Sierra Leone First Lady Fatima Bio

Sierra Leone’s President Julius Maada Bio signed into law the Prohibition of Child Marriage Act last week, introducing a penalty of at least 15 years and a fine of around $4,000 for any man who marries a girl under 18.

The law also prohibits cohabiting with a child, and fines for anyone arranging, aiding or attending such marriage ceremonies.

First Lady Fatima Bio’s “Hands Off Our Girls” campaign has been instrumental in advocating against child marriage in Sierra Leone.

Sierra Leone has one of the highest rates of child marriages in Africa, alongside Niger and Nigeria. According to the 2019 Sierra Leone Demographic and Health Surveys, 30% of girls in Sierra Leone are married before their 18th birthday.

In 2020, there were 800,000 child brides, half of whom were married before they turned 15, according to UNICEF. The country of slightly over eight million people also has a high rate of female genital mutilation.

“Child marriages fuel the high adolescent pregnancy rate in Sierra Leone where, tragically, pregnancy complications are the leading cause of death for girls aged 15-19,” according to Human Rights Watch (HRW).

In 2021, the country introduced a policy of “radical inclusion” in schools, targeting and marginalised groups including girls, particularly pregnant girls and parent learners. 

Last year, Sierra Leone passed an education law that guarantees children free education, including one year of pre-primary. 

“The legislation is a milestone in Sierra Leone’s journey towards gender equality and child protection. It also sets a pathway forward for other African nations, such as Tanzania and Zambia, to revoke laws that permit child marriage, and ensure girls can complete primary and secondary education,” said HRW.

 

Neurons with tau protein highlighted in red.

Eli Lilly’s Alzheimer’s therapy, donanemab, has received FDA approval, offering new hope for patients with early symptomatic Alzheimer’s disease. The newly approved treatment, branded Kisunla, is set to challenge existing therapies from Eisai and Biogen. 

Clinical trials have shown Kisunla to be effective for individuals in the mild cognitive impairment or mild dementia stages of the disease, potentially marking a significant advancement in Alzheimer’s care.

The drug is administered as an intravenous infusion every four weeks. 

Alzheimer’s disease is a degenerative condition of the brain that impacts over 6.5 million Americans and over 55 million people worldwide. It causes a gradual decline in memory, cognitive functions, and, eventually, the ability to perform daily activities. The disease is marked by structural changes in the brain, such as the buildup of amyloid beta plaques and neurofibrillary tangles made of tau protein, which is supposed to help stabilize the internal skeleton of neurons in the brain. 

The Alzheimer’s Association celebrated the FDA’s decision.

“This is real progress,” said Joanne Pike, Alzheimer’s Association president and CEO, in a statement. “Today’s approval allows people more options and greater opportunity to have more time. Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease.”

Slows cognitive decline by at least 22%

The approval was based on an extensive double-blind, placebo-controlled, parallel-group study evaluating the efficacy of Kisunla in slowing cognitive decline in participants with varying levels of tau protein in the brain. Tau is a protein that helps to stabilise the neurons in the brain. 

The study, conducted over 72 weeks with 1,736 patients averaging 73 years old, revealed that those receiving Kisunla experienced a 35% reduction in cognitive decline compared to those on placebo among individuals with low to medium tau levels. 

Even among participants with higher tau levels, the treatment demonstrated a meaningful but slightly reduced effect. Overall, including all tau levels, Kisunla slowed cognitive decline by 22% and reduced the likelihood of progressing to the next stage of the disease by 39% compared to placebo.

Additionally, the study monitored amyloid plaque levels using positron emission tomography (PET) scans throughout the treatment period. Results showed substantial reductions in amyloid plaques over time among patients receiving Kisunla, with reductions of 61% at six months, 80% at 12 months, and 84% at 18 months compared to baseline levels. These findings suggest that Kisunla not only targets cognitive decline but also effectively reduces the hallmark amyloid pathology associated with Alzheimer’s disease progression.

Potential side effects

For some patients, there is a risk of amyloid-related imaging abnormalities (ARIA) developing, the FDA said. ARIA typically manifests as temporary brain swelling, sometimes accompanied by small areas of bleeding on or in the brain. While ARIA often resolves on its own and may not cause symptoms, rare instances of severe and potentially life-threatening events have been reported. ARIA is a recognized side effect of antibody therapies targeting amyloid.

Infusion-related reactions are also a concern, including flu-like symptoms, nausea, vomiting, changes in blood pressure, and hypersensitivity reactions such as anaphylaxis (a severe allergic reaction) and angioedema (swelling). 

Kisunla joins Leqembi, on market since 2023

Kisunla is the third drug to receive FDA approval, although only the second is now available for use. Leqembi, a collaboration between Biogen of the United States and Eisai of Japan, gained approval in July 2023. In an 18-month Phase III trial, Leqembi demonstrated a 27% reduction in cognitive decline among early-stage Alzheimer’s patients compared to those receiving a placebo.

Another drug, aducanumab, also developed by Biogen and Eisai, was granted accelerated approval by the FDA in June 2021. However, due to some side effects, the therapy was pulled from the market. 

The Alzheimer’s Association emphasized the importance of early detection and diagnosis now that multiple FDA-approved treatments for Alzheimer’s are available. The organization stressed that timely access to these treatments is crucial for maximizing their benefits, asserting that no stage or entity should hinder or delay such access.

“Too many roadblocks have prevented individuals from getting equitable access to these beneficial treatments for far too long,” said Pike. “It is equally important that clinicians and health care systems are informed and prepared to help the individuals who could benefit. The Alzheimer’s Association is working with health systems and providers to ensure they have the tools and resources to meet the needs of their patients.”

Image Credits: Gerry Shaw/ EnCor Biotechnology Inc.

Fishing vessels at the Bridgetown Fisheries Complex in Barbados damaged by Hurricane Beryl.

Hurricane Beryl, which has destroyed homes and infrastructure in large parts of the eastern Caribbean, is the first first-ever Category 4 hurricane recorded in the region in June – and a portend of devastating changes in weather patterns.

It also underscores the need for urgent international assistance to Small Island Developing States (SIDS) to strengthen early warning systems and the climate resilience of key infrastructure – notably water, sanitation and health services, according to experts.

The hurricane reached peak speed of 265 km per hour at times as it whipped though Barbados, Grenada, St Vincent and the Grenadines, Haiti, northern Venezuela, the Dominician Republic, Cayman Islands, and Jamaica.

“The storm first impacted Barbados, causing severe damage to the south coast and significantly affecting the fishing industry with over 200 fishing vessels damaged or destroyed,” according to the International Federation of Red Cross and Red Crescent Societies (IFRC).

On Union Island, part of Saint Vincent and the Grenadines, 90% of infrastructure has been damaged, including houses, roads and the airport. 

Some 95% of homes in Grenada’s Carriacou and Petite Martinique islands, are damaged, and around 3,000 people are shelters, the IFRC added.

Parts of Jamaica’s St Elizabeth region in the south east were also devastated, with around 1,000 people taking refuge in shelters. The Dominican Republic, Cayman Islands reported damage. 

Venezuela’s President Nicolas Maduro said that 8,000 houses had been destroyed, according to Reuters.

More to still come?

“Hurricane Beryl, the first hurricane of the 2024 Atlantic hurricane season, rapidly strengthened to a Category 5 storm unusually early in the year,” according to a report from the National Ocean and Atmospheric Administration (NOAA), which is part of the US Department of Commerce 

“This explosive strengthening was fuelled in part by exceptionally warm ocean temperatures. That heat was one of the factors behind NOAA’s prediction in May of an 85% chance that the 2024 Atlantic hurricane season would be above normal.”

Sea surface temperatures were close to those usually found in mid-September, the peak of hurricane season, added NOAA.

In late May, NOAA weather forecasters predicted an 85% chance of above-normal hurricane for the 2024 Atlantic hurricane season, which runs from 1 June 1 to 30 November.

It also forecast eight  to 13 hurricanes, with four to seven likely to be “major” hurricanes (winds of over 178km per hour) in coming months.

Early warning systems 

“The unprecedented hurricane demonstrates the importance of effective multi-hazard early warning systems to save lives,” according to United Nations Disaster Risk Reduction (UNDRR).

“Globally, the sustained investments in those systems are making progress in reducing the loss of life in disasters. But economic losses are escalating. Every year millions of households lose their livelihood and risk being pushed into poverty. Ensuring that infrastructure is resilient and that communities ‘build back better’ in the face of future hazards is essential,” added UNDRR.

Damage sustained to the airport and surrounding areas on Union Island in the Grenadines during Hurricane Beryl.

In late May, the Fourth International Conference on SIDS adopted the Antigua and Barbuda Agenda for SIDS, a 10-year development agenda that  appeals for international assistance to address climate change.

The Agenda notes that “SIDS are facing the unrelenting and compounding impacts of climate change, biodiversity loss, pollution, disasters and natural hazards, health and other social related challenges and economic vulnerabilities.”

Key climate change challenges include “erratic precipitation, increasingly frequent and extreme weather phenomena, more frequent and severe tropical cyclones, floods and drought, diminishing fresh water resources, desertification, coastal erosion, land degradation and sea-level rise.”

However, there has been a “progressive deterioration” in SIDS’ ability to “withstand external shocks and enhance their resilience” – largely as a result of the economic impact of COVID-19 and climate challenges.

Financial reform to build resilience 

Protestors call on wealth countries to pay for climate-related loss and damage at COP27.

“In the wake of Hurricane Beryl, it is clear that we must redouble our efforts to build resilience and preparedness in the face of growing disaster risk, especially for small island developing states, which have contributed the least to the climate crisis but suffer the greatest costs,” said UNDRR head Kamal Kishore.

Kishore appealed for international support for the Antigua and Barbuda Agenda, which “integrates disaster risk reduction as central to climate change adaptation and sustainable development in SIDS with clear calls to action on enhancing multi-hazard early warning systems and resilient infrastructure.”

There have also been numerous calls for reform of the international financial architecture to assist developing countries most affected by climate change who are being forced to borrow money to address climate crises largely caused by wealthy nations. 

The most significant of these is the 2022 Bridgetown Initiative, spearheaded by Prime Minister Mia Mottley of Barbados. This called for key actions including new loan mechanisms, reform of the world’s development banks, and a loss and damages fund to enable developing countries to access to resilient finance to address climate and development crises.

The UN climate change conference, COP27, agreed to establish a loss and damage fund during the UN Climate Change Conference (COP27) in 2022. However, there is resistance from a number of wealthier countries to this as the world continues to experience record-breaking extreme weather events.

Meanwhile, the International Cort of Justice (ICJ) is expected to hold public hearings and issue an advisory later this year on the international legal obligations countries have to safeguard people against climate change. 

This follows the adoption last year of a landmark UN resolution to seek such an advisory opinion from the ICJ. While not legally binding, the advisory opinion holds legal and moral weight and will spotlight the human rights impacts of climate policy.

Image Credits: UNDP, AfricaNews.

Over one-half of Americans are not sure if pasteurised milk is safer than raw milk. In the time of avian flu epidemics in US cattle, this could even prove dangerous.

As the fourth human case of H5N1 avian flu in a US farmworker in Colorado was confirmed Wednesday by the US Centers for Disease Control and Prevention (CDC), so far, only farm workers, and not consumers, have reported avian flu infections.

This is likely due, at least in part, to the successful inactivation of the virus during the milk pasteurization process, experts say. And yet one-half or more Americans seem to have little idea about the dangers of drinking raw milk, according to a recent poll conducted by the University of Pennsylvania researchers.

The survey, which included a demographically representative sample of the US adult population, found that less than half (47% percent) of the U.S. adults surveyed understood that drinking raw milk not as safe as drinking pasteurized milk. Conversely, 53% of respondents don’t actually believe that pasteurized milk is safer. And 9% of respondents actually believed raw  milk is safer, while 15% said it was just as safe and 30% were unsure.  

Nearly a quarter (24%) of Americans either do not believe that pasteurization is effective at killing bacteria and viruses in milk products (4%) or are not sure whether this is true (20%), according to the survey of over 1000 US adults, conducted by the Annenberg Public Policy Center (APPC). The survey has a 3-3.5% statistical error rate.

Around half of US adults failed to recognize that raw milk  can be more dangerous than pasteurized milk products.

That, despite the fact that studies report that pasteurized milk limits hospitalizations for related illnesses by an order of 45, according to the APPC report. 

The French Scientist Louis Pasteur invented the pasteurization process 160 years ago, after recognizing that it killed off otherwise dangerous bacteria present in unheated wine. The process, which soon became a milk industry standard in the United States, successfully inactivates the modern-day avian flu virus, significantly limiting the risk of infection for the general public. 

Politics and milk 

In fact, only about 2% of Americans report drinking raw milk at least once a month, according to a Food and Drug Administration (FDA) study based on 2019 data.

Paradoxically, however, raw milk sales in the US have increased in recent months, according to some US media reports, despite the recent risks posed by a widening circle of avian influenza among dairy cattle.

Debate has been spurred  by the increased anti-science bent of some US political leaders. Presidential candidate Robert F. Kennedy Jr., for instance, who also has been a staunch opponent of COVID vaccination, has been quoted saying that he drinks raw milk exclusively.

The APPC survey also found that Republicans are more likely than Democrats to believe that drinking raw milk is as safe as pasteurized milk (57% vs. 37%). People living in an urban environment also are more likely to believe that pastuerized milk is safer than raw milk as compared to people in a rural environment (49% vs. 32%).

“The difference in views of raw milk that we see between Democrats and Republicans is difficult to disentangle from the difference between rural and urban dwellers,” said Kathleen Hall Jamieson, director of the Annenberg Public Policy Center. “Those in rural areas are both more likely to identify as Republicans and to consume raw milk.”

55 more dairy herds reported infected in last 30 days

Some 55 more cattle herds in seven states have been infected with the virus over the past 30 days, according to CDC tracking. Infections in the past 30 days represent 40% of the total of 138 cattle herds infected in 12 states since the outbreak in dairy cattle was first reported on 25 March, the CDC reported. 

States affected by avian flu spread in dairy cattle

The real number of infections of both humans and cattle is very likely underestimated, insofar as farmers have been reluctant to have their staff or herds tested, experts warn.

Even so, the CDC maintained that infection risks for the general public remain low. 

“Based on the information available at this time, this infection does not change CDC’s current H5N1 bird flu human health risk assessment for the U.S. general public, which the agency considers to be low,” the CDC said in a statement.

Image Credits: Cotonbro studio, APCC, CDC.

The air in relatively ‘clean’ Mumbai is still killing citizens.

NEW DELHI – On 2 November 2023, extreme air pollution caught Delhi off-guard. It shut down schools and led to flight cancellations, curbs on construction and other emergency responses. 

That every little increase in air pollution increases the risk of death has been well-established for some years. But till now the effect of short-term air pollution on mortality has remained largely undocumented in detail in India, where most of the world’s most polluted cities are located. 

In a new, peer-reviewed study published in the Lancet on Thursday (4 July), researchers found that 7.2% (or approximately 33,000) of all deaths each year across 10 cities could be linked to short-term PM 2.5 exposure higher than the World Health Organization (WHO) guideline of 15 micrograms/cubic metre (µg/m³). PM 2.5 is a highly toxic ultra-fine particulate matter with a diameter of 2.5 microns, which is far thinner than a strand of human hair. 

This is the first multi-city study in India to assess the link between short-term pollution exposure and death with cities spanning different agri-climatological zones.

The bottom line, the authors say, is that the current Indian government standard for PM 2.5 of 60 µg/m³ is “substantially higher” than it should be as a measure of ‘safe’ air quality. In comparison, WHO’s 24-hour standard is 15 µg/m³.  

NCDs are the leading cause for air pollution-related deaths

The Lancet paper doesn’t look at the cause of death as that level of primary data isn’t always available. However, many studies including recent ones in India have shown that air pollution triggers or aggravates non-communicable diseases – specifically NCDs like heart attacks, strokes, lung cancer, and chronic lung disease – which can turn fatal. Of the total air pollution deaths, NCDs account for nearly 90% of the disease burden. 

The researchers are from 14 organisations including Sustainable Futures Collaborative in Delhi, Institute of Environmental Medicine in Stockholm, Indian Institute of Management Ahmedabad, Public Health Foundation of India, Ashoka University in Sonipat, Mount Sinai in New York, and Boston University. 

To come to their conclusions, the researchers analysed primary data on mortality between 2008 and 2019 in 10 cities of India. They used an advanced system of machine learning-based analysis which, simply put, used factors that would have a bearing on air pollution-related deaths, namely wind speed, atmospheric pressure and mixing height. 

This causal modelling approach enabled the researchers to isolate the effect of locally generated pollution as these factors are linked to the dispersal and transport of air pollution. 

Combined with other data from monitors, satellites and other sources, the study looked at over 3.6 million deaths in the 11-year study period. What the more complex causal modelling shows is that the risk of death is greater than what the earlier basic approach showed. 

No safe level of air pollution

The causal modelling estimated an increase in the risk of death by 3.57% for every rise of just 10 µg/m³ metre over a two day period, as compared to 1.42% by a more basic study. 

Apart from the usual high-pollution suspects like Delhi and Varanasi, the study looked at places commonly perceived as having clean air, like the Himalayan city of Shimla and the coastal metropolises of Chennai and Mumbai. The authors say this is the first such multi-city study on the links between short-term air pollution exposure and deaths in India. 

Overall, 7.2% of all daily deaths were attributed to PM 2.5 concentrations higher than the WHO guidelines. Annually there are estimated to be approximately 33,000 deaths in these 10 cities. Over a third are in Delhi, where the average annual PM 2.5 level was 113 micrograms which is more than 22 times the WHO’s safe standard. The share of PM 2.5 linked deaths was also the highest in the Capital, at 11.5% compared to the lowest 3.5% in Shimla. 

The surprises are Mumbai and Kolkata, with deaths numbering around 5,000 each, annually. 

“We are seeing a high level of risk and a high number of deaths even in cities that have moderate levels of air pollution exposure. Mumbai, for instance, despite being a coastal city with around a third of the annual PM 2.5 levels of Delhi is still seeing over 5,000 deaths yearly from air pollution,” a lead author of the report, Dr Bhargav Krishna, Fellow at the Sustainable Futures Collaborative, explained to Health Policy Watch.

“Similarly Hyderabad, Kolkata, Bengaluru, Chennai, Ahmedabad and Pune, all of which have annual PM2.5 levels below the current Indian standard, are still seeing a high number of deaths each year. This should drive us to focus not just on those cities that have high seasonal exposures, but even those that may be considered relatively ‘clean’ but are in reality polluted at a level that causes significant health impacts.”

Mumbai air in March 2023.

Mumbai, where remarkably the air pollution has been higher than Delhi on some days, was shown to have almost 5,100 deaths, the second highest after the national capital. That is 5.9% of all deaths in what is India’s financial capital. Here, every increase of 10 micrograms of PM 2.5 was associated with a 2.41% increase in daily deaths. 

Over 7% of daily deaths attributable to increases in short-term PM 2.5
First such study in Indian cities, say authors
City Average Annual Pollution 

(PM2.5, mg/m³)

 Attributable Fraction of Deaths (%) Attributable Deaths Per Year
Delhi 113 11.5 11,964
Varanasi 82.1 10.2 831
Kolkata 55.2 7.3 4,678
Pune 45.3 5.9 1,367
Mumbai 41.7 5.6 5,091
Hyderabad 38.9 5.6 1,597
Ahmedabad 37.9 5.6 2,495
Chennai 33.7 4.9 2,870
Bangalore 33 4.8 2,102
Shimla 28.4 3.7 59
Total 53.6 7.2 33,627

Source: Lancet

Shimla proves that there is no safe level of air pollution, according to the report. It has the lowest air pollution level of  the 10 cities, yet that was still a risk as 3.7% of all deaths were attributable to short-term PM 2.5 exposure. 

Impact on policy action 

The findings are crucial for immediate policy action and further studies to cover hundreds more towns and rural areas. Immediate action would cover sources of pollution like diesel generators, waste burning, and transport, sources that are commonly seen in many urban neighbourhoods. 

While much of the headline-grabbing focus is on extreme pollution, these findings show the need to act against all sources of air pollution all year round. Acting only on extremely high days of pollution will only  yield marginal benefits regarding daily mortality.

 In particular, the paper calls out the Graded Response Action Plans, largely used in Delhi and its neighbouring cities. GRAPs are usually cited by local governments as their action to cut pollution but are implemented only in peak pollution season which is from October right through winter. 

Toxicity of local pollution

There are some interesting findings which aren’t widely known. The study confirms that the risk of mortality rose more quickly at lower levels of PM 2.5 but plateaued as levels increased. More studies are needed to understand why exactly this happens. The causal modelling showed that the effects of air pollution on deaths were especially strong in cities with lower levels of pollution such as Bengaluru, Chennai and Shimla. 

The study fills a data and communication gap in addressing the health crisis caused by toxic air. On one hand, it establishes a link between rising air pollution and deaths, on the other, it makes the risks a lot more relatable because it shows the impact over just two days of exposure than over many months or years. 

So what can residents in these cities do to protect themselves? Bhargav says individual responses could include wearing a mask, choosing when to step outdoors (pollution tends to be highest during the morning and evening when temperatures dip), and reducing pollution sources inside their home. 

However, the onus lies on governments and policymakers. 

“The levels of air pollution we see in India are extremely high and this study clearly shows how day-to-day variations in these levels lead to considerable mortality,” said Dr Petter Ljungman of the Karolinska Institute, and one of the researchers involved in the study.

“Interestingly we saw that local pollution sources are likely to be more toxic than more distant sources which has implications for policymakers addressing this highly relevant threat to human health.”

Image Credits: Chetan Bhattacharji.

Scientists at the West African Centre for Cell Biology and Infectious Pathogens (WACCBIP), University of Ghana, setting up a genome sequencing experiment in the laboratory.

Almost 15 years ago, when the University of Ghana established its Office of Research, Innovation, and Development, it did so with the goal of bolstering the West African nation’s research capacity. 

In the African region, where less than 0.5% of GDP is devoted to research, and a significant number of Africa’s educated is siphoned off to other countries, the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) has spearheaded the effort to make universities like the University of Ghana research-intensive and competitive. 

TDR support for research capacity-strengthening activities at the University of Ghana focuses on enabling researchers to tackle infectious diseases of poverty through quality implementation research, the study of bridging basic science research and practice. 

This could mean examining why many patients on antiretroviral therapy drop out of treatment, or identifying barriers to TB treatment adherence – both the subject of recent publications authored by researchers at the University of Ghana.

Capacity-building works

Professor Gordon A. Awandare at TDR’s Joint Coordinating Board meeting in Geneva, 12 June 2024

“Capacity-building actually works,” remarked Professor Gordon A Awandare,  Pro Vice-Cancellor of Academic Student Affairs at the University of Ghana, at a TDR 50th anniversary event in Geneva, where he gave a detailed review of the collaboration before TDR’s Joint Coordinating Board on June 12. 

He cited, as one example, his own career trajectory. Awandare began a career in research through a TDR grant that allowed him to complete his masters training, and then got an opportunity to study for a PhD at the University of Pittsburgh while attending a  conference on malaria with support from TDR.  He returned home to the University of Ghana in 2010, founding the West African Centre for Cell Biology of Infectious Pathogens (WACCBIP) in 2014. Since then, the Centre, supported by the Wellcome Trust and the World Bank, has endowed 400 fellowships and received $53 million in grants, thereby directly reducing the “brain drain” across the African region.

A decade-long partnership

The University of Ghana leads efforts to train students in implementation research. Newly enrolled master’s students during their lab induction at WACCBIP, University of Ghana.

In 2014 the University of Ghana’s School of Public Health  signed a partnership agreement with TDR to create a regional training center that leads activities in the African region for strengthening capacity in implementation research to tackle infectious diseases of poverty.

The initiative has so far trained more than 25,000 individuals across Africa, including health practitioners, decision-makers and researchers.                                    

“Looking at how far we’ve come as a training centre, it is our desire to become a centre of excellence where the annual programmes can be extended to say five years,” said Professor Phyllis Dako-Gyeke, who led the TDR-supported research training programmes at University of Ghana until her passing on 11 June. 

But the success of an almost decade-long relationship is not without its challenges. Sustainable donor support and aligned interests on research priorities remain key, she said.           

Real-time research 

Implementation researchers at UG have tackled issues from TB treatment adherence to antiretroviral therapy. Here, a community health worker conducts an interview in Obuasi, Ghana to identify barriers and facilitators for TB control.

Dr Emmanuel Asampong, coordinator of the regional training centre at the University of Ghana, notes that “the impact of implementation research on disease themes in Africa and beyond is impressive because the initiative uses  real-time research results in various contexts – such as the neglected tropical diseases programme, the national malaria programme, and the tuberculosis control programme – to provide solutions to challenges.” 

The global program, which has played a significant role in positioning University of Ghana as a research-intensive university, supports seven regional training centres across six WHO regions. With additional partners in Colombia, Indonesia, Kazakhstan, Malaysia, Senegal and Tunisia, the program develops and updates implementation research courses, provides faculty training and supports career development. 

Map of capacity building TDR regional training centers
The global program, which has played a significant role in positioning University of Ghana as a research institution, also supports NTD research in six WHO regions.

The University of Ghana also partners with TDR on a postgraduate training scheme, which provides a full academic scholarship  for master’s students. The training is specifically focused on implementation research to tackle infectious diseases of poverty. 

The list of TDR alumni across the world runs long, and the University of Ghana can claim many  public health leaders among them. 

“My postgraduate training at the University of Ghana, supported by TDR, was an invaluable catalyst in shaping my academic and professional journey,” said Dr Mbele Whiteson, Senior Resident Medical Officer at the Ministry of Health in Zambia. “I have learned to recognize the intricate interplay between health outcomes and social determinants.”‎

This is the third article in a series on TDR’s research capacity strengthening programme – building skills of public health researchers, implementers, health practitioners and policy-makers in the fast-developing field of implementation research for improving uptake of effective health interventions.

Sophia Samantaroy contributed to the writing and research of this story.

Image Credits: WACCBIP, TDR, African Regional Training Centre (ARTC), University of Ghana/TDR.

modernaAs H5N1 avian flu spreads in US dairy cows, the US Department of Health and Human Services (HHS) has granted approximately $176 million to Moderna to develop an mRNA-based vaccine for influenza with pandemic-potential.

“We have successfully taken lessons learnt during the COVID-19 pandemic and used them to better prepare for future public health crises. As part of that, we continue to develop new vaccines and other tools to help address influenza and bolster our pandemic response capabilities,” said HHS Secretary Xavier Becerra this week.

This award will help Moderna to set up additional pandemic influenza vaccine response capability, using existing domestic large-scale commercial mRNA-based technology and manufacturing platforms developed during the COVID-19 pandemic and ongoing seasonal influenza vaccine development, according to HHS.

The US government has also secured a fair pricing agreement “which will continue ensuring enduring equitable access to vaccines,” it added. Moderna’s COVID-19 vaccine was one of the most expensive on the market during the pandemic.

“The award made today is part of our longstanding commitment to strengthen our preparedness for pandemic influenza,” noted Assistant Secretary for Preparedness and Response Dawn O’Connell.

“Adding this technology to our pandemic flu toolkit enhances our ability to be nimble and quick against the circulating strains and their potential variants.”

The rapid spread of H5N1 bird flu in US dairy cows has rattled the US, affecting 12 states, according to the American Veterinary Medical Association.

The award will enable the rapid development of an mRNA vaccine targeted to various influenza strains with pandemic potential, and enable development and manufacturing to pivot quickly, if needed, to address other threats.

Image Credits: Jernej Furman/Flickr.

 Some 750 million people globally want to quit smoking but most lack access to help to do so.

Digital cessation programmes, behavioural support, and medication for tobacco cessation in adults are some of the measures contained in first-ever guidelines to help people quit smoking published recently by the World Health Organization (WHO). 

One in five adults – 1.25 billion users worldwide – consume various tobacco products such as  cigarettes, heated tobacco products, water pipes, smokeless tobacco products, or cigars. 

Even though more than half of them – around 750 million – want to quit, only 30% have access to effective cessation services.

Among the treatments recommended to help them are counselling, teaching patients to change their smoking-related habits, dedicated apps or calls, nicotine replacement therapy and medication.

 What works best is a combined approach: behavioural support and pharmacotherapy, WHO states. Member states are encouraged to provide quitting help for no or low fee to make it as accessible as possible.

The guideline marks a “crucial milestone” in combatting tobacco addiction, WHO Director-General, Dr Tedros Adhanom Ghebreyesus said in a press release. “It empowers countries with the essential tools to effectively support individuals in quitting tobacco and alleviate the global burden of tobacco-related diseases.”

Tobacco smoking affects nearly every organ of the body, causing over 20 types of cancer, increasing the risk of heart disease, stroke, and many other conditions. According to the WHO, tobacco kills half of its users and affects non-smokers through second-hand exposure.

Health system change, medication and behavioural support

The guidelines feature advised changes in the health systems: tobacco use status and implemented cessation interventions should be included in the patient’s medical records; it is also recommended that health care workers are trained on the appropriate therapies and provide a short behavioural support talk to smokers who want to quit. 

Treatments included in the guidelines: counselling, digital support, pharmacotherapy, and embedding smoking cessation in the healthcare system are key recommendations.

Pharmacotherapy using nicotine replacement therapy and drugs such as varenicline, bupropion, and cytisine, especially when combined with behavioural support. This may include skills and strategies for changing behaviour as well as more general counselling. 

Traditional, complementary and alternative therapies are not recommended due to insufficient evidence for their effectiveness.

Varenicline, but not vapes

While the guidelines strongly recommend the use of varenicline, they do not mention a possible role for vapes in quitting traditional cigarettes, more harmful than their e-cigarette alternative. 

A recent study published by the JAMA Network suggests vaping can be as efficient as varenicline in helping smokers quit – although, as WHO argues, it has little effect at the population level. 

WHO states that “e-cigarettes are beyond the scope of this guideline because the potential benefits and harms of using these products are complex, and are addressed in a separate body of literature. These products may be addressed in the future as evidence accumulates.”

The tobacco industry is highly invested in marketing vapes, framing them as a safer alternative to traditional smoking even though they are also addictive and harmful. The WHO might be more cautious to promote e-cigarettes knowing its statements can be used by tobacco firms to promote their products.

“We need to deeply appreciate the strength it takes and the suffering endured by individuals and their loved ones to overcome this addiction,” said Dr Rüdiger Krech, Director of Health Promotion at WHO, in a press release. “These guidelines are designed to help communities and governments provide the best possible support and assistance for those on this challenging journey.”

Image Credits: Sarah Johnson, WHO.

Women at a gynaecology clinic in Nepal.

While a vaccine exists to prevent human papillomavirus (HPV), the main cause of cervical cancer, over 20 therapeutic HPV vaccine candidates are currently in development.

These therapeutic vaccines aim to “boost the body’s immune response so that it can either fight and clear high-risk strains of the virus or abnormal ‘precancerous’ cells,” according to the World Health Organization (WHO).

The global body issued a report on Wednesday to guide vaccine developers about the preferred product characteristics (PPCs) for any new therapeutic vaccines in priority disease areas – primarily low and middle-income countries (LMICs).

Eliminating cervical cancer, which kills one woman every 90 seconds,  is a major public health initiative for WHO. The key goals of its current strategy are to vaccinate 90% of girls with preventive vaccines, screen 70% of women with a high-performance tests like DNA screening, and treat 90% of women with cervical cancer or precancerous cells in the cervix by 2030.

Cervical cancer mortality 2022

Millions of adults have missed out

A therapeutic vaccine “is likely to be especially beneficial for adult women who did not receive the HPV vaccination before contracting the virus and in poorer countries, where millions of women still lack access to effective cervical screening and cancer treatments,” according to WHO.

Currently, the HPV preventive vaccine is targeted at school children before they become sexually active. Most countries offer it to boys too as they can carry HPV and infect girls and women.

Only 28 of the 47 countries in the WHO African Region, the region with the highest rates of cervical cancer, had introduced prophylactic HPV vaccine into their national immunisation programmes by January.

Africa’s most populous country, Nigeria, introduced the vaccine in parts of the country last October. Others do not yet have it as part of their immunisation programme. 

This means that millions of adult women are not vaccinated. In addition, many women do not get screened for HPV, while others might be diagnosed with pre-cancerous cells or cervical cancer yet not get access to treatment.

Complementary vaccines

“Therapeutic HPV vaccines could be a catalytic innovation that complement these existing interventions, increasing options for the millions of women who have already acquired HPV and reducing their risks of developing life-threatening cancer in the future,” said Dr Sami Gottlieb, a medical doctor and epidemiologist at WHO’s Department of Sexual and Reproductive Health and Research. 

Cervical cancer screening 2019
Cervical cancer screening 2019

An expert group convened by the WHO identified that therapeutic vaccines would be useful in places where it has been difficult to scale up cervical cancer screening and treatment, and as “an alternative, simpler treatment to reduce loss to follow-up” of women who are effectively treated following a positive test. 

“A wide variety of approaches have been used to develop therapeutic HPV vaccine candidates, including peptide, protein, DNA, RNA, and bacterial- and viral-vectored vaccine platforms,” according to WHO.

Vaccine candidates have mainly targeted the regression of CIN2/3 lesions and invasive cervical cancer, while a few candidates focusing on clearance of high-risk HPV infection are now in phase 1 and 2 studies.

Vaccines in development include candiates from Barinthus Biotherapeutics, TheraVectys and Genticel.

‘Therapeutic HPV vaccines would ideally have high efficacy in both clearing high-risk HPV infection to prevent development of cervical precancers, and treating high-grade precancers that have already developed,” according to WHO. 

At a minimum, first-generation vaccines would be expected to clear infection and/or prevent high-grade cervical precancer due to HPV types 16 and 18, according to WHO.

These vaccines could be given to adult women through population-based vaccine delivery – without a diagnostic test if that was not available. 

Therapeutic HPV vaccines that could reverse the progression of high-grade cervical precancers (at a minimum HPV 16 and 18) could be used as an alternative or adjunct to existing cervical treatments in women with cervical precancer according to positive screening tests. 

“Both types of vaccine could potentially play a role in addressing each of the identified gaps in cervical cancer prevention programmes. 

“The choice of target population, including the optimal age range and the delivery strategy in a given setting, will not only depend on intrinsic vaccine characteristics – such as efficacy in clearing infection rather than causing regression of high-grade precancers – but also on factors related to the environment into which these vaccines are introduced.”

 

Image Credits: Tom Pietrasik/ WHO.

Ashley Bloomfield, co-chair of the Working Group on Amendments to the International Health Regulations and Precious Matsoso, co-chair of the Intergovernmental Negotiating Body (INB) on the eve of the World Health Assembly

Following the 77th World Health Assembly (WHA)’s endorsement of a delay of up to one year for finalizing a pandemic agreement, the Intergovernmental Negotiating Body (INB) is set to resume talks on 16-17 July 2024. 

INB member states will face contentious procedural issues and thorny debates over the resolution of substantive matters including a system for Pathogen Access and Benefit Sharing (PABS), One Health; and a formula assuring more equitable access to pandemic health products, where wide gaps remain.

Debate around these outstanding issues is a focus of this latest issue of the Governing Pandemics Snapshot. The issue, produced by the Global Health Centre at the Geneva Graduate Institute, also unpacks the WHA-approved amendments to the International Health Regulations and their meaning.  

Contentious procedural issues

The INB is set to resume its work with a two-day session on 16-17 July 2024. At the 10th INB session, members face two potentially contentious procedural issues and resume discussions on how to tackle key unresolved substantive matters. 

The May WHA decision to continue the pandemic talks for up to one more year, also allows for the INB to decide on rotation of the INB’s leadership. Known as ‘the Bureau’, this consists of six regional country representatives including two co-chairs from The Netherlands and South Africa. 

Over the past few months, there was widespread grumbling amongst INB members regarding the Bureau’s management of the process involving both technical issues as well as perceptions of missed opportunities for bridging gaps in diverse country positions. At the same time, delegates also have acknowledged the difficult challenges the Bureau faces in forging consensus on hotly debated issues such as PABS.

INB co-chairs Roland Driece and Precious Matsoso.

While there are unconfirmed reports that the Dutch co-chair, Roland Driece, may be stepping down, the Africa Group is supporting its co-chair, Precious Matsoso, to continue in her position. Meanwhile, the status of the other Bureau members remains unclear. Maintaining the same members would ensure continuity, institutional knowledge, and established working relationships. 

Conversely, a change in the leadership structure could introduce fresh ideas and new approaches, and a more gender-balanced leadership team, given that the current structure is predominantly male (5 out of 6 members).

The composition of the Bureau is closely linked to the second matter of interest for member states: methods of work. How the Bureau has run the INB has frequently been mentioned as another source of frustration for member states. The wording of the WHA decision suggests that member states wish to retain the possibility of revising both the leadership structure as well as the organization of the INB’s work going forward. 

Closely linked to this is the question of how the group will handle the work completed during the first phase of negotiations? Will the ‘convergence’ already achieved on 143 paragraphs out of 177 be preserved? Or will they reopen the entire text for further negotiations?

PABS remains the key unresolved issue

One of the most challenging, unresolved issues is certainly the establishment of a PABS system, currently included in Article 12 of the draft agreement. Given its technical complexity and the deep disagreement signified by the almost complete lack of convergence text in the INB outcome report, it is likely to continue being the make-or-break article of the talks.  

Negotiators have so far reached agreement only on the fact that such a system should exist, and should enable the rapid and timely sharing of pathogen materials and sequence information with pandemic potential alongside the “fair and equitable” sharing of benefits that derive from them. 

But the precise architecture for pathogen sharing remains unresolved and will be central to the next phase of negotiations. Disagreements persist over the modalities, terms and conditions for sharing relevant materials – with pharma and high-income countries pressing for modalities that ensure the preservation of free access, while low- and middle-income countries aim for a closer linkage between sharing of pathogens and access to benefits. 

Related to this, the use of standardized, legally binding contracts, user registration requirements, intellectual property rights, remain open. And finally, there is the question of whether any sharing mechanism set out in the Pandemic Agreement would effectively supersede similar provisions of other international instruments, notably the Nagoya Protocol of the Convention on Biological Diversity – a key demand of pharma and high-income countries.

In relation to the sharing of benefits, another key disagreement regards the actual percentage, or proportion, of vaccine and medicines set-asides to be offered for free or at concessionary prices in the event of public health emergencies of international concern and pandemics.

Some factions, notably LMICs are pushing for higher, fixed percentages, while higher income countries say that the proportions need to remain flexible and responsive to the context and geo-location of any pandemic emergency.

PABS as a separate technical instrument? 

Given the obvious complexities, it also remains unclear whether the final details of the PABS system will be delineated in the framework of the Pandemic Agreement, or if they might possibly be moved into a separate protocol or other legal instrument. 

Pre-WHA, proposals on the INB table included the possibility of having the WHA launch an open-ended intergovernmental process to negotiate the details of the PABS system in a separate instrument. Notably, this option is not included in the most recent version of the draft INB text, as it was “frozen” before the Assembly. But the idea was being informally circulated by the INB co-chairs as part of a draft WHA resolution in the last INB negotiations (INB 9) just prior to the Assembly.

Given the substantial amount of technical and operational complexity required to create an effective PABS system, it is very possible that INB negotiators may ultimately reconsider this approach.

It is noteworthy that several countries have emphasized the necessity of broadening the discussion to include experts from beyond governmental spheres in the PABS debate, full of technical nuance. Engaging expert participation will be crucial for developing a robust and effective PABS system that will significantly impact scientists, universities, researchers, and industries.

One Health 

A researcher explores evidence around the wildlife-trade- pandemic nexus

Negotiators have also extensively debated the inclusion of the One Health approach in the agreement, which acknowledges the interconnection between the health of people, animals, and ecosystems. Developed countries mainly support a strong One Health article in the pandemic text. But a number of developing countries, backed by CSOs, have raised concerns about the regulatory burden, costs, and potential barriers to agricultural trade that such provisions could imply.

While the draft agreement suggests an initial convergence on a One Health approach, the current text is very general and there remains divergence on developing an additional instrument after the adoption of the agreement to further define its modalities, terms, conditions, and operational dimensions. 

Developing country negotiators are aware of the importance attached to this approach by developed nations and may leverage it tactically in future negotiations.  

At the same time, a number of other prominent CSOs have protested this becoming a geopolitical football. Those One Health advocates point to the fact that high income countries, as well as LMICs, need to adopt stronger measures to prevent the spread of pathogens such as H5N1. And at the same time, LMICs that are on the front lines of pathogen spillover from the wild can reap huge benefits from greater integration of One Health approaches into pandemic prevention. 

Access to health products 

Intense discussions are also to be expected on substantive issues related to access to health products, as highlighted by our colleague Suerie Moon, in a separate article in this edition of the Governing Pandemics Snapshot. 

Considering these deep divides as outlined above, and a fading political momentum, experts have warned that one additional year of work still might not be enough to bring these discussions to a close.  

Strong leadership, political commitment, and good-faith international cooperation, such as that which facilitated the successful amendment of the International Health Regulations, will be essential to bring the Pandemic Agreement to a final agreement in time for the May 2025 WHA. 

Dragging deadlines

Concerns about meeting the latest deadline for WHA 2025 are all the more pertinent in light of the fact that the past six months of negotiations have seen member states repeatedly add to, and prolong, working sessions well beyond their original time frames. 

As of January 2023, negotiations had already been underway for almost two years, when the INB faced a crunch to complete the agreement by May 2024. That, as per its original WHA mandate received in December 2021, at the height of the COVID pandemic. 

Since the beginning of the year, four sessions of the Intergovernmental Negotiating Body (INB) have taken place. 

The eighth meeting of the INB, held from February 19 to March 1, 2024, advanced discussions through the work of the drafting group and thematic subgroups, focusing on a proposal tabled by the Bureau in October 2023. However, this marathon, two-week negotiation session did not achieve a significant breakthrough.

In early March, following member states’ request, the Bureau circulated a Revised Draft of the negotiating text of the WHO Pandemic Agreement. The INB9, which convened from 18-28 March 2024, considered that draft. 

Member states proposed numerous amendments and textual edits, resulting, at the end of the session, in a 110-page document with no clear strategy for bridging differing views. The gaps were all the more glaring in light of the Bureau’s stated intention of convening INB9 as the final meeting before WHA77. But delegates were so far divided on key topics at the close, that a new INB session was scheduled to continue negotiations.

‘Consensus-ready’ text did not bridge gaps 

A new Proposal for the WHO Pandemic Agreement was released on April 22 ahead of the ‘resumed’ INB9 (29 April to 10 May). This draft text, according to the Bureau, featured a streamlined, ‘consensus-ready’ text. 

It included ample use of qualifiers such as ‘voluntary’ and ‘as appropriate’. It also deferred the resolution of more contentious issues like PABS and One Health to two additional, separate instruments to be negotiated at a later stage.

The “consensus-ready text,” unfortunately, did not bridge divided opinions, as member states remained deadlocked in opposing blocs – including the “Equity Bloc” of primarily LMICs; a bloc of European Union, North American and other high income nations, as well as the African Group and other geopolitical alliances.  

Unwilling to concede turf, member states agreed to continue working in yet another resumed INB9 session from May 20-24, concluding only on the Friday just before the Monday start of WHA77. 

The net result was nearly a month of non-stop negotiations for member states under the auspices of the INB, as well as the separately constituted Working Group on International Health Regulations. 

By 24 May at 6pm it became clear that no agreement on the pandemic agreement would be reached, with convergence achieved for only 13 out of 34 articles – and the ball was punted to the WHA. 

More successful IHR Working Group 

IHR co-chairs Dr Ashley Bloomfield and Dr Abdullah Asiri shortly before the WHA approved the amended rules.

By that same Friday, the IHR Working Group managed to arrive at a more successful conclusion, and the few outstanding issues remaining were resolved during WHA, leading to final approval of the amended IHR, on June 1, 2024. Unlike the Pandemic Agreement, the amendments don’t require member state ratification – although nations may opt-out from the amendments if they wish. 

Buoyed by the successful completion of the negotiations on the IHR, the hope is that the coming months will also put the INB over the goal post in time for the 78th WHA in 2025, at the latest, or if ready earlier, at a special session of the WHA in 2024.

Daniela Morich is Manager and Adviser of the Governing Pandemics Initiative at the Global Health Centre, and a lawyer with previous professional experience in multilateral negotiations.

Ava Greenup is Project Associate of the Governing Pandemics Initiative at the Global Health Centre.

This is an article from the fourth issue of the Governing Pandemics Snapshot, which also carries an analysis of the recently adopted International Health Regulations by Geneva Graduate Institute Professor Gian Luca Burci, as well as a discussion on access to health products within the IHR and the Pandemic Agreement, by Global Health Centre Director and Geneva Graduate Institute Professor of Practice Suerie Moon.

Image Credits: Wildlife Conservation Society .