vaccine
The third phase of the clinical trials is expected to have 26,000 participants, including those living with HIV and without TB infection, across more than 50 sites in Africa and SouthEast Asia.

A tuberculosis (TB) vaccine candidate that has shown modest efficacy rates received a $550 million boost from the Bill and Melinda Gates Foundation (BMGF) and Wellcome Trust, which announced on Tuesday that they will cover its Phase 3 clinical trials.

The candidate vaccine, M72, showed modest 54% efficacy in preventing the development of symptomatic TB in a Phase 2b trial involving over 3500 adults with latent TB.

The third phase of the clinical trials is expected to have 26,000 participants, including those living with HIV and without TB infection, across more than 50 sites in Africa and Southeast Asia. 

If this phase of the trials returns effective results, M72 will be the first vaccine targeting adults and adolescents, protecting those who already have latent TB infection from developing severe infection.

Around 5%-10% of those with latent TB infection go on to develop TB disease. People with weak immune systems, especially those living with HIV, are at a higher risk for developing the disease. 

Although M72’s efficacy is modest, a TB vaccine for adults with at least 50% efficacy can avert up to 8.5 million TB deaths and up to 76 million new infections by 2050.

“To support the M72 Phase III clinical trial, which will cost an estimated US$550 million, Wellcome is providing up to $150 million and the Gates Foundation will fund the remainder, about $400 million,” a press release from BMGF said. 

“TB remains one of the world’s deadliest infectious diseases,” said Julia Gillard, chair of the Board of Governors at Wellcome. “Sustainable progress against TB and wider disease threats will depend on global collaboration, financial backing, and political will.”

The only TB vaccine in use today, Bacille Calmette-Guérin (BCG), was first given to people in 1921. It helps protect babies and young children against severe systemic forms of TB but offers limited protection against pulmonary TB among adolescents and adults.

“With TB cases and deaths on the rise, the need for new tools has never been more urgent,” said Bill Gates, co-chair of the BMGF. 

“Greater investment in safe and effective TB vaccines alongside a suite of new diagnostics and treatments could transform TB care for millions of people, saving lives and lowering the burden of this devastating and costly disease.”

M72 was initially developed by GlaxoSmithKline (GSK) in partnership with Aeras and the International AIDS Vaccine Initiative (IAVI), but GSK has since transferred the vaccine’s license to the Gates Medical Research Institute (Gates MRI), an affiliate of the BMGF. 

M72 is one of 17 TB vaccine candidates currently in the development pipeline. 

Image Credits: Photo by Diana Polekhina on Unsplash.

covid-19
The results of a controversial “human challenge” study challenged the assumption that the contagiousness of a person is correlated to the severity of their symptoms.

Since the beginning of the SARS-CoV-2 pandemic, the popular assumption was that people displaying severe symptons were also the most contagious. But new data from a controversial Imperial College London study published on Tuesday found the two participants that were the biggest “superspreaders” of the virus both displayed only minor symptoms. 

“How symptomatic a person is has often been assumed to indicate their contagiousness,” said the authors of the ‘challenge’ study, published in The Lancet.  The study, involving healthy volunteers who were deliberately infected with COVID at a time when no vaccine or treatments existed, found that the severity of symptoms experienced by the volunteers “did not influence the extent of viral emissions.” 

At the time of its launch in 2021, one leading expert called it “dumb and dangerous“, in an interview with Health Policy Watch.

But the data collected from the 34-person study paid off.  There was no direct relationship between symptom severity and viral load among the 18 volunteers who went on to develop COVID, and were monitored for two weeks from a hospital bed. The variability is something the researchers suggested may be attributable to the diversity of physiological factors such as breathing mechanics or mucous acidity. 

“It’s that variability among humans that has made this virus so difficult to control,” Monica Gandhi, an infectious-diseases expert at the University of California told Nature, in a review of the findings.    

Ethics and risk

The study’s findings are as provocative as its design. The trial is a “human challenge” study, in which researchers deliberately infected participants with COVID-19 in what is known as a “human challenge” study. The ethics of infecting healthy, young participants with a potentially life-changing and potentially deadly virus – regardless of scientific upside – are fiercely contested.

When the Imperial College study was announced in 2021, Dr Ken Kengatharan, co-founder and chairman of the California-based biotech firm Renexxion, told Health Policy Watch that a COVID-19 challenge study was “as dumb and dangerous an idea as it gets”.

“SARS-CoV-2 is an atypical coronavirus (without any comparable out there or historically, and we are just learning about its mode of action,” Kengatharan said at the time.   

Many of Kengatharan’s apprehensions have since been proven right. Around 36 million people in Europe – one in 30  – may have developed long-COVID over the first three years of the pandemic, the World Health Organization (WHO) announced Tuesday.

“Clearly much more needs to be done to understand it,” WHO European Director Dr Hans Kluge said. “Ultimately, the best way to avoid long-covid is to avoid COVID-19 in the first place.”

Understanding the role of “superspreaders” in the COVID pandemic could be and important component of effective policy making frameworks for future outbreaks.  Superspreader patterns were also identified during earlier coronavirus outbreaks, such as the SARS outbreak that began in 2002, and the outbreak of Middle East respiratory syndrome coronavirus a decade later.  

WHO’s symptomatic criteria for testing were ill-founded

Viral emissions mostly occurred after participants developed early symptoms and began to test positive by lateral flow tests, the study found.

The authors of the study reckon the unique perspective their data provides on several key public health questions about the COVID-19 virus justifies the risks taken by the volunteers.

The unpredictable nature of COVID-19 has led scientists and average people alike to speculate that pre-symptomatic infections were a big reason the virus proved so hard to contain. Scientific modelling has estimated that at least 30-50% of community transmission occurred before people became visibly sick, but models are only accurate to the extent of the assumption that underpin them.

The data released by the Imperial study is also the first to quantify pre-symptomatic viral emissions in a real-world setting, and tells a different story: just 10% of virus emissions recorded occurred before the onset of symptoms. 

In that respect the study also challenged the usefulness of the WHO’s suspected case criteria, observing that over one-third of virus particles emitted by participants were shed before symptoms met the WHO guidelines.

The UN health agency’s criteria, used by governments around the world to determine eligibility for COVID-19 testing at the height of the pandemic, are “relatively poor definers of the onset of contagiousness,” the study said.

In contrast to the inefficacy of the WHO criteria, lateral flow tests were able to identify infections in most participants before symptoms and viral shed began – demonstrating their potential power for containing future outbreaks.  

“A heightened awareness of early symptoms prompting self-testing could identify a large proportion of infectiousness,” the study said.

Researchers said further challenge studies on newer variants of COVID-19 such as Omicron are planned for the near future.

Image Credits: Unsplash, ClimateWed/Twitter, Maxpixel.

The Gambia
Medicated syrups manufactured in India have come under the global scanner for contamination.

The Gambia has mandated pre-shipment quality testing on all pharmaceutical products exported from India. The requirement will come into effect on 1 July 2023. It can be understood as an after-effect of last year’s scandal whereby India-manufactured cough syrups allegedly claimed the lives of 66 children in The Gambia in 2022 . 

Following the episode, WHO conducted independent testing of the cough syrup samples that had been administered to the children in Switzerland, finding 23 samples contaminated with the industrial chemicals, DiEthylene Glycol (DEG), and Ethylene Glycol (EG).  

In May, following a series of scandals involving contaminated cough syrups both domestically and abroad, India made it mandatory for all exported syrups to undergo testing and certification from a government laboratory from 1 June.  No such requirement yet exists, however, for domestic production. 

However, the new rules regarding exports, as well as imposition of quality-assurance requirements by other countries, such as The Gambia, should further put the industry on alert regarding long standing issues with quality assurance.  

According to a communique sent by the Medicines Control Agency (MCA) of The Gambia to the Drugs Controller General of India (DCGI), and published by the Indian drug control agency, all pharmaceutical products that will be exported to the country shall be inspected and sampled for testing to ensure they conform to quality standards. 

To make sure that the products meet quality-assurance criteria, the MCA has appointed Quntrol Laboratories Private Limited, an independent verification, inspection and testing company, to carry out the process and issue a Clean Report of Inspection and Analysis (CRIA) for each shipment from India to The Gambia, beginning in July. 

“All shipments arriving into The Gambia with bill of lading [export document] dated on or after 1 July 2023 will be required to provide the CRIA for customs clearance at the Ports of Entry in The Gambia,” the communiqué dated 15 June 2023 said. 

The DCGI has circulated the communiqué among all the state drugs controllers, their counterparts at the zonal and sub-zonal levels, and the various manufacturing associations in India. “This is for your information and immediate action,” the letter from the Indian DCGI to the other stakeholders said. 

According to the process outlined by The Gambian MCA, the exporter of the pharmaceutical products is responsible for raising an inspection request with Quntrol Laboratories, which will then retrieve samples from the shipment and send them to be tested in MCA approved labs. Upon successful testing of the samples, a CRIA is sent to the exporter, which shall be shared with the importer. The importer shall use this certificate to take possession of the shipments from The Gambian Ports of Entry. 

Deaths in The Gambia strongly linked to Indian cough syrups

In October 2022, the World Health Organization (WHO) issued a product alert for substandard cough syrups manufactured in India, linked to the deaths of at least 66 children in The Gambia. The syrups were manufactured by Maiden Pharmaceuticals in India. 

India halted production at the plant temporarily after WHO commissioned lab tests found DiEthylene Glycol (DEG) in the range of 1% to 21.30% weight/volume in the cough syrup samples. DEG is completely banned in pharmaceutical products. 

India has, however, also maintained that its tests on the control samples of the cough syrups collected from the batches exported to The Gambia showed no traces of contamination.

Meanwhile, The Gambia had sought the assistance of the US CDC to investigate the sudden spike in AKI in children between June and September 2022. In March 2023, the US CDC released its report that suggested strong links between the cough syrups consumed by the children and their AKI. 

“This investigation strongly suggests that medications contaminated with DEG or Ethylene Glycol (EG) imported into The Gambia led to this AKI cluster among children,” the report stated. 

Other product alerts for Indian cough syrups

In January 2023, WHO issued another alert flagging two products manufactured in India and exported to Uzbekistan and Cambodia as containing “unacceptable amounts” of DEG and/or EG. Both these products were manufactured by Marion Biotech Private Limited in India. The alert came after Uzbekistan alleged that 18 children died after consuming the syrup. 

In April 2023, the WHO issued yet another product alert flagging a contaminated syrup identified in Marshall Islands and Micronesia. The syrup was manufactured by Trillium Pharma in India and also contained “unacceptable amounts of DEG and EG”, as per the WHO report. Trillium Pharma, however, has maintained that it did not sell these products in these countries. 

Within India, as well, communities in states as far-flung as Kashmir and central as Uttar Pradesh have reported a series of adverse events associated with the administration of cough syrups. 

The problems occur primarily in the manufacturing process. When paracetamol syrup or cough syrups are manufactured, they need a solvent to dissolve the active ingredients, add sweetness, and act as a lubricant. The solvents used are either glycerine or propylene glycol, a clear, faintly sweet, and viscous liquid.

Glycerine Indian Pharmacopoeia (IP) grade is supposed to be used in drugs and medicines, in line with good manufacturing practices framed by the WHO.  However, when industrial glycerine, used in chemicals and cosmetics, is used instead, it can contain contaminants such as diethylene glycol and ethylene glycol. 

Image Credits: Photo by Towfiqu barbhuiya on Unsplash.

Medicines Patent Pool

The Medicines Patent Pool (MPP) announced sublicensing agreements with seven manufacturers to produce and distribute generic versions of Japanese pharmaceutical company Shinogi’s COVID-19 antiviral treatment in 117 low- and middle-income countries. 

Ensitrelvir is an oral antiviral currently only approved in Japan under the country’s emergency regulatory approval system. The drug is being evaluated under a fast-track designation by the US Food and Drug Administration, and its regulatory authorization is still pending in all the 117 countries listed in the license agreement. 

“Even though COVID-19 is no longer classified as a Public Health Emergency of International Concern, we see numbers ebb and flow across continents as we learn to live with the disease,” said Charles Gore, Executive Director of MPP. “Having quality effective treatments readily available in LMICs is still so important.” 

The absence of regulatory approval for Shinogi’s drug stands in contrast to Paxlovid, a similar oral antiviral rolled out by Pfizer in the early months of the pandemic. Paxlovid has been available under emergency authorization in the United States since December 2021, which was followed a month later by the European Union. Full marketing approval was granted by both the US and EU in the first half of 2023. 

Ensitrelvir has a steep hill to climb

MPP signed sublicensing agreements to manufacture and distribute Paxlovid in 95 low- and middle-income countries in November 2021. Under the terms of the agreement, Pfizer abstained from royalties on sales as long as COVID-19 remained classified as a Public Health Emergency of International Concern.

The WHO’s declaration of the end of the COVID-19 public health emergency in May changed the terms, but not by much. Pfizer became entitled to a 5% royalty fee on sales to the public sector in lower-middle-income and upper-middle-income countries. Low-income countries, however, can still purchase Paxlovid without paying royalties. 

Ensitrelvir still has a steep hill to climb if it is to make an impact. But for communities on the ground in LMICs, the prospect of having access to another treatment is good news. 

“Through my work, I support two sisters who lost their parents to COVID-19 at the height of the pandemic. In our communities, such loss goes beyond the terrible grief as the young adolescents have been left to fend for themselves at a vulnerable age,” said Nombeko Mpongo of the Desmond Tutu HIV Center in South Africa. 

“Access to treatment is so much more than a question of life and death, it is about the well-being of entire communities,” he said. “I welcome this announcement that will enable equitable access to COVID-19 treatments in my country and other LMICs.”

Oasis de Huacachina in Ica, Peru

Peru is experiencing its worst-ever outbreak of dengue fever, with over 172,000 cases by Monday, according to the country’s health department.

Of these, over 92,000 are confirmed while almost 80,000 are suspected cases, with countrywide floods and increasing temperatures driving the outbreak.

The country has declared a health emergency in 222 districts. The north-western provinces of Piura and Lambayeque are worst affected, while the worst affected cities are Lima and Ica.

Some 228 people have been confirmed to have died from the viral infection that is transmitted by infected Aedes mosquitos. However, the fatality rate is expected to rise as health authorities investigate further deaths.

Peru’s caseload is already double that reported in the same period last year, and more than four times higher than the average of the last five years, according to the World Health Organization (WHO).

Meanwhile, Argentina also experienced one of the largest dengue outbreaks in its history in the first three months of this year (dengue is most prevalent there between October and May). 

“The incidence of dengue has grown dramatically around the world in recent decades, especially in the Americas, which reported 2.8 million cases and 1,280 deaths last year,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing last week.

“The WHO is preparing for the very high probability that 2023 and 2024 will be marked by an El Nino event, which could increase transmission of dengue and other so-called arboviruses, such as Zika and chikungunya,” Tedros added.

“The effects of climate change are also fueling mosquito breeding and the spread of this disease.”

By 8 June, 2,162,214 cases and 974 dengue deaths have been reported globally, according to the European Centre for Disease Prevention and Control. Brazil, Bolivia, Peru and Argentina, in that order, had the highest caseloads.

Dengue is endemic in 129 countries, with 70% of cases in Asia. There are about 390 million infections per year, and there has been an 85% increase in cases between 1990 and 2019, according to the Drugs for Neglected Diseases initiative (DNDi).

Last year, the WHO launched the Global Arbovirus Initiative to strengthen the world’s ability to prevent, detect, and respond to outbreaks of arthropod-borne viruses (Arboviruses) such as dengue, yellow fever, chikungunya and Zika. Arboviruses are public health threats in tropical and sub-tropical areas where approximately 3.9 billion people live.

Image Credits: Wikipedia.

Pollution in Delhi peaks in late autumn when drifting emissions from crop burning exacerbate the usual urban household, traffic and industrial sources

New science shows how air pollution triggers lung cancer, how children are the most vulnerable in Delhi’s smog, and how even small rises in PM 2.5 increase the risk of heart attacks, strokes and dementia. 

NEW DELHI – You can opt for silver, gold or platinum options for cancer-specific health insurance, according to an advertisement in India – the first group outside the health sector that has realised the country’s cancer burden is rising sharply. 

Five years ago, the number of new cancer patients was 1.15 million annually. Now it’s about 1.4 million. 

Modelling based on India’s National Cancer Registry Programme Report estimates that the incidence of cancer will increase by 12.8% between 2020 and 2025.

A series of recent studies expand our understanding of at least one major cause:  air pollution. For India, home to 39 of the world’s 50 most polluted cities, any understanding of the devastating health impact of lousy air quality is welcome. But is it enough to push the needle?

Fine particles of pollution – PM 2.5 – are known to be linked to not just cancer, particularly of the lungs, but also heart attacks, strokes, dementia and chronically diseased lungs (COPD) apart from much else. 

One of the most critical recent scientific breakthroughs comes from scientists at the Francis Crick Institute in the UK, who show how air pollution can cause lung cancer in people who have never smoked in research recently published in Nature.

“We have improved our understanding of how particulate matter air pollution can trigger cancer to start – by waking up dormant mutant cells present in the lung,” Professor William Hill, one of the lead authors, explained to Health Policy Watch.

In what should be a wake-up call to governments and lawmakers, these scientists have linked PM 2.5 air pollution and potentially fatal health risks beyond any reasonable doubt. 

In email correspondence with Health Policy Watch, Hill and colleague Emilia Lim explained: “We take a three-pronged approach, integrating epidemiology in Western and Asian cohorts, preclinical models and clinical cohorts to understand how air pollution promotes EGFR mutant lung cancer.” 

Simply, EGFR is a protein in cells that helps them grow. A mutation in the gene for EGFR can make it grow too much, which can cause cancer. 

Worryingly, they say their findings may mean that only three years of exposure to a high level of air pollution may be enough to cause lung cancer.

‘Never smokers’

The study looked at three countries, England, South Korea and Taiwan. It looked at ‘never smokers’ because they say that although smoking remains the biggest risk factor for lung cancer, outdoor air pollution causes roughly one in 10 cases of lung cancer in the UK. 

An estimated 6,000 people who have never smoked die of lung cancer every year in the UK, some of which may be due to air pollution exposure. Globally, around 300,000 lung cancer deaths in 2019 were attributed to exposure to PM 2.5. 

THE LUNG CANCER THREAT

  • Most commonly diagnosed cancer globally
  • Leading cause of cancer death
  • Highly fatal, with an overall five-year survival rate of only 18%
  • In India, in 2018, of almost 68,000 cases, mortality was over 90%
  • One in 9 people are likely to develop cancer, including of lungs

India’s official denial

Despite the recent research, the government of India maintains that there is no conclusive link between air pollution and fatal disease. In April 2023, in response to a parliamentary question on air pollution deaths, the Ministry of Environment, Forest and Climate Change stated: “There are several studies conducted by different organizations, using different methodologies, on the impact of air pollution. However, there is no conclusive data available to establish a direct correlation of death/ disease/ life expectancy exclusively with air pollution.”

The Ministry added: “Air pollution is one of the many factors affecting respiratory ailments and associated diseases. Health is impacted by a number of factors which include food habits, occupational habits, socioeconomic status, medical history, immunity, heredity, etc., of the individuals apart from the environment.”

 But even the government-run Indian Council of Medical Research (ICMR) journal has identified air pollution as offering the same attributable risk as tobacco use (43% each) for lung cancer Disability Adjusted Life Years (DALY). One DALY represents the loss of the equivalent of one year of full health either due to premature death or living with a disability due to a disease, for example, chronically diseased lungs or COPD.

The PM 2.5 threat

What the new reports show is that even small increases in pollution can increase the risks. 

One report, based on 14 studies, shows that there is as much as a 9% increase in risk for lung cancer or mortality for an increase in PM 2.5 of as little as 10 micrograms (mcg) per cubic metre. To put that into context, the WHO’s safe limit guideline is 5 mcg and Delhi averaged 105 mcg over three years between 2019-21.

Studies in dementia show similar trends. For every 2 mcg increase in average annual PM 2.5 concentration, the overall risk of dementia rose by 4%. 

According to the  BMJ journal, current estimates suggest that PM2.5 concentrations in major cities vary considerably from below 10 mcg in Toronto to more than 100 mcg in places like Delhi. However, the scientists have flagged uncertainties like the role of socio-economic status and ethnicity. 

Source: Commission for Air Quality Management, Government of India

Heart attacks and strokes

Air pollution also contributes to fatal heart attacks and strokes: A five-year study in Poland looked into almost 88,000 deaths of which over half – 48,000 – were caused by heart attacks and strokes. 

A 10 mcg increase in PM 2.5 exposure was associated with a 3% increased risk of dying from cardiovascular disease on the same day and the increased risks continued for up to two days after the polluted day. 

For strokes, the risk was far higher – an 8% increased risk. Again, to put this in context for India, there are days and weeks in parts of the north where the PM 2.5 levels shoot up from already high levels of 100 mcg to super-high levels of 700 mcg or more.  

Dr Arvind Kumar, one of India’s senior-most chest surgeons at Medanta Hospital in Gurugram, says the Poland study is well conducted and a valuable addition to existing literature. 

“The message for India is that we have even higher levels of pollution here,” said Kumar, a prominent campaigner for clean air.

“People say the economic costs are high of not building new coal power plants, of not cutting emissions. But the cost of not doing so is far higher – premature deaths are far costlier.”

Farmers burning crop stubble north of Delhi is one of the causes of the city’s air pollution.

Babies and children worst affected

 In a response to a question from Dr Amar Patnaik, a Member of Parliament, on the impact of air pollution on children, the environment ministry said in April 2023, that it had not conducted any specific studies on the mechanisms and future projections of air pollution on children’s health, education and social adaptability levels. 

 But other branches of the government have supported studies in pollution-cancer linkages. One study has explicitly stated that babies (aged three- to 21 months) and children (8-14 years of age) are more susceptible to getting fine particles’ deposited in their inner lungs (alveolar region). Alveoli are millions of tiny air sacs in your lungs that absorb oxygen. 

The study was published at the end of 2022 and looked at Delhi’s ‘severe’ smog event over two weeks in November 2017, when the PM 2.5 level crossed 700 mcg, and on average was about 29 times the WHO’s safe limit. 

The smog was largely attributed to the burning of crop residue in states north of Delhi, in addition to climatic factors like low temperatures and wind speed. 

The report looked at the toxic elements deposited in three parts of the body – head, trachea–bronchial, and pulmonary regions. It found the highest mass flux in babies and children. 

What people inhale in Delhi smog:

Doses of Toxic Elements Found to be Many Times Higher in Children Than Adults. 

  • Cr: Chromium
  • Fe: Iron
  • Zn: Zinc
  • Pb: Lead
  • Cu: Copper
  • Mn: Manganese
  • Ni: Nickel

Source: Physico-Chemical Properties and Deposition Potential of PM2.5 during Severe Smog Event in Delhi, India

 Many parents are increasingly careful about what their kids eat – and now many are also concerned about what they breathe. The science is unequivocal but there’s little they can do without the help of lawmakers, governments and courts. 

Government’s inadequate response

It’s not as though the various branches of India’s government aren’t doing anything. Millions of dollars have been allocated as part of various schemes. 

But analysts point out it is insufficient. For example, the union (federal) budget for the National Clean Air Programme has almost doubled in the last two years but it is now only a little over $90 million.

The Commission for Air Quality Management, a statutory body set up to improve air quality in and around the capital of New Delhi, one of the world’s most polluted areas, saw its budget reduced last year by about 13% to $2 million. It remains frozen at that level for the current year, and the provincial government of Delhi has marginally cut the budget for the environment. 

This is in spite of the government having set an ambitious target to cut pollution levels in cities by 40% by 2025-26. 

But even this apparently ambitious target is concerning when it is unpacked. The target only applies to PM 10, the larger particulate matter pollutant, and does not define targets for the finer and far more lethal PM 2.5. In addition, the government’s earlier target was to cut pollution by 20-30% target – but two years sooner.

Given that Delhi and its neighbourhood’s PM 2.5 levels are, on average, some 20 times higher than the WHO’s safe limits, there is a need to explicitly measure and target this. Citizens have a fundamental right to clean air. 

Image Credits: Flickr, Source: Commission for Air Quality Management, Government of India, Neil Palmer.

Mpox
Countries including the US, the UK, Spain, Belgium, and the Netherlands are seeing an increase in Mpox cases in the past few weeks.

Europe reported 22 cases of Mpox in May, prompting the World Health Organization (WHO) to urge people in high risk communities to get vaccinated if possible. 

WHO Europe director Dr Hans Kluge said that the virus is still in circulation, particularly affecting men who have sex with men. He added that people in high risk groups can also protect themselves from getting infected by following preventative measures. 

“There are things you can do – get vaccinated against Mpox if vaccines are available, limit contact with others if you have symptoms, and avoid close physical contact including sexual contact with someone who has Mpox,” Klugo told a WHO Europe briefing on Tuesday. 

In addition to the Mpox update, the Kluge addressed the health emergency situation in Ukraine after the Nova Kakhovka dam was destroyed three weeks ago, long COVID, and extreme heat in Europe. 

“Mpox resurgence not surprising”

Countries including the US, the UK, Spain, Belgium, and the Netherlands are seeing an increase in Mpox cases in the past few weeks. Health officials in Los Angeles and Colorado have issued alerts and launched vaccination campaigns to protect those in high risk groups, while London has extended the vaccination programme for Mpox due to the spike in cases in the city. 

WHO Euro
Dr Catherine Smallwood, Senior health emergency officer, WHO Europe.

Requesting those at high risk to remain vigilant and protected, Dr Catherine Smallwood, WHO Europe’s senior health emergency officer, said extreme vigilance is necessary, especially during the summer when travelling is at its peak. 

“As we enter this period of the Pride celebrations and the travel across the region, we need to remain extremely vigilant at that population level to catch early signs of disease,” she said. 

Adding that the current resurgence is not a surprise, Smallwood explained that the learnings from the outbreak in 2022, with thousands of new cases being reported every day across the continent, were immense. 

“We took a lot of time to look at why that was happening, and look at the factors that determined not only the rise in infections, but also the decline. And we understood that certainly it was linked to increased travel, particularly around June months, where there was a lot of travel to Pride events for the first time during the pandemic.”

The clear policy response to tackle Mpox, she said, is to continue investing in an elimination strategy. “We have the benefit here in Europe of not having an animal reservoir of the virus. It means stopping sustained human to human transmission is quite possible. And that’s what we implore member states, countries in the region to look into doing.”

Extreme weather events killed 16,000 in 2022

Referring to a recent report on the impact of global warming on Europe, Kluge warned that in the coming years, extreme heat in the continent will be a norm rather than an exception. 

The World Meteorological Organization (WMO) and the Copernicus Climate Change Service (C3S*) jointly released their annual State of the Climate in Europe 2022 report on 19 June. 

The report states that Europe is the fastest warming region in the world, “warming twice as much as the global average since the 1980s”. In 2022, high-impact weather and climate events have killed over 16,000 persons, of which around 99.6% were attributed to heat waves. 

WHO Euro
Dr Hans Henri P Kluge, WHO Europe Regional Director.

“Extreme heat in the summer months is becoming the norm, not the exception,” Kluge said, adding that the high temperatures greatly increase the risk of wildfires across the continent.

He pointed out that parts of Spain and Portugal recorded temperatures over 40 degrees Celsius last year between June and August. “So look out for each other during the summer months by checking in on your elderly relatives and neighbours, limiting outdoor activity when it’s very warm, staying hydrated, keeping your home school, and allowing yourself time to rest alongside an increased recent risk of extreme heat.”

In addition, Kluge also mentioned that WHO Europe will be co-hosting the first Indoor Air Quality Conference in Berne, Switzerland, in September, 2023, with the Institute of Global Health. The conference will aim to make a case for monitoring and improving air quality inside buildings, in order to prevent transmission of respiratory infections.

Ukraine’s health risks compounded by dam disaster

Three weeks since Ukraine’s Nova Kakhovka dam gave in, the region remains susceptible to high risk of water borne diseases. Around one million people are without safe, clean water. 

WHO Euro
Dr Gerald Rockenschaub, WHO Europe regional emergency director.

“All kinds of communicable diseases due to the contamination of drinking water are a major public health risk there… We had already prepositioned supplies, testing kits etc which we could mobilize to provide to local authorities,” said Dr Gerald Rockenschaub, regional emergency director at WHO Europe.  

Expressing concern over the risk of leaving people behind, especially in areas like Mariupol and Donbas where the WHO still does not have access to provide healthcare services, Kluge said the agency has been calling for an international humanitarian corridor in the region for over a year to reach people living in these areas. 

“We are working together to beef up surveillance particularly for what we call ‘water borne diseases’ which include diseases like cholera, typhoid, hepatitis etc… We have been calling for an international humanitarian corridor for over a year now [to address] the lack of access to people in areas such as Mariupol and Donbass where still WHO does not have access and are very concerned that people are being left behind.”

Spotlight on Long COVID in transition plan

Although the WHO has declared an end to the pandemic, long COVID continues to remain a huge challenge to people and experts alike. According to the latest data from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, nearly 36 million people across western European may have experienced long COVID in the first three years of the pandemic, Kluge said. 

“That’s approximately one in 30 Europeans over the past three years. That’s one in 30 who may still be finding it hard to return to normal life, one in 30 who could be suffering in silence left behind as others move on from COVID-19,” he said. 

“We are listening to the calls from long covid patients and support groups and raising awareness of their plight, but clearly much more needs to be done to understand it.”

The WHO Europe released “The transition from the acute phase of COVID-19: Working towards a paradigm shift for pandemic preparedness and response in the WHO European Region” on 12 June, detailing the regional strategy in dealing with COVID-19 and its after effects in Europe in the coming years. 

While emphasizing on the importance of individuals getting vaccinated according to their risk status, the document also outlines the structural and sustainable changes that need to be made in order to bolster up the resilience of health systems in the region. 

“Some of these measures are very, very clear, but for member states, governments, public health authorities, the real message here is that this is not the time to pack up and move away from COVID-19,” Smallwood said. 

“Right now, we have a huge opportunity to invest in and sustain the gains made…We need to right-size those COVID response operations into day-to-day public health operations, public health services.” 

Image Credits: National Institute of Allergy and Infectious Diseases (NIAID).

climate finance
The summit unlocked billions in new climate finance but failed to address spiralling the debt levels and high borrowing costs handicapping green transition efforts in developing countries.

An international summit in Paris to debate reforms of the global financial system to meet the threat of climate change was billed by UN Secretary-General Antonio Guterres as a chance for “a new Bretton Woods moment”. It was, he said, an opportunity for “governments to come together, re-examine and re-configure the global financial architecture for the 21st century”.

The Bretton Woods institutions, the World Bank and International Monetary Fund (IMF), will celebrate their eightieth birthday this year. Erected to help countries rebuild after the devastation wrought by World War II, the multilateral development banks are central cogs in a system of international finance that is increasingly viewed as unable or unwilling to address the threat of climate change by global leaders.

“Consider this: over three-quarters of today’s countries were not present at the creation of the Bretton Woods institutions … It essentially reflects, even with some changes, the political and economic power dynamics of that time,” Guterres said in his opening remarks to the delegates in Paris. “Nearly 80 years later, the global financial architecture is outdated, dysfunctional and unjust. There will be no serious solution to this crisis without serious reforms.”

In a letter published ahead of the summit, 13 world leaders, including Joe Biden, Rishi Sunak, Olaf Schulz, and Ursula von der Leyen, described the meeting as a “decisive political moment” to “forge a new consensus” on global development finance.

The Summit for a New Global Financing pact, co-hosted by French President Emmanual Macron and Barbados Prime Minister Mia Mottley in Paris last week, did not reinvent the global financial system. But it did notch several long-awaited wins on the climate finance front, leaving many delegates with a sense of optimism often absent from climate finance negotiations.

The World Bank announced it will allow countries struck by natural disasters to pause debt repayments, but only for new loans. This financial breathing room in the wake of floods, droughts and storms meets a key demand set out by Mottley in the Bridgetown Initiative – a set of development finance reforms first presented at the UN climate summit in Egypt last year that provided the impetus for Macron to host the Paris summit.

On the climate finance front, an additional $100 billion will be made available to climate-vulnerable countries through the IMF’s special drawing rights instrument (SDR), a reserve currency. The SDR funding is separate from the historic loss and damage fund agreed upon at COP27 to finance climate adaptation efforts in low- and middle-income countries, which is expected to be finalized at COP28 in Dubai later this year.

In another first, the outcome statement said the World Bank and IMF would unlock an additional $200 billion in “lending capacity” over the next ten years, subsidized by new investment by rich countries.

The conference statement also mentions the prospect of finding “new avenues for international taxation”, reflecting momentum built on the sidelines of the summit for a tax on international shipping to fund climate efforts. This tax will be debated at the International Martime Organization meetings next month.

Discussions on additional international levies to fund climate adaptation – such as taxes on wealth, aviation, and fossil fuels – remained sharply divisive.

Bringing billions to a trillion-dollar fight

Climate activist Greta Thunberg criticized the summit for failing to address fossil fuels. “If your house is on fire, the first thing you do is to stop pouring oil and gas onto the fire,” she said.

Climate finance, however, is an endeavour requiring trillions, not billions, of dollars.

Ahead of the Paris Summit, the International Energy Agency warned that investments in clean energy in developing countries need to triple from $770 billion in 2022 to nearly $3 trillion by the first half of the 2030s to meet climate targets. A joint report by the United Kingdom and Egypt published ahead of last year’s UN climate summit, meanwhile, found developing countries require an estimated $2.4 billion to cut emissions and build resilience to climate change.

Developed countries said at the Paris summit that they will likely pass the $100 billion climate finance pledge for the first time this year. The pledge, first agreed in 2009, was supposed to be met by 2020, and the accuracy of the figures provided by rich countries are disputed.

Earlier this month, Oxfam’s Climate Finance Shadow Report found that while donor countries claimed to provide $83.3 billion in 2020, “the real value of their spending was – at most – $24.5 billion”.

“The actual support they provide is much less than reported numbers suggest, and is coming mostly as debt that has to be repaid,” said Oxfam. “By providing loans rather than grants, these funds are even potentially harming rather than helping local communities, as they add to the debt burdens of already heavily indebted countries — even more so in this time of rising interest rates.”

The Oxfam findings spotlight the elephant in the conference room of the otherwise successful summit: debt.

The tightening financial conditions resulting from the efforts of central banks to tame inflation amid the array of recent shocks to the global economy – from the pandemic’s disruption of global supply chains to soaring energy and food prices following Russia’s invasion of Ukraine – have hit financially vulnerable countries the hardest.

The cost of debt

Low-income countries face their biggest bills for servicing foreign debts in 25 years, with a group of 91 of the world’s poorest countries paying an average of over 16% of government revenues to repay foreign debts in 2023.

The cost of borrowing for counties with C-rated credit scores has skyrocketed by nearly 15% since February 2022, forcing many to refinance already untenable loans with more expensive ones. The resulting debt spiral has forced 62 countries worldwide to spend more on refinancing foreign debt than on health care, and impeded efforts to invest in meeting development targets and adapt to climate change.

The share of emissions contributed by emerging and developing economies is growing. Their successful transition to a green economy is critical to limiting global warming.

The prohibitive borrowing costs offered to low- and middle-income countries are a major barrier to increased private climate investments, which are critical to countries suffering high debt distress, as is the case for 60% of low-income countries.

“Developing countries do not have the space on their balance sheets for the debt required even if they wished to finance [the green transition] themselves,” Advinash Persaud, a key advisor to Barbados’ Prime Minister Mia Mottley argued in a recent paper. “Recall that developing countries start from high debt levels, worsened by the pandemic, the food and fuel crisis following the Russian–Ukraine conflict, and rising loss and damage from climate change impacts.”

Building a solar field, wind farm or flood barrier in Barbados or Pakistan can incur interest rates two to three times higher than a similar project in Belgium or Germany. Persaud notes that to build a comparable solar farm, annual borrowing costs in the EU sit at an average of 4%, compared to 10.6% in developing countries. As a result of the high cost of capital, only 14% of green investment in developing countries is funded by private finance, compared to 81% in developed countries.

Europe and North America have emitted over 70% of global greenhouses gases over the past 270 years, nearly exhausting the world’s carbon budget.

“The cause of this huge spread is not project-specific risk. A solar farm is no riskier in India than Germany,” Martin Wolf, chief economics editor of the Financial Times wrote in his analysis of Persaud’s report. “More than all of the risk premium represents market estimates of macroeconomic (specifically, currency and default) risks.”

In short, off-base macroeconomic considerations are pricing private capital out of investing in the green transition of the countries most in need of funding.

“Private investors are leaving money on the table,” wrote Persaud. “But even more significant are the far greater social gains from saving the planet and boosting green growth in developing countries that are being left alongside.”

One solution proposed by Mottley is for the IMF and World Bank to provide cheap loans for climate projects. But until the spectre of growing debt and borrowing costs in low- and middle-income countries is tackled, other measures risk being limited to band-aid solutions.

“If we don’t change our institutions, the world will remain the same,” Brazilian president Luiz Inácio Lula da Silva said in his closing remarks amid parting shots at the IMF and World Bank. “The rich will go on being rich, and the poor will go on being poor.”

Image Credits: Markus Spiske/ Unsplash.

Gavi was one of the key pillars of the global COVID-19 vaccine platform, COVAX.

Six weeks before its new CEO was due to assume office, global vaccine alliance Gavi has announced that Dr Muhammad Pate is no longer available for the position.

The appointment of Pate, a former Nigerian health minister, was announced in February following a meeting of the Gavi board. He was to replace current CEO Dr Seth Berkley, who has led the alliance for the past 12 years and is stepping down in August.

However, in a short statement on Monday, Gavi said that its board had appointed Chief Operating Officer David Marlow as interim CEO, following communication from Pate that he will not be able to join Gavi. 

“Dr Pate informed the Gavi Board Chair and Vice Chair that he has taken an incredibly difficult decision to accept a request to return and contribute to his home country, Nigeria. Gavi fully respects the decision and wishes Dr Pate the very best for the future,” said Gavi.

Gavi was unable to tell Health Policy Watch what position Pate would be assuming in Nigeria. However, the Harvard-based Pate has been active in promoting primary healthcare and was well-respected as the country’s health minister between 2011 and 2013.

The announcement came as the Gavi board was meeting this week in Geneva, amidst a Reuters report that a $2.6 billion surplus remains to be spent in COVAX, the WHO co-sponsored COVID-19 vaccine platform that Gavi co-operdinates alongside the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO).

While around a quarter of the funds is likely to go towards COVID-19 vaccination programmes, big decisions need to be made about whether some of the money should be poured into COVID vaccine distribution, pandemic preparedness, and bolstering vaccine production capacity in Africa.

“These are COVAX [Advanced Market Commitment] funds which have been donated to Gavi so the decision on how to spend them is ultimately for the Gavi Board and donors to make,” a CEPI spokesperson told Health Policy Watch.

The Gavi COVAX AMC is the innovative financing instrument that supported the participation of 92 low- and middle-income economies in the COVAX Facility.

“Our understanding is that no decision has been made to repurpose the COVAX AMC funds as yet,” added the CEPI spokesperson.

Even though the WHO has declared that COVID-19 no longer is a public health emergency of international concern, thereby acknowledging that the worst and most deadly phase of the pandemic is over, it is important to recognize that we will all be living with COVID-19 and its effects for a long time to come so it is prudent to remain prepared to respond quickly should the COVID-19 situation deteriorate.

“One of the key learnings from the COVID-19 pandemic is that predictable and sustainable end-to-end financing and flexible surge financing – including for R&D and manufacturing – that is readily available in the event of a new outbreak with pandemic potential are key to enabling equitable access to vaccines and other medical countermeasures.

“CEPI is advocating for such financing mechanisms to be established through our engagement with the Pandemic Accord process and the G20 and G7, and we would welcome leftover COVAX funds contributing towards them if the Gavi Board and donors chose to pursue that option.”

Gavi is the biggest vaccine procurement group in the world and is currently responsible for vaccinating almost half the world’s children.  It had not responded to queries about the COVAX surplus funds at the time of publication.

UN Special Rapporteur on the right to health, Dr Tlaleng Mofokeng submits her report on digital health to the UN Human Rights Council (HRC)

Real challenges exist in improving human rights within the digital world of health, according to the UN Special Rapporteur on the right to health, Dr Tlaleng Mofokeng, addressing a UN Human Rights Council (HRC) side event on Friday. 

Shortly after submitting her report on “Digital innovation, technologies and the right to health” to the HRC, Mofokeng said: “We will need to ensure that rights holders know their rights. They understand that digital technologies are not just a safe space.”

The COVID-19 pandemic brought to the fore the use of digital systems and artificial intelligence in healthcare. For many, health care was only provided through online appointments with health professionals. 

Meanwhile, the use of the track-and-trace applications used by many governments worldwide raised legal and ethical questions about people’s private and personal human rights. 

Due to the speed at which the pandemic hit, new rules were often introduced speedily, without the necessary guarantees to protect human rights that other regular frameworks would include. 

The Special Rapporteur’s report analysed the impact of digital technologies on privacy and data protection, and these issues were brought up several times during Friday’s event. 

Allan Maleche, KELIN Executive Director; Timothy Wafula Makokha, KELIN; Timothy Fish Hodgson, ICJ (Africa); Dr Tlaleng Mofokeng, UN Special Rapporteur on the Right to Health; Joyce Ouma, Y+ Global; Dr Mandeep Dhaliwal, UNDP.

“Companies such as Facebook have been quietly amassing health data for years,” Mandeep Dhaliwal, director at the HIV and Health Group, Bureau of Policy and Programme Support, United Nations Development Programme, stated. “Now is the time to make sure that we put that on the table so that people understand that they own their data. That, for me, is fundamental to the rights-based approach to this.”

Timothy Fish Hodgson, a legal advisor on economic, social, and cultural rights at the International Commission of Jurists (ICJ), agreed, telling the audience, “The issue here is that big corporations that are operating in the space of technology and on technological platforms have control over what we do and do not share all over the world. They need to be held responsible.

“To regulate these companies is very difficult for any country because they operate on a global scale, and we need to improve that. Secondly, we need to make very clear specific guidelines for these companies.”

Aside from corporate access to private health data, a second central area of concern related to the impact of growing digital use in countries, particularly in the Global South, where medical data could help perpetuate racism, sexism, or other forms of discrimination – such as countries where abortion is illegal or LGBTQ+ rights are infringed upon. 

One example explained how a woman who approaches a doctor about abortion in a state where abortion is criminalised may risk repercussions for herself and her doctor unless safeguards protecting her right to privacy are maintained. 

Documentation and criminalisation

“There is a direct line between documentation and criminalisation of marginalised groups all around the world, which needs to be taken seriously in this process,” Fish Hodgson said. 

The report concludes with 23 recommendations for the HRC, stating, “Vulnerable groups who face multiple forms of discrimination and oppression in some cases lack access to digital technology and face criminalization, stigmatization, and state surveillance.”

“If we are not thinking properly and thinking through, we run the risk of actually further marginalizing people because the issues of privacy data breaches are heightened,” Mofokeng said.

“Some states have used data searches on your phone, which leave a digital footprint. They can then go and ask the police to trace your search history or retrieve your search history. If you find that it is related to abortion or contraception, they may charge you, and you may end up in prison.”

Mofokeng’s report reiterates the need for state actors to ensure their responsibilities are fulfilled, affirming: “States must embed human rights principles of equality, non-discrimination, participation, transparency and accountability in implementation, in order to meet their obligations to respect, protect and fulfil the right to health in relation to digital innovation and technologies.”

Joyce Ouma, Advocacy and Campaigns Officer at the Global Network of Young People living with HIV (Y+ Global), was optimistic about digital healthcare. 

“Digital technologies and digital health are bringing us closer to Universal Health Coverage. They are bringing us closer to self-care, to taking self-care where we, as young people, can take control of our own lives and our own health,” said Ouma.

As the report maintains, digital innovation and technologies can be an asset when used appropriately to realize the right to health. However, it is up to the HRC to implement the Special Rappoteur’s recommendations as best they can and ensure states and companies protect the rights of all. 

The event was organized by the Kenya Legal and Ethical Issues Network on HIV and AIDS (KELIN) in collaboration with the Permanent Mission of Brazil in Geneva, the Permanent Mission of the Federal Republic of Germany in Geneva, Global Network of People Living with HIV (GNP+), Privacy International, STOPAIDS, the Global Health Centre of the Graduate Institute, International Commission of Jurists (Africa), the Global Governance Centre at Geneva Graduate Institute, and the Centre for Interdisciplinary Methodologies at University of Warwick.