agreement with Scancell Holdings to use PharmaJet’s Stratis Intramuscular (IM) Needle-free System for the delivery of its advanced melanoma DNA vaccine. Through the agreement, Scancell will use Stratis for the clinical development and commercialisation of ImmunoBody, the advanced melanoma DNA vaccine. PharmaJet will receive development and regulatory milestone payments and royalties on net sales upon commercialisation.
Stratis
PharmaJet’s Stratis technology is a needle-free system for 0.5 ml intramuscular and subcutaneous injections that enhances the performance of nucleic acid vaccines and therapeutics. Stratis delivery has demonstrated the ability to enable “effective uptake” of the Scancell DNA melanoma vaccine; 60 patients across 15 clinical trial sites have received a total of 171 doses of SCIB1/iSCIB1+ through Stratis. This approach offers the “convenience of an off-the-shelf therapeutic cancer vaccine with the speed and enhanced patient experience of needle-free delivery”.
ImmunoBody vaccines
Scancell’s ImmuoBody vaccines are designed to generate “potent” T cell responses that provide a broad anti-tumour effect. They are DNA vaccines that encode a protein in antibody form, with the elements of the antibody that would normally bind to the target protein replaced with cancer antigen epitopes. ImmunoBody vaccine design features include:
- Epitopes that bind to MHC class I and MHC class II
- Retention of the Fc region of the protein, which targets activated dendritic cells via its specific receptor
However, Scancell highlights the “most important aspect” of the technology as the ability to initiate both direct and cross-presentation of epitopes to T cells. The “highest avidity T cell responses” are generated if different pathways are used to present the same epitope. In ImmunoBody, the DNA form is taken up and processed directly by dendritic cells and the protein form binds to the high affinity Fc receptor on dendritic cells, leading to cross-presentation.
Advancing innovation
Professor Lindy Durrant, Chief Executive Officer of Scancell, is pleased that PharmaJet delivery “works effectively” with the SCIB1/iSCIB1+ vaccines and offers a “well-received immunisation for patients”.
“Securing long term supply for the PharmaJet Stratis Needle-free Injection System is important to allow clinical and commercial development of iSCIB1+…Our ultimate goal for Scancell has been to deliver an off-the-shelf, safe, tolerable, effective therapy that can provide potent and durable anti-tumour responses for unresectable stage IV melanoma, which currently has a 5-year survival of 35%.”
PharmaJet’s Chief Scientific Officer, Nathalie Landry, looks forward to working with Scancell to “advance their innovation further in clinical development and commercialisation” with benefits for melanoma patients.
“The Scancell strategic partnership further solidifies PharmaJet’s commercial delivery platform as a leader in the delivery of nucleic acid vaccines and immunotherapies.”
For more on PharmaJet’s needle-free delivery technology, join us at the Congress in Barcelona next month. Don’t forget to subscribe to our weekly newsletters for regular vaccine updates.
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 18, 2024 | Technology |
MinervaX and Wacker Biotech announced a collaboration to manufacture active protein ingredients for MinervaX’s Group B Streptococcus (GBS) vaccine in September 2024. The vaccine candidate is a novel protein-only vaccine, based on fusions of “highly immunogenic and proactive protein domains” from selected GBS surface proteins. Wacker Biotech is to manufacture the active ingredients and perform technology transfer, process validation, and process characterisation activities for commercial manufacturing. The organisation will also perform key functions to ensure “stable commercial supply” at its Amsterdam site.
GBS
Group B Streptococcus (GBS) is a “leading cause” of neonatal and infant sepsis and meningitis. The highest incidence is in neonates and young infants up to 3 months old. Between 15% and 25% of the population are “spontaneously colonised” with GBS, but during pregnancy this carries the risk of transmitting the bacteria to the child in the womb, during birth, and/or during the first months of life. WHO emphasises the need for an effective maternal GBS vaccine to protect neonates and infants before they can elicit and effective immune response.
MinervaX identifies an “unmet medical need” as there is no “general implemented and fully protective preventative treatment” for GBS. Furthermore, older adults and adults with some co-morbidities are at increased risk of severe GBS infections. This population would also benefit from a prophylactic vaccine.
A protein approach
MinervaX has developed a novel protein-only vaccine based on fusions of “highly immunogenic and protective protein domains” from the Alpha-like protein family (AlpN). This approach is intended to deliver a vaccine with “broad coverage and protection”. The lead candidate, AlpN GBS, comprises two fusion proteins, each containing two AlpN-terminal domains: GBS-NN (containing RibN and AlpCn) and GBS-NN2 (containing Alp1N and Alp2/3N).
Two Phase II clinical trials of the maternal vaccine have been successfully completed, and MinervaX is preparing for Phase III trials in this indication. Data are “very positive”, with an “acceptable” safety profile in pregnant participants and their infants, and “high immunogenicity”.
Joining forces
Dr Per Fischer, CEO of MinervaX, commented that GBS “can be life-threatening for newborn babies” and is associated with “over half a million preterm births annually”. However, after €54 million financing last year, the team is advancing the development of their novel prophylactic vaccine “for the benefit of all populations at risk, worldwide”.
“Wacker Biotech is a robust manufacturing partner with a strong track record in late clinical and commercial supply and we look forward to collaborating with the team ahead of commencing Phase III studies.”
Managing Director of Wacker Biotech B.V in Amsterdam, Ronald Eulenberger, looks forward to bringing Wacker Biotech’s strengths to the collaboration.
“With our strong background in E. coli processes, process characterisation, and process validation experiences, we at Wacker Biotech are perfectly suited to support MinervaX with its ongoing programme for the prevention of invasive GBS disease.”
We look forward to hearing from MinervaX’s CSO, Dr Bengt Johansson Lindbom, on a panel exploring the role of vaccines and mAbs in neonatal sepsis prevention at the Congress in Barcelona next month. Get your tickets to join us there and don’t forget to subscribe to our weekly newsletters for the latest vaccine news.
by Charlotte Kilpatrick | Sep 16, 2024 | Global Health |
In September 2024 WHO announced the establishment of an access and allocation mechanism for mpox medical countermeasures, including vaccines, treatments, and diagnostic tests. The Access and Allocation Mechanism (AAM) is intended to increase access to these essential tools for people at highest risk, ensuring that limited supplies are used “effectively and equitably”. This announcement comes after WHO declared the mpox outbreak a PHEIC in August 2024 and addresses one of the key International Health Regulations Emergency Committee’s recommendations: “equitable access to safe, effective, and quality-assured countermeasures”.
AAM
The AAM is part of the interim Medical Countermeasures Network (i-MCM-Net). Developed in response to “global vulnerabilities” exposed by the COVID-19 pandemic, i-MCM-Net enhances collaboration through a “Network of Networks” approach. It seeks to provide timely and equitable access to quality, safe, effective, and affordable medical countermeasures in response to public health emergencies through existing networks and global collaboration. The network was endorsed by WHO Member States as an interim mechanism while negotiations on a pandemic agreement continue.
The mpox AAM includes members of the i-MCM-Net as well as WHO: Africa CDC, CEPI, the EU Health Emergency Preparedness and Response Authority (HERA), FIND, Gavi, the PAHO Revolving Fund, UNICEF, Unitaid, and others. It will work to allocate the “currently scarce supplies” to those at highest risk of infection.
It will operate according to three guiding principles:
- Preventing illness and death – prioritise vaccination and other tools to interrupt transmission for those at greatest risk to prevent illness and death.
- Mitigating inequity – ensure equitable access to medical countermeasures for all people at risk, irrespective of socio-economic or demographic background.
- Ensuring transparency and flexibility – establish and maintain clear and open communication about allocation decisions and be ready to adapt strategies as new data emerge or situations change.
More than 3.6 million vaccine doses have been pledged for the mpox response, including 620,000 doses of MVA-BN pledged to affected countries by the European Commission, Austria, Belgium, Croatia, Cyprus, France, Germany, Luxembourg, Malta, Poland, Spain, and the United States of America, as well as Bavarian Nordic. Japan has pledged 3 million doses of the LC16 vaccine. This is the largest pledge so far.
International coordination
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, recognised the need for “powerful tools” like vaccines, therapeutics, and diagnostics, to bring the mpox outbreak “under control”.
“The COVID-19 pandemic illustrated the need for international coordination to promote equitable access to these tools so they can be used most effectively where they are most needed. We urge countries with supplies of vaccines and other products to come forward with donations, to prevent infections, stop transmission, and save lives.”
Dr Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, emphasised that WHO and its partners are working with the government of the Democratic Republic of the Congo and other affected countries to “implement an integrated approach to case detection, contact tracing, targeted vaccination, clinical and home care, infection prevention and control, community engagement and mobilisation, and specialised logistical support”.
“The AAM will provide a reliable pipeline of vaccines and other tools in order to ensure the success on the ground in interrupting transmission and reducing suffering.”
Join us at the Congress in Barcelona next month to share your insights on the best ways to ensure equitable access to essential medical countermeasures, and don’t forget to subscribe to our weekly newsletters for the latest vaccine news.
by Charlotte Kilpatrick | Sep 6, 2024 | Global Health |
The Vaccine Group (TVG) announced in September 2024 that its partnership with the University of Plymouth and the University of Cambridge has been awarded “significant” government funding to develop a vaccine to stop the development and spread of Streptococcus suis. Streptococcus suis is a bacterial infection that commonly affects the UK pig population. It can cause serious disease in pigs and has the potential to infect the humans working with them.
Streptococcus suis
Affecting more than 60% of pig farms across several countries in Europe, Streptococcus suis threatens both the pork industry and public health. It is a “noteworthy” pathogen responsible for significant bacterial mortality in piglets after weaning. There are no proven vaccines to address the disease’s “many strains”, and infected pigs are treated with different antibiotics.
The UK Government is targeting a 50% reduction in antibiotic use in livestock by 2030, so TVG is responding to the urgent demand for an effective vaccine. Their project will assess if a vaccine candidate that is already effective against the most common strain of the disease can protect pigs against multiple, or all, known strains. This has potential to also prevent transmission to humans.
DEFRA’s Farming Innovation Programme is providing a grant of over £1 million through Innovate UK. The project will unite experts from vaccine development, antimicrobial resistance, and veterinary medicine; it develops previous research that identified the potential candidate for the Streptococcus suis vaccine. Trials will be carried out with Moredun Scientific Ltd to explore the vaccine’s potential. The team will engage the pig farming community in their research to ensure that the vaccine meets requirements and can be administered in an “efficient and cost-effective manner”.
Dr Jeremy Salt, CEO at The Vaccine Group, described Streptococcus suis as a “major cause for concern” for farmers across the UK. It can lead to “significant losses”. Furthermore, as a zoonotic infection, it presents a risk of transmission to humans in the industry.
“Our goal in developing an effective vaccine is to stop the bacterial infection from developing in pigs and humans in the first place. By doing so, we can better protect the farmers, their animals, and their livelihoods.”
Dr Salt also hopes to make pork production “more efficient, human, and sustainable”, whilst helping the sector “address the global challenges of antibiotic resistance and carbon emissions”.
We look forward to welcoming Dr Salt back to the Congress in Barcelona to chair our One Health and Veterinary Track; get your tickets to join us there, and don’t forget to subscribe to our weekly newsletters for vaccine updates.
by Charlotte Kilpatrick | Sep 4, 2024 | Technology |
3PBIOVIAN announced in September 2024 that it has been selected by Rokote Laboratories Finland Ltd. as CDMO partner for GMP manufacturing of adenovirus type 5 (Ad5) vector-based candidate expressing a modified SARS-CoV-2 spike protein. The partnership aims to bring Rokote Laboratories’ intranasal FINCoVac 2.1 vaccine to Phase I clinical studies with 3PBIOVIAN providing Drug Substance and Drug Product. FINCoVac 2.1 is intended to elicit a strong mucosal immune response in the nasopharyngeal cells, potentially preventing infection and transmission.
Ad5 vector
The agreement covers GMP manufacturing of the Ad5 vector using 3PBIOVIAN’s standard process at facilities in Turku, Finland. With “extensive experience” in adenovirus GMP manufacturing solutions, 3PBIOVIAN pursues “successful scalability and GMP compliance”. To meet Rokote Laboratories’ “urgent” needs, the programme has advanced “exceptionally fast”.
FINCoVac 2.1
Rokote Laboratories seeks to “consolidate” the use of new vaccine technology in Finland, focusing on a second-generation coronavirus vaccine, FINCoVac 2.1. It is designed to “meet the challenge of the rapidly mutating variants” with applications as an “easy-to-dose booster”. The vaccine consists of an adenoviral vector, to which the SARS-CoV-2 viral spike protein gene has been transferred. FINCoVac is administered intranasally, so it is expected to offer a “wider immune response” than vaccines that are administered intramuscularly.
Dr Erkko Ylösmäki, CEO of Rokote Laboratories, is pleased with the partnership with 3PBIOVIAN to manufacture the vaccine.
“The ability to use 3PBIOVIAN’s standard process for rapid GMP batch production, along with their extensive experience with adenovirus-based processes, made 3PBIOVIAN the ideal CDMO partner.”
Dr Ylösmäki is excited to start the collaboration and hopes that “together we can further advance Finnish vaccine development”. Deputy CEO at 3PBIOVIAN, Antti Nieminen, commented that the company has “about two-decade-long history” in viral vector development processes and GMP-manufacturing of adenoviruses.
“We are happy to have a role in the journey of this novel second-generation coronavirus vaccine to clinical trials.”
For the latest vaccine manufacturing insights and updates at the Congress in Barcelona this October, get your tickets here, and make sure you’ve subscribed to get our weekly newsletters.
by Charlotte Kilpatrick | Sep 2, 2024 | Global Health |
UNICEF announced in August 2024 that it has issued an emergency tender for the procurement of mpox vaccines amid the public health emergency declared by Africa CDC and WHO. UNICEF is the world’s largest single vaccine buyer, reportedly procuring “more than 2 billion” doses annually for routine child immunisation and outbreak response on behalf of almost 100 countries. The tender is to help secure mpox vaccines for the “hardest hit countries” in a collaboration with Africa CDC, Gavi, WHO, PAHO, and other partners.
“This collaboration to increase access and timely allocation also includes working to facilitate donations of vaccines from existing stockpiles in high-income countries with the aim of containing the ongoing transmission of mpox.”
Emergency tender
Through the emergency tender UNICEF will establish conditional supply agreements with vaccine manufacturers to purchase and ship vaccines “without delay” once countries and partners have secured financing, confirmed demand and readiness, and regulatory requirements are in place. WHO is reviewing the information submitted by manufacturers in response to its invitation for expressions of interest for Emergency Use Listing.
The emergency tender is intended to secure immediate vaccine access and expand production. Agreements for up to 12 million doses through 2025 could be put in place, depending on demand, production capacity, and funding.
Ensuring equitable access
Director of UNICEF Supply Division, Leila Pakkala, highlighted the “paramount importance” of addressing the mpox vaccine shortage and delivering vaccines to “communities who need them now”.
“There is also a pressing need for a universal and transparent allocation mechanism to ensure equitable access to mpox vaccines.”
Dr Jean Kaseya, Director General of Africa CDC, agreed that “timely procurement and distribution” is “crucial to protecting the most vulnerable populations”. Dr Kaseya described the emergency tender as a “critical step forward in our collective effort to control the spread of this disease”.
“Africa CDC is committed to ensuring that vaccines are allocated swiftly and equitably across the continent, in partnership with UNICEF, Gavi, WHO, and other key stakeholders. Our unified response is essential to curbing the impact of this public health emergency and safeguarding the health and well-being of our communities.”
Dr Derrick Sim, Gavi’s interim Chief Vaccine Programmes and Markets Officer, echoed the significance of the emergency tender.
“Securing access to supply and financing, delivering doses, and in parallel ensuring countries are ready to administer them, are all vital actions that need to be conducted rapidly but thoroughly, and in a coordinated manner.”
Dr Sim welcomed the tender as “another positive step” in the response. WHO’s incidence manager for the global mpox response and acting Director for Epidemic and Pandemic Preparedness and Prevention is Dr Maria Van Kerkhove, who stated that a “swift, coordinated, and equitable response is critical” in the control of this mpox emergency and future iterations.
“All of us must act decisively now or risk allowing mpox to spread further and become an even greater global threat. In an interconnected world, the fight against mpox – as with other infectious diseases and health threats – cannot be waged alone.”
Dr Van Kerkhove shared that WHO is “glad to partner” on efforts to “get life-saving tools to people in need”.
For more on effective access strategies at the Congress in Barcelona this October, get your tickets to join us here, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Aug 28, 2024 | Technology |
Bharat Biotech announced the launch of HILLCHOL in August 2024, describing the novel single-strain oral cholera vaccine (OCV) as a “significant advancement in global health”. With only one manufacturer supplying OCVs globally, there is a yearly deficit of ~40 million doses. Thus, Bharat Biotech has established manufacturing facilities in Hyderabad and Bhubaneswar with the capacity to produce “up to 200 million doses” of the vaccine. HILLCHOL is administered orally on Day 0 and Day 14 to individuals older than one year.
HILLCHOL
Hilleman Laboratories compares HILLCHOL with existing cholera vaccines, which contain more than one strain; HILLCHOL uses a single, genetically engineered, inactivated ‘Hikojima’ strain, which reduces production costs and will expand access amid increasing outbreaks. HILLCHOL is presented in a mono-multidose format and should be stored at temperatures between 2°C and 8°C. It is intended to contribute “substantially” to the Global Task Force on Cholera Control (GTCC) effort of reducing cholera-related deaths by 90% for 2030. The vaccine is the result of “extensive” international collaboration.
Dr Krishna Ella, Executive Chair of Bharat Biotech, states that it is an “excellent success story of partnership leading to public health solutions”.
“Vaccines provide the best intervention to prevent, limit, and control cholera outbreaks.”
With new large-scale cGMP production facilities, Dr Ella is confident that Bharat Biotech’s production and supply capabilities are “significantly” enhanced. Hilleman Laboratories’ CEO, Dr Raman Rao, commented that “from day one our mission has been to develop affordable vaccines and biologics” for “countries with the most severe unmet medical needs”.
“This new vaccine delivers on that pledge and provides an innovative template for the internationalisation of future vaccine and biologics development from Singapore, that can positively impact global health.”
Dr Rao highlighted the pride that Hilleman Laboratories takes in the “joint effort” and ongoing “dedication to advancing global health equity through affordable, high-impact, and sustainable solutions for those who are most susceptible”.
For more on powerful vaccine partnerships driving global health innovation, get your tickets to the Congress in Barcelona this October, and don’t forget to subscribe to our weekly newsletters here.
