Pharmaceuticals, Diabetes
An exhibition marks the discovery of insulin, a life-saving treatment for diabetes, at the University of Toronto in 1921

French drugmaker Sanofi is the latest pharmaceuticals manufacturer to offer a package of essential medicines at cost to health systems in the world’s most impoverished countries – including much-needed cancer and diabetes treatments.

Sanofi on Monday announced the launch of the new nonprofit Impact® brand for dozens of medicines, that is supposed to ease support medicines procurement in 40 low-income countries. 

The new brand will enable the secure distribution of 30 Sanofi medicines, including glibenclamide and insulin for diabetes and oxaliplatin for chemotherapy, France’s largest drug company said in a statement.

The prevalence of diabetes has nearly doubled over the past three decades, with rates soaring in low- and middle-income countries beset by an epidemic of obesity related to higher processed foods and junk food cosumption and less physical activity. But high prices have limited people’s access to essential diabetes treatments, with a market dominated by three firms worldwide- including Sanofi.

Only about 50% of the estimated 100 million people requiring insulin worldwide are able to access treatment, according to a 2017 study led by Health Action International.  Human insulin, traditionally the least costly insulin treatment, is also gradually replaced in markets by longer-acting and often higher-priced “insulin analogues” – which can make treatment even harder to access  in low- and middle income countries and even in some high-income settings. 

Making essential medicines affordable for diabetes, cancer, malaria, tuberculosis and other areas

All of the medicines to be distributed by Sanofi Global Health, a nonprofit unit within the company, are on the World Health Organization’s list of essential medicines that is updated in consultation with experts worldwide every two years.

The list covers a wide range of therapeutic areas, including diabetes, cancer, cardiovascular disease, malaria, and tuberculosis, as well Hepatitis C and common bacterial infections.

Last year’s Model Lists of Essential Medicines (EML) from WHO – which provides a baseline of guidance to national health authorities on products and services that should be made the most widely available – included for the first time ever, long-lasting insulin analogues, also produced by Sanofi.

Previously, the EML expert committee had rejected their inclusion on the basis of fears that broader reliance on the higher-priced analogue formulations could restrict access to lower-cost human insulin products.

However, in view of increasing availability, WHO Director-General Dr Tedros Adhanom Ghebreyesus said the inclusion of insulin analogues is a step in the right direction towards affordable access to a lifesaving treatment.

The inclusion of four new cancer medicines also was a priority for the updated EML. Additional childhood cancer indicators were also added for 16 medicines already listed, including low-grade glioma, the most common form of brain cancer in children.

Underserved populations, startups and innovators

The launch of the Impact® brand is among the steps taken by Paris-based Sanofi since forming Sanofi Global Health last year to increase healthcare access by distributing medicines and to improve local healthcare systems among some of the poorest nations.  It has also launched a $25 million Impact Fund to support healthcare startups and other innovators to deliver “scalable solutions for sustainable healthcare in underserved regions,” according to the company.

“Sanofi Global Health aims to improve the lives of millions of people who now cannot get the help they need,” Sanofi’s CEO Paul Hudson said. 

Added Jon Fairest, who heads the Global Health Unit: “But we know that we cannot do this alone, and so we are building partnerships at global, regional and local levels that will help to improve and establish health systems to reach our goal of a healthier, more resilient world,” 

Towards a tiered pricing approach for pharmaceuticals

Sanofi’s moves follow on a other announcements by a number of leading drug companies expanding their use of “tiered pricing” to include drugs for common NCD treatments, including Pfizer, the world’s top pharma revenue earner, which is making billions from its COVID-19 vaccine.

The company announced last month at the World Economic Forum that it will begin selling 23 of its patented medicines and vaccines marketed in the United States and European Union on a non-profit basis to 45 of the world’s low-income countries.

The medicines and vaccines in Pfizer’s “Accord for a Healthier World” project include treatments for infectious and rare inflammatory diseases, and some cancers.

Thomas Cueni, director general of International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), said tiered pricing can help improve access to vital treatments, although it is not enough on its own. 

“This works on the basis that lowest-income countries have a pricing that reflects their reduced ability to pay, just as richer countries will pay more,” Cueni told Health Policy Watch.

“However, pricing needs to be understood in the broader context of access to treatments,” he said. “It also requires having in place the health systems to diagnose; the healthcare workers to treat patients; and mark up of medicine prices throughout the supply chain by medicine wholesalers.”

Cape Town’s Afrigen Vaccines & Biologics laboratory. The company has now made a deal with Univercells to produce the first African-owned COVID-19 vaccine.

The wider use of pooled procurement in national health systems can help low- and middle-income countries get a better deal on pharmaceuticals – here’s how and why.

Low- and middle-income countries are making strides in bolstering their domestic pharmaceutical sectors—evidenced by the recent deal between South Africa’s Afrigen Biologics and Belgium’s Univercells, to develop the first African-owned COVID-19 vaccine. 

On the demand side, governments can do more to get better deals when they do need to purchase drugs outside their borders. They should consider banding together their negotiating power via a category of supply chain models known as pooled procurement. 

South Africa’s experience with antiretrovirals for HIV illustrates the benefits buyers can reap. The country has cut the price of the life-saving HIV treatments by 68% since 2011 using a national pooled procurement mechanism that combines the buying power of the country’s nine provinces. This has opened the way for millions more people to access HIV/AIDS treatment every year with the help of affordable antiretrovirals. 

The mechanism is underused but can be a powerful tool to help drive down drug costs, which are often a significant slice of health care budgets in lower-income countries. 

Such an approach will surely boost access to care and promote quality assurance. 

The power of the buyers is facilitated by aggregating their combined knowledge, a harmonized approach, and consequent collective demand. That power is then used to negotiate terms of supply.  

Suppliers, in return, receive greater visibility into production demands, allowing them to maximize capacity and improve product movement. 

How it works in South Africa  

A child with HIV takes a paediatric dose of antiretroviral medication – in South Africa pooled procurement has made life-saving ARV’s much cheaper and more widely accessible.

Here’s how it works in South Africa: The provinces aggregate their demand into a national three-year contract, with multiple awards per product and minimum volume pledges for vendors. To stimulate a dynamic market, price preferences are given for local producers and new market entrants. 

The results? The Clinton Health Access Initiative’s HIV Market Study shows that the price per unit the South African government pays is lower than what many multilaterals such as the Global Fund and even PEPFAR pay. A variety of local manufacturers have invested in local production capacity.  

The benefits for buyers are clear, but vendors may need convincing to take part. Highlighting the predictability of volume, duration of contracts, and security of funding can help.  

On the donor side  

Drone delivery of Gavi bulk-purchased vaccines in Ghana in 2019 to over 2,000 health facilities serving 12 million people across the country.

In the international donor arena, among the most high-profile pooling examples is Gavi, the Vaccine Alliance. Gavi’s private-public partnership comprises a range of players, including the World Health Organization, the Bill & Melinda Gates Foundation and governments such as the U.S., to pool demand for vaccines for the world’s neediest. 

Gavi’s scale has achieved cost savings that have spurred countries to expand their immunization programs, thus broadening the potential market into which vendors can sell. That in turn has inspired manufacturers to invest in scaling up production and to introduce new vaccines. 

Pooled procurement should not be a ‘race to the bottom’

Bulk drug procurement. Price concerns need to be balanced with concerns for quality and the need to foster diverse manufacturers – both to develop LMIC manufacturing and insure stable supply chains.

At the national level, the most efficient pooling systems are often composed of members at similar levels of economic development. Notably, where one province is economically dominant in the South Africa example, this has proven to be an obstacle to developing regional pooling initiatives across the Southern African Development Community.  

Cross country pooling will require a more concerted focus on regulatory harmonization, an intended priority of the newly-minted African Medicines Agency.  

Additionally, a race to the bottom in terms of price shouldn’t be the targeted outcome. It carries the risk of encouraging substandard medicines or even vendors leaving the market. A focus on price alone may also lead to a concentrated marketplace with too few suppliers dominated by big players.   

The pandemic was a wake-up call in this regard, for example, when broken supply chains and the diversion of India’s vaccines for domestic use left many African countries counting on the procurement and distribution of Indian vaccines via COVAX without doses. 

Developing stronger, country-led procurement systems 

Pharmacy in Kenya; stronger national procurement systems are needed to improve medicines access and reduce prices on the African continent.

Also, big funder-controlled pools like UNICEF and the Global Fund have historically tended to dominate decisions on timing, quantity, and standards. That dynamic can impede the development of strong, country-led procurement systems.   

Rather, donors or buyers should seek to maintain a healthy market whereby suppliers want to remain in the business given the potential for volume. This focus moves away from a given set price for a given commodity and realizes there may be a variance, albeit small, between suppliers to keep them in the game.  

All of this underlines the importance of diversified procurement from multiple sources.  

Such a shift in approach is needed to empower countries to work on their own or partner with peers and to reward local industry development. 

Despite these challenges, the upsides far outweigh these potential hurdles. 

Using pooled procurement to tackle NCDs  

Receiving a shot of insulin  – hundreds of millions of people across the world still lack access to this and other basic NCD treatments.

The South Africa example shows what can be achieved in HIV. Extending the approach to more conditions through pooled procurement represents a new frontier of opportunity. 

Noncommunicable diseases (NCDs) like cancer and diabetes are on the rise and affect swathes far greater than HIV. They account for 800,000 deaths annually in the world’s poorest countries—more than HIV, tuberculosis and maternal health combined.  

To be sure, pooled procurement is not a panacea to achieve a resilient, effective health system. 

But focusing only on the supply side of the equation will solve one major problem: availability. 

By banding together, buyers in low- and middle-income countries can work toward achieving greater equity and access in purchasing life-saving pharmaceuticals. 

_______________________

Iain Barton is Senior Fellow at the global health non-profit, Management Sciences for Health, and Founding Principal of Health4Development, which supports the development of successful healthcare services and commodities enterprises in Sub-Saharan Africa. Dr. Barton is a medical doctor with a unique mix of experience, including serving as the CEO of the Clinton Health Access Initiative and as an executive vice president and CEO of various health supply chain logistics companies.

René Berger is the pharmaceutical systems and supply chain practice area lead at Management Sciences for Health. Mr. Berger is a global health, supply chain, and HIV and AIDS expert with more than 25 years of international development experience across sub-Saharan Africa.

 

Image Credits: Rodger Bosch for MPP/WHO, Paul Kamau/ DNDi, Gavi/2019/Tony Noel, Commons Wikimedia, Luigi Guarino , WHO, LinkedIn, Management Sciences for Health .

Ebola vaccination in Mbandaka, Équateur Province (DRC); swift response helped reduce the toll of the province’s most recent outbreak.

The Ebola outbreak that erupted on 23 April in the Democratic Republic of the Congo today was declared to be over  by DRC and WHO authorities – with fewer cases and deaths than previous episodes thanks to a swift response including vaccinations.

The outbreak erupted in Mbandaka, the capital of Equateur Province in the country’s northwest. It was the third outbreak seen in the province since 2018 and the country’s 14th overall.

While DRC is among those countries seeing outbreaks of Ebola and other zoonotic diseases with greater frequency, a swifter response using a new arsenal of Ebola vaccines, as well as stepped-up contact tracing and education around prevention, is also reducing the length of outbreaks and the deadly toll of the disease, the head of WHO’s African Regional Office said.

“Thanks to the robust response by the national authorities, this outbreak has been brought to an end swiftly withlimited transmission of the virus,” said Matshidiso Moeti, WHO Regional Director for Africa. “Crucial lessons have been learned from past outbreaks and they have been applied to devise and deploy an ever more effective Ebola response.”

In the most recent case, vaccinations were launched just four days after the outbreak was declared. In all, there were four confirmed one probable Ebola case – all of whom died. In comparison, in the previous outbreak in Equateur Province that lasted from June to November 2020, there were 130 confirmed cases and 55 deaths.

The recent outbreak saw a total of 2104 people vaccinated, including 302 contacts and 1307 frontline workers. To facilitate the vaccination rollout, an ultra-cold chain freezer was installed in Mbandaka which allowed for vaccine doses to be stored locally and safely and be delivered effectively.

The DRC has now recorded 14 Ebola outbreaks since 1976, six of which have occurred since 2018.

“Africa is seeing an increase in Ebola and other infectious diseases that jump from animals to humans impacting large urban areas,” Moeti warned. “We need to be ever more vigilant to ensure we catch cases quickly. This outbreak response shows that by bolstering preparedness, disease surveillance and swift detection, we can stay a step ahead.”

Image Credits: WHO/Junior D. Kannah.

Within a week of overturning the constitutional right to an abortion, the United States Supreme Court has now dealt a severe blow to the nation’s ability to strictly regulate and reduce carbon dioxide emissions from power plants that contribute to global warming, with escalating impacts on health and well-being.

US President Joe Biden described Thursday’s ruling as “devastating”, while China questioned the United States’ sincerity in tackling international carbon emission targets.

Voting along ideological lines, the court ruled 6-3 in favour of an appeal brought by 19 states and coal companies against the U.S. Environmental Protection Agency (EPA) that contended it only had narrow authority to regulate carbon emissions generated by power production. 

According to the ruling, the US Congress did not explicitly grant EPA the authority to cap greenhouse gas emissions across the sector in the Clean Air Act, but only to regulate actions at individual power plants.

Chief Justice Roberts, supported by five other conservative judges, stated in the judgement that “it is not plausible that Congress gave EPA the authority to adopt on its own such a regulatory scheme”.

“A decision of such magnitude and consequence rests with Congress itself, or an agency acting pursuant to a clear delegation from that representative body,” he added.

Dissenting opinion – emissions also contribute to air pollution that endanger public health

Health-harmful pollution emissions have declined sharply since 1990, but ozone emissions stalled a decade ago and some PM indicators slightly increased recently.

However, in her dissenting statement, Justice Elena Kagan wrote that “Section 111 of the Clean Air Act directs EPA to regulate stationary sources of any substance that ’causes, or contributes significantly to, air pollution’ and that ‘may reasonably be anticipated to endanger public health or welfare.’ “

Dirty coal and oil-fired power plants that emit the highest levels of CO2 also emit other pollutants harmful to health, including fine particulates (PM10 and PM2.5) , volatile organic compounds (VOCs) and nitrogen dioxide (NO2), which contribute to the formation of ozone. While there has been a decline in such emissions over the past 20 years, ozone emissions have plateaued in the past decade, and PM2.5 emissions even increased recently – and are above new WHO guideline standards of 5 µg/m3. New EPA rules to prompt broader, sector-wide shifts to cleaner power and more renewables would have also helped address those nagging pollution issues.

Higher levels of PM 2.5 and PM10, for instance, lead to more premature deaths from heart attack, stroke, cancers and lung disease, while ozone is closely associated with increased asthma, including childhood asthma cases. There are still an estimated 100,000-200,000 deaths annually from air pollution in the United States, according to a 2020 paper by a leading group of researchers. And one-half of those deaths can be attributed to just five activities, including heat and power production.

In addition to deaths directly attributed to power plant pollution emissions, there is a growing toll in the United States  in terms of deaths and injuries related to wildfires and other extreme weather events, also being exacerbated by climate change.

Power plants are one of the five core sources of health-harmful air pollution in the United States (Thakrar et al, 2020)

Green economy threatened

One of the cornerstones of US President Joe Biden’s administration is boosting the so-called ‘green economy’ of low carbon and low polluting energy technologies, and this ruling could undermine multibillion-dollar efforts underway to phase out fossil fuels and replace them with cleaner energy sources. 

“I have directed my legal team to work with the Department of Justice and affected agencies to review this decision carefully and find ways that we can, under federal law, continue protecting Americans from harmful pollution, including pollution that causes climate change,” Biden said in a statement.

“Since the Clean Air Act was passed by a bipartisan majority in Congress in 1970, the landmark law has enabled both Democratic and Republican administrations to protect and improve the air we breathe, cutting air pollution by 78% even as our economy quadrupled in size,” he said. “Yet today’s decision sides with special interests that have waged a long-term campaign to strip away our right to breathe clean air.”

China’s foreign ministry spokesman Zhao Lijian told a regular media briefing on Friday that his nation took note of the ruling and the international community’s “fair criticism” of it.

“As we always say, to address climate change, it is not enough to just chant slogans. It is about everyone doing their own part,” said Zhao.

“We urge developed countries, including the US, to earnestly abide by the principle of common but differentiated responsibilities, own up to their historical responsibilities and show greater ambition and actions,” he said. “At the same time, developed countries should effectively help developing countries enhance their capacity to cope with climate change in terms of funding, technology and capacity building.”

The main source of greenhouse gas emissions in the US is from electricity, which accounted for a quarter of the emissions in 2020. 

‘Disappointing and disheartening’

EPA Administrator Michael Regan said he was “deeply disappointed” by the decision but emphasised that EPA remains committed to protecting communities and cutting emissions that drive climate change.

“EPA’s number one priority is to protect people’s health, especially those who are on the front lines of environmental pollution. Make no mistake: we will never waiver from that responsibility,” Regan said in a statement. “We will move forward to provide certainty and transparency for the energy sector, which will support the industry’s ongoing efforts to grow our clean energy economy,” he added.

Regan said addressing climate change means putting the US economy on a more competitive footing by creating jobs in the clean energy sector, lowering costs for families and protecting people’s health and well-being.

“EPA will move forward,” he added, “with lawfully setting and implementing environmental standards that meet our obligation to protect all people and all communities from environmental harm.”

More court challenges by polluters? 

The global public health organisation Vital Strategies condemned the Supreme Court ruling, which it described as “an assault on the nature of government as much as nature itself, stripping agencies of their ability to act with scientific authority”. 

The organisation’s senior vice-president, Daniel Kass, warned the ruling would “accelerate our very real climate crisis, leading to more preventable illness and death”, and was likely to result in new challenges by “polluters” in state courts.

“Just this March, the EPA, under its authority from the Clean Air Act, re-enabled California and other states to regulate greenhouse gas emissions from [vehicle] tailpipes. We can now expect polluter-financed challenges to all state-level efforts to regulate CO2 emissions,” Kass said.

“Public health officials must pressure policymakers to join amica briefs to defend state regulations and to align with the overwhelming majority of the public that want to see CO2 regulated,” he said. “The urgency of climate change demands it. There is no time to wait for a generational swing back to centre.”

John Noel, a senior climate campaigner for Greenpeace USA, noted in a statement that air pollution from fossil fuel burning caused about one-in-five deaths worldwide in 2018. 

“Radicals in robes are severely restricting the federal government’s ability to protect people and the ecosystems that support life,” he said. “It is unconscionable that six Supreme Court Justices have ruled in favour of sacrificing more lives to enrich millionaire coal and oil barons.”

Image Credits: Ella Ivanescu/ Unsplash, US EPA, (Environ. Sci. Technol. Lett. 2020, 7, 9, 639-645), Us Environmental Protection Agency.

Dr Ahmed Ogwell Ouma, Africa CDC’s acting director, asserts the continent should be top priority for vaccine doses for monkeypox.

WHO and Africa CDC are trying to close a huge testing gap for monkeypox that has left some health workers reliant on symptomatic diagnosis.

The World Health Organization (WHO) and African Centres for Disease Control and Prevention (Africa CDC) acknowledge they will not be able to gain a clear understanding of the monkeypox outbreak in Africa until the continent improves its ability to test better and close the gap between confirmed and suspected cases.

Just 104 new cases of monkeypox have been confirmed compared with 1,678 suspected cases in Africa since the beginning of 2022, Africa CDC’s acting director, Ahmed Ogwell Ouma, announced during a press briefing on Thursday.

He told Health Policy Watch the gap is due to limited capacity at labs and lack of enough test kits.

“This usually means appropriate training is not yet widespread and the test kits are also not available,” he said, adding that health workers in Africa are resorting to “clinical acumen and high levels of high index of suspicion” to identify monkeypox cases “because of capacity issues.”

This will hopefully change soon, he said, as Africa CDC acquires and provides more training and test kits. In Europe, the Americas and elsewhere some 3414 cases had been confirmed as of 22 June, WHO reported on Tuesday.  

Monkeypox rash

WHO is also procuring test kits for Africa

Along with Africa CDC, the UN health agency is working on building up testing capacity on the continent.

All African countries have the polymerase chain reaction (PCR) equipment needed to test for monkeypox.  But many lack essential reagents and training in specimen collection, handling and test administration, Dr Matshidiso Moeti, WHO AFRO’s regional director, told a press briefing on Thursday.

WHO is working to procure 60,000 tests, she announced, including 2,000 that will be dispatched to the countries at highest risk.

“Over the past month, five African cities have received donations of reagents from partners, bringing to 12 the number with enhanced monkeypox diagnostic capacity, and another group of countries in West Africa receiving agents just after participating in the necessary training,” Moeti said.

Monkeypox virus genome sequencing in Africa

Seven African countries are sequencing the monkeypox virus genome and using an improved genomic sequencing capacity acquired during the COVID-19 pandemic, according to Moeti. That should improve understanding of how the monkeypox virus is spreading across countries and continents.

Some 300 samples have been sequenced since the beginning of the year, with most of the published sequences showing the West African clade of the virus.

WHO says it is working to accelerate capacity through training in monkeypox genome sequencing that it is offering to lab experts from 20 countries in coming weeks.

Image Credits: US Centers for Disease Control.

Rush hour traffic in Ho Chi Minh City, one of the cities supported by Bloomberg Philanthropy’s Global Road Safety Partnership

The world’s transport ministers pledged to cut road traffic deaths and injuries by 50% by 2030, as part of a political declaration adopted at the first-ever United Nations High Level Meeting on Global Road Safety, which opened Thursday in New York City.  

The debate came as a new Lancet series suggested that some half a million lives could be saved by  targeting just four key risk factors for road injuries – speeding, drunk driving, lack of helmet, and seatbelt use –  in 185 countries could save up to half a million lives a year.

Worldwide, road crashes currently kill around 1.3 million people each year – more than 2 every minute, and more than 90% occur in low- and middle-income countries, according to the Lancet study. Road injuries are the leading killer of children and young people globally. 

Despite years of lip service to the issue, the burden of adolescent deaths in poor countries has only grown.  Almost half of adolescents killed by road injuries in 2019 lived in low-income countries, up from around a quarter in 1990, according to the Lancet study.  The study estimates that routinely wearing helmets and seat-belts, obeying speed limits and avoiding drunk-driving could save between 347,000 and 540,000 lives worldwide every year.

Low and middle-income countries experience  disproportionate deaths, due in part to the preponderance of unsafe vehicles on the road as well as lack of safety belts, helmets and speed controls. But there is also a dearth of safe cycling and walking infrastructures for non-motorized users who are often the victims of a crash.

UN Secretary-General António Guterres

Vital opportunity 

“Today’s meeting is a vital opportunity to tackle this silent epidemic,” said UN Secretary General  Antonio Guterres,” speaking at the opening of the UN high level meeting. “We need to address this leading killer of young people.”

Gutteres added that traffic accidents also are a key obstacle to sustainable development, costing 2-5% of GDP in developing countries every year and pushing “entire families into poverty due to the loss of a breadwinner or the costs associated with lost income and prolonged medical care.”

Along with technological and regulatory approaches, Guterres called upon transport ministries to adopt “a more holistic approach to road safety,” with increased financing for more sustainable mobility and greener urban planning, which can advance both safety as well as climate mitigation goals. 

“Traffic crashes caused nearly 1.3 million preventable deaths and an estimated 50 million injuries each year, making it the leading killer of children and young people worldwide. And Jamaica has not been spared,” declared the country’s Minister of Transport, Audley Shaw, as over a dozen countries took to the podium in the opening session of the UN debate.  “We have observed a steady increase in fatality rates since 2012. Fatalities have increased on average by 10%. 

“It has been generally accepted that developing nations despite, having fewer vehicles than developed countries have a larger portion of fatalities globally. The socio- economic impact on developing states is devastating,” he said, calling for those norms to change.

Unsafe road infrastructure

Historically, road safety measures have focused on safer vehicles and users.  

Particularly in developing countries, transport development has focused overwhelmingly on roads for vehicles, ignoring even the presence of pedestrians and other users on roads, experts say.

Road safety programmes have also tended to focus on private vehicles – neglecting the importance of public transport, including the creation of public transport lanes that can ease private vehicle congestion and promote safety. 

Increasingly, evidence points to the importance of urban design as a critical part of the mix, including safe spaces for pedestrians and cyclists. Measures such as footpaths, cycling lanes, safe crossing points, as well as “traffic calming” tactics like speed bumps and stricter limits in cities are therefore critical to reducing the risk of injury among these road users, says WHO. 

Decade of Road Safety 

In September 2020, the UN General Assembly adopted a resolution to proclaim the Decade of Action for Road Safety 2021–2030. WHO and the UN regional commissions, in cooperation with other partners in the UN Road Safety Collaboration, have developed a Global Plan for the Decade of Action, which was released in October 2021.  

The plan calls for continued improvements in the design of roads and vehicles, enhancement of laws and law enforcement, and provision of timely, life-saving emergency care for the injured. In addition, it sought to promote more actively “healthy and environmentally sound modes of transport” that can positively impact child health, gender, poverty and the environment. 

Image Credits: Flickr/ M M.

A Somalian mother with her baby who is being treated for malnutrition.

In the face of growing malnutrition and related diseases of pneumonia, diarrhoea and measles, the World Health Organization (WHO) has announced that it is setting up a hub in Kenya to help fight the “major physical and mental health repercussions” of the food crisis in the Eastern Africa region.

More than 80 million people, or one-in-four people who live in East Africa are food insecure and resorting to desperate measures to feed themselves and their families, according to WHO. And the Horn of Africa, which includes Ethiopia, Kenya and Somalia, is in the midst of a four-year drought.

WHO Director-General Dr Tedros Adhanom Ghebreyusus says the hub will coordinate deliveries of medical supplies to where they are needed most in the region, which is hard hit by the global price spikes of food, fuel and other commodities caused by pandemic-hit supply chains, Russia’s war in Ukraine and inflation.

“People need access to affordable and nutritious food, as well as support through these difficult times. Some regions like the Horn of Africa are facing extremely serious food insecurity issues that could lead to famine,” he told a press briefing on Wednesday. “Over 80 million people, one in four, in the Eastern Africa region are food insecure and resorting to desperate measures in order to feed themselves and their families. Lack of food and nutrition weakens people’s immune system and puts them more at risk of disease.”

Lack of food and nutrition weakens people’s immune system, putting them more at risk of disease. Children who are undernourished are at higher risk of death from pneumonia, diarrhoeal disease and measles, Tedros noted.

WHO says it is working with partners on the ground to deliver essential health services, treat sick children with severe malnutrition, and prevent, detect and respond to infectious disease outbreaks. As part of that effort, Tedros said, WHO is “setting up a hub in Nairobi, from where it will coordinate the response and organize the delivery of live-saving medical supplies to where they are needed most. These supplies include medicines, vaccines, as well the products and equipment to treat children who are severely malnourished.”

The U.N. health agency also is working with the health ministries in Djibouti, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda to build what Tedros described as a “robust disease surveillance system to be able to quickly detect and respond to disease outbreaks.”

Unprecedented drought

Some 146,000 Somalian children with severe acute malnutrition have already been admitted into therapeutic care this year, and more than 640,000 people have been given emergency water supplies, according to the UN Office for the Coordination of Humanitarian Affairs (OCHA). Almost half the population – 7.7 million people – face starvation.

“The current extreme, widespread, and persistent multi-season drought is unprecedented,” said OCHA. “Four consecutive rainy seasons have failed, a climatic event not seen in at least 40 years. The 2022 March-May rainy season has not materialized and is likely to be the driest on record, devastating livelihoods and driving sharp increases in food, water, and nutrition insecurity.” 

Earlier this month, UNICEF reported that the severe water shortages have led to a severe acute watery diarrhoea and cholera outbreak. “Over 18 million people – one in four – in the eastern Africa region are food insecure and resorting to desperate measures in order to feed themselves and their families,” Tedros told a media briefing on Wednesday.

“Lack of food and nutrition weakens a person’s immune system and puts them all at risk of disease. Children that are malnourished are at higher risk of death from pneumonia, diarrhoeal disease and measles.”

Over 9,500 suspected cases of measles have been reported in Somalia alone between January and 30 May, according to UNICEF.

Tedros blamed spiking prices of food, fuel and other commodities, which is “having major physical and mental health repercussions”, warning that the Horn of Africa was facing famine.

“The cost of inaction is high,” said Dr Ibrahima Socé Fall, WHO Assistant Director-General for Emergency Response.  “While the clear priority is to prevent people from starving, we must simultaneously strengthen our health response to prevent disease and save lives. Even one life lost from a vaccine-preventable disease, diarrhoea, or medical complications from malnutrition in today’s world is one life too many.”

Fall was speaking in Nairobi where WHO convened a two-day meeting [26-27 June 2022] to plan its response across the seven countries affected by the health emergency – Djibouti, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda – and coordinate with other UN agencies and partners.

Image Credits: UNICEF.

WHO Director-General Dr Tedros Adhanom Ghebreyesus.

Monkeypox appears to be establishing itself as a prominent danger to high-risk populations such as children, immune-compromised people and pregnant women, World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus warned.

Already, WHO said authorities confirmed cases involving two children in the UK and a child each in Spain, France and the Netherlands.

Tedros, however, defended last week’s decision by a WHO emergency committee not to declare monkeypox as a public health emergency of international concern (PHEIC). Only three of the 14-person emergency committee felt the outbreak should be declared an emergency, Tedros told a media briefing Wednesday. 

“While the emergency committee did not advise that the current outbreak represents a Public Health Emergency of International Concern, they acknowledged the emergency nature of the event and that controlling the further spread requires intense response efforts,” he said. “They advised that I should reconvene them quickly based on the evolving situation, which I will do.”

In contrast, the US Center for Disease Control and Prevention (CDC) activated its Emergency Operations Center (EOC) on Tuesday to ensure “an aggressive public health response” to the outbreak.

As of one week ago, the WHO reported there were 3,413 laboratory-confirmed cases of monkeypox and one death from the virus reported from among 50 countries, with 86% of the new cases occurring in Europe. The highest numbers of cases were reported in Germany, Spain and the UK.

In Africa, one death was reported in Nigeria. Though it has been hit with an outbreak since 2017, the nation reported more cases than usual this year.  

Vaccine shortage

Amid the public health crisis, the world has been grappling with a global shortage of vaccines that are effective against monkeypox. The nations that have them generally have limited supplies to fight a smallpox outbreak.

The only one that is licensed for use by adults against both monkeypox and smallpox –  Bavarian Nordic’s Jynneos vaccine – is in particularly short supply, and there is limited clinical data about its efficacy as the only evidence is from animal studies.

While more supply of Emergent BioSolutions’ ACAM2000 vaccine is available, it is only licensed for smallpox, has more side effects and cannot be used by immunocompromised people – including people with uncontrolled HIV.

Another vaccine called LC16m8 is licensed for smallpox – but only in Japan.

The US and Canada have made doses of the Jynneos vaccine available to health clinics for people with known exposures to the virus and those who are considered to be at “high risk,” which is currently defined as men who have sex with men with multiple recent sexual partners living in areas where there has been high transmission among this particular population.

The US CDC announced on Tuesday it had 56,000 doses available immediately, but that a further 240,000 would be available in coming weeks and 750,000 more by the end of August.

There remains some concern, however, just as there has been with COVID-19 vaccines, that the monkeypox vaccines will be monopolised by wealthy countries that can afford them and corner the market.

Even Spain, which is facing the biggest outbreak in the world at present, has only been able to give 71 vaccines to close contacts, according to La Vanguardia. These were made available to Spain from the European Union’s smallpox response stockpile.

However, Dr Mike Ryan, WHO’s executive director of health emergencies, told the media briefing that countries such as the US that have vaccine stockpiles in case of smallpox have agreed to share these with other countries in need.

“But again, we must remember that these products have been licenced in the main for the use of smallpox,” Ryan cautioned. “In one case, they’ve been licenced for monkeypox but based on animal models, and, I believe, immuno-bridging data from the smallpox side of things.”

He called for more clinical data to be collected at the same time that vaccine use is expanded, as has been the case during the Ebola outbreaks. In particular, he says, there has been no evidence of the vaccine’s effectiveness in treating high-risk groups.

Four-step approach

Tedros also called on all countries facing monkeypox outbreaks to take a series of public health steps.

First, he said, surveillance of the virus must be increased through much more testing. The next step, he said, is to follow WHO best-practice guidance in managing their responses.

Third is to actively engage communities such as LGBTQI groups to educate people about how to protect themselves, he said. And the fourth step, he said, is “to provide equitable access to countermeasures, like vaccines and antivirals.”

Dr Ibrahima Soce-Fall, WHO’s assistant director-general for emergencies response, said monkeypox already is a “multi-country, multi-regional emergency,” with Europeans facing the high risk. He said WHO regions can activate emergency measures to address it.

Post-COVID lockdown, health workers in eastern Uganda go door to door in villages to catch up on preventive measures for other diseases, such as malaria.

In the wake of last week’s Kigali Summit on Malaria and Neglected Tropical Diseases, getting malaria elimination back on track is a top priority says a senior Bill and Melinda Gates Foundation official – in addition to ensuring the world learns from the COVID pandemic that “global health” is truly a global matter.

The world has lost years of progress on malaria control thanks to the COVID pandemic, with malaria mortality close to what it was almost a decade ago, Philip Welkhoff, Director of the Malaria Program at the Bill & Melinda Gates Foundation, told Health Policy Watch, just after the conclusion of the Kigali Summit. 

“Malaria is really unforgiving. And when there are disruptions in either access to care or some of the routine services, that malaria burden will go up. Because of COVID, we’ve gone backwards,” Welkhoff said, in an interview. 

Philip Welkhoff, director of the malaria program at the Bill and Melinda Gates Foundation.

But Welkhoff is determined to get the world back on track now. Last week’s Kigali Summit on Malaria and Neglected Tropical Diseases, saw a new US$140 million, four-year commitment by the Gates Foundation to support new malaria research initiatives as well as amplified control measures in terms of diagnostics, drugs bednets and health system strengthening. 

14 million more cases in 2020 

Last December, the WHO’s World Malaria Report 2021 highlighted just how dramatically COVID had disrupted malaria services in the first year of the pandemic. There were 14 million more malaria cases in 2020 as compared to 2019, and 69,000 more deaths. The year 2020 saw a total of 241 million malaria cases leading to 627,000 deaths worldwide. 

“Approximately two-thirds of these additional deaths (47,000) were linked to disruptions in the provision of malaria prevention, diagnosis and treatment during the pandemic,” WHO concluded.

The Sustainable Development Goals, associated with WHO’s malaria strategy, include achieving a 90% reduction in global malaria incidence and mortality rates by 2030.  

Now progress towards that goal  is substantially off track. In 2020, the global malaria case incidence rate was 59 cases per 1000 people at risk against a WHO target of 35/1000 for 2020 —  40% above the target.  The global mortality rate was 15.3 deaths per 100,000 people at risk against a WHO target of 8.9/1000 — or 42% higher.

Drive down burden aggressively – and then advance elimination

With 2030 just eight years away, achieving the 2030 SDG goals will be capital-consuming, considering the cost of health commodities involved. Welkhoff points out. 

He is therefore looking forward to a successful donor response in September to the replenishment drive of the Global Fund to Fight AIDS, Tuberculosis and Malaria, which is the primary funder of malaria drugs, diagnostics and bed nets.  The Global Fund aims to raise US$ 18 billion from donors then for its 2024-2026 budget cycle.

Global Fund replenishment –  aims to raise at least US $18 billion from donors.

“But then there’s many things that we can build on from there. This is a very critical moment in this fight against malaria,” he said.

He notes that current malaria funding is estimated to save more than 500,000 lives annually – cutting the burden of malaria mortality by half. 

Scaling up new bednet technologies and fighting resistance to ACTs

The efficacy of artemisinin-based antimalarial drugs is threatened by parasite resistance.

New funding will also help in the fight against insecticide resistance, including the introduction of bed nets impregnated with new ingredients that kill mosquitoes more effectively. 

“So we want to start introducing and scaling up these nets. We are [also] starting to see the beginnings of drug resistance in parts of Africa to the Artemisinin combination therapies (ACTs). So this is going to need funding, to make sure that we don’t lose these drugs that each year save so many lives.”

The COVID-19 pandemic has also highlighted the need for the prioritization of local leadership. In that vein, increasing national government involvement in malaria control is all the more critical.   

“I think we’re going to see further steps in that direction with this next set of funding,” he told Health Policy Watch.

Delivering insecticide-treated mosquito nets after initial delays during the COVID-19 pandemic. 

Reimagining global health and NTDs

From the COVID-19 pandemic to the latest Monkeypox outbreak, there are calls for more collaboration on disease outbreaks that can now rapidly spread across vast distances. This means reimagining risks posed by neglected tropical diseases (NTDs) to global health, including parts of the world where such diseases do not currently pose any major threats, Welkhoff noted. 

Lessons learned in the pandemic should motivate actors from the global North and South to work even more closely together to drive down existing disease threats, he observed.  

“We do have to work together to drive down these diseases as much as possible. And they shouldn’t be neglected. I think the lessons of COVID and many other diseases is that we as a world need to really recognize how interconnected everything is,” Welkhoff said.

Image Credits: WHO, Samson Wamani , Courtesy of BMGF, The Global Fund , Paul Adepoju , WHO.

JYNNEOS smallpox vaccine produced by Bavarian Nordic, approved by the FDA for use against monkeypox.

The European Medicines Agency is considering the extension of the use of the smallpox vaccine Imvanex to include people at risk of Monkeypox disease, the agency said on Tuesday. 

Imvanex is a modified form of the vaccinia virus, which is related to smallpox and currently authorised in the European Union (EU) for the prevention of smallpox in adults. But it is also considered a potential vaccine for monkeypox because of the similarity between the viruses, both of the Orthopoxvirus genus. 

Supplies of Imvanex limited in the European Union    

Supplies of Imvanex are currently very limited in the EU. However, the same vaccine is marketed as JYNNEOS in the US where it is authorised for the prevention of both monkeypox and smallpox. Full EMA authorization also would clear the way for broader use of the US vaccine brand in Europe.

The EMA review follows a recent recommendation by EMA’s Emergency Task Force (ETF) that JYNNEOS, produced by the Danish firm Bavarian Nordic, be used by European national authorities for at risk groups, in view of the rising rates of Monkeypox infection across the EU.

The US Food and Drug Administration has already concluded that the efficacy of JYNNEOS in the prevention of monkeypox disease can be inferred from antibody responses against the vaccinia virus in clinical studies.  In addition, animal studies showed that the vaccine protected those exposed to the monkeypox virus and boosted pre-existing immunity induced by earlier generations of smallpox vaccines.

3413 confirmed cases outside of endemic region

As of 22 June 2022, 3413 laboratory confirmed cases of Monkeypox and one death have been reported to WHO from 50 countries/territories in five WHO Regions, WHO reported in its latest Disease Outbreak News, on Monday 27 June.     

Another 1310 cases in eight new countries have been reported over the past ten days since the previous WHO update on 17 June. 

Even so, a WHO Emergency Committee that met last week last week deferred a decision on whether to declare Monkeypox a public health emergency of international concern (PHEIC), saying it would review the matter again in another three weeks. 

The Emergency Committee said its evaluation would be based on whether there had been further “significant spread” of the infection, particularly among vulnerable groups such as people with HIV, pregnant women and children.

The concerns over the spread of monkeypox in Europe and other developed countries, followed by moves like those of the EMA to prepare for the vaccination for at risk groups, have triggered fresh allegations of inequitable treatment amongst health officials in Africa’s Region, which has lived with the virus for years with no vaccine initiatives ever proposed or considered until the virus began to expand its boundaries.

New patterns of skin-borne transmission increases risks to other groups

Since the beginning of 2022, some 1597 cases – 1488 suspected and 109 laboratory-confirmed- of monkeypox have been reported in the nine central and west African countries where the disease circulates.  That data likely reflects significant under-reporting insofar as the disease is prevalent in remote rural areas where contact with infected wild animals such as rodents and squirrles is a major source of transmission.  A total of 66 deaths have been reported by Africa CDC – although WHO recently put the death toll at 72.

Either way, that is a case fatality ratio (CFR) of  4.1% or more on the continent, including all suspected cases. Some studies have shown Monkeypox mortality rates as high as 10% in the Democratic Republic of Congo – where the most virulent clade of the virus circulates.  

Monkeypox: Africa CDC Demands Equal Treatment in Global Allocation of Limited Vaccine Doses

Traditionally, monkeypox virus outbreaks in Africa, the result of zoonotic spillover events, saw limited person-to-person transmission.  In contrast, the outbreak in Europe and other non-endemic countries has been characterised by significant community transmission, often among men having sex with men. It is the increased pattern of skin-borne transmission of the virus that also increases risks to other vulnerable groups. 

WHO had pledged to come up with a plan for equitable distribution of monkeypox vaccines between at risk groups in endemic and non-endemic areas where the recent outbreak is being experienced.  However it remains to be seen if vaccine rollout is really feasible in conflict-ridden areas like the DRC and Central African Republic, where the disease is historically most prevalent, and deadly.  It’s equally unclear if and how developed countries, such as the United States, which controls much of the world’s limited smallpox vaccine supply, will heed WHO’s appeals.

Image Credits: Barda .