by Charlotte Kilpatrick | Oct 24, 2024 | Technology |
The University of Connecticut (UConn) announced in October 2024 that associate Professor Thanh Nguyen’s research has received “significant” backing from The Bill and Melinda Gates Foundation. The Gates Foundation has awarded a series of grants totalling $6.6 million, following support from the National Institutes of Health (NIH) and the US Department of Agriculture (USDA). The funding will contribute to research and innovation for a microneedle array patch that can deliver multiple human vaccines at once. The Foundation initially awarded $2 million, which has increased after early success.
Microneedle array patch technology
Dr Thanh Nguyen works in the College of Engineering’s School of Mechanical, Aerospace, and Manufacturing Engineering. His microneedle method is “far less painful” than traditional syringe delivery and offers access and uptake benefits.
“What if we were able to mail people vaccines that don’t need refrigeration, and they could apply to their own skin like a bandage?”
The technology delivers highly concentrated vaccines in powder from over months, through a “nearly painless” 1-centimetre-square biodegradable patch.
“The primary argument is that getting vaccines and boosters is a pain. You have to go back two or three times to get these shots. With the microneedle platform, you put it on once, and it’s done.”
Funding increases
After the initial award of $2 million, the project made good progress and received additional funding to support the development of a scale-up manufacturing technology to produce patches on an industrial scale. In late September, the Gates Foundation awarded $4 million to take the patch “a step farther” as a pentavalent and Polio vaccine targeting diphtheria, tetanus, pertussis, HIV, Hepatitis B, and Polio. With this funding, the team can “build up productivity”. They are partnering with LTS to scale up production and are expanding the size of laboratory.
The award also marks a fundraising milestone for Dr Nguyen, who has earned more than $25 million in research awards, which he reflects “doesn’t come naturally”.
“It comes from the recognition of the high impact of the research and the lab’s success in publishing articles. It is a testament to the importance of what we are doing.”
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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 18, 2024 | Technology |
In October 2024 the Animal and Plant Health Agency (APHA) and The Vaccine Group (TVG) announced that Innovate UK has awarded them a Smart grant in excess of £400,000 to advance a novel viral vector platform. In a project lasting 19 months, the two organisations will use technology developed by TVG scientists in candidate vaccines for two “important diseases in cattle”: bovine respiratory syncytial virus (BRSV) and lumpy skin disease (LSD). The project will continue previous research, which identified potential vaccine candidates; it is supported by the World Reference Laboratory for Non-Vesicular Diseases at The Pirbright Institute, determining how the candidates can produce an adequate serological response in animals and protect cattle.
BRSV and LSD
Bovine respiratory syncytial virus (BRSV) is the leading viral cause of respiratory illness in young calves in the UK. It affects around 1.9 million calves each year, costing approximately £54 million. It is “prevalent worldwide” and poses a “substantial economic burden” on beef and dairy producers. In the past 10 years, lumpy skin disease (LSD) has spread “dramatically” beyond former natural enzootic geographies in Africa and the Middle East to cause “severe disease” in other regions.
Both diseases have “broad global prevalence”, and BRSV particularly affects intensively reared cattle. Currently available commercial vaccines for BRSV do not prevent shedding and are restricted from use in young calves by maternal immunity. There are no DIVA (differentiating infected from vaccinated animals) vaccines available for LSD, so use is limited to areas where serosurveillance and eradication programmes are in place.
TVG’s vaccine solutions
The Vaccine Group (TVG) hope to address these challenges. With “key opinion leaders” for the two diseases in the UK and Canada, TVG has inserted transgenes for protective antigens from each virus into two separate constructs through genetic manipulation. Both vaccine candidates have been shown to be genetically stable and have demonstrated “stable and prolonged” protein expression in tissue culture over multiple passages. The technology works by introducing a benign virus to cattle, which stimulates the expression of proteins to induce an immune response.
Chief Executive Officer at TVG, Dr Jeremy Salt, reflected that infectious diseases are a “major cause for concern” for cattle farmers around the world, leading to “significant losses – both in terms of animal health and welfare, and in financial terms”.
“Our goal in developing a viral vector platform for use in cattle effective vaccines is to overcome some of the deficiencies that affect the current commercialised vaccines. By doing so, we can better protect the farmers, their animals, and their livelihoods.”
Dr Salt also hopes to “make beef and milk production more efficient, humane, and sustainable”, whilst “helping the sector address the global challenges of antibiotic resistance and carbon emissions”.
We look forward to hearing from Dr Salt at the Congress in Barcelona in just a few weeks; get your tickets to join us there and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Oct 17, 2024 | Technology |
Valneva and LimmaTech Biologics announced in October 2024 that they have been granted Fast Track designation by the United States FDA for Shigella4V (S4V). S4V is “the world’s most clinically advanced” tetravalent bioconjugate shigellosis vaccine candidate. In August 2024 the two organisations announced a strategic partnership and exclusive licensing agreement to develop, manufacture, and commercialise S4V. The FDA designation is granted to products in development that have the potential to treat serious conditions and fill an unmet medical need, with the goal of facilitating clinical development and expediting review.
Addressing a global health threat
An estimated 165 million cases of disease and 600,000 deaths are attributed to Shigella every year; the greatest burden is among children in low- and middle-income countries (LMICs). Shigellosis also affects international travellers from high-income countries and deployed military personnel in endemic regions.
Thomas Lingelbach, Chief Executive Officer of Valneva, stated that shigellosis is the “second leading cause of fatal diarrhoeal disease worldwide” with no approved Shigella vaccine.
“The development of Shigella vaccines has been identified as a priority by the World Health Organisation (WHO). Fast Track designation allows us to work closely with the FDA to accelerate our efforts to deliver a preventative solution against this deadly disease.”
Dr Franz-Werner Haas, Chief Executive Officer of LimmaTech, is “highly encouraged” by the designation, which “reinforces our efforts”.
“[It] underscores the significant potential of the S4V Shigella vaccine candidate to address a serious global health threat.”
The way forward
After positive Phase I/II results earlier in the year, LimmaTech will conduct a Phase II Controlled Human Infection Model study (CHIM) in the United States and a Phase II paediatric study in LMICs. These are expected to begin before the end of 2024. Valneva will assume all further development, including chemistry, manufacturing, and controls (CMC) and regulatory activities. It will also be responsible for global commercialisation if the vaccine is approved.
by Charlotte Kilpatrick | Oct 17, 2024 | Global Health |
A study in The Lancet Global Health estimates the impact that the 100 Days Mission could have had on the COVID-19 pandemic. The authors find that the implementation of non-pharmaceutical interventions (NPIs) within the 100 Days Mission could have averted around 8.33 million deaths, corresponding to a monetary saving of US$14.35 trillion. Investment in manufacturing and health systems contribute an increase to 11.01 million deaths averted. The researchers comment on the value of the 100 Days Mission but emphasise the importance of “prioritising a more equitable global vaccine distribution”.
In search of greater vaccine benefits
Although COVID-19 vaccines are estimated to have prevented almost 20 million deaths, the authors demand a better understanding of the “further health and economic benefits that could have been achieved” through shorter development times and “improved global equity in pandemic preparedness”. CEPI’s 100 Days Mission was proposed in 2021, establishing the ambition of cutting vaccine development time for new pathogens to 100 days. This about a third of the time taken to deliver the first COVID-19 vaccine.
“The availability of COVID-19 vaccines within 100 days would have substantially changed the pandemic; however, these benefits would be finite without enabling equitable access to vaccine products through system equity.”
Various efforts to encourage global vaccine distribution were “hampered” by inequities, and it is recognised that manufacturing capacity should be “expanded but also diversified” to “promote self-sufficiency and regional resilience”. Furthermore, supply chains and infrastructure must be scaled to enable the delivery of vaccines that rely on cold-chain infrastructure.
The study
The searchers hoped to quantify the potential impact of the 100 Days Mission by retrospectively estimating the effect it would have had on the COVID-19 pandemic, thus offering evidence to support decision making around future investments in research and development capabilities. They also aimed to quantify the impact of “additional investments”.
The analyses use an extended version of a previously published compartmental susceptible-exposed-infectious-recovered transmission model of COVID-19 vaccination with an explicit healthcare pathway. The vaccination pathway was expanded to include booster vaccination alongside waning efficacy, capturing the “restoration of immunity” through booster doses. The new vaccination pathway was parameterised to match platform-specific vaccine efficacy data and the duration of protection.
The authors modelled the impact of the 100 Days Mission by simulating a counterfactual scenario where the global vaccination campaign began on 20th April 2020, 100 days after the publication of the full SARS-CoV-2 genome. This scenario assumes that vaccinations in each country took the same roll-out process, but 232 days earlier. Two additional scenarios reflected “increased investment” in research and delivery infrastructure.
The Manufacturing scenario removed supply constraints, enabling the rollout of vaccination on 20th April 2020 in every country, without stockouts. The infrastructure-equity scenario enhanced both national health systems and global distribution networks so that all countries achieved 40% vaccine coverage in the first year and 40% booster coverage in the second year.
To account for the relaxing of non-pharmaceutical interventions (NPIs), the authors simulated three scenarios for NPI relaxation speeds as vaccination coverage improved. The History scenario assumed no changes, whereas the Target and Economic scenarios assumed earlier relaxing; the Target scenario lifted all restrictions over two months after reaching more than 80% adult coverage in high-income countries or more than 80% coverage in those older than 60 in other countries. The Economic scenario lifted NPIs more gradually after reaching the over-60 target, prioritising the reopening of schools.
Study findings
The results suggest that the 100 Days Mission could have averted an additional 8.33 million deaths due to COVID-19 by the end of 2021 when combined with the History NPI lifting scenario. In this scenario, an estimated 26.72 million severe cases of COVID-19 requiring hospitalisation and 1/44 billion infections would have been averted. Most of these averted deaths, hospitalisations, and infections would have occurred in low- and middle-income countries (LMICs).
The estimated VSLs (value of a statistical life) that could have been saved by the 100 Days Mission through the History scenario is US$22.61 trillion globally. As VSLs are “significantly higher” in HICs, 57% of the global value of statistical life averted occurred in HICs, even though most deaths would have been averted in LMICs. To estimate the monetary values associated with lives saved the authors multiplied the number of lives saved by the country-specific monetary VSL and by the value of a statistical life-year (VSLY).
“Increased investment in both global manufacturing and health systems infrastructure further increases the number of deaths that could be averted and the associated health-economic savings.”
In the 100 Days Mission with both manufacturing and health systems investments, an estimated 11.01 million deaths could have been averted and a value of $31.29 trillion in statistical lives saved. However, the authors describe this scenario as “unlikely”. In all scenarios involving the relaxing of NPIs thanks to earlier availability of vaccines, additional lives would have been saved.
In the Target NPI lifting scenario, an estimated 5.76 million deaths (100 Days Mission alone) to 9.20 million deaths (100 Days Mission with both manufacturing and infrastructure investments) could have been averted. In these scenarios, 12,600 and 23,900 fewer days of NPIs would have been implemented globally: 70 days and 133 days on average per country. Under the Economic scenario there were “similar trade-offs between public health and economic gains”. The public health and health economic outcomes would be greater than under the Target scenario, but still lower than the History scenarios.
Substantial benefits
“Earlier access to COVID-19 vaccines could have had substantial benefits.”
Most of the estimated averted deaths would have been concentrated in LMICs, but this demands investments in vaccine research, supported by “improvements to manufacturing and health system infrastructures”. With these investments, the authors estimate that 11 million deaths could have been prevented globally.
Although NPIs were effective at reducing transmission they incurred “significant economic and societal costs”, including consequences for education. Therefore, a major benefit of earlier access to vaccination is the reduction in school closures; in the Economic scenario, prioritising school opening could have averted 1,120 weeks of full school closures and 2,490 of partial school closures. This represents an average of 6 weeks of fully open schools and 14 weeks of partly open schools per country.
“Reopening schools and relaxing NPIs safely will crucially require scaling up both vaccine delivery infrastructure and manufacturing. Without addressing both aspects, advancements in vaccine development speed might not translate into equitable benefits globally.”
The results emphasise the importance of investments in support of the 100 Days Mission in controlling a future potential pandemic, with benefits for both health and economy.
“The 100 Days Mission is ambitious, requiring global innovation through creating vaccine libraries, clinical trial networks, accelerated immune response marker identification, rapid vaccine manufacturing, and strengthened global disease surveillance.”
CEO of CEPI, Dr Richard Hatchett, hopes that this research will encourage global commitment to the 100 Days Mission.
“This work shows in the starkest terms why the world needs to be prepared to move faster and more equitably when novel pandemic disease threats emerge. Investing in preparedness now to make the 100 Days Mission possible for future incipient pandemics will save millions upon millions of lives and protect the global economy against catastrophic losses.”
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by Charlotte Kilpatrick | Oct 16, 2024 | Technology |
CEPI announced in October 2024 that it is working with experts at the National Research Council of Canada (NRC) to bioengineer a “commonly used approach” to safely make protein antigens in “as little as two weeks”. This would be between eight and twelve times faster than the current timeline of antigen production for protein-based vaccines. CEPI is contributing up to CAD $850,000 and the NRC is providing up to CAD $308,000 (in kind) to establish proof-of-technology.
Low cost and high speed
CEPI notes the importance of manufacturers being able to make “sufficient quantities” of vaccine components at low cost to enable mass production. Although mammalian cell lines are a common choice for vaccine processes, boasting ease of culture and a high production yield, they can take four to six months to develop and optimise for antigen production. This is a “major challenge” to efforts to develop vaccines quickly in response to fast-spreading viral outbreaks.
An optimised approach
Scientists at the NRC have developed a mammalian cell line that could be optimised for rapid antigen production. The research is expected to “majorly accelerate” the time needed for infectious disease vaccine development, says CEPI’s Executive Director of Manufacturing and Supply Chain (Acting), Ingrid Kromann.
“If successful, this optimised cell line could help vaccine doses be more rapidly available for clinical trials and initial emergency use during future outbreaks, supporting CEPI’s goal – embraced by Canada, and other G7 and G20 nations – to respond to a novel virus with a new vaccine in just 100 days after its discovery.”
Importantly, the technology is going to be suitable for transfer to low- and middle-income countries, enabling “local and rapid” vaccine production closer to the source of a future outbreak and improving accessibility. Dr Lakshmi Krishnan, Vice President of Life Sciences at the NRC, looks forward to working with CEPI to take the platform technologies forward to “accessible tools that could help accelerate vaccine production around the world”.
“Recognising the critical need for rapid vaccine production during a health emergency, this research and development project in our labs will advance innovative technologies to improve biomanufacturing processes and increase the efficiency of large-scale manufacturing of vaccines and other biologics.”
For the latest in vaccine technology for improved accessibility, join us at the Congress in Barcelona this month, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Oct 16, 2024 | Technology |
A paper in Nature Biotechnology in October 2024 presents an “end-to-end clinical proteogenomic pipeline” to address the challenges associated with identification and prioritisation of antigenic peptides. NeoDisc combines “state-of-the-art publicly available and in-house software” with in silico tools to identify, predict, and prioritise tumour-specific and immunogenic antigens from multiple sources. The authors demonstrate the pipeline’s superiority over recent prioritisation pipelines and showcase the features that enable “both rule-based and machine-learning approaches”. They also reveal how NeoDisc’s multiomics integration identifies “defects in the cellular antigen presentation machinery”.
Antigen discovery
The researchers comment on the importance of personalised antigen discovery for the development of cancer vaccines. Common approaches for translational research and clinical trials include whole-genome sequencing (WGS) or whole-exome sequencing (WED) and RNA sequencing (RNAseq). However, the recent application of mass spectrometry (MS) to identify HLA-bound peptides and the use of proteogenomics have “facilitated the exploration of novel targets from a variety of antigens naturally processed and presented in cancer”.
“Their identification is laborious and current clinical pipelines do not support immunopeptidomics and are restricted to predicted neoantigens.”
Although immunotherapies are “remarkably effective” against some indications, “robust immune pressure” can force immune editing. Therefore, it is “essential” to understand the heterogenous antigenic landscape and the tumour’s capacity to present antigens.
The study
In the study, the authors introduce an “end-to-end” clinical antigen discovery proteogenomic pipeline: NeoDisc. It compiles publicly available and in-house software for the identification of immunogenic tumour-specific HLA-I and HLA-II antigens from genomics and transcriptomics and MS-based immunopeptidomics and enables their prediction and prioritisation with rule-based and machine-learning (ML) tools. It allows assessment of tumour heterogeneity and the functionality of the antigen processing and presentation machinery (APPM). The study compares NeoDisc’s performance with other tools, demonstrating its application for personalised antigen discovery and clinical implementation.
NeoDisc is a “dedicated computational framework” combining genomic, transcriptomic, and immunopeptidomic data and integrating curated public databases of known immunogenic TSAs, TAAs, oncoviral elements, and noncanonical transcripts. It uses matched tumour and germline genomic data for sample-specific variant characterisation, tumour content estimation, and copy number variation (CNV) and somatic mutation (SM) identification.
Four variant-calling algorithms are applied to WES and WGS data; variants that are detected by two or more callers are considered to have “high identification confidence”. Although highly mutated tumours usually respond better to immunotherapy, the selection of immunogenic neoantigens among “numerous possibilities” is “challenging”. Recent screening of large datasets of neoantigens in tumours from 112 participants has allowed the training of ML for prioritisation. ML classifiers trained on a fraction of this dataset have been integrated into NeoDisc to ensure “effective prioritisation”.
When NeoDisc’s rule-based and ML ranking approaches were compared with existing tools, the ML prioritisation algorithm “surpassed all the evaluated tools”. The researchers demonstrated NeoDisc’s “efficient prioritisation” on a cervical adenocarcinoma (CESC-1) characterised by an “exceptionally high mutational burden” (25 SMs per Mb).
Of the 393 identified actionable mutations, representing a pool of 19,051 peptides with a predicted binding rank ≤2%, 66 HLA-I neoantigenic short peptides (minimal epitopes) were selected through rule-based prioritisation for T cell screening of autologous tumour-infiltrating lymphocytes (TILs) by IFNγ ELISpot. 11 of the 66 peptides were immunogenic, including two that “ranked among the top ten candidates”. The NeoDisc ML model reordered the tested neoantigens, resulting in an “impressive” ranking of six immunogenic peptides in the top ten. NeoDisc also successfully identified two confirmed immunogenic neoantigens in the CESC-1 tumour MS immunopeptidomic data.
Personalised vaccines
While the default NeoDisc settings “exhibit good performance”, biopsies with low tumour content and low mutation burden could result in the detection of an “insufficient number of actionable high-confidence expressed mutations”. This would lead to a “suboptimal vaccine”. Thus, NeoDisc offers two additional modes:
- “Sensitive mode” considers the union of mutations called by all four variant-calling tools, to be used when an insufficient number of mutations are detected.
- “Panel mode” uses mutations listed in the available diagnostic clinical gene panel (GP) as input, allowing the design of vaccines for persons lacking dedicated biopsies. Note that GPs “often provide insufficient number of mutations leading to suboptimal lists of neoantigens or potentially none”.
The paper states that, in cancer vaccines, long sequences are favoured over minimal short peptides, motivated by the “efficient uptake and processing by APCs”. The NeoDisc ML tool ranks mutations according to their potential immunogenicity. Long sequences are “optimally” designed through maximised coverage of high-quality predicted HLA-I and HLA-II neoantigens.
In use in the field
NeoDisc is already being used in Phase I clinical trials for personalised cancer vaccines and adoptive T cell therapies in Switzerland; the authors hope that these demonstrate its “practical utility and potential for clinical translation”. Dr Michal Bassani-Sternberg of the Lausanne Branch of the Ludwig Institute for Cancer Research comments that NeoDisc provides “invaluable” insights into the immunobiology of tumours and the “mechanisms by which they evade targeting by cytotoxic T cells”.
“Notably, NeoDisc can also detect potential defects in the machinery of antigen presentation, alerting vaccine designers and clinicians to a key mechanism of immune evasion in tumours that can compromise the efficacy of immunotherapy. This can help them select patients for clinical studies who are likely to benefit from personalised immunotherapy, a capability that is also of great importance to optimising patient care.”
Florian Huber, first author, also reflected on the significance of this research.
“NeoDisc can detect all these distinct types of tumour-specific antigens along with neoantigens, apply machine learning and rule-based algorithms to prioritise those most likely to elicit a T cell response, and then use that information to design a personalised cancer vaccine for the relevant patient.”
Join us at the Congress in Barcelona this month to hear from experts in the Cancer and Therapeutic Vaccines track on their approaches to personalised vaccine development, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Oct 15, 2024 | Technology |
In October 2024, Panthera Biopartners announced that Parexel has confirmed its inclusion in the Parexel Site Alliance Vaccine Network. Panthera becomes the first UK public or commercial clinical trial organisation to join the global network of high performing clinical trial sites. Parexel’s Site Alliance Vaccine Network “fosters long-term collaborative relationships” with research organisations across the globe to “deliver efficiencies”. Panthera was chosen to join the Network because of “exceptional performance in recruiting patients” across “numerous” studies and an existing “strong working relationship” with Parexel.
Patient recruitment
As the “UK’s largest recruiter and runner of commercial clinical trials across its UK sites”, Panthera has recently been the top recruiter globally in four studies, the top recruiter in the UK in six studies, and achieved first patient in globally or in the UK in nine studies. The company statement acknowledges that “less than 10%” of physicians and patients participate in clinical research. Among patients who do participate, “minority groups are significantly underrepresented”.
“Research activities are often concentrated in academic institutions and investigator sites, so patients and their providers are often unaware of the work, and even if they’re interested, many lack the time and resources required to join studies.”
Site Management Organisations (SMOs) like Panthera are focussed “entirely” on recruiting patients and running clinical trials, collaborating with local GP practices and using targeted advertising and social media campaigns to ensure that “all sections of the community” can participate.
Delivering efficiencies
The Parexel Site Alliance Network engages more than 340 sites and 16,000 investigators in “long-term collaborative relationships”. It is intended to “deliver efficiencies” to patients, sites, and customers. Members partner with Parexel to improve research and patient experiences.
Chris Dodd, Chief Commercial Officer at Panthera, described the company’s selection as a “testament to the effort we have put in to ensure we meet or exceed our patient recruitment targets”.
“We are delighted to be working in partnership with such a successful organisation with such great site communications and stakeholder management. We look forward to working together to bring even more clinical research to the UK.”
Join us at the Congress in Barcelona to explore ways in which the whole vaccine value chain can contribute to greater diversity in research and improved participant experiences. Don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Oct 14, 2024 | Therapeutic |
Transgene announced in October 2024 that the primary objective of its randomised Phase II study of TG4001 has not been met. The study was evaluating TG4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital tumours. The primary objective was improvement in progression-free survival. Although this failure is “disappointing” to the company, Transgene states that it is evaluating the full results to “determine the best way forward”.
TG4001
Transgene’s TG4001 is an “innovative therapy capable of combating papillomavirus-induced cancers”. It teaches the immune system to identify and destroy the cancer cells expressing HPV-16 antigens, specifically E6 and E7.
Results and implications
The pre-planned subgroup analysis showed a positive efficacy trend in favour of the TG4001-containing regiment in cervical cancer patients. However, this requires further confirmation through additional analyses. These patients account for around half of the total patients enrolled in the study. Treatment was well tolerated, with adverse events “consistent” with previous observations.
“Transgene is currently evaluating the full study results in detail to determine the best way forward for this programme and will communicate further once this is completed.”
Dr Alessandro Riva, Chair and CEO of Transgene, acknowledged that “failure to meet the primary objective in our Phase II study with TG4001 is disappointing”.
“Nevertheless, we are encouraged by the positive efficacy trend in favour of the combination regiment in cervical cancer patients. We plan to complete a full and rigorous analysis of the data before deciding on any path forward for this asset.”
Dr Riva thanked patients and caregivers for their “important contribution” to the study.
“With a diversified portfolio of novel immunotherapies targeting solid tumours, our strategy remains focussed on advancing our lead asset, TG4050, an individualised cancer vaccine for head and neck cancers for use following surgery and adjuvant therapy.”
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by Charlotte Kilpatrick | Oct 14, 2024 | Global Health |
In October 2024 the European Investment Bank (EIB Global) announced €2 million financing for early-stage vaccine development in Rwanda by Akagera Medicines Africa Limited. The support is intended to accelerate research, development, and manufacturing of new vaccines against infectious diseases like tuberculosis, HIV, Lassa fever, and Ebola. It will also be used to “strengthen technical skills and expertise” to support “home-grown discovery, manufacturing, and development of vaccine delivery systems” in Rwanda.
Global Gateway
This financing is part of the EU Global Gateway initiative, a strategy to “boost smart, clean, and secure links in digital, energy, and transport sectors and to strengthen health, education, and research systems”. Team Europe is mobilising up to €300 million between 2021 and 2027 to “allow EU’s partners to develop their societies and economies” whilst creating opportunities for EU Member States to “invest and remain competitive”. EIB Global supports “high impact investment” to enhance healthcare and pharmaceutical manufacturing, encourage greater “health resilience”, and support equitable access to healthcare.
Continent-based solutions
EIB Global states that Africa bears the highest disease burden globally, demanding “more home-grown or continent-based solutions”.
“Vaccination is a critical activity to ensure and guide investments in universal health and has a crucial role to play in achieving 14 of the 17 United Nations Sustainable Development Goals.”
Akagera Medicines was founded in 2018 and registered a 100%-owned subsidiary in Kigali in 2022. Its mission is “targeting tuberculosis and other infectious diseases with liposomal nanotherapeutics”. Commenting on the financing announcement at the World Health Summit in Berlin, Chief Executive Officer Michael Fairbanks recognised the “significant support” of the European Investment Bank.
“We are now a clinical company and moving faster to build human capacity and specialised infrastructure in Africa to support vaccine development.”
CEO of the Rwanda Social Security Board (RSSB) Regis Rugemanshuro stated that the financial support is an “important contribution to the realisation of Rwanda’s vision to become a biotech hub” and the wider vision of “Africa becoming self-reliant in vaccine and medicine manufacturing”.
“RSSB is looking forward to deepening partnerships with EIB and other international institutions to build resilient healthcare ecosystems in Rwanda and in Africa.”
Vice President of EIB Thomas Ostros identified the Bank’s “close cooperation with public and private partners” to “accelerate development of innovative solutions”.
“The EIB is committed to further strengthening our partnership with local and international players, to scale up investment and support innovative technology together.”
Belen Calvo Uyarra, EU Ambassador to Rwanda, agreed that the investment was another “important milestone”.
“Through Global Gateway, the EU is focussed on advancing equitable access to health products and local manufacturing in Africa.”
For more from key players in efforts to establish local manufacturing capacities in Africa and champions of equitable access to health products, join us at the Congress in Barcelona later this month. 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 11, 2024 | Technology |
CEPI announced in October 2024 that the Centre for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota is to receive US$3.2 million to advance its open access Coronavirus Vaccines Research and Development (R&D) Roadmap. This is an “important tool created to guide the development of vaccines” against multiple coronaviruses. CIDRAP will monitor and evaluate R&D progress and “catalyse efforts” to develop broadly protective vaccines. The investment from CEPI will monitor progress towards the roadmap goals and milestones and enable the creation of an online database of current literature and reports on coronavirus vaccine research.
The CIDRAP roadmap
CIDRAP’s roadmap is developed with guidance from over 50 scientific leaders and financial support from The Rockefeller and Gates Foundations. It aims to respond to the threat of coronaviruses, highlighted in the experience of three new coronavirus epidemics (SARS, MERS, COVID-19) in just 20 years. Coronaviruses are a “real and present threat” that demand a “large, comprehensive, and coordinated” initiative.
“The ultimate goal of developing broadly protective coronavirus vaccines is therefore multi-faceted: to create more efficacious and durable COVID-19 vaccines, mitigate the potential threat of future coronaviruses that have not yet emerged, and, ideally, prevent infections and transmission.”
The roadmap covers five topic areas each with “key barriers and knowledge gaps” and corresponding “technical milestones for measuring success”:
- Virology applicable to vaccine R&D
- Immunology and immune correlates of protection
- Vaccinology
- Animal and human infection models for coronavirus vaccine research
- Policy and financing
CEPI’s support
The funding contributes to monitoring progress on these goals and milestones and supports an open access online research database as well as an open access online summary of all broadly protective coronavirus vaccines in preclinical and clinical development and a dashboard tracking funding and investment.
Dr Michael Osterholm, Regents Professor and Director of CIDRAP recognised CEPI’s contribution to coronavirus vaccine research and development.
“CEPI’s support and collaboration with CIDRAP will fast forward our efforts at creating broadly protective coronavirus vaccines.”
Dr Kent Kester, Executive Director of Vaccine R&D, CEPI, commented that COVID-19 was the “third new coronavirus to strike in the past 20 years, portending the emergence of further novel coronaviruses”.
“Having the latest information on vaccine research and progress within coronavirus vaccine R&D readily and openly available in CIDRAP’s roadmap will enhance the approach being pursued by CEPI and other scientific investigators around the world to develop vaccines that could confer protection against multiple coronaviruses at the same time.”
For the latest coronavirus vaccine research updates, including insights into the challenges of universal vaccine development, join us at the Congress in Barcelona this month. Don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Oct 11, 2024 | Technology |
Orlance, Inc., announced in October 2024 that it has been awarded a National Institutions of Health (NIH) Fast Track Small Business Innovation Research (SBIR) grant to develop an Enhanced Seasonal Influenza Vaccine that provides “better protection against disease” even in years when there is a mismatch between predicted and actual circulating strains. The award includes $300,000 for Phase I; the total funding for the Phase I and II combined programme amounts to $3.3 million. The grant enables Orlance to leverage its innovative MACH-1 powdered vaccine and immunotherapy platform to address both seasonally changing and highly conserved influenza immunogens.
MACH-1 for influenza
MACH-1 is a high-performance microparticle ‘gene gun’ technology that “efficiently and uniquely” delivers DNA or RNA vaccine-coated microparticles into cells in the epidermis, which is “rich in immune stimulating cells”. An advantage of this technology in comparison with currently licensed mRNA vaccines is that MACH-1-delivered vaccines are stable at room temperature and are painless and needle-free. These vaccines also offer protective levels of immunity with the “smallest doses yet achieved within the field”.
The grant will enable a project to address the limitations of current flu vaccines by broadening the number of influenza strains targeted in one vaccine. This means vaccine production can occur closer to influenza season and achieve a better match between predicted and actual circulating strains. It will also stimulate “more diverse types of immune responses” in systemic and localised cells. The programme builds on Orlance’s universal influenza vaccine, adding seasonally changing influenza antigens to maximise protection.
Excelling in the field
Orlance’s Head of Research and Development and Principal Investigator Dr Kenneth Bagley commented on the importance of the MACH-1 technology.
“The unique properties of MACH-1 delivery into the highly immune competent epidermis that generates potent systemic and local respiratory mucosal antibody- and T cell-mediate immunity, coupled with the large payload capacity of DNA vaccines, may allow for Orlance’s universal influenza vaccine to excel where other universal vaccines have failed.”
Kristyn Aalto, CEO of Orlance, recognised the “continued funding support” from NIH.
“[The] support of the MACH-1 platform including this enhanced seasonal influenza vaccine reinforces the potential impact and significant step forward MACH-1 can bring to vaccine technology.”
We welcome Kristyn to the Congress in Barcelona this month for the Mucosal and Alternative Delivery workshop; get your tickets to join us for this 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 9, 2024 | Global Health |
GSK announced in October 2024 that data from the AreSVI-006 (Adult Respiratory Syncytial Virus) Phase III trial of Arexvy indicate that a single dose could offer protection for three RSV seasons. Arexvy is the world’s first RSV vaccine, first approved by the United States FDA in May 2023 for the prevention of lower respiratory tract disease (LRTD) caused by RSV in older adults. The latest trial evaluates the efficacy of a single dose of the recombinant, adjuvanted vaccine against LRTD caused by RSV in adults aged 60 years and older.
RSV is a “common contagious virus” that affects an estimated 64 million people of all ages globally each year. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV causes over 465,000 hospitalisations and 33,000 deaths in adults aged 60 and older in high-income countries.
Clinically meaningful efficacy
The results suggest that after a single dose of the vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD compared to placebo. In the third season, vaccine efficacy was 48.0% against RSV-LRTD. The data include efficacy against different RSV subtypes, in adults between 70 and 79 years of age, and those with underlying medical conditions.
“Since RSV can exacerbate medical conditions and potentially lead to hospitalisations, cumulative efficacy over three RSV seasons has the potential for significant health impact.”
Another benefit of this protection is that healthcare professionals might have flexibility to administer the vaccine year-round. Over time, revaccination is “expected to be required to maintain an optimal level of protection”. Therefore, GSK will continue to share efficacy and immune response data to inform decisions on immunisation schedules and future revaccination.
GSK’s Chief Scientific Officer Dr Tony Wood is excited by the data, which show that a single dose could “help protect millions of older adults” to “benefit public health”.
“This is the only RSV vaccine with efficacy and safety data available through three full seasons. We will continue to provide data on longer term follow-up to help recommending bodies determine future revaccination schedules.”
We look forward to hearing from senior representatives of GSK, including for perspectives on directing vaccine development for older populations, at the Congress in Barcelona this month. Get your tickets to join us here, and don’t forget to subscribe to our weekly newsletters here!
by Charlotte Kilpatrick | Oct 9, 2024 | Technology |
In October 2024, CEPI announced that it is awarding funding of up to £3.7 million to support researchers at the University of Sheffield as they seek proof-of-concept for RNAbox. RNAbox is a specialised process designed to scale up the production of mRNA vaccines at regional vaccine sites. It is “easily adaptable and automated”, with the potential to improve global pandemic readiness by enabling increased equitable access to various mRNA vaccines, as and when needed. It also could help speed up responses to future emerging outbreaks.
Addressing mRNA challenges
mRNA vaccines be “more rapidly tailored” to specific diseases or variants, and the technology “holds promise” for different illnesses, including emerging infectious diseases. However, mRNA vaccines are “expensive to manufacture at a high product quality” and require complex cold-chain storage and transportation infrastructure. This makes them “extremely difficult to deliver to remote areas or low-resource settings”.
The RNAbox presents a potential solution to these challenges through its bespoke manufacturing process, designed to overcome the need to deliver the vaccine by facilitating local manufacture at small production sites. The process will run continuously to create between seven and ten times more mRNA at a time and enable more efficient use of raw materials. RNAbox uses digital-twin technology, in which a virtual replica of the vaccine manufacturing process is modelled on a computer in real-time with smart sensors collecting data on the physical product.
CEPI’s interest
CEPI states that the “fast, optimised vaccine production is critical to the 100 Days Mission”. The investment will explore applying the technology to vaccine development for CEPI priority pathogens, including the viruses that cause deadly diseases like Ebola, Lassa fever, MERS, and Nipah. Ingrid Kromann, Acting Executive Director of Manufacturing and Supply Chain at CEPI suggested that the University’s “versatile” technology “builds on the ‘vaccine revolution’ experienced during the COVID-19 pandemic”.
“It aims to overcome a number of scientific hurdles which resulted in poorer countries facing devastating vaccine inequity by helping to make high-quality, low-cost vaccines quickly and easily close to the source of an outbreak.”
Dr Zoltán Kis, School of Chemical, Materials, and Biological Engineering at the University of Sheffield, reflected on the “importance of being prepared” with the “necessary tools”.
“We need to tackle outbreaks equitably around the world, as diseases can spread across country borders.”
The RNAbox will “accelerate the development of new vaccines” and “mass-manufacturing against a wide range of diseases”.
“This transformative technology can also be used to develop much-needed vaccines against a range of unmet needs during non-epidemic/pandemic times. In case of a new epidemic/pandemic, the RNAbox can be quickly adapted to produce vaccines to tackle outbreaks. This will enable vaccine development and manufacturing capacity locally in countries around the world to serve local needs.”
The researchers will work with vaccine manufacturers in low- and middle-income countries to ensure the technology is fit-for-purpose in lower-resource settings.
At the Congress in Barcelona this month we will hear from experts who are revolutionising mRNA vaccine production to ensure products are accessible. Join us there to learn more, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Oct 8, 2024 | Global Health |
A report from Coalition for Life Course Immunisation (CLCI) considers the financial and policy frameworks of various National Immunisation Programmes in Europe with a focus on sustainable financing and informed decision-making. The report addresses access and distribution disparities with “actionable strategies” to ensure everyone receives the vaccinations they need throughout their lives. CLCI describes the analysis as “crucial for stakeholders and policymakers” as a foundation for “advocating for robust, inclusive public health policies” that can be adapting to various healthcare challenges.
Financing and decision-making
The paper presents profiles for 16 European Union Member States: Austria, Belgium, Cyprus, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Lithuania, Norway, Poland, Romania, Spain, and the Netherlands. These countries are divided into Eastern and Western European nations.
The study finds that the seven Eastern countries had a lower over-65 influenza vaccination coverage rate than the nine Western countries (33% vs 54%). They also spent less of their GDP on healthcare (4.6% vs 6.2%) and less of the healthcare budget on prevention (7.6% vs 10%). Countries with decentralised health systems allocated a higher percentage of their GDP to healthcare and a larger proportion of their healthcare budget to prevention than centralised systems.
7 out of 16 countries reported ringfencing of funds for vaccination and prevention, a common approach for countries that have Ministry of Finance involvement in budgeting. Two countries reported using long-term, multi-year contracts to secure vaccine supply and stabilise financing.
Spotlight on Spain and the Netherlands
As The World Vaccine Congress Europe is taking place in Barcelona this year (2024) and Amsterdam next year (2025) we chose to look more closely at the country profiles of Spain and the Netherlands. The report offers a brief history and an insight into the potential future landscape for both countries:
- Spain – healthcare, including vaccination programmes, has been publicly funded since the establishment of the Spanish National Health System in 1986. Decentralisation in the late 20th century led to “variability” in programme implementation. Spain is “firmly focussed on vaccination as a cost-effective public health measure”. It is increasing investment in public health infrastructure and immunisation coverage will expand to include more diseases and eligible populations. It is also advancing digital transformation through national immunisation registries, enhanced data analytics for decision-making, and digital tools to improve uptake and surveillance.
- The Netherlands – the Dutch National Immunisation Programme (RVP) was established in 1957 to provide free vaccines to all children. This has expanded to include more vaccines. During the COVID-19 pandemic, the budget was allocated “immediately”. Current efforts are underway to “push more proactive allocated budgets to accommodate new vaccines more efficiently”. Demand is driven by an ageing population.
Head-to-head
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Feature
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Spain |
The Netherlands
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Health system
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Decentralised |
Decentralised
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Stakeholders
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The Public Health Commission of the Ministry of Health, the National Immunisation Technical Advisory Group (NITAG), and regional health authorities |
The Health Council, Dutch National Institute for Public Health and the Environment (RIVM), Ministry of Health
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Introducing a new vaccine
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New vaccines are evaluated by NITAG before the Public Health Commission recommends updates to the National Immunisation Plan (NIP) and final financing decisions made by regional Ministries of Finances. This means vaccine recommendations can vary between regions. |
New vaccine recommendations from the European Medicines Agency (EMA) go through the Minister of Health and State Secretary, who asks the Health Council to evaluate before funding is considered. After a recommendation from the Health Council, the MoH asks the RIVM to implement the vaccine in the National Immunisation Plan (NIP).
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Primary funding sources
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Regional governments |
Public funding
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Critical financing challenges
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High cost of new vaccines, decentralised health system, insufficient political will |
No set budget causes delays, economic pressures, and healthcare budget constraints
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% of GDP spent on healthcare
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10.4% |
10.2%
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| % of healthcare budget spent on prevention |
9% |
3.5%
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Calls to action
The report concludes that the landscape of vaccine financing and decision-making in Europe is “complex”, with “significant variations”. Notably, Ministries of Finance play a key role in healthcare budgeting.
“While some countries have implemented sustainability mechanisms, such as long-term contracts and split investments, budget limitations and political will remain significant barriers to expanding adult vaccination programmes.”
Decentralised health systems demonstrated higher healthcare spending and more investment in prevention; however, this did not necessarily correlate with broader adult vaccine coverage.
The report “advocates for an EU-wide integrated approach to enhance the efficacy of national vaccination strategies for adults” with four specific “calls to action”:
- Strengthen political commitment and sustainable financing
- Increase prevention budgets and foster unity
- Enhance understand and support for vaccination
- Promote comprehensive immunisation programmes
Is your country profile presented in the report? Do you find any of the results surprising, and do you agree with the calls to action? At the Congress in Barcelona this month we look forward to discussing different financing and decision-making approaches with global health experts. Get your tickets to join us for these conversations, and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Oct 7, 2024 | Technology |
In October 2024, WHO announced that a fourth WHO-prequalified human papillomavirus (HPV) vaccine product, Cecolin, has been confirmed for use in a single-dose schedule. This update is an “important milestone” that will contribute to “improving sustainable supply of HPV vaccines”, ensuring that more people get access to the vaccines that prevent cervical cancer. HPV vaccine programmes have been “hampered” by supply shortages since 2018, and recent production challenges have led to further shortfalls, which will affect girls in need of HPV vaccines Africa and Asia.
Eliminating cervical cancer by tackling HPV
More than 95% of the 660,000 annual cervical cases are caused by HPV. Every two minutes, a woman dies from the disease, and 90% of these deaths happen in low- and middle-income countries. 19 out of the 20 “hardest hit” countries are in Africa. However, vaccination is an effective way of addressing this health need. Dr Tedros Adhanom Ghebreyesus, WHO Director-General, states that “we have the ability to eliminate cervical cancer, along with its painful inequities”.
“By adding another option for a one-dose HPV vaccination schedule, we have taken another step closer in consigning cervical cancer to history.”
Dr Kate O’Brien, Director of the Department of Immunisation, Vaccines, and Biologicals at WHO, reflected that achieving a 90% coverage in girls by the age of 15 is the target of the first pillar of WHO’s global strategy for cervical cancer elimination.
“Given the continuing supply challenges, this addition of single dose vaccine product means countries will have greater choice of vaccines to reach more girls.”
Cecolin
Cecolin is a bivalent HPV vaccine delivered intramuscularly as a single dose. It is manufactured by Xiamen Innovax Biotech and should be stored between 2°C and 8°C. It is designed to protect against HPV types 16 and 18, which are commonly associated with the development of cancer. When Cecolin received prequalification, PATH stated that it had provided “technical assistance” for the process to facilitate greater accessibility. PATH’s China country representative Yuan Yuan commented that the vaccine would put the world “on its way to more equitable HPV vaccination”.
Single-dose coverage
Several products that were initially prequalified for use in a 2-dose schedule can now be used in a single-dose schedule. Cecolin can be recommended for “off-label” use after data support the modified schedule until the manufacturer adds the modified use to the label. Data from July 2024 show an increase in one dose HPV vaccine coverage among girls aged 9-14 years, from 20% in 2022 to 27% in 2023. In 2023, 37 countries were implementing a single-dose schedule; this increased to 57 by September 2024. WHO suggests that the adoption of a single-dose schedule has resulted in “at least” 6 million additional girls being reached with HPV vaccines in 2023.
For insights into the role of vaccination in elimination strategies, why not join us at the Congress in Barcelona this month? Don’t forget to subscribe to our weekly newsletters here for more vaccine news.
by Charlotte Kilpatrick | Oct 4, 2024 | Technology |
In September 2024, Vaxart announced the initiation of the sentinel cohort of its Phase IIb clinical trial evaluating the oral pill COVID-19 vaccine candidate in comparison with an approved mRNA vaccine. The funding is now approved for this part comprising 400 participants; 200 will receive Vaxart’s COVID-19 vaccine candidate and 200 will receive the approved mRNA vaccine comparator. The full trial will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events.
Changing the vaccine landscape
Vaxart states that “for two hundred years vaccines have been administered by intramuscular injection”, offering the company’s oral pill vaccines as a way to “change everything”. The COVID-19 vaccine attacks invading pathogens at their points of entry, triggering strong IgA and T-cell responses to “repel and overwhelm” the invaders. It is designed to be stable at room temperature to allow global distribution with “wide public acceptance, minimal cost, and maximum speed”.
In trial
The Phase IIb trial has two parts and will enrol healthy adults in the United States. The first part will engage 400 participants; once an independent Data and Safety Monitoring Board (DSMB) and FDA review the data from these participants, the second part will be initiated, enrolling 10,000 participants. A goal of the trial is to enrol participants “in line with U.S. demographics”, and to include at least 25% over the age of 65.
The primary endpoint is relative efficacy of Vaxart’s candidate compared to the approved mRNA vaccine for the prevention of symptomatic disease. Primary efficacy analysis will be performed after all participants have either discontinued or completed a study visit 12 months after vaccination. Funding was granted through BARDA’s Project NextGen initiative to accelerate and streamline the development of innovative COVID-19 interventions, including vaccines.
A strong step
Dr James Cummings, Vaxart’s Chief Medical Officer, described the initiation of the sentinel cohort as a “strong step” towards the goal of “developing a vaccine that may bring us closer to a sustainable solution to the persistent threat of COVID-19″.
“We continue to progress toward our goal of conducting the Phase IIb study and look forward to the results of our mucosal technology’s first head-to-head comparison against an approved mRNA vaccine for this virus.”
We look forward to learning more about the vaccine’s progress from Dr Cummings at the Congress in Barcelona this month; if you’d like to join us there do get your tickets now. Don’t forget to subscribe to our weekly newsletters for more 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.
