Infectious Diseases - Q1 2024

Infectious Diseases

“The incidence to tuberculosis (TB) in countries with a high burden of this airborne disease is falling at a glacial pace.”

“Approximately 4 million deaths worldwide are prevented by childhood vaccination every year.”

Volunteers visit a community in New Delhi, India to raise awareness of TB infection.

Professor Guy Marks, International Union Against Tuberculosis and Lung Disease Page 04

Laetitia Bigger IFPMA Page 07

Volunteers India

Javier Galeano

The Union

“Far too many people with TB remain undiagnosed and untreated.” Professor Guy Marks President and Interim Executive Director, International

“The changing climate further complicates the fight against malaria.”

Umaro Sissoco Embaló President of Guinea-Bissau and Chair, ALMA

BY Meg C. Doherty World Health Organization, Geneva, Switzerland

WRITTEN BY Michael R. Jordan Tufts University School of Medicine, Boston, MA, USA

Antiretroviral therapy (ART) has revolutionised HIV care and treatment, allowing nearly 30 million people to live healthy lives. HIV drug resistance (HIVDR) reduces the effectiveness of antiretroviral drugs for HIV treatment and prevention, leading to an increase in HIV incidence, morbidity and mortality.

In 2018, dolutegravir (DTG)-based ART became the World Health Organization’s (WHO) preferred HIV treatment for children, adolescents, and adults. By July 2023, 91% of 127 low and middleincome countries adopted DTG-based ART, which has the benefit of rapidly achieving undetectable HIV viral load levels and has a reduced risk of developing drug resistance compared to other ART drug combinations. However, with the incorrect use of DTG-based ART, there is a risk of the emergence of HIV drug resistance (HIVDR) — leaving DTG ineffective at controlling HIV.

Dolutegravir: population-level viral suppression and drug resistance outcomes

HIV drug resistance to dolutegravir on the rise in low and middle-income countries

Learn about HIV viral suppression and emerging HIV drug resistance to dolutegravir.

WHO’s response to this new evidence

WHO recommends that countries routinely implement standardised surveillance of HIVDR to follow the prevalence and patterns of resistance among people not achieving suppressed viral load.

Despite massive efforts to transition to DTGbased HIV treatment since 2018, only 10 countries have finalised acquired HIVDR surveys among adults receiving DTG-based ART, and only six countries have implemented surveys of acquired HIVDR among children and adolescents receiving DTG-based ART.

“2023 marked the first time in 20 years that the US saw locally acquired mosquito-transmitted (LAMT) malaria cases.”

In its HIV Drug Resistance Report 2024, WHO documents high levels of viral load suppression (>90%) in populations receiving dolutegravircontaining ART. These results bring us one step closer to the goal of ending AIDS by 2030. Yet, recent observational data reveal that HIVDR to DTG is emerging at levels that are surprising to many experts, exceeding those observed in clinical trials.

Among people not achieving viral suppression, levels of dolutegravir resistance range from 3.9% to 8.6%, with levels as high as 19.6% observed among highly treatment-experienced people who transitioned to a DTG-containing ART while having high HIV viral loads. In a study in South Africa,1 DTG resistance soared from 2.7% in 2021 to 11.9% in 2022 in people with laboratory-confirmed treatment failure and DTG use.

To date, countries reporting HIVDR data were early adopters of DTG-based treatment and have not repeated surveys; available results may underestimate the true prevalence of DTG resistance and preclude analysis of trends over time. WHO calls on countries to routinely implement and report data from standardised surveys characterising the prevalence, risks and patterns of DTG drug resistance. Surveys inform the quality of treatment programmes and influence care and treatment guidelines.

How to support HIVDR surveillance

Greater funding and political will are required to sustain and expand global HIVDR surveillance efforts. Without steadfast commitments from international organisations, governments, programmes and funders to address challenges associated with HIVDR, we risk unnecessarily losing lives, the effectiveness of our best HIV treatment in decades, being without a replacement in sight and putting us off-track to reach UN sustainable development goals by 2030.

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Fighting back against drug resistance in malaria

Antimicrobial resistance (AMR) is a global health crisis. Learn about the impact of AMR on infectious diseases, such as malaria, and the race against evolving microbes.

WRITTEN BY

Infectious diseases are driven by microbes seeking to thrive, with little regard for the impact on their hosts. When these hosts are us — humans — we pay particular attention to limiting microbes’ ability to live at our expense.

Antimicrobial medicines are a large part of the answer to this problem — whether for the fight against bacteria, viruses, fungi or parasites. Microbes, however, are determined to live. When a microbe evolves to survive exposure to an antimicrobial medicine, a new strain of resistant infection can be created. When the drug-susceptible microbes die, the resistant strains spread.

This process of natural evolution and survival of the fittest has dire implications globally for human health and can be summarised in three letters: AMR (antimicrobial resistance).

Global impact of AMR beyond bacteria

The impact of AMR is felt most acutely for bacterial infections, such as ‘superbugs’ like MRSA (Methicillinresistant Staphylococcus aureus) and multi-drug-resistant tuberculosis.

Bacterial AMR is estimated to kill

1.27 million people annually, with the potential to reach 10 million by 2050.

Much of the collective global public health community’s attention has centred — for good reason — on addressing bacterial AMR. Antibiotics are essential not only for addressing infections but also for supporting essential elements of modern medicine, including chemotherapy for cancer and routine surgeries.

Yet, AMR is not limited to bacterial AMR, and resistant microbes are challenging global efforts to eradicate other infectious diseases, including HIV and malaria, which are facing rising trends of resistance.

Emerging threat of malaria drug resistance

Malaria, a life-threatening parasitic infection, transmitted to humans through the bites of infected mosquitoes, is no stranger to drug resistance. In the mid-20th century, broad access to an anti-malarial treatment led to gains in addressing the infection, however those gains were jeopardized within 50 years due to widespread resistance to the

treatment. The discovery and rollout of an updated combination therapy revived the ability to successfully treat malaria, and it remains highly effective today.

Unfortunately, troubling signs are gathering for malaria drug resistance. Treatment failure rates have increased, beginning in South-East Asia; and partial resistance has been confirmed in multiple African countries.

The implications for the malaria response across Africa, which bears 95% of the global malaria burden, are severe. Nearly 80% of malaria deaths are in children under five years of age, equating to one death every two minutes. Due to the spread of drug-resistant malaria, there is tangible potential for this threatening development to worsen.

Nearly 80% of malaria deaths are in children under five years of age, equating to one death every two minutes.

Progress to address AMR in malaria

Work is being done to address the threat of AMR in malaria. Efforts to control malaria involve a combination of vector control, prompt diagnosis and treatment of cases.

The World Health Organization (WHO) has a strategy to respond to antimalarial drug resistance in Africa. Organisations like Roll Back Malaria and the Global Fund to Fight AIDS, TB and Malaria are coordinating activities and mobilising resources to address the issue.

“Malaria is facing the perfect storm: rising threats from insecticide resistance, the climate crisis, financing gaps and biological threats intensifying the risk of malaria to public health with progress having already plateaued pre-Covid-19. While we do not need to create an alarm for malaria, addressing this issue requires urgency and seeking viable solutions becomes imperative,” says Sherwin Charles, Co-Founder of Goodbye Malaria, who has been at the forefront of global efforts to fight malaria for decades.

“Crucially, tackling this threat demands innovative products along with market-shaping tools to ensure easy market access and scalability, particularly in financially constrained environments. The journey ahead necessitates robust public-private partnerships to navigate and withstand the complexities of this storm.”

Tackling AMR is an ongoing effort. Microbes never stop working to evade the tools developed to stop them. The question is whether we can evolve fast enough to outpace the resistance.

Erika Satterwhite Head of Global Policy, Viatris

Featuring input from Sherwin Charles, Co-Founder of Goodbye Malaria

WRITTEN BY Peter Roth Head of Publishing, MDPI, Basel, Switzerland –independent academic publisher

Transdisciplinary partnerships for disease elimination and global health

Combating infectious diseases calls for great scientific minds — and great scientific collaboration. Learn about the milestones in disease elimination and the global solidarity shaping our response.

The history of humankind is the history of infectious disease. From the plagues of the Old Testament through the Plague of Justinian, the Black Death, the Spanish Flu and recent Covid-19 pandemic, society has been repeatedly redefined by its response to pathogens. Looking to the future, our continuing success as a species will depend critically on how we manage infectious diseases — both those we know and those yet to develop.

Milestone in disease elimination

Celebrating its 75th anniversary last year, the World Health Organization (WHO) noted that 2023 was a record year for disease elimination.

Azerbaijan, Tajikistan and Belize all eliminated malaria while Benin, Mali and Iraq eliminated trachoma, and Bangladesh and Lao People’s Democratic Republic eliminated lymphatic filariasis.1

worldwide battle against infectious diseases in our age is Professor Marcel Tanner, Director of the Swiss Tropical and Public Health Institute, Basel, from 1997 to 2015. Famed for his motto, “You can never know everything, but you always know enough to do something4,” Tanner has received global recognition for his expertise in the field of infectious disease research and control.

Imagination, dedication and collaboration In 2022, MDPI had the privilege of publishing a special issue of its journal, entitled Diseases, celebrating Tanner’s 70th birthday. The many heartfelt tributes in this special issue highlight what an extraordinary mind can achieve during a lifetime of scientific imagination, dedication and collaboration.

If you want to solve a societal problem, it does not matter which discipline contributes the most — the solution is always transdisciplinary.

Simultaneously, however, Johns Hopkins University lists the following as emerging diseases: HIV infections, SARS, Lyme disease, Escherichia coli O157:H7 (E. coli), hantavirus, dengue fever, West Nile virus and the Zika virus.

Arguably, even more concerning is the occurrence of re-emerging diseases including malaria, tuberculosis, cholera, pertussis, influenza, pneumococcal disease and gonorrhoea.2

Global solidarity and rising to challenges

In its 2023 reflections, WHO emphasised how ‘working together in global solidarity has enabled us to rise to complex challenges in the past and will continue to do so in future.’3

An outstanding figure in the

Tanner himself has said: “If you want to solve a societal problem, it does not matter which discipline contributes the most — the solution is always transdisciplinary.”5 Governments, NGOs, publicprivate partnerships and academic institutions all have an essential role to play here — so does scientific publishing.

I have spent my life in this field — and am just as excited as ever at the prospect of publishing more transformative research from worldrenowned experts in the service of the global scientific community.

References

1 https://www.who.int/news-room/spotlight/global-healthachievements-2023 (accessed 13.03.24).

2.https://www.hopkinsmedicine.org/health/conditionsand-diseases/emerging-infectious-diseases (accessed 13.03.24).

3.https://www.who.int/news-room/spotlight/global-healthachievements-2023 (accessed 13.03.24).

4.https://www.mdpi.com/journal/diseases/special_issues/ Marcel_Tanner (accessed 13.03.24).

5.https://www.mdpi.com/journal/diseases/special_issues/ Marcel_Tanner (accessed 13.03.24).

Change needed to break the chain of tuberculosis

BY Professor Guy Marks President and Interim Executive Director, International Union Against Tuberculosis and Lung Disease

End tuberculosis in high-burden countries. Adapt and implement evidence-based interventions to stop the spread of this deadly, but curable, disease.

The incidence of tuberculosis (TB) in countries with a high burden of this airborne disease is falling at a glacial pace. In 2022, 10.6 million people fell ill with TB and 1.3 million died — more deaths than from any other infectious disease.

Tuberculosis with no symptoms

Far too many people with TB remain undiagnosed and untreated, often because they do not experience or recognise symptoms and, therefore, don’t seek care. These people are infectious and transmit TB to others who then develop TB from these unrecognised exposures. It was the same with Covid-19, where much of the spread occurred from infectious people who had no symptoms.

Setting context and targeted approach

Some interventions deployed in high-burden countries are transferred from low-burden countries. This is not always appropriate. For example, targeting high-risk groups is effective in low-burden countries because, in those settings, most TB occurs in these groups. However, in high-burden settings, everyone is at risk of TB. Targeting selected ‘high-risk’ groups alone will leave most people with TB undetected and infectious.

Approach to stopping transmission

The current strategy for ending TB in high-burden countries is not working. We must change our approach, based on new evidence, to win the fight against TB. In high-burden settings, most people who develop TB have been infected within the last two years. This means reducing the rate of new TB infections can have a big impact on breaking the chain of transmission.

Most people with infectious TB in these settings do not have symptoms. A key intervention must be population-wide screening, regardless of symptoms. This will enable us to find the majority of people with TB. This was highly effective for Covid-19 and in the 1960s and 70s in the UK, Australia and other countries that successfully ended TB.

Paradigm shift in response

Such modifications will not end TB in isolation; a shift in mindset must accompany them. Another learning from Covid-19 is how well governments and the global population respond to public health measures when they understand the threat.

An issue is that TB is not perceived to be a great enough threat to warrant the urgency and priority achieved for Covid-19. We need to recognise that the current strategy is not working. We must take it upon ourselves to change our approach and make TB history.

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Why polymerase chain reaction diagnostics are key to fighting AMR

When it comes to treating infectious diseases, the target is constantly shifting as bacteria mutate. This might not be an issue if antibiotics were being developed to keep pace, but the fact is: they’re not.

Polymerase chain reaction technology

“There’s just not a huge pipeline of antibiotics, so we’re left with a relatively small menu of antimicrobials that we can use,” confirms Dr Michael Loeffelholz, Vice President of Scientific Affairs at diagnostics company Cepheid.

“Of particular concern are superbugs. They are resistant to most antimicrobial agents, making infections caused by superbugs difficult or impossible to cure. In their fight against AMR, countries including the UK have launched guidelines that focus on managing superbugs.”

While the discovery of a potential new antibiotic compound earlier this year offers some hope, there is much work ahead, and it will be years before patients see the benefits. So, as the search continues, we need to preserve the precious resources we have — and polymerase chain reaction (PCR) technology has a vital role to play.

Speed and efficiency of PCR testing

Most of us were first introduced to PCR tests during the Covid-19 pandemic. Being swabbed in a remote car park became synonymous with those years, but did any of us give a second thought to what the letters PCR meant?

In the fight against antimicrobial resistance (AMR), accurate polymerase chain reaction testing is key to safeguarding antibiotics and improving patient care.

In 2019, the UK set itself an ambitious five-year target to reduce antibiotic use by 15%. Without accurate diagnostics, drugs continue to be prescribed in a ‘best guess’ scenario, which is why PCR testing is crucial.

Studies completed in a sexual health clinic several years ago compared how antibiotics were prescribed when rapid onsite PCR tests were offered versus slower forms of diagnosis. Findings showed that healthcare professionals, who had to wait at least a day for results, often felt compelled to prescribe drugs based purely on the symptoms presented by patients. This meant overuse of antibiotics was common while patients in the early stages of disease or with mild symptoms were falling through the net completely.

Loeffelholz explains: “By doing the PCR right away during their clinic stay, fewer people were put on the antibiotics who were negative, and more people who actually had a sexually transmitted infection were put on appropriate antibiotics.”

By doing the PCR right away during their clinic stay, fewer people were put on the antibiotics who were negative.

PCR is a laboratory tool where sections of DNA are reproduced millions, or even billions, of times. The technique, which has been around since the mid-1980s, makes it much easier for scientists to identify even the smallest number of pathogens in the body in a matter of minutes to hours.

This insight ensures healthcare professionals can prescribe the right medication much faster, improving patient care and protecting one of our most valuable assets: antibiotics.

PCR for accurate antibiotic prescription

Overuse of drugs is a major contributing factor to AMR.

Increasing access to PCR testing PCR testing is being used with increasing frequency for numerous diseases, from respiratory conditions and blood viruses to oncology and sexually transmitted infections. While the initial cost of equipment has been a prohibiting factor in the past, access is now increasing.

“Evidence is driving clinical practice guidelines produced by UK and European agencies and in the US,” confirms Loeffelholz. “We want to look beyond simply what is the cost, but the impact that this causes cost-wise to the whole system and the continuum of patient care.”

Loeffelholz is among those pushing to make PCR testing more accessible in the communities that would benefit most. “We’re looking at decentralisation — testing in sites that are closer to the patients through walk-in clinics and mobile vans where there are high-risk patients with, for example, sexually transmitted infections or hepatitis C.”

The UN anticipate that, by 2050, around 10 million people will die each year as a result of antimicrobial resistance. With few other tools in our arsenal, PCR needs to feature prominently in the fight.

INTERVIEW WITH Dr Mike Loeffelholz Vice President Scientific Affairs, Cepheid

WRITTEN BY Kate Sharma

Collaborative science: key aspect to successful vaccine development

When another pandemic strikes, new technologies and collaborative strategies will be crucial to helping the scientific community develop drugs and vaccines in the fastest way possible.

It’s not a question of ‘if’ another global pandemic will strike, insists Luc Gagnon, PhD — but a question of ‘when.’ “It’s just a matter of time,” he says bluntly.

That’s the bad news. The better news is that, when it does come, the scientific community should be better prepared to deal with it, according to Gagnon.

mRNA vaccine development strategies

As Global Head Vaccine Sciences at Nexelis, a Q² Solutions Company — provider of advanced assay development and laboratory testing services for infectious, oncologic and metabolic diseases — Gagnon leads scientific operations supporting vaccines and biologics development for infectious diseases throughout clinical trial phases.

“As a community, we must be able to learn from the past and find new pandemic vaccine solutions in the fastest way possible,” he says. “For example, every large player in this space now has an mRNA strategy in their vaccine portfolio.” This is a transformative technology where scientists use a molecule called messenger RNA (mRNA), rather than part (or inactivated) of a bacteria or virus, to produce an immune response.

Collaborative science for pandemic preparedness

If there’s one thing the Covid-19 pandemic highlighted, it’s the importance of collaborative working. In 2020, Canada-based Nexelis laboratory was chosen by Coalition for Epidemic Preparedness Innovations (CEPI) as the reference laboratory to transfer assays and build a centralised network represented by over 10 laboratories globally, working to reliably assess and compare immunological responses generated by Covid-19 vaccine candidates.

The world can’t afford to be complacent about vaccine science, which is an incredibly challenging field.

“It’s a new, fast way of producing a vaccine,” notes Gagnon. “In addition to vaccines, there is the promise of monoclonal antibodies, which can offer passive protection for a certain level of time.”

Turning the tide against malaria: a call to action

Over the past two decades, significant strides have been made in improving health outcomes globally, particularly in reducing malaria-related deaths by over one-third. However, challenges remain.

T“We’ve been deeply involved in CEPI’s mission, which asks what it would take to make delivery of pandemic vaccines possible within 100 days,” says Gagnon. “The CEPI network is already in place and expanding, giving us the agility to deploy key assays around the world very quickly. The goal now is to utilise this network for the next pandemic.”

Vaccine science saves lives

Nexelis has also worked as a reference lab for the Bill and Melinda Gates Foundation, providing centralised assays to support studies of vaccine and monoclonal antibody candidates. However, despite these developments, the world can’t afford to be complacent about vaccine science, which is an incredibly challenging field. It is, however, a supremely worthwhile one, says Gagnon. “What drives my passion for my day-to-day work?” he remarks. “In the vaccine space, it’s always the same answer: saving lives.”

he certification of Cabo Verde as malaria-free by the World Health Organization stands as a beacon of hope, especially for Africa, which carries the heaviest burden of the disease. In 2022, Africa accounted for 94% of global malaria cases and 95% of deaths, with children under five being the most affected.

Overcoming malaria challenges

The battle against malaria is hindered by various challenges, including financial constraints, resistance to drugs and insecticides and the exacerbating effects of the climate crisis. These obstacles have stalled progress since 2015, signalling a

need for a renewed effort to meet the African Union’s ambitious malaria reduction and elimination targets.

Integrated approach for malaria solutions

To effectively get back on track, we must address malaria through integrated approaches that utilise both existing and new tools. Our existing tools, including some insecticides and medicines, are becoming less effective. Newer tools work better but cost more. Fortunately, market-shaping efforts by Member States and partners have the potential to reduce some of the costs, making them accessible and creating a greater impact.

Climate crisis exacerbating malaria challenges

The changing climate further complicates the fight against malaria, with warmer conditions expanding the habitats of mosquitoes and accelerating parasite development. Despite Africa’s minimal – only 4% – contribution to global carbon emissions, it is the most affected by the impacts of the climate crisis. Therefore, reducing the health sector’s carbon footprint, strengthening health systems and adopting a multi-sectoral response are critical.

Call for malaria funding and integration

Furthermore, financial and political commitment towards malaria is urgently needed. With current resources being insufficient to fully implement national malaria control programmes, an additional US$1.5 billion is required over the next three years to maintain essential interventions.

Malaria offers a viable pathfinder and pacesetter for a fully integrated approach where every sector contributes to accelerating progress. As such, investing in malaria control is not only a health necessity but also a catalyst for economic development and achieving a prosperous Africa.

INTERVIEW WITH Luc Gagnon VP, Vaccine Sciences, Nexelis, a Q² Solutions Company

Paid for by Nexelis, a Q2 Solutions Company

WRITTEN BY Tony Greenway

WRITTEN BY Umaro Sissoco Embaló President of Guinea-Bissau and Chair, ALMA

Controlled human infection models: accelerating tropical disease solutions

Controlled human infection models can accelerate vaccine efficacy testing and treatment validation for malaria, dengue, tuberculosis and other tropical diseases.

Tropical diseases, including malaria, dengue and tuberculosis impose a significant global health challenge, with millions of cases reported worldwide. Existing preventive treatments often fall short, necessitating the development of new vaccines and antimicrobial therapies. However, progress is slow, and demand for solutions is high.

Accelerating treatment development with CHIMs

Controlled human infection models (CHIMs) offer a strategy to accelerate treatment development. By inoculating healthy participants with a controlled pathogen, it is possible to test for treatment efficacy or identify vaccine correlates of protection. This approach ensures the precise timing of inoculation, facilitating advanced biomarker assays. It helps differentiate between promising and weak treatment candidates quickly.

Optimising malaria infection models

In a recent example, a GMP-manufactured Plasmodium Falciparum NF54 strain is accessible for clinical trials. Through a titration trial conducted collaboratively with the strain’s owner, SGS experts determined the optimal infectious dose for this strain. This ensured ample parasite supply, enabling a meaningful comparison between active treatment and placebo while maintaining mild to moderate symptoms for participants.

Versatility of CHIMs in tropical disease development

CHIMs are a powerful tool to establish early proofof-concept of vaccine efficacy in humans. These models have already assisted with the selection of vaccine candidates for diseases including cholera, E. coli, malaria, shigella, streptococcus pneumoniae, tuberculosis, typhoid and H. pylori

CHIMs are particularly valuable when the pathogen process is sufficiently understood, the agent can be GMP manufactured, and rescue treatments are available. For instance, tuberculosis, with its known pathogen process and established treatments like isoniazid, rifampin, pyrazinamide and ethambutol, could be effectively utilised in this model. Dengue CHIM trials, featuring DENV type I, have also been successfully conducted.

Advancing treatment solutions for pharmaceutical companies

Incorporating CHIMs into tropical disease drug/ vaccine development provides essential data for precise field trial design. These models enable controlled testing, validating treatment efficacy or rapid termination if ineffectiveness is evident. With careful trial design, CHIMs become invaluable tools for advancing tropical disease treatments, benefiting pharmaceutical companies aiming to address critical infectious disease challenges.

Ageing society: why adult immunisation delivers health and societal benefits

Vaccines remain one of the most effective public health measures we have. Learn how a greater focus on adult vaccination saves lives, boosts productivity and drives economic growth.

Approximately 4 million deaths worldwide are prevented by childhood vaccination every year. Beyond the number of lives saved, the public health benefits of childhood vaccination lead to cost savings for healthcare systems and wider economic benefits. However, these benefits are often underestimated in adult vaccination.

Adult vaccination combats costly diseases

Preventable diseases cost G20 economies USD 1 trillion in annual productivity loss among those aged 50 to 64 years. This is expected to rise given the demographic shift that many countries face. By 2050, the number of adults over 60 is expected to double. While chronic diseases are taking a greater toll than ever, preventable infectious diseases — including flu, pneumococcal diseases or shingles — still have an enormous burden on societies.

The Office of Health Economics (OHE), commissioned by IFPMA, conducted new research evaluating evidence of the value generated by adult immunisation programmes for population health, healthcare systems and societies.

Healthcare systems should adopt a prevention-first mindset

The recommendations are clear, according to report author Professor Lotte Steuten. “To cope with an ever-growing demand, healthcare systems should adopt a prevention-first mindset that focuses on highly cost-effective interventions like immunisation.”

By preventing individuals from needing frequent visits to doctors’ offices and hospitals, resources can be allocated more efficiently, and the working conditions of healthcare professionals will improve. “But the impact of adult immunisation programmes goes beyond healthcare systems. Adult vaccination has a multifaceted value, with positive impacts on caregivers, families, employers and society as a whole,” Steuten adds.

Keeping the workforce healthy and active throughout life gives an obvious boost to productivity and the economy. This is also true for those involved in informal care — employed or retired — assuring the wellbeing of their loved ones.

Realising the full benefits of adult vaccination

Taking this broader perspective can help governments and health services across the world invest in and unlock further potential from adult vaccination programmes — supporting not just public health but productivity and economic growth.

Mairo’s vital role in defeating severe malaria as a children’s health nurse

Mairo is the matron of an emergency paediatric unit at a hospital in Nigeria. She is part of a team caring for seriously ill children experiencing severe malaria.

Caregivers anxiously wait by bedsides, hoping treatments will work and their loved ones make a full recovery. Severe malaria is a medical emergency resulting from delayed treatment of ‘uncomplicated malaria.’ It puts people at risk of serious illness, organ failure and death.

Saving children from malaria

Mairo juggles various tasks to prevent the deaths of the children on beds a few feet from her desk. She is a leader to the junior nurses, counsellor to worried caregivers, stock-keeper of vital malaria commodities and friendly face to children receiving treatment.

Children arrive at the hospital, often following referral by a community health worker, trained as part of the Community Health Influencers, Promoters and Services programme to spot malaria symptoms. Children are triaged to determine how sick they are and receive a ‘rapid diagnostic test’ to confirm they test positive for malaria. If they have symptoms including deep breathing, hypoglycaemia or convulsions, they may have severe malaria and require an enhanced level of medical inquiry, treatment and care.

Support health workers to save lives

Mairo’s ward stocks artesunate, a WHOrecommended injectable for severe malaria firstline treatment. Rapid diagnosis and treatment are key, and this is the work that Mairo does, day after day.

Across Nigeria, malaria is a major health concern. In 2022, the country accounted for over a quarter of the 249 million cases globally and almost a third of all malaria-related deaths. In Kano state and hospital wards like Mairo’s, these statistics are made real by the young children, often under five years old, occupying the beds.

Malaria Consortium is working with Nigeria’s Ministry of Health, the National Malaria Elimination Programme and Kano State Elimination Programme to strengthen the diagnosis and case management of severe malaria and build the skills of health workers like Mairo.

Sustained action and investment in malaria can increase the availability of essential equipment, train more health workers and support wider health system strengthening in Nigeria and across malaria-endemic countries.

Staying proactive: how the 2023 US local malaria cases remind us of global concern

Learn about the resurgence of locally transmitted malaria in the US in 2023. Find out about its history, causes and public health responses.

Malaria is a parasitic disease caused by the bite of an infective Anopheles mosquito.

Approximately 2,000 cases of malaria are reported every year in the United States — almost all in people who have recently travelled internationally. However, 2023 marked the first time in 20 years that the US saw locally acquired mosquitotransmitted (LAMT) malaria cases.

US history of achieving malaria-free status

Malaria was introduced in what would become America in the 16th century and spread to the Southeastern and Southcentral regions of the country. Through effective insecticide spraying, swamp drainage and thorough case investigations and treatment, malaria control was eventually achieved and the US was certified as malariafree in 1970. Over 156 sporadic local cases occurred in the US from the late 1950s to 2003. The 20-year period between 2003 and 2023 may be the longest malaria-free interval on record.

Understanding the 2023 US cases

From May to October 2023, state health departments reported 10 cases of LAMT malaria to the Centers for Disease Control and Prevention (CDC). The cases occurred in Florida, Texas, Maryland and Arkansas, and all patients were treated and recovered. Though these cases were

surprising, they were not unexpected.

Because of international travel to and from malariaendemic areas, in addition to the sustained presence of mosquitoes able to transmit malaria in the US, LAMT malaria cases are still possible. Although the risk of LAMT malaria in the US remains very low, the 2023 cases highlight the importance of response.

Having a strong public health response allows for rapid detection, prompt treatment, enhanced surveillance and partnering with state and local health departments (SLHD). SLHDs led investigations with support from the CDC’s Division of Parasitic Diseases and Malaria to effectively address the outbreaks.

Global diseases require local vigilance

The 2023 LAMT malaria cases in the US spurred an important reminder that global diseases can be local ones, and it’s crucial to maintain vigilance. Travellers to malariaendemic countries can take important steps to protect themselves when travelling to malaria-endemic areas through talking with their healthcare providers and taking medications to prevent malaria.

Healthcare providers should consider malaria as a potential diagnosis and test patients returning from malaria-endemic countries who have symptoms. For local cases, health department staff can investigate additional cases and decide on mosquito reduction actions in the surrounding areas.

Why

‘doing just enough’

to combat malaria is a deadly strategy

We cannot afford to stand still in our fight against malaria, a treatable disease causing preventable deaths. There needs to be a cosmic shift in how it’s tackled.

Malaria is an ever-evolving disease. If we continue to do ‘just enough’ to combat it, any progress we make simply ebbs away — and, consequently, many more will die.

Insufficient malaria tools fuel disease severity

Dr Kolawole Maxwell, West and Central Africa Programmes Director at Malaria Consortium, a charity dedicated to the comprehensive prevention, control and treatment of targeted diseases, including malaria, describes the disease as a moving target. “When we deploy tools to attack (the vector and the parasite) but do not finish the job, they innovate and survive,” he says.

“Then, our immunity is not enough to keep the disease at bay — so we

start to see an increase in numbers (of people affected by malaria), but also the severity of the disease itself.”

In 2022, there were 608,000 reported deaths from malaria, Kolawole reveals that 80% of these were children under five years old — it’s why he describes it as ‘a disease of the voiceless’ — and insists there needs to be a cosmic shift in how it’s tackled.

Nigeria is a microcosm of the global malaria landscape

Nigeria — accounting for nearly 27% of the world’s malaria cases — may provide a template for change. The country can be viewed as a microcosm of the global malaria landscape, with its rapidly increasing population, variations in burden and additional threats to progress such as resistance.

“There are areas like Kebbi State

in which prevalence is very high, compared to Lagos where prevalence is very low,” explains Kolawole. Importantly, these variations could provide clues as to how tailored interventions — such as the combination of nets, vaccines and chemoprevention — can be successfully layered locally. “If we can make a dent in malaria in Nigeria, we are able to make a dent globally,” he says.

Digital health solutions and innovative financing

Kolawole stresses the importance of efficient and effective technology to enable real-time data availability.

“That will be essential as we move to eliminating the disease because it requires quick decision-making,” he says. “It will mean tracking every case as they occur, not reporting every month.”

Also fundamental is innovative health financing, allowing countries to meaningfully describe and plan their own elimination agendas and invest money where it’s needed most.

Governments should also encourage — and lead — more public-privatephilanthropic partnerships, insists Kolawole, who remains optimistic but never complacent about the future.

“Innovative financing is coming; new vaccines are coming; new monoclonal antibiotics are coming,” he notes. “I believe that we can defeat this disease.”

WRITTEN BY Seymour Williams MD, MPH, Domestic Response Team Lead, Malaria Branch, DPDM, CDC

The invisible threat: how common foodborne pathogens challenge public health

History shows value of partnership to tackle health challenges Customised support for major vaccine manufacturers

An innovative model of partnership has brokered global health breakthroughs for 40 years. Now, partners are eyeing the future.

In 1980, the world was declared free of smallpox — the the only human disease ever to be eradicated, marking a historic milestone and catalysing subsequent global health achievements.

Eradicating smallpox was like landing on the moon; it’s easy to believe it can’t be done ... until it is. Then, people say: ‘So that was possible! What can we do next?’ The Task Force for Global Health was one answer to that.

Founded in 1984 by Dr. William Foege — the former CDC director who led smallpox eradication — The Task Force aimed to ensure that children everywhere would be protected from measles, polio and other vaccine-preventable diseases. Shockingly, at that time, only 20% of children were routinely vaccinated, and thousands were dying daily from preventable diseases.

Partners with different skillsets working together to deliver

By working together with support from The Task Force, various partners — including UNICEF, WHO, World Bank, UNDP, Rockefeller Foundation and others — ensured that four times as many children had been vaccinated by 1990, with 80% of the world’s children protected by at least one vaccine.

This model of collaboration, involving a variety of partners over the years, has been used to tackle countless global health challenges, such as polio, neglected tropical diseases and Covid-19, with extraordinary success. Since 1990, child mortality has dropped by roughly 60%, and many countries have eliminated diseases that have plagued humans for centuries.

This type of collaboration isn’t easy. For example, getting medicine to people in the poorest and most remote places is remarkably complex. It requires a huge range of partners with different skillsets, including health ministries, non-governmental organisations, private sector partners, funders and local health workers who know how to make things happen in their communities.

Collaboration powers through emerging health issues

The world now confronts new and evolving health challenges, including the effects of the climate crisis and antimicrobial resistance. History proves that when faced with difficult challenges, people committed to global health can join forces to solve them.

As common foodborne pathogens become increasingly resistant, the global challenge to food safety intensifies, demanding immediate action to protect public health and economic stability.

Foodborne infectious diseases are illnesses caused by consuming contaminated food or beverages. Several common pathogens, such as Listeria monocytogenes, Salmonella spp or E. coli, are responsible for these diseases, each with its own symptoms and complications.

Innovations in foodborne pathogen detection

Implementing rapid detection methods in food production areas, such as the NEMIS N-Light™ System, enables proactive identification of potential contamination hotspots in food facilities. Continuously monitoring the environment for pathogens (PEM) enables targeted interventions to maintain food safety standards throughout the supply chain.

Early detection empowers food producers to implement preventive measures, such as sanitation protocols, to halt contamination within production areas and prevent cross-contamination in the food supply chain.

Pillars of prevention and ‘YOPI’ group

Prevention is key in combating foodborne infectious diseases. This includes practising safe food handling, cooking and storage techniques and promoting food safety regulations and education to reduce the risk of contamination and illness.

Producers and regulators must implement rigorous food safety measures to mitigate contamination risks. Infectious foodborne illnesses pose serious risks to vulnerable populations like the YOPI group. They must take extra precautions, including practising safe hygiene and avoiding high-risk foods.

Young: children’s growing immune systems make them more vulnerable to foodborne illnesses. Old: elderly individuals with weakened immune systems and health issues are at higher risk. Pregnant: changes in the immune system during pregnancy increase susceptibility to certain foodborne illnesses. Infections can harm both the mother and foetus. Immunosuppressed: those with weakened immune systems, like chemotherapy or organ transplant patients, face severe illness risks from contaminated food.

Ensuring a healthier tomorrow

Food producers are responsible for proactively addressing biological hazards by embracing robust frameworks such as Good Manufacturing Practices (GMP) and implementing a strong HACCP concept (Hazard Analysis and Critical Control Points).

Producers safeguard products, ensuring consumer trust and safety globally through consistent adherence to standards. Dedication to high food safety standards fosters industry growth while prioritising health and wellbeing for everyone.

Within the rapidly moving vaccine landscape and changing face of infectious diseases, vaccine manufacturers are under increasing pressure to make the latest products available as soon as safely possible.

As major vaccine manufacturers require increasing levels of customised support in the areas of development, quality control and release testing, they are seeking partnerships with other scientifically-driven organisations.

Vaccine development solutions

Smaller, agile organisations serve as trusted partners, accelerating vaccine development processes. Among them is InDevR, Inc., providing analytical tools and services that enable vaccine researchers to speed their path to market.

Craig Hoechstetter, Vice President of Sales and Marketing, says: “Our technology helps vaccine companies and research organisations simplify, standardise and accelerate their analytical testing processes from development to product release.”

Their analytical technologies are based on a microarray platform using antibodies, antigens or oligonucleotides printed on a glass plate and detected by a fluorescence tag. Products include the VaxArray® Portfolio of multiplexed assays for vaccine analytics and the CypherOne System for digital imaging and automated interpretation of hemagglutination (HA) and hemagglutination inhibition (HAI) assays.

Customised vaccine tests

New influenza strain(s) are assessed and potentially recommended for vaccine inclusion every six months by the World Health Organization. InDevR has a library of over 300 curated antibodies with deep expertise encompassing over 20 flu seasons — both can be leveraged by customers for their specific detection assays.

In the case of pneumococcal vaccines, they support manufacturers by combining unique serotype constellations for different vaccines. These combinations are swiftly integrated into an immunoassay test, meeting the latest unique vaccine requirements effectively.

“We analyse their vaccine samples and rapidly create a test specifically for them,” explains Hoechstetter. The process is customised as each manufacturer and vaccine is different and helps customers optimise their vaccine product in a competitive industry. “This ultimately helps patients get higher-quality vaccines sooner,” he adds.

mRNA-based technologies

As mRNA-based technologies compete with traditional vaccines moving forward, InDevR demonstrates its application in all platforms (eggbased, cell-based and mRNA-based).

Hoechstetter concludes: “The strength of our company is our scientific expertise, longstanding vaccine industry experience and commitment to partnering with global organisations to ease their assay development burden.”

Improving patients’ medical course and reducing AMR with NGS and digital pathogen detection

Digital pathogen detection and NGS technology can quickly and accurately pinpoint the cause of infection, so patients can quickly receive more targeted and effective therapies.

Microbiological diagnostics in medicine are complex and diverse,” explains Dr med. Klaus Rensing, MBA, VP Medical Affairs at Noscendo, a provider of softwarebased pathogen identification technology. “Meaning, pathogens that cause sometimes life-threatening infections can be extremely difficult to identify.”

Pathogen detection and diagnostic challenges

That’s a serious problem because, in severe cases, clinicians may need to make educated guesses for the most effective therapy without fully understanding the infection’s cause due to time constraints. Meanwhile, a blood culture is sent to a lab for analysis so that this suspected diagnosis can either be confirmed — or ruled out.

However, conventional diagnostic methods based on blood cultures can take over a week and may only identify a limited set of pathogens. Plus, studies show they are only positive in up to 30% of cases. During this time, if unsuitable therapy is started, the patient’s condition could deteriorate. Alternatively, incorrect diagnosis may lead to unnecessary antibiotic use, fuelling antimicrobial resistance (AMR).

New digital method for pathogen detection

Yet, all that could change, thanks to digital pathogen detection technology developed by Noscendo. With next-generation sequencing (NGS) and bioinformatics, this disruptive new IT innovation — which is a CE-IVD and is used by institutions around the world — can analyse and identify 1,500 pathogens (including bacteria, DNA viruses, fungi and parasites) within 24 hours. Quicker results equal better outcomes for patients, insists Dr Rensing.

“Faster diagnostics that accurately pinpoint the cause of non-specific symptoms allow for more targeted and effective anti-infective therapies to be given to the patient,” he says. “Or, if therapy has already begun, it can be adapted or changed entirely to more precisely fight the cause of infection.” Tailored treatment prevents unnecessary administration of less effective therapies on one side or broad-spectrum antibiotics that might not be needed on the other side.

Although digital pathogen detection is in its infancy, Dr Rensing expects next-generation sequencing and IT-based analysis to be the future of infectious disease diagnostics. “It’s fascinating technology,” he says. “I believe that within 10 years, it will be a standard tool for faster, clearer microbiological diagnosis.”

Tools to predict and prevent malaria outbreaks in a changing climate

The changing climate is complicating the fight against malaria. We must redouble our efforts to eradicate this disease.

Rising temperatures, shifting rainfall patterns and extreme weather events are creating unpredictable malaria outbreaks, expanding its geographical reach and potentially costing millions. However, through strengthened partnerships, the effective scale-up of existing tools and increased investment in new ones, eradicating malaria is possible.

Warming trends, shifting malaria landscapes

Pakistan’s 2022 monsoon, amplified by the climate crisis, triggered a fourfold surge in malaria cases, turning low-risk areas into hotspots nearly overnight. Rising temperatures are extending malaria seasons and nudging the mosquitoes that carry the disease into new areas and higher altitudes.

Better predicting the spread of malaria

Like weather forecasting, we now predict malaria outbreaks. These systems monitor climate, mosquito populations and parasite genetics, creating early warning models for upcoming case surges. This data enables malaria programmes to prepare for outbreaks, deploy resources efficiently and protect vulnerable communities.

Initiatives like the Malaria Atlas Project and the Institute for Health Modeling and Climate Solutions are helping countries understand their unique vulnerabilities and tailor responses accordingly. Imagine being able to deploy limited resources like bed nets or medicines to prevent malaria in pregnant women before an outbreak — that’s the power of prediction in action.

Invest in new tools to end malaria

Better predictions are only the first step. To truly win the fight against malaria within a generation, we need a full suite of innovative tools and strategies, forged through a united effort. Researchers, governments, health authorities and professionals must work together to ensure the right tools are used to accelerate the development of new interventions.

Consider durable vaccines with high efficacy, monoclonal antibodies and other potentially groundbreaking solutions like the modification of mosquitoes that carry malaria, so they can no longer spread disease.

The climate crisis may be creating new challenges, but by embracing cutting-edge disease monitoring technologies, strengthening partnerships and investing in innovative solutions, we can turn the tide on malaria. In doing so, we will save millions of lives, alleviate economic pressure and pave the way for healthier, more prosperous communities around the world.

The power of the perfect storm: gender, malaria and the climate crisis

As humans, we are facing several threats: biological, climate, global instability, weakened health systems. The threat of malaria is compounded by all of these — and the most vulnerable are women, girls and children.

In Africa, malaria is not only deadly but exacerbates poverty, strains health systems and deepens gender inequality by disproportionately affecting women and girls.

Disproportionate malaria threat to women and girls

Particularly dangerous to pregnant women and infants, malaria contributes to 10,000 maternal deaths per year. Adolescent girls are also at significant risk of falling through the many gendered gaps in the provision of malaria services.

Now, the climate crisis worsens this challenge. Natural disasters displace vulnerable populations, limiting their access to essential malaria services. According to the United Nations, 80% of those displaced by the climate crisis are women and girls.

Unifying against malaria

Let’s not wait for another natural disaster. Flooding, droughts and extreme weather patterns are breeding grounds for mosquitoes, which makes our battle harder. National leaders, donors and policymakers must ensure that the fight against malaria is gender-responsive, confronting bias and discrimination and mainstreaming it into conversations and interventions.

We must also adopt a multi-sectoral approach, strengthening health systems to address malaria and enhance resilience and sustainability. We can’t tackle this alone. Malaria is just a small part of the broader global health challenge. Countries with the highest malaria rates also have low Universal Health Coverage scores, increasing the risk of fatalities.

Transforming health equity

Transformational change is required to achieve health equity, protecting people’s rights worldwide and enabling global preparedness amid increasingly severe changes in our climate. Systematic change can only happen if we come together, coordinate and raise awareness of the urgent need for healthier societies. Otherwise, an increasing number of people will die from this preventable disease.

Focus now must be on developing programmes, policy and research targeting more sustainable health systems — with a gendered lens. By recognising the additional burden that women carry, we can build a stronger, more equitable world.

For 25 years, Medicines for Malaria Venture and partners have forged a path towards the global goal of a malaria-free future, delivering an antimalarial toolbox with 15 rigorously tested malaria therapies, which have helped save over 13 million lives. MMV will continue to innovate until the goal of a malaria-free world is achieved.

Photo: Marcus Hebbelmann/MMV

Success in self-testing as 86% of people living with HIV globally now know their status

Pioneering work over the last eight years to bring HIV self-testing to Africa has been instrumental in shaping global policy and advancing diagnostics for various infections.

Eight years ago, only 53% of those living with HIV globally were aware of their status. By 2022, the World Health Organization (WHO) reported that had risen to 86%, with 76% receiving antiretroviral treatment (ART) and 71% achieving viral suppression.

Access to HIV self-testing

The convenience and discretion of self-test kits have proven attractive to those who may not otherwise test due to stigma or logistical challenges accessing healthcare facilities.

Dr Karin Hatzold is Director of HIV, Tuberculosis and Viral Hepatitis at Population Services International (PSI) and Director of the Unitaid-funded STAR (Self-Testing AfRica) Initiative — the largest evaluation of selftesting. She explains: “Before, there were groups of people who weren’t accessing testing (for HIV), such as men and adolescents as well as key populations, sex workers, men having sex with men. It was about removing barriers for them.”

Uptake in testing and treatment

Zimbabwe was one of six countries in sub-Saharan Africa where the STAR initiative was piloted alongside Malawi, South Africa, Lesotho and Eswatini. Results from the study in Zimbabwe speak for themselves.

Over two years, 360,000 self-tests were distributed, and testing uptake increased from 35% to 75%. Results showed that 25% of those who accessed HIVST had never used an HIV test before — evidence that the strategy was indeed reaching new audiences.

Prior to the study, there were reservations about whether those who conducted self-tests would seek a confirmation test at a clinic and embark on the appropriate treatment. Concerns were unfounded as the study revealed a promising 30% rise in ART usage, which was mirrored across the pilot countries.

Self-testing is the new norm

Before the Covid-19 pandemic, self-testing wasn’t part of any national psyche, so it has taken massive effort to build awareness and trust in the process. “We used various distribution models adapted to context and population to be reached in different countries,” explains Dr Hatzold.

“In South Africa, for example, community workers were distributing kits at bus stations and in taxi ranks and hotspots where we knew we could reach people who would benefit from HIV self-testing, especially men who do not have time … for testing.”

Social media posts and advertising campaigns reinforced the groundlevel activity, increasing awareness and driving participation. “We have achieved what we wanted, and this has even taken over from conventional testing. It has become the norm,” confirms Dr Hatzold.

Between 2017 and 2019, 360,000 HIV self-tests (HIVST) were distributed in Zimbabwe during STAR pilot implementation, and testing uptake increased from 35% to 75%.

Diagnostics drive policy change

When STAR launched in 2015, there were no affordable, quality-assured HIV self-tests approved for use in low and middle-income countries (LMICs). With no quantitative evidence on market demand or the effectiveness of self-testing, manufacturers weren’t willing to take the risk.

STAR helped fill that data gap and encourage further investment in diagnostic tools. By 2016, WHO rolled out global guidelines for HIVST and, as of June 2022, WHO had prequalified six HIV self-test kits. These include both oral fluid and blood-based products, ensuring their quality, safety and effectiveness for use. Now, 102 countries have HIVST policies, and 38 are actively implementing HIVST.

Empowering self-testing for public health

HIVST is now recognised as a key tool in reaching the UN’s 95-95-95 targets, whereby 95% of people with HIV know their status, 95% of diagnosed cases are receiving ART and 95% are virally supressed by 2030.

“The project has been catalytic, informing a scaling up of activity,” says Dr Hatzold, who, through STAR, is applying lessons learned from HIV to advance self-testing for Covid-19, Hepatitis C and B plus sexually transmitted infections — with potential to develop a single test for multiple infections.

Self-testing initiatives will undoubtedly underpin a move toward more integrated and decentralised systems. “If we want to achieve universal healthcare, we must put tools in the hands of the people, and that starts with diagnostics,” concludes Dr Hatzold.

INTERVIEW WITH Dr Karin Hatzold Director of HIV, Tuberculosis and Viral Hepatitis at Population Services International (PSI) and Director of the Unitaid-funded STAR (Self-Testing AfRica)