Covax
A COVAX vaccine delivery to Africa in April 2021. 

Some of the $2.6 billion that remains in a COVID-19 vaccine delivery scheme, COVAX, could be redirected into investment into investigational vaccine candidates for Marburg Virus Disease (MVD) and Ebola Sudan strain virus, as well as over half a dozen other vaccine programmes that were suspended due to the pandemic or delays in product development, a spokesperson for the Global Vaccine Alliance (Gavi) told Health Policy Watch. COVAX is a COVID vaccine initiative jointly run by Gavi, the World Health Organization (WHO), and the Coalition for Epidemic Preparedness Innovations (CEPI) co-sponsored by WHO and financed by donations from high-income countries. 92 low- and middle-income countries can participate through COVAX Advanced Market Commitment [AMC], a financing instrument launched by Gavi.

Pilot trials for new MVD and Ebola vaccines were among a series of new investments  approved by the Gavi Board last week, in part with the support of the surplus funds from unused COVID vaccine delivery to low-income countries. 

The board also approved new investments into a hexavalent vaccine which will offer protection against six diseases–- diphtheria, tetanus, pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b, and the inactivated polio vaccine (IPV). However, the Board remains committed to making COVID-19 vaccines available to high-risk groups in eligible low-income countries until 2025, a Gavi press statement underlined

Restarting programmes in new vaccinations 

The agency is also taking advantage of the lull in COVID vaccine demand to restart programmes introducing approved vaccines against hepatitis B, DTP boosters, a post-exposure prophylaxis for rabies, maternal RSV, and a multivalent meningococcal conjugate vaccine. 

“Decisions taken by our Board will help countries fight disease more cost-effectively, be better equipped to fight back against emerging threats and continue to protect those most at risk from COVID-19,” said Professor José Manuel Barroso, chair of the Gavi Board. He said the decisions will bolster Gavi’s record as “an innovator and a disrupter in global health.”

“The next steps in this process are to continue working with Alliance partners, particularly the WHO, UNICEF and countries to create timelines, technical guidance for introduction of these new products, and outline the parameters of these new programmes,” the press statement added. 

In its meeting, the Board also approved a long list of vaccines to be considered in the agency’s next vaccine investment strategy, which is expected to be finalized in 2024.

Those include licensed or pipeline products against hepatitis E, Mpox, dengue, COVID-19, tuberculosis, group B streptococcus, chikungunya and shigella. 

Investment in the global stockpile of vaccines

The Gavi board described its allocation to global stockpiles of vaccine candidates against MVD and Ebola Sudan virus as a  “time-limited investment”, pending recommendations by “scientific expert groups”.  

“The concept of Global Virtual Pool Inventories (GVPIs) is to establish small reserves of investigational vaccine candidates, which would be ready for use [condition] in the event of an outbreak,” the press statement said.

Opportunities to jumpstart a clinical trial of vaccine candidates for Ebola Sudan Virus were missed late last year because it took time to get the vaccines into place in Uganda, at which point the outbreak was already in decline, and was finally declared over in early 2023.

In early 2023, 2000 doses of MVD vaccine candidates were made available for administration as part of a planned “ring trial” among those diagnosed with the disease during the recent outbreak in Africa. 

However, the WHO couldn’t proceed with the trials due to lack of sufficient participants, followed by the eventual declaration that the MVD outbreak was over in late March. 

There are no global stockpiles of vaccines for MVD and Ebola Sudan virus at present, partly because the vaccines have not been approved by regulators. But experts have emphasized that having stockpiles available and ready for more rapid deployment could facilitate trials that demonstrate vaccine efficacy – or lack thereof. 

Image Credits: WHO.

The World Health Organization (WHO) launched a new guideline on Monday in a bid to push governments to adopt more stringent regulations on the marketing of unhealthy foods high in saturated fatty acids, trans-fatty acids, free sugars or salt (HFSS) to children. 

The UN health body has hardened its stance on what it describes as predatory practices used by fast food companies. This is the first time the WHO has advised countries that only mandatory regulations to curb the industry’s ability to target children will address the problem. WHO added that the ubiquity of advertising means the measures must also “go beyond children’s media”.

“Marketing is done to promote products, and promoting products is done to improve profits,” Francesco Branca, WHO Director of Nutrition and Food Safety told reporters on Monday. “This is a classic situation where there is a conflict between the objectives of private entities and the interests of public health.” 

The updated guidance follows over a decade of stalled progress since the World Health Assembly first endorsed recommendations to protect children from harmful food marketing in 2010. Thirteen years on, policy coverage around the world remains poor, with just 60 countries worldwide adopting policies restricting food marketing to children. Only 20 of them have passed mandatory legislation. 

And the laws that are in place often have holes. For example, policies currently in place often only protect young children under the age of five, and many do not cover digital marketing, the main source of ad exposure for children in a digitized world.

“It is an increasing worry for all of us that children are now exposed to harmful food marketing in digital spaces,” said Dr Ailan Li, Assistant Director-General for Healthier Populations at WHO. “Digital marketing is the most important now, and for the future.” 

Guideline’s goal is to stem childhood obesity

Almost no progress has been made in reducing childhood obesity in two decades.

WHO’s drive to limit the power of unhealthy foods marketing to children is grounded in concern around the childhood obesity epidemic gripping the world, especially low- and middle-income countries. Almost no progress has been made in batting back childhood obesity rates in over two decades.

Nearly 40 million children under the age of 5 were estimated to be overweight or obese in 2020 – 41% them living in low- and lower-middle-income countries – and another 337 million children aged 5-19 suffered the same conditions in 2016, the most recent year for which data is available. 

Efforts by industry to address the negative health effects of their food products exist, but continue to fall short. Interference in policymaking by the food industry through lobby groups remains commonplace, Li said, often resulting in “weakened, delayed or defeated policies”.

With no sign industry will voluntarily restrict itself in more meaningful ways, WHO officials say it is time to accept the market realities and impose regulations from the top down.

“The obligation of commercial actors is to continue practices that prioritize profit over health unless required to do otherwise,” said Juliette McHardy, a legal expert consulting on the commercial determinants of health at WHO. 

“Certain health-harming industries are by the very nature of their business models misaligned with the public health interests … including those segments of the food industry whose product portfolio largely comprises unhealthy options,” she said.  “The principal profit generating products and services of these industries require they grow their markets by shaping our preferences and knowledge in favour of harmful products and behaviours.”

Children’s right to health threatened

Mother and son in Usolanga, Tanzania. Childhood fat is traditionally seen as a sign of abundance, but too much of it can lead to obesity and related diseases later in life.

Marketing harmful foods to children is not just a question of healthy diets: it is a question of children’s rights. 

This is the conclusion arrived at by WHO based on the nearly 200 studies of children’s exposure to food marketing and its influence on eating-related attitudes, beliefs, and behaviors in children reviewed to estblish its updated guidance. 

“Arguments in defense of marketing fade when the marketed products harm health and when marketing poses a threat to children’s rights,” WHO said. “Marketing is a recognized means to promote products that are harmful to health.”

The UN Convention on the Rights of the Child, ratified in 1989, recognizes the right of children to health, the achievement of their full developmental potential, privacy and freedom from exploitation. 

The omnipresence of marketing for unhealthy foods in the day to day lives of children – whether on television, at school, on social media or at sports clubs – violates those rights, as does the non-consensual exposure of children to advertisements that have the power to dictate health outcomes for them when they are adults, WHO said.

“Countries that are State Parties to the Convention are obliged to take action toward the fulfilment and realization of children’s rights,” said WHO. “This should include actions to protect children from marketing of HFSS foods as such marketing negatively affects children’s rights, such as the rights to health, adequate and nutritious food, privacy and freedom from exploitation.”

Dietary risks caused nearly 8 million deaths and over 10% of all disability-adjusted life years lost to NCDs in 2019. The evidence conclusively shows that marketing foods high in saturated fats, sugars and salt can influence children’s dietary preferences, and governments must do what they can to prevent children from becoming one of those statistics, WHO experts said. 

“A core part of regulating health-harming markets and market segments is narrowing in on the core business models of relevant commercial actors and reducing their ability to use marketing and other tactics to shape public preferences and undermine public knowledge of harms,” said McHardy.

“Building up public sector capacity in this way reduces those asymmetries in power which undermine political will and capacity to effectively devise, adopt and enforce marketing and other regulations,” she said. 

For the younger generations accustomed to seeing their futures overlooked for the sake of profit in the climate debate, the financial motive behind the marketing of unhealthy foods strikes a personal chord.

“By allowing predatory marketing to infiltrate our schools, our media and our communities, we are really jeopardising the rights of our children to grow, learn and develop free from exploitation,” said Pierre Cook Jr., Technical Advisor for Youth Voices at the Healthy Caribbean Coalition. “Profit often trumps the well-being of our children. We need to be steadfast in our resolve to challenge this pervasive culture of exploitation.” 

Image Credits: World Obesity, Jen Wen Luoh.

South Africa’s Economic Freedom Fighters’ party protests against Uganda’s Anti-Homosexuality Act in Pretoria, South Africa.

As Pride month celebrations wind down in parts of the world that recognise LGBTQ rights, Ugandan human rights organisations have recorded a record number of abuses against that community following the introduction of the Anti-Homosexuality Act in that country one month ago.

Meanwhile, the World Bank sent a fact-finding mission to Uganda last week following an international appeal by over 170 organisations to suspend future lending to Uganda following the enactment of the law.

Beating, kidnapping and evictions of LGBTQ people have been recorded by the Human Rights Awareness and Promotion Forum (HRAPF) b y people who have come to its legal aid clinic for help.

A consortium of civil society groups called the Strategic Response Team (SRT) has estimated that the number of attacks on the LGBTQ community in the past month is around 300 – 10 every day.

In the three weeks (30 May-20 June) following the introduction of the Act, the HRAPF’s legal aid clinic attended to 30 cases involving discrimination against LGBTQI people based on their sexual orientation or gender identity – in contrast to 10 cases over the same period last year.

In one case, a man was attacked in his home by a group of men one night. He was beaten and some of his property burnt by the mob, which accused him of being a homosexual.

In a similar incident, a lesbian was attacked by two men in her home. She had been evicted by her landlord on the grounds of homosexuality but did not have the resources to move.

“Most of the violations are by non-state actors, who use the prevalent homophobic environment to carry out attacks and threats knowing that LGBTQ persons will not have recourse to the police for fear of being arrested,” according to HRAPF.

“Indeed, most of the cases were not reported to the police for fear of arrest under the Act. The law is therefore promoting an environment of lawlessness to the detriment of real or suspected LGBTQ persons in Uganda, without any recourse to the law for remedies.”

The forum noted that its report is not comprehensive as it only reflects clients that have sought its help, whereas there are other legal aid providers.

The attacks are being documented to support the court petition to get the Anti-Homosexuality Act overturned for being in contravention of the country’s Constitution.

World Bank under pressure

During last week’s fact-finding mission to Uganda, World Bank delegates met human rights organisations but have yet to act against Uganda.

When that country introduced a similar law in 2014 – referred to as the “kill the gays” law, – then-World Bank President Jim Yong Kim postponed a $90 million loan to the Ugandan government in response. The current law goes even further as it contains the death penalty as well as potential prison terms for minors.

However, aside from issuing a statement on May 31 stating that Uganda’s Anti-Homosexuality Act is “not consistent with the values of non-discrimination and inclusion that the institution upholds”, the Bank has yet to take action.

Numerous attempts by Health Policy Watch to get comment from the World Bank about its visit to Uganda and any action they intend to take went unheeded, although the Bank finally acknowledged receipt of the queries on Thursday.

HIV programmes under threat

Meanwhile, Uganda’s Ministry of Health sent a circular to health facilities recently urging them to continue to assist all citizens seeking healthcare. 

This is likely to be in response to pressure from international health agencies, including the US President’s Emergency Plan for AIDS Relief (PEFAR), which is concerned that the Act will prevent LGBTQ people from getting access to health services.

PEPFAR has suspended meetings with the Ugandan government to discuss the adoption of its Country Operational Plan for 2023, citing the Anti-Homosexuality Bill as the reason. PEPFAR spends around $400 million in the country annually.

PEPFAR has “invested over $5 billion in HIV prevention, care, and treatment services in Uganda” over the past 20 years, including the massive scale-up of its antiretroviral therapy (ART) programme, which is estimated to have averted almost 600,000 HIV-related deaths and 500,000 new HIV infections, according to a statement from the US Embassy in Uganda earlier this year.

“The first person in the world to receive PEPFAR-supported HIV treatment almost 20 years ago is a Ugandan who is alive and thriving, further demonstrating the success of this lifesaving program,” the US Embassy added.

According to UNAIDS data, 1.4 million Ugandans are estimated to be living with HIV, and over 1.3 million are currently receiving PEPFAR-supported HIV treatment. 

However, a cornerstone of the HIV/AIDS sector’s approach to HIV globally is targetting “key populations” who are most vulnerable to HIV – including men who have sex with men (referred to as such as many do not identify as gay, particularly in countries where they would face persecution if they did).

PEPFAR head Dr John Nkengasong recently said that the “passage of the Anti-homosexuality Act jeopardizes efforts to end HIV/AIDS, achieve health equity, and risks the lives of LGBTQI+ individuals and other key populations that need lifesaving treatment and prevention services.”

A petition challenging the constitutionality of the Act has been filed, as well as a notice of motion to suspend its enforcement pending the determination of the petition. The notice of motion was filed by eight people including Fox Odoi-Oywelowo, the only Member of Parliament to oppose the law.

Uganda’s Attorney General has responded to the petition, and Odoi-Oywelowo and others are in the process of responding to his letter, according to a civil society report.

Santragachi Lake near Kolkata is heavily polluted, as are many waterways in India.

India this week published the draft of a Green Credit Programme aimed at incentivising environmentally conscious practices to promote a sustainable lifestyle as part of the broader Indian initiative, Lifestyle for Environment (LiFE)

The new Green Credit Programme aims to lay the foundation for a market-based mechanism to promote “a grassroot mass movement for combating climate change, enhancing environment actions to propagate a healthy and sustainable way of living based on traditions and values of conservation and moderation, and for sustainable and  environment-friendly development.” 

The official Gazette notification from the Ministry of Environment and Forests was published on Tuesday, five months after the plan was announced in Parliament.

However, climate and environmental activists have generally taken a “wait-and-see” attitude to the initiative, saying it would be difficult to assess until the value of the credits is established – along with a mechanism for awarding them efficiently and with integrity. 

Key areas overlooked

The Green Credits Programme will be implemented through pilots in eight sectors, primarily affecting rural areas. These, according to the text of the government gazette, will include: 

  • tree planting; 
  • water conservation, water harvesting and water use efficiency, including treatment and reuse of wastewater; 
  • regenerative agricultural practices and land restoration to improve productivity, soil health and nutritional value of food produced; 
  • sustainable and improved practices for waste management, including collection, segregation and treatment;  
  • conservation and restoration of mangroves; 
  • measures for reducing air pollution and other pollution abatement activities; 
  • construction of buildings and other infrastructure using sustainable technologies and materials.

But electricity production and transport – two of the biggest sources of pollution in India – are not mentioned at all.  

The initiative does, however, make reference to credits for “measures for reducing air pollution and other pollution abatement activities.”

India currently suffers from some of the highest air pollution levels in the world – with peaks regularly recorded in late autumn when rural crop waste burning by farmers, a spike in household heating, and weather conditions all combine to make the Delhi region, in particular, an air pollution sinkhole. 

So far the central government has failed to make serious efforts to incentivize alternatives to crop stubble burning, one of the leading drivers of seasonal air pollution emergencies.  

Punja, India – Crop burning reduces crop yield and worsens air pollution

Budget allocation unclear

The government first proposed the Green Credit initiative on 1 February as part of its 2023-2024 budget, describing it as a national voluntary market mechanism. 

Although funds weren’t allocated explicitly for this, any administrative costs for this initiative are likely to come from the increased budget allocation for the Ministry of Environment, Forest and Climate Change, which went up from a revised estimate of Rs 2,478 crore ($301million) in the last budget to Rs 3,079.4 crore ($375 million) this year. 

Alternatively, funds could come from the Rs 35,000 crore allocated to achieve energy transition and net zero emissions.

By leveraging a “competitive market-based approach for Green Credits,” the government said it aims to motivate individuals, private sector producers, farmers, small-scale industries, cooperatives, urban and rural local bodies, forestry enterprises and any organisations that generate positive environmental actions by “ incentivising voluntary environmental actions of various stakeholders”. 

Green credits will be tradable and those earning them will be able to sell these on a proposed domestic market platform.  However, the mechanisms for assigning value to credits, awarding credit and enabling their transfer have yet to be created. 

Bureaucratic structure

The initiative will be managed by a steering committee headed by the environment secretary and comprise officials across the ministries and departments concerned. 

To administer such an ambitious programme, the government envisages an Accredited Green Credit Verifier, an entity accredited and authorised by the Green Credit Programme Administrator to monitor and assess activities under the umbrella of India’s  Environment Protection Act. 

Entities will have to register to qualify to generate Green Credits through an electronic database system maintained by the Green Credit Programme Administrator or its accredited agency to record the issuance and exchange of Green Credits.

The government has appointed the Indian Council of Forestry Research and Education as the programme administrator responsible for implementing the Green Credit Programme including its management, monitoring and operation. 

The administrator will develop all guidelines, processes and procedures for implementation of the programme, constitute technical or sectoral committees for each activity to facilitate in developing methodologies and processes for registration of Green Credit activities and issuance of Green  Credits and help set up a credible trading platform and generate demand for such credits.

According to the draft policy, anyone engaged in positive environmental interventions can earn Green Credits. For example, a company which undertakes water harvesting and reuse or invests in restoring mangrove forests in a state can earn Green Credits, which can subsequently be sold at the trading platform once a steering committee has validated them. 

Each Green Credit would have a monetary value assigned to it and can be traded, but there is no indication of how the different activities will be weighed. In addition, there is a danger of too much bureaucracy.

Industry associations will be included in the steering committee that governs the implementation of the Green Credit policy – meaning that pressures from polluting industries could overwhelm the programme.

The various parties mentioned by the notice –a steering committee of officials from different ministries, accredited Green Credit verifiers, third-party certifiers and many other committees –  could have very different views on environmental issues. It would complicate its implementation

“It’s a work-in-progress, well-intentioned, using all the correct words, but without financial details,” said a Delhi-based scientist who spoke with Health Policy Watch, but declined to be named. “It appears quite subjective. Let us see how this policy comes up. Its actual impact will depend on many factors.”

A polluted water canal in India

Incentivising farmers

The emphasis on farmland and forests could, however, be at least an entry point to incentivising farmers to adopt alternatives to crop stubble burning – which creates devastating pollution in northern India every autumn. 

Conversely, however, there isn’t much emphasis at all on fostering alternatives to the other two leading drivers of air pollution and climate change – through clean power production and green mobility. In addition, it could be used by dirty industries to greenwash their environmentally unsound projects.

However, it is still early days to evaluate this policy. The draft policy will be finalised in two months’ time after comments and objections are received and reviewed.

Following that, the Ministry of Environment and Forests is supposed to begin to establish mechanisms for implementation, including technical committees for each sector to develop methodologies, standards and processes for registration of projects granting the credits. 

The technical committees will also determine the value of green credit to be awarded and more detailed eligibility criteria. 

The Indian Council of Forestry Research and Education (ICFRE) will also accredit a provider who will set up the trading platform for the exchange of Green Credit Certificates,  as well as decide what entities can act as green credit verifiers. 

An environmental activity generating Green Credits may also generate climate co-benefits, the government noted. Therefore, many activities eligible for Green Credits may also be eligible for Carbon Credits, under a carbon credit trading scheme that is currently being developed by the Bureau of Energy Efficiency in the Ministry of Power, along with Ministry of Environment, Forests and Climate Change.

Jyoti Pande Lavakare is co-founder of the Indian clean air non-profit Care for Air. Her memoir, Breathing Here is Injurious to Your Health on the human cost of air pollution simplifies and amplifies the science behind air pollution.

Image Credits: Biswarup Ganguly, Neil Palmer, MacKay Savage.

The World Health Organization (WHO) estimates that some 99% of the world’s population lives where the WHO air quality guidelines are not met.

Air pollution poses one of the most significant environmental risks to health in the modern world, and in the latest episode of the “Global Health Matters” podcast, host Garry Aslanyan speaks with two grassroots advocates about their experiences in dealing with the impact of air pollution on their communities.

“We have poor black communities that were never intended and were never allowed to reach any other potential other than unskilled or low-skilled workers,” Rico Euripidou, Campaign Coordinator for GroundWork, an environmental justice NGO working primarily in southern Africa, said. Referencing what he sees in poorer South African communities, Euripidou stated, “These people bear a disproportionate burden from the environmental determinants of health. They have higher levels of air pollution.”

Speaking of her own experiences working in Indian communities, Shweta Narayan, Global Climate & Health Campaigner of Health Care Without Harm, told Aslanyan that “fence-line communities in India are also in a similar position. They are economically, socially, and politically marginalised. The most polluted sites in the country are away from their policy-makers. They are far from where you see. They are just invisibilized. So a lot of our work with fence-line communities is to make visible this invisible.”

South Asia and India have suffered from lack of investments in clean transport and energy generation that would reduce outdoor air pollution sources

It is widely acknowledged that government policies and investments supporting cleaner transport, renewable power generation, more energy-efficient homes, industry, and better municipal waste management would reduce key sources of outdoor air pollution. South Africa and India have long suffered from poorer implementation of legislation. South Africa brought in a Clean Air Act in 2004, but Euripidou stated that actual implementation has been difficult.

“Those plans were never, ever put into effect. So municipalities in South Africa that are struggling with service delivery just didn’t have the wherewithal; they didn’t have the budgets to appoint air quality officers, to maintain the air pollution monitoring equipment in their jurisdictions, or to do sufficient investigations for exceedances of ambient air quality.”

Narayan has had some success in engaging local government in India, referencing a project working with the Health Department in the State of Chhattisgarh, where local health workers “have trained themselves in the science of air pollution, and they have been able to use low-cost devices to identify what the air quality is like so that they can use that information to advise vulnerable populations.”

As for what the future holds, both Naryan and Euripidou are optimistic that the situation is still reversible as long as governments take immediate action. And immediate action is needed: the WHO estimates that between seven and nine million people die annually from health complications caused by air pollution. The tipping point of no return is not too far in the future though, as Narayan states: “It is impossible to have healthy people on a sick planet. The blatant disregard for the environment, which is entrenched in our current economic and social models, has pushed the natural world to its limits.”

Listen to more episodes of Global Health Matters.

Image Credits: TDR.

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.”