Researchers in Sanofi’s laboratory in France.

Sanofi and GlaxoSmithKline, two drugmakers, announced that they would provide 200 million doses of their potential COVID-19 vaccine to the WHO and Gavi Alliance co-sponsored COVAX procurement facility, which more than 180 countries have joined.  

“To address a global health crisis of this magnitude, it takes unique partnerships. The commitment we are announcing today for the COVAX Facility can help us together stand a better chance of bringing the pandemic under control. This moment also reflects our long-term commitment to global health and ensures our COVID-19 vaccines are affordable and accessible to those most at risk, everywhere in the world,” said Thomas Triomphe, Global Head of Sanofi Pasteur. 

Sanofi and GSK began their Phase 1/2 clinical trial in September and they expect to start late-stage testing by the end of the year. Although Sanofi and GSK aren’t leading in the race to develop a COVID-19 vaccine, compared to Pfizer, Moderna, or Johnson & Johnson, their recombinant protein-based vaccine could become an important player in the long-term push for a COVID-19 vaccine.

Mortality Rates Decreasing, Even As Many Countries Experience Rising COVID-19 Cases, Finds Study

Meanwhile, although COVID-19 infection rates are rising globally, a recent report published last week in the Journal of Hospital Medicine found declining rates in mortality. The study conducted in New York among COVID-19 patients observed a significant drop in mortality rates from 25.6 percent in March to 7.6 percent in August. 

The other trends in COVID-19 hospitalization and infection were shifts in demographics and severity of the illness. The median age of COVID-19 hospitalization dropped from 63 years old in March to 49 in August. The comorbidities of patients diagnosed with COVID-19 has also decreased from 80.7 percent to 71.6 percent. 

The researchers adjusted for the demographic changes and found that the results represented actual improvements. The 18.2 percentage point decrease between March and August could be attributed to improved treatment of COVID-19 in hospitals. 

“This is still a high death rate, much higher than we see for flu or other respiratory diseases,” said Leora Horwitz, director of NYU Langone’s Center for Healthcare Innovation and Delivery Science. “I don’t want to pretend this is benign. But it definitely is something that has given me hope.” 

Developments in care of patients with SARS-CoV2, including using ventilators, blood thinners, steroids, and knowing what complications to watch for, contributes to better illness outcomes, said Horwitz. “We don’t have a magic bullet cure, but we have a lot…of little things that add up.”

SARS-CoV2 Antibodies decline within Two Months of Exposure, New Study Finds

At the same time, results from recent study by Imperial College London found declining rates of antibody prevalence among individuals in England from June to September 2020. The results suggest rapidly decreasing population immunity and increasing risk of reinfection. 

The “REACT-2” study included 365,104 adults in three random, non-overlapping samples, and tested for antibody prevalence at three points after the peak of COVID-19 in England in April. 17,576 tested positive for SARS-CoV2 antibodies. The prevalence of antibodies was highest in individuals aged 18-24 and lowest in the 75 and over age group. 

The first round of testing in June found that six percent of those tested had detectable antibodies. In August, the prevalence had reduced to 4.8 percent, and September recorded a rate of 4.4 percent. The highest decline in antibody prevalence was in the oldest population group, 75 and over. 

Image Credits: Sanofi.

Ngozi Okonjo-Iweala, in her former role as Nigerian Finance Minister, speaking at French-African economic conference

Ngozi Okonjo-Iweala, board chair of Gavi, The Vaccine Alliance, on Wednesday was named as the favored candidate to be the next World Trade Organization director-general  – after a months-long WTO campaign process and in a decisive moment of the COVID-19 pandemic.

But as the United States came out in favor of the Republic of Korea’s Yoo Myung-hee, stalling the final consensus-building process, WTO officials said that a final decision will have to go before the full 164-member General Council of member governments on November 9 – a week after the US presidential elections.

The US opposition to a recommendation by the WTO’s “Troika” selection committee, is a double slap in the face since Iweala is a dual US-Nigerian citizen. She also comes to the table with strong global health credentials at a time in which the WTO is being asked to broker sensitive issues of patent rights versus medicines access.

The new WTO Director General will play a critical role in negotiating the rough waters ahead between countries in the global South that want to create a broad “patent waiver” for COVID-19 health products and high-income countries in the G7 and the European Union that oppose such a move. Iweala, a former Nigerian Trade Minister, is serving as a special African Union envoy charged with mobilizing economic support for the fight against the pandemic.

In the final, late September round of her campaign, Iweala made it clear that she sees WTO as playing a pivotal role in pandemic response, saying that “trade can contribute to public health and the WTO can lead”.  While she has also issued positive signals to business leaders, she also   tweeted that “the health of populations is the business of the WTO… The world can’t wait WTO must play a central role in the COVID-19 supply chain.”

India and South Africa’s Bid for A WTO “Waiver” on COVID-related Intellectual Property

Not since the HIV/AIDS crisis of the late 1990s, has the WTO been so much in the health limelight. India and South Africa recently proposed that the WTO agree to a blanket “waiver” on the WTO trade-related agreements (TRIPS) rules regarding patent and copyright restrictions and trade secrets related to any COVID-19 health products and equipment for the duration of the pandemic. This, they argued, would enable easier production, export and access to generic versions of not only drugs but vital equipment like respirators and diagnostic tests.

The fact that the European Union has lined up in favor of Iweala’s candidacy reflects widespread confidence among skittish developed countries that she will be able to steer contentious WTO debates in a fair and balanced manner.

“I am pleased to announce that the European parliament is endorsing @NOIweala as the Director-General of the WTO,” said EU parlimentarian Sven Simon in a tweet last week. “After our joint hearing on Monday, we are convinced by her vision for the future of multilateralism and advise WTO members to support her bid.”

Indeed, among the 27 delegations that spoke at today’s WTO meeting, only the US went on record opposing Iweala’s candidacy – saying that her Korean rival had more trade experience and could “hit the ground running.”.

“The Troika presented to the membership their assessment of the candidate that had th best chance of attaining the consensus of the [WTO] membership — that candidate is Dr. Ngozi Okonjo-Iweala of Nigeria,” said said WTO’s director of information, Keith Rockwell, at the Wednesday briefing. “One delegation could not support the candidacy of Dr Ngozi, and said they would continue to support South Korea’s Yoo Myung-hee. That delegation was the United States of America.

”The US says that they supported Minister Yoo because of her 25 years of trade experience – that she would be able to hit the ground running,” Rockwell said. “They said that they could not endorse Dr. Ngozi.”

He added: “There will be a General Council meeting held on the ninth of November, at which we hope to take a decision on this very important matter.”

“This [meeting] was never intended to make a final decision,” Rockwell underlined at the Wednesday afternoon briefing,  delayed for nearly two hours while more than two dozen countries debated the recommendation of the “WTO Troika” that has been managing the DG selection process.

That “Troika” led by WTO Ambassador David Walker of New Zealand, along with Honduras’ Dacio Castillo and Harald Aspelund of Iceland.

Rockwell said that the Troika had made their recommendation after a wide-ranging series of  private consultations with member states. The Troika’s consultations found that Iweala had “by a wide margin, the most preference, that she had wide support across all regions and across levels of development, LDCs (least developed countries) developing countries and developed countries.

“They said she had had these since the very beginning of the process.”

However, no formal roll-count of WTO members has been taken, Rockwell added, noting that WTO elections aim to build a consensus of all 164 members.

“The process of consultation is confidential. It’s not a vote.  It’s very important to understand that this is a process of building a consensus around one candidate, so that the Director General will be the director general for all WTO members.”

“There will be a General Council meeting on the 9th of November, in which we hope to take a final decision on the matter.”

Navigating a Pandemic, Bickering Economies and National Protectionism

Ngozi Okonjo-Iweala at the Igniting Innovation in Financial Access panel, 2020.

On October 26, the European Union joined African and Caribbean states, among others, in endorsing Okonjo-Iweala. China has also reportedly expressed support for her appointment.

A former finance minister and World Bank managing director, Okonjo-Iweala is currently the African Union’s Special Envoy to Mobilise International Economic Support for the Continental Fight Against COVID-19. She has been named as one of Transparency International’s 8 Female Anti-Corruption Fighters Who Inspire (2019).

In a recent interview with Reuters she said: “I feel I can solve the problems. I’m a known reformer, not someone who talks about it. I’ve actually done it both at the World Bank and in my country.”

If her bid is successful, Okonjo-Iweala will need not only to navigate a pandemic, but also wider issues involving bickering economies as national protectionism has risen during the pandemic. She will need to overhaul the WTO’s top appeals body which has had judge appointments repeatedly blocked by US President Donald Trump’s administration.

Gavi Board Chair Ngozi Okonjo-Iweala.

Even if Trump is defeated next week by Democratic contender Joe Biden, Trump will remain a “lame duck” president until the inauguration of his successor in January 2021.

Potentially, if Trump digs in his heels, that could prolong any WTO debate over the final choice of a director-general for a couple of months, leaving the organization with no one at the helm — even as the expected announcement of COVID-19 drug and vaccine breakthroughs will make the scramble for health products and the urgency of resolving emerging disputes over patent rights even more immediate.

Commitment to Health and Global Immunization Goals

Okonjo-Iweala first moved to the United States in the 1970s to study Economics at Harvard University, graduating magna cum laude. She later received an International Fellowship from the American Association of University Women (AAUW) to support her doctoral studies at the Massachusetts Institute of Technology (MIT).

She later served as Nigeria’s longest-running finance minister from 2003-2006 and 2011-2015, during which time she negotiated a $US 30 billion reduction in the country’s external debt.

In 2015, Okonjo-Iweala was appointed Chair-elect of the Gavi Board, and four years later received the Lasker-Bloomberg Public Service Award for her role in supporting work to provide sustained access to childhood vaccines for more than 760 million children.

It was that same year she became a dual US citizen, having spent several decades already working and studying in the country.

Image Credits: DGTresor , WTO, World Bank Photo Collection, Ngozi Okonjo-Iweala.

More than 200m people in sub-Saharan are infected by playing in contaminated water.

It starts with a child bathing in a stream to escape scorching temperatures. Silently, beneath the water, larvae that have emerged from a tiny snail burrow into their leg before entering the bloodstream. Over the next few weeks, the larvae turn into adult worms which mate and produce hundreds of eggs every day. This is schistosomiasis, also known as bilharzia – a neglected tropical disease (NTD) affecting more than 200 million people in sub-Saharan Africa, many of whom are children who have acquired infection just by playing or washing in contaminated water.

People across the world have become attuned to the fight for public health on a global scale in 2020. Never before has there been this amount of discussion about vaccines, treatments and prevention of disease. This year’s World Health Summit – held virtually from Berlin and which I had the honour to address earlier this week – had a strong focus on preparedness and resilience in the age of COVID-19, and the importance of global cooperation. Yet while the world rightly fights coronavirus, we must not forget about another widely prevalent and devastating subset of infections: the neglected tropical diseases (NTDs).

What are Neglected Tropical Diseases (NTDs)?

NTDs are a diverse group of 20 infectious diseases that are prevalent in tropical and subtropical conditions of some 149 countries worldwide. They affect more than 1.5 billion people, and cause an estimated 500,000 annual deaths globally.

Despite these shocking figures, they are termed ‘neglected’ because they continue to receive little attention.

Dr Mwelecele Ntuli Malecela, World Health Organization

During the World Health Summit, I spoke of the need to change how we think about NTDs. They not only compromise people’s health, keep children out of school and cause disfigurement and mental distress that disproportionately affects and stigmatises women. NTDs do not just affect health – they also hamper the economic growth and productivity and impede education. The good news is that most NTDs are easy to treat and can be prevented. The moral responsibility now lies with us to invest in their treatment and prevention and help the poor and marginalized communities who are mostly affected.

In fact, investing in treatment and prevention of NTDs not only helps alleviate suffering against these diseases, but also prevents other diseases that share the same origins: namely, poor sanitation and inadequate access to clean water. This investment would lead to better sanitation and access to clean, safe water that will help prevent NTDs and minimise other serious threats across the African continent, including COVID-19.

Eliminating NTDs while meeting COVID-19 Challenges

As a community, we are continuing our mission to eliminate NTDs, while ensuring that the challenges of COVID-19 are met. Investing in NTDs is one of the most cost-effective buys in public health, with treatment for the top 5 NTDs costing less than $0.50 per person, yet it is instrumental to improving development and equality, and lifting up communities.

The lessons that we have learned from NTDs can also be applied to other public health threats, like COVID-19 which is now pervasive across the world. This is also the case in Africa, with almost 1.5 million cases and over 35,000 deaths reported by the African Centre for Disease Control and Prevention. Many of those affected by NTDs also live in poverty without adequate access to water, hand sanitizer and masks, all of which are non-pharmaceutical public health interventions recommended to reduce their risk of contracting COVID-19. With so much at stake, it is now more important than ever to focus on investing in NTDs to prevent more deaths from COVID-19. To look at it from another angle, an investment in public health measures to combat COVID-19 is also an investment in the fight against NTDs.

The World Health Organization is set to launch its 2021-2030 Global NTD Roadmap, setting out important milestones and targets in our ongoing endeavour to eliminate and eradicate these diseases. These milestones will be even more important and will also benefit the work the global health community is undertaking against COVID-19.

The new NTD roadmap will provide the direction needed to ensure that the global health community does not take its foot off the pedal when it comes to the fight against NTDs. A lot remains to be done to ensure that those who require interventions against NTDs receive them. I urge countries, donors, political leaders and citizens to not lose sight of these low-cost, high-impact interventions.

We must ensure that NTDs and those who suffer from them do not find themselves neglected even furhter while the fight against COVID-19 rages on. The livelihood of 600 million African people depends on us all.

Dr Mwelecele Ntuli Malecela is the Director of the Department of Control of Neglected Tropical Diseases, WHO.

After weeks of inaction, Prime Minister Narendra Modi’s government has signalled that it will create a comprehensive law to halt rice stubble burning in rural areas of northern India, where drifting smoke from thousands of fires is a major contributor to Delhi’s annual autumn air pollution emergencies.

But experts remain skeptical, stating that there are already enough laws on the books and yet another one could just cause more confusion; what is really missing, they say, is strong central government action.

India’s solicitor general announced the plans for the law on stubble burning in a hearing on Monday before the Supreme Court, as the Court again reviewed the state of  government planning and options for judicial intervention.

“The Centre has taken a holistic view of the matter and now a comprehensive law is being planned with a permanent body with the participation of neighbouring states,” said Tushar Mehta, the solicitor general for the government at the hearing, referring to the federal government led by Prime Minister Narendra Modi.

Recent view of air pollution haze over Delhi

The Government announcement on Monday came after weeks in which Delhi Chief Minister Arvind Kerjiwal, pledged to declare “war” on air pollution caused by the crop stubble burning, but so far has failed to advance his attack from a high-tech “war room” in the city itself.

India’s Supreme Court also has championed solutions – none of which have really been implemented.  Meanwhile air pollution levels have already mounted dangerously in the city and throughout the northern India region, as a result of the unabated crop burning.

This is happening even as India also struggles to manage one of the world’s highest rates of COVID-19, a respiratory infection whose hallmark is breathing difficulties even in the best of air quality.

Critics skeptical 

Against those setbacks and a budding crisis, critics remained doubtful about whether government action could even be effective at this late date.  Historically, the prime minister has been largely indifferent to the chronic air pollution hazard of India’s northern region and Delhi itself.

“The problem lies in the fact that political will is missing when it comes to implementation,” Polash Mukherjee, environment health and air pollution management researcher, told The Tribune newspaper. “Having said that, it will be welcome if there is a specific provision to deal with crop residue burning at a national level, and not leave it contained as a problem in Punjab and Haryana only. Satellite images from central and southern India show the extent of crop residue burning in these parts as well, which have an impact on local climate resilience.”

“Let’s see what they come up with,” said Vimlendu Jha, founder and executive director of environmental non-profit Swechha, adding, “anything will be better than the one-member judicial committee.”

“Hazardous” air quality in Anand Vihar, Delhi: 9pm CET 27 October 2020. (AQICN.org)

He was referring to the October 16 move by the Supreme Court to appoint a single judge to monitor and manage crop stubble burning with a team of volunteers from the National Cadet Corps and Bharat Scouts and Guides. On Monday, the court suspended the order after Modi finally said he would act. The Court said the October 16 order would be “kept in abeyance”.

Jha said that that any plan devised by the central government would have funding as well as legally binding provisions. “And I hope it’s not just the stubble burning issue, but an overall airshed approach,” he added.

“I hope that this is not just a reactionary step that creates a hastily conceived new agency,”  said Dr Santosh Harish, Fellow at the Centre for Policy Research who specialises in energy and environment policy and air quality governance in India. “The present crisis could provide us an opportunity to make much needed institutional changes for more effective coordination and implementation at the NCR level. While various powers can be provided to a new agency on paper, several other factors determine how those powers get used– funds and staffing being two critical inputs,” he added.

Experts remain doubtful that any sort of  “comprehensive law”, even if enacted immediately, would be able to dampen down the farm fires, midway through the stubble burning season.

Sunil Dahiya, an analyst at Centre for Research on Energy and Clean Air, said: “Coming up with new legislation alone is not going to help clean the air. Actual action on pollution sources is needed.”

Smoke Envelopes Delhi and Northern India

NASA satellite data began showing fires and small spikes in fine particulate matter (known as PM2.5) in early October.

Now, thousands of crop stubble fires are already burning across the states of Punjab, Haryana and Uttar Pradesh in the north Indian plains, and smoke blowing into Delhi is driving up air pollution levels to emergency levels.

Delhi’s Air Quality Index (AQI) levels on Sunday were 303 – considered to be ‘very poor’ according to the government’s SAFAR app India Air Quality service – but had improved slightly to 256, with some wind movement later in the week.

Crop burning contributes about 5-8% of Delhi’s pollution over the course of the year. But in  the late autumn peak period, crop fires can contribute to as much as 40% of Delhi’s daily air pollution load – due to a combination of unfavorable geography, wind direction, and the lack of rainfall.  Earlier this week, Indian Express reported that according to SAFAR, the Ministry of Earth Sciences’ air quality monitor, “farm fires accounted for 22% of the air pollution in the national capital on Saturday, and 17% on Sunday.” It seems that any measures to deal with crop stubble, if successful, would be significant.

“Managing for winter burning of crop residue has to be a year-long effort and cannot be started in September each year,” said Karthik Ganesan, Research Fellow at the Council on Energy, Environment and Water. “No matter what the size of the committee, unless we clearly have a consultation process that captures inputs from relevant stakeholders – and most importantly the farmers – and put up final recommendations for public review, these are unlikely to achieve any more success than past efforts,” he added.

The “Wild Card of Meteorology” Likely To Decide  

Delhi’s AQI levels have already breached 300 several times in October. Before the fires began, the AQI dipped to 41 on Sept 1, 2020, a record low since 2015 when AQI monitoring began at national level. By the time agricultural fires have peaked, these index usually cross levels well beyond 500.

And with October this year showing many more early fires, some experts fear pollution could be worse.

An analysis by the Council on Energy, Environment and Water (CEEW), for instance, stated that 9,000+ fires had been observed by satellite data covering the period between September 1 and October 20. Last autumn, in comparison, farm fires peaked to around 4,000 per day by October 31. The day after crop residue burning in the States of Punjab and Haryana accounted for 44% of total air pollution, Central Pollution Control Board Member Secretary Prashant Gargava stated.

On the other hand, since the fires began a little bit earlier this year, prevailing winds may yet blow some of the smoke away from the city, other observers say. In addition, more mechanical machinery has been introduced to grind, rather than burn the stubble quickly, so that farmers can plant their next crop right away.

In addition, there has been a 10% reduction in plantations of the kinds of industrial rice stalks, that are the hardest to manage: more local basmati rice varieties are being grown, less of which is burnt. “We believe that this year should see lower levels of burning and more spread out burning” depending on the wild card of meteorology, said Karthik Ganesan & Tanushree Ganguly, researchers at the Council on Energy, Environment and Water.

No National Plan For Integrated Air Pollution Solution 

Indeed, with no accountability and no political party at the state or central government levels right up to the Prime Minister, a population larger than that of the entire continent of north America now depends on meteorology to save it from disease, disability and death triggered by toxic air.

New Delhi, India – Toxic smog blocks out the sun.

“On one hand we have courts which have good intentions, but not the expertise, on the other, the government and its large cohort of expert institutions, which have the expertise but not the intention to solve this issue,” said Dr Amrita Bahl, another CFA board member.

Said Vimlendu Jha: “Each year the Supreme Court passes strong worded observations, reprimanding every stakeholder, and this year has gone a step ahead and appointed a retired Justice.

“Rather than creating new mechanisms and institutions, it is important to strengthen existing ones, collectively, collaboratively and responsibly. We need to fix accountability of our government servants and departments. Stubble burning in particular and air pollution in general cannot and will not be fixed unless we relook at our agricultural practices including crop choices, construction and demolition regime, production and management of waste in our cities and its disposal, enhancing public transport.”

Delhi’s ‘GreenWar Room’ Fails To Advance To Battlefield

Just two weeks ago, Delhi’s chief minister Arvind Kerjriwal had said that he was setting up a ‘war-room’ to fight pollution and said he would be promoting a miracle composting agent amongst his rural neighboring states, which could rapidly degrade the rigid rice stalks that are the lion’s share of the crop stubble problem.

These cheap, easy and accessible Pusa decomposer pills that the Delhi chief minister has been promoting convert the stalks into valuable fertilizer as well – something that should be an incentive to stop farmers burning.

Delhi sky on a clean air day earlier this summer, when the COVID-19 lockdown brought many factories, transport and construction – which are other major sources of the city’s air pollution.

But although his Green War Room is up and running with technical experts who meet every day in an office equipped with large screens displaying NASA-ISRO images to monitor real-time data and hotspot conditions, actually moving out into the smoke-filled rural regions with the Pusa decomposer pellets or other solutions, isn’t being given much importance, said one insider, speaking on the condition of anonymity.

And it remains unclear how readily Delhi’s political leaders could really influence policies among their rural neighboring states. It is equally unclear if Kerjiwal will be getting much backing from Prime Minister Narendra Modi – a political rival.

Modi has remained largely indifferent to the criticism heaped upon him nationally and globally over his failure to take action on practical matters like stubble burning – as well as the bigger picture of expanded dirty coal power production. Modi’s ruling Bharatiya Janata Party is already grappling with farmers agitating against the passage of three agriculture bills in Parliament last month.

1.67 million Indians Died from Air Pollution in 2019

The latest air pollution crisis comes as the The State of Global Air 2020 was released, showing that 1.67 million Indians died from air pollution in 2019. That represents an increase of 61% over deaths in India attributable to air pollution nearly a decade ago in 2010. It’s also roughly one-quarter of the total deaths attributable to air pollution worldwide.

In addition, India has been steadily recording average annual increases in PM2.5 pollution since 2010, contrary to the federal government’s claims that annual air pollution levels are falling. This is despite marked regional reductions in pollution levels in east Asia driven primarily by declines in China.

Last October, the University of Chicago’s Air Quality Life (AQLI) tool showed the average citizen living in the Indo-Gangetic plain region – comprising the states of Bihar, Delhi, and West Bengal, among others – can expect to lose about seven years of life expectancy because air quality fails to meet the WHO guideline for fine particulate pollution. Particulate pollution rose 72 per cent from 1998 to 2016 in an area that is home to around 40% of India’s population.

Solutions Abound – Incentives For Alternative & More Nutritious Grains    

Even if the Pusa decomposer doesn’t gain rapid, widespread acceptance, there are plenty of other solutions that would likely trigger rapid change. Most of them revolve around money.

In 2019, stepping in once more to the national vacuum in air quality decision-making, the Supreme Court ordered governments in the three states with the highest level of fires to actually pay farmers a set sum, per paddy crop, as an incentive for not burning their crop stubble. The initiative was opposed even by environmentalists – and later set aside.

“There should be deterrence but not a perverse incentive. That works against the polluter pays principle,” Sunita Narain, Director General of Centre for Science and Environment told The Indian Express.

However, environmentalists say that positive incentives for farmers to cease growing water-hungry rice – and shift fields to other types of nutritious grains would be a welcome corrective to distortions in existing policies.

Punja, India – Crop burning reduces soil fertility and worsens air pollution

The hybrid rice varieties that have come to predominate in the region, are heavily subsidized by the government.  But the rice also depletes the water tables of the water-scarce Punjab region – while much of the production actually creates a huge surplus that goes for export.

Rather than subsidizing the wrong crop in the wrong place, they say, the government should incentivize farmers to shift their fields back into more of the indigenous grains that used to predominate on India’s northern plains, use far less of precious water reserves.

Minimum support prices are an easy way to guide farmers on what they should grow. The Ministry of Food and Agriculture could trigger a shift in growing patterns simply by offering higher subsidies via minimum support prices, said agricultural economist  Ashok Gulati, in one recent blog.

Growing patterns of the traditional crops, and the stubble they produce, both would give farmers a longer window of time to clear their fields so they don’t have to burn their fields in a rush to prepare a field for the next planting season.

These crops also are healthier. They include nutrition dense grains like pearl millet (bajra), finger millet (ragi), sorghum (jowar), barley, rye and maize (makki) – all of which are native to the area. Punjab was once known for its makki ki roti, a flat bread made from cornmeal.

Gulati referred to the potential to incentivize corn as a “crop for clean air.” But the same solution could be used for traditional grains that have a high iron content and are perfect for a country that harbors one quarter of the world’s cases of anaemia.

“Stubble burning needs a well-understood multi-pronged strategy: easy access to happy seeders and other in-situ methods, markets for collected stubble, and a shift away from paddy cultivation in the long term. And yet, the execution by the state governments remains poor. The ban on burning was always going to have a limited impact, and we should not expect new committees to monitor the situation to yield very much,”  said Harish.

Zero Till  – Another Immediate Option. 

Tere is yet another solution, which if implemented sincerely and rapidly can still firefight and help north India from suffocating this winter – even at this late date. It has been around since 2016, with the International Maize and Wheat Improvement Centre (CIMMYT) advising and propounding this simple, zero-till practice. 2016 was the year NASA reported the higher number of crop residue fires.

If adopted, this would bring emissions down by almost 80%. It can also increase productivity and maximize profits for farmers, according to a 2019 study published in Science.

No-till practices that leave straw on top of the soil as mulch can preserve soil moisture and improve soil quality and crop yields in the long-run, said Principal Scientist of the International Maize and Wheat Improvement Center M.L Jat, who co-authored the study.

All these are solutions that have existed for years, but the lack of both the state and central government’s intentions have continued to allow north India’s residents to suffer the severe pollution levels that we breathe each winter. Last winter, the Supreme Court had pulled up the chief secretaries of all the surrounding states, berating them for allowing stubble burning.

Now in place of the might of the entire government which should have been working to solve this problem stands a vague proposal for yet another new law.  Meanwhile, the population of northern India holds its breath.

Jyoti Pande Lavakare is a New Delhi-based journalist and the author of “Breathing Here is Injurious to Your Health: The Human Cost of Air Pollution” to be published by Hachette next month.

Image Credits: @pawanpgupta, Jepoirrier, AQICN.org, Sumitmpsd , Neil Palmer.

World Health Summit closing session- top global health leaders including Peter Sands (The Global Fund), Henrietta Fore (UNICEF), Jeremy Farrar, (The Wellcome Trust), Muhammad Pate (World Bank), Detlev Ganten, World Health Summit, and Mohammad Pate (World Bank); Marison Touraine (UNITAID) and Tedros Adhanom Ghebreyesus (WHO) share views on a post-COVID future with Ilona Kickbusch, former head of Geneva Graduate Institute’s Global Health Centre.

New modes of interagency collaboration triggered by the COVID-19 pandemic should be used as a model to advance more progress, post-pandemic, on important Sustainable Development Goals (SDGs) related to health, said a group of top international agency leaders in Tuesday’s closing session of the World Health Summit.

The three-day summit, which featured 310 speakers at 53 sessions, drew more than 6,000 participants from more than 100 countries – despite being shifted from its usual Berlin venue to a virtual platform as a result of the COVID-19 pandemic.

While sessions naturally saw a huge focus on the pandemic, other panels also reflected on a wide variety of topics ranging from climate and health to neglected tropical diseases and women in the health workforce.

At this, the concluding panel, leaders at the World Health Organization, UNICEF, The World Bank, The Global Fund and Unitaid, which had signed on last year to an ambitious Global Action Plan for Healthy Lives and Well-being (GAP) to accelerate progress on health- related SDGs, talked about how plans had both been upended and advanced by the pandemic.

The Global Action Plan, including 12 multilateral health and humanitarian agencies in total, aims to accelerate progress on the SDGs by improving inter-agency coordination, streamlining international support offered to countries. and thereby reducing inefficiencies in the delivery of health services and programmes on the ground.

Panellists underlined that some of the active cooperations between agencies that have been launchd around the pandemic, like the WHO-coordinated  Access to COVID-19 Tools Acclerator – should help advance the GAP’s overall aims – although they were scarce on the details of immediate plans.  The so-called ACT Accelerator has brought together leading health agencies around three core initiatives to develop, procure and distribute COVID-19 tests, treatments and vaccines, when they become available.

“We need to seize the opportunity to feedback what we’ve learnt through the ACT Accelerator,” said Peter Sands, Executive Director of The Global Fund to Fight AIDS, Tuberculosis and Malaria. The ACT Accelerator is a collaborative programme established by WHO to provide equitable access to COVID-19 tests and vaccines globally.

Sands added that countries must work together to ”ensure that these changes aren’t a flash in the pan” and to “turn the fight against COVID-19 into a moment for rethinking the role of health in society and the economy.”

Jeremy Farrar, director of the Wellcome Trust, said that post-pandemic, the Global Action Plan can pick up where the ACT Accelerator leaves off, to sustain the new forms of global health collaboration that have been forged by crisis.

But he added that  countries also have an “absolute responsibility” to invest in health systems, adding that, “the neglect and undermining of institutions has been part of the build up to the COVID-19 pandemic, including in very rich ones.”

The panellists also touched on the overwhelming amount of attention the pandemic has demanded, highlighting a disparity in the support provided for countries with high rates of other infectious diseases.

“We need to use the way we have responded to COVID-19 as a catalyst,” said Sands.  He pointed out that while COVID-19 deaths rates are rising higher and higher, it remains unclear if the pandemic will really outpace the burden of TB, traditionally the world’s most deadly infectious disease, or not.  And at the same time, TB surveillance is so much weaker than what has already been put in place for the pandemic, that the final answer won’t be apparent for some time to come.

“[Either] TB or COVID-19 will be the biggest infectious disease killer in the world,” said Sands. “We will know within 99-99.5% accuracy, on January 1st how many people died of COVID-19 in 2020. To get that number for TB, we will probably wait until October 2021.”

Summit Declaration by Leading Health Research Institutes Calls For Patent Waivers and Debt Relief in Pandemic Wake

M8 Alliance that supports the World Health Summit annual event.

Also on closing day, the M8 Alliance of public health education and research institutions, issued a Summit Declaration calling upon global policymakers to take more radical action to level the playing ground on access to needed COVID-19 health products – through measures such as patent “waivers” for the duration of the emergency – a proposal recently debated at the World Trade Organization’s TRIPS Council  (Trade-Related Aspects of Intellectual Property Rights).

The call by the Alliance of prominent public health institutions from around the world, also called upon the G7 and the G20 groups of industrialized countries to enact measures that would bring significant debt relief to poor countries hard hit by the “economic COVID”:

“The corona pandemic is not a single-issue pandemic – it is a syndemic, impacting on societies in a multitude of ways, uncovering deep inequalities and structural disadvantages,” stated the manifesto.

“To stem the pandemic not only “at home” but everywhere the global community must use every tool at its disposal throughout the multilateral system to leave no-one behind,” it stated, adding,

“There can be no health security without social security and access to health services and medicines. This includes TRIPS waivers through the World Trade Organisation for COVID-19 therapeutics, diagnostics and vaccines as requested by a group of countries. The World Health Summit stands by its commitment to equity in global health.

“The required COVID19 responses range far beyond the global health organisations – they require determined decisions by political bodies such as the G7 and the G20, financial institutions such as the IMF and the World Bank and many other development banks. Financing global health action has already reached new dimensions – it requires billions not millions.

“Equitable distribution of a COVID19 vaccine through the COVAX mechanism is estimated at $US 35 billion. But other short-term financing measures are also required, such as debt cancellation for the poorest countries. The world is paying the price for the lack of investment in preparedness and sustainable financing models.”

The M8 alliance includes the Baltimore-baed Johns Hopkins-Bloomberg School of Public Health, the London School of Hygiene and Tropical Medicine, Geneva University Hospitals and the Geneva Graduate Institute, along with other institutional counterparts in the USA, Japan, Uganda, Iran, Singapore, Australia and elsewhere.

Left to right: Miriam K. Were; Amandeep Singh Gill; Alicia Ely Yamin; Dame Sally Davies; Soumya Swaminathan; and Aishath Samiya at the World Health Summit Achieving Health for all through Digital Collaboration session.

At a time when the COVID-19 pandemic has exposed the fragility of health systems – digital health technologies are playing a fast-expanding role – showing their revolutionary potential to address old and new needs and gaps, said participants on a Digital Health panel at the World Health Summit on Monday. 

“COVID-19 is the first pandemic of the digital age. We’re seeing first-hand how these new tools can support our efforts. Digital health technologies are helping to screen populations, track infection rates, and monitor resources,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the WHO. “They’re also helping us monitor the social and environmental determinants of health, which are fundamental elements in the fight against COVID-19.” 

Data sharing with biological specimens and whole genome sequences have enabled an unprecedented level of vaccine development within 10 months of the discovery of the novel virus, WHO Chief Scientist Soumya Swaminathan, another panel participant pointed out. 

Digital solutions also are making health care services more accessible and allowing people to better monitor and manage their own health – and their potential in that respect has only begun to be tapped, said Stella Kyriakides, Commissioner for Health and Food Safety in the European Commission.  

Stella Kyriakides at the World Health Summit Achieving Health for all through Digital Collaboration session.

“COVID-19 has accelerated the use of digital tools in health and helped make telemedicine more effective and accessible. However, it is also a stark reminder that we must ensure the growth in mutual support, inclusive resilience, and sustainable economies and societies. Every person must be able to benefit,” said Kyriakides. 

She and others called for more global collaboration on prioritizing and investing in digital health technologies, while ensuring high ethical standards to protect patient privacy and confidentiality. 

But despite the opportunities digital technologies offer, 47 percent of the world’s population is not connected to broadband internet and many low-income countries don’t have the capacity to invest in digital health. 

In this context, three values are critical to reaping the benefits of digital health technologies: inclusivity, collaboration, and innovation, said Dame Sally Davies, Special Envoy on Antimicrobial Resistance in the UK Government.

Digital Technologies Need to Spread Globally 

“These are global issues, so any digital technology cannot be confined – if it’s successful – to a national space. We need to collaborate to govern these technologies, but we also need to collaborate to maximize the use for addressing concrete challenges,” said Amandeep Singh Gill. Gill is Project Director of the International Digital Health and AI Research Collaborative (I-DAIR), which aims to do just that. It was recently launched by the Geneva Graduate Institute and Fondation Botnar and Geneva Science & Diplomacy Anticipator Foundation. 

“The promise of the SDGs, leaving no one behind, will not be met if we don’t change the rules of the game that continue to drive income to be redistributed upwards from poor to rich within countries…Part of unlocking the resources that are necessary to fully use digital technologies needs to include some assessment of those rules,” including rules around technology and intellectual property, warned Alicia Ely Yamin, Senior Advisor on Human Rights at Partners in Health. 

A draft WHO global strategy on digital health will be brought before the World Health Assembly for approval when it reconvenes in November. Member states will review a WHO roadmap to promote expanded, worldwide use of digital technologies over the next five years. 

The end goals for digital technologies are improved health outcomes, a people-centered approach, empowered community health workers and the public, and trust, said Swaminathan. 

The innovations from digital technologies that emerged during the COVID-19 pandemic could also help address other existential threats, such as climate change and antimicrobial resistance (AMR) – all of which were key themes at this year’s World Health Summit. 

In other sessions of the Summit, participants have debated how to improve pandemic preparedness going forward in the age of COVID-19 as well as examining risks and solutions to drug-resistant bacteria, viruses and other pathogens – which could in the future trigger another major outbreak of diseases for which few treatments exist. Here are snapshots of key messages conveyed: 

Antimicrobial Resistance  – The Importance of Innovation
Scientists test a variety of bacteria for antimicrobial resistance.

If not addressed, the evolution of new strains of drug resistant bacteria and viruses could eventually pose an even bigger health emergency than the COVID-19 pandemic, potentially causing 10 million deaths annually by 2050, according to one recent UN report. At a session on Perspectives from the Covid19 Pandemic, the Importance of Innovation, Panelists at another World Health Summit session zeroed in on the future threat posed by antimicrobial resistance (AMR), the process by which some bacteria, viruses and other common pathogens become resistant to commonly used drugs, threatening effective prevention and treatment of a wide range of infectious diseases.

“The main threat of AMR is that it undermines modern medicine as we have it today. Antimicrobials are fundamental tools and how modern medicine is practiced. As resistance emerges against the tools that we have refined, the ability to deliver other types of medical interventions becomes more difficult and the threat of infectious diseases more generally, becomes a much bigger problem,” said Tim Jinks, Head of the Drug Resistant Infections Priority Program at Wellcome Trust.

It is perhaps no accident that in July 2020, at the height of the COVID-19 pandemic, the AMR Action Fund, was launched. The fund, developed in a partnership between the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), WHO, Wellcome Trust, the Biopharmaceutical CEO Roundtable, and the European Investment Bank, aims to address the current dearth of funding in R&D for new antimicrobial agents, and bring 2-4 new antibiotics to market this decade.  Some two dozen leading pharma companies, including Pfizer, Roche, Johnson & Johnson, Merck and others, have invested in the fund.  

Panelists noted that other innovative R&D frameworks created in response to the COVID-19 pandemic could be used in the future to develop better treatments to address AMR. One example is  the Access to COVID-19 Tools (ACT) Accelerator, a global collaboration to speed up the development, manufacture, and distribution of tests, vaccines, and treatments for COVID-19. 

Along with innovation, much more needs to be done to strengthen global collaboration on AMR surveillance and regulation, to ensure that existing antibiotics and other antimicrobial drugs are better rationalized in human and animal populations to prolong their usefulness, while ensuring access to legitimate, full-formulas in developing country markets where weakened or counterfeit formulations may also contribute to growing drug resistance.

“Through data-driven practices, we can ensure that our antimicrobials, particularly the last line of drugs are there for patients who really depend on them, sharing data and collaborating to deliver…health care,” and encouraging investment in the antibiotic pipeline, said Davies.

Pandemic Preparedness in the Age of COVID-19
Tom Frieden at the World Health Summit’s Pandemic Preparedness in the Age of COVID-19 session.

The global experience with COVID-19 has cast a spotlight on the emergency preparedness of health systems, revealing that “the world remains woefully underprepared for epidemics,” warned Tom Frieden, President of Resolve to Save Lives, at the Pandemic Preparedness in the Age of COVID-19 session of the World Health Summit. 

“We have to recognize that COVID it is a long term threat to public health and the pandemic is nowhere near over...It’s very clear that this is the most destructive infectious disease threat the world has faced in a century,” said Frieden. “The disruption that COVID causes could kill many millions. The risk of explosive spread is not going to end when we have a vaccine.”

The lessons learned from combatting SARS, MERS, Ebola, and SARS-CoV2, thus far, are essential to better prepare for the continued threat of COVID-19 and future pandemics that will follow, he said. 

On a brighter note, the unprecedented speed of progress made in developing tests, treatments and vaccines since the beginning of the pandemic has created models for new modes of global collaboration, and strengthened public-private partnerships. 

“The industry, the IFPMA manufacturers, have committed to sharing their know-how, their experience, to work together, to collaborate with each other, but also with society at large… And one of the reasons [this happened] is that there was this deep sense of responsibility that the industry has the unique skill set to help us,” said Thomas Cueni, Director-General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). “As a result, eight months later we have almost 1000 clinical trials [looking at], more than 300 treatments. We have 200 vaccine candidates, 12 of them in late stage clinical development.”

Thomas Cueni speaking at the World Health Summit session on Pandemic Preparedness in the Age of COVID-19.

Industry mobilization, as well as some of the technologies being developed, both can help improve future pandemic preparedness. he cited examples such as: “ever-warm” vaccine technologies, which could be stored at a higher range of temperatures than existing vaccines, and drug treatments using monoclonal antibodies, which require a complex manufacturing process, but could provide a basis for treating other pathogens that could emerge as future pandemic threats. 

Image Credits: World Health Summit, World Health Summit , Flickr – UK Department for International Development.

A milestone study has found that women giving birth when they are infected with COVID-19, even if asymptomatic, may have more post-birth complications, including fever and hypoxia leading to hospital readmission, as compared to women who are not infected.

The study, conducted by Malavika Rabhu of Weill Cornell Medicine, observed 675 women admitted for delivery in New York. Of the women, 10.4% tested positive for SARS-CoV-2, although  78.6% of these women were asymptomatic. 

However, following birth, complications such as fever, hypoxia, readmission occurred in 12.9% of women with COVID-19 versus 4.5% of women without. 

There was also increased frequency of fetal vascular malperfusion among their newborn babies, which indicates thrombi in fetal vessels – occurring in 48.3% of women who had COVID-19 versus the 11.3% who didn’t. 

Malavika Prabhu, Weill Cornell Medicine

Cesarean rates also were higher in women infected by COVID-19, at rates of 46.7% in symptomatic COVID-19 cases, 45.5% in asymptomatic women, and 30.9% in women without COVID-19.  

These potential complications suggest impacts from COVID-19 for women and their newborn babies at the moment of delivery and beyond, Prabhu notes, speaking at a press briefing on Thursday. More research needs to be done she said, regarding the implications of COVID-19 on pregnancy. 

The risks identified are especially important for pregnant women to be aware of – if they are infected and due to give birth – particularly since some pregnant women have avoided accessing care at clinics in COVID hospitals, according to Prahbu. 

Obesity also represents a significant risk factor for enhanced disease for pregnant patients with COVID-19, added  Professor Kristina Adams Waldorf, speaking at The Union session. Waldorf who has studied the impacts of the infection on obese pregnant women in a study in Washington State.

Excess adipose tissue, which can impair immune response to viral infections, and the impact obesity has on pulmonary mechanics and breathing can make “pregnant patients that are obese prior to pregnancy more symptomatic,” Walfdorf states. 

There is evidence that suggests that there’s an increased risk for hospitalization and need for mechanical ventilation for pregnant infected patients. This is especially for pregnant patients with COVID-19, who have had their pregnancy compromised by the infection, which results in a preterm birth. Obesity would add another layer to these risks. 

“We have almost what we would consider kind of a perfect storm where there are multiple factors that are interacting at the same time that complicate the management of this pregnant patient, ultimately leading to the decision to deliver preterm.”

Image Credits: Flickr: Nuno Ibra Remane, R Santos/HP Watch.

Madhukar Pai, Director of McGill Global Health Programs and Director of the McGill International TB Center.

In combatting COVID-19, many countries around the world are currently facing “house on fire moments,” as described by Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. However, the syndemic of COVID-19 and TB poses an even more deadly threat. 

TB and COVID-19 respiratory diseases affect mostly the same vulnerable populations. Disproportionately, marginalized communities, those living in poverty, those with underlying conditions, those who don’t have access to clean drinking water or sanitation, and those who can’t afford masks or are unable to socially distance have been hit hardest medically and socioeconomically by both COVID-19 and TB. 

According to Madhukar Pai, associate director of the McGill International TB Center, 25 years of progress in malaria, TB, HIV detection and treatment, as well as widespread vaccinations of vaccine preventable diseases and care for non-communicable diseases, has been rolled back in 25 weeks. He and Osterholm were both speaking at a session at the 51st Union World Conference on Lung Health on Thursday. 

COVID-19 has severely disrupted health systems and services globally. 1.4 million people died from TB-related illnesses in 2019. With a 25 percent disruption in TB detention and treatment, 13 percent more TB deaths could potentially occur this year, found the recent WHO Global Tuberculosis Report. In addition, a decade’s worth of progress in reducing deaths from TB, the world’s oldest known and still the most deadly infectious disease, has been pushed back over the 10 months of the pandemic. 

The infrastructure laid down by TB systems and programmes was in fact essential to mounting the early response to COVID-19, particularly in low- and middle-income countries. 

“When this virus hit us, many countries were able to leverage existing capacities, be it the influenza surveillance systems or the molecular diagnostic testing capacities of TB programs, to respond more effectively to COVID-19,” said Maria Van Kerkhove, WHO COVID-19 Technical Lead. 

In order to rebuild the disrupted health systems, Pai called for the leveraging and repurposing of innovative COVID-19 systems and technologies to fight TB. 

“The amount of investments that have gone into COVID-19 vaccines in six to eight months exceeds all the investments ever made on TB vaccines in the history of humanity. How is this acceptable, given the death toll that TB has cost in the last several years. We must ensure that these R&D investments are not wasted,” said Pai. 

Community-based testing for COVID-19 in April in Madagascar.

The same infrastructures that have been created to respond to and manage the COVID-19 pandemic could revolutionize TB detection, treatment, and care, if they were applied to the latter. These include: 

  • Mobile apps designed for COVID-19 self-assessment, public education, screening, and contact tracing, all of which are necessary for TB. 
  • Innovative diagnostics, such as digital chest x-rays using artificial intelligence based software, could be used to screen for both COVID-19 and TB. 
  • Decentralized, community based testing could be scaled up for TB.
  • Remote service provision systems and technologies, including tele-health and at-home delivery of medicines, could be repurposed for both COVID-19 and TB. 
  • Behavioral changes in healthcare facilities, with wearing PPE, and among the public, with distancing and wearing face masks, can interrupt transmission for TB and COVID-19. 
  • Global partnerships, such as COVAX – a multilateral collaboration of over 171 countries, established to pool funding for COVID-19 vaccine development and distribution – are critical to increase access to research, technology, and treatment for TB. 

“If we don’t use this crisis and invest in universal health coverage [UHC] as a long standing solution for better pandemic preparedness…then TB will suffer because TB desperately needs the protection of UHC,” said Pai. “And therefore my biggest dream would be for UHC to get front and center on the political agenda and for our countries’ leaders to have learned this hard lesson that health is wealth and wealth is health.”

 

Image Credits: Flickr – World Bank, International Union Against Tuberculosis and Lung Disease.

While most of us hope that if we can just get one vaccine to market that will be enough to solve our global COVID-19 matrix – the controversial ‘human challenge’ studies now getting underway highlight how many more twists and turns we are likely to face before we finally get out of the pandemic maze.

On Tuesday, London’s Imperial College sent ripples of both excitement and protest through the COVID research community, announcing that it would embark on the first “human challenge” trials of COVID-19 vaccines – involving the deliberate infection of healthy, young volunteers with the potentially deadly SARS-CoV-2 virus.

The first stage of the project, scheduled to begin in January 2021, will expose the volunteers to the coronavirus in controlled, gradually increasing doses, in order to determine the smallest amount of virus that it may take for a person to develop the disease. In a second stage, researchers aim to use that newfound knowledge to test different vaccine alternatives more rapidly and efficiently than could be done in conventional large-scale clinical trials – including by administering a vaccine to volunteers, and then infecting them with infectious doses of the virus.

Can Human Challenge Trials Make A Difference?

Vaccine pre-purchase orders by pharma firm; by Suerie Moon, Global Health Centre, Geneva Graduate Institute

Even if a couple of the leading vaccine candidates from Moderna, Pfizer, AstraZeneca and Johnson & Johnson make it to the market by early 2021, the world faces a myriad of other problems in deploying the new tools to actually stop the pandemic. Among the barriers:

  • Limited vaccine supplies. As low-income countries have pointed out over and over, a large proportion of vaccine supplies created by the front-running candidates that are expected to become available in 2021, have already been bought up by rich countries. This includes not Canada, the United States, Japan, the United Kingdom, and the European Union.  Just last week, Switzerland also made a big new pre-order of 5.3 million doses from AstraZeneca – on top of a previous Swiss pre-order of 4.5 million doses from Moderna.
  • Unsuitability of some vaccines in some places or for some populations. The AstraZeneca vaccine, for instance, requires cold storage at extreme temperatures; its trials also have been marred by a series of adverse events -including the death Wednesday of a 28-year-old trial participant in Brazil from COVID-19, although it was not clear if he had received the vaccine or a placebo. In addition, some vaccines may be more or less effective in older people, than others.
  • Limited vaccine acceptance. A new study of vaccine hesitancy covering 18 OECD countries indicates that only about 72 per cent of people would even use a vaccine, at this stage, even if one is proven safe and available. More vaccine testing leading to more choices also might, indirectly, help build public support.
Canada leads in vaccine pre-orders per capita, followed by the UK, Japan and the EU.  Data does not include the recent Swiss pre-order, which just about doubled its pledged commitments; Suerie Moon, Global Health Centre, Geneva Graduate Institute at The Union World Conference on Lung Health. 

So while hardly a panacea, proponents of so-called human challenge trials say that their approach could help cull out other effective vaccines among the 40-odd candidates still in the research and development pipeline, making more vaccine choices more widely available to more people around the world.

Proponents note that human challenge trials are, in fact, not unusual; they have been used in the past to rapidly test and scale up new types of vaccines for other deadly infectious diseases like cholera and typhoid, the fairly unique aspect of these trials is the fact that they will be undertaken before any known treatment or cure exists for COVID-19.

But sceptics point out that while the UK study would recruit healthy, young volunteers (18-30 years) with no previous history or symptoms of COVID-19, no underlying health conditions and no known adverse risk factors for COVID-19 such as heart disease, diabetes or obesity, the SARS-CoV-2 virus has proven to be a particularly tricky one, causing a weird array of unexpected side effects from neurological impacts to heart disease – even in some presumably, young and healthy people. Some of them lasting for months, or longer – a phenomenon described as “long COVID.”  In light of the still unknown factors that cause some people to fare much worse than others,  and the fact that there is no known treatment, let alone cure, the ethical challenges posed by human challenge trials of this particular virus are particularly vivid.

Critics: Plenty Of People Naturally Infected With COVID-19 – No Need For Researchers To Deliberately Infect More

Critics of the approach include Dr Ken Kengatharan, co-founder and chairman of the California-based biotech firm Renexxion, who told us the following:

“A COVID-19 challenge study is as dumb and dangerous an idea as it gets considering the fact that SARS-CoV-2 is an atypical coronavirus (without any comparable out there or historically) and we are just learning about its MOA [mode of action] plus acute and chronic effects in all age groups with or without co-morbidities. Even the mechanism by which the virus causes, cytokine storm or SIRS (systemic inflammatory response syndrome), multi-organ failure, sepsis orseptic shock is very different.”

A recent study published in Lancet Respiratory Medicine vividly describes the distinctive quality of that immune response and dangerous over-response, in words and in graphics.

Cytokine Storm .jpg
Lancet Respiratory Medicine – mapping of immune over-reaction to SARS-CoV-2 as compared to other viruses

Human Challenge studies may be very useful to get rapid answers, Kengatharan adds: “If there are no large participants’ pool. These studies should be used once you know a lot about the virus; there aren’t that many people in the world to test; the vaccines have an expected efficacy of greater than 90 per cent especially if the virus does not have long-lasting effect; and when there is a way to treat people using drugs once they develop the disease (useful, if the vaccine does not work in a particular person), for example, Zika.”

He adds that the biggest costs around late-stage vaccine development involve the length of time required to recruit large numbers of patients. This in turn depends on infection numbers and thus how many stand to benefit from a vaccine.

“So when there is a potentially small number of available vaccine users, challenge studies will be useful to know if a vaccine is safe and efficacious using a small number of patients which means shorter timeline and lower cost.

But in the case of COVID-19, where the world has already exceeded 41 million cases worldwide, “we have -19 hot spots around the world, one can do the vaccine Phase 3 studies as fast as challenge studies!

“If there are many participants available, and one wants to test vaccines that are likely to have lower efficacy e.g. less than 80 per cent, and the virus has long lasting effects, then these challenge studies are not advisable. They don’t and won’t compress the length of Phase 3 trials!

“Besides, challenge studies [involving limited number of participants in just one setting] won’t tell you much about the effect of vaccines on heterogeneous populations with different co-morbidities. Already we know SARS-CoV-2 affects different people in different ways.”

So are human challenge studies both reckless and a waste of time?

A number of top global bioethics experts, who spend their careers pondering the pros and cons of these kinds of ethical dilemmas, put a much more positive spin on the Imperial College initiative and the relevance of the human challenge concept to COVID-19.

Dr Arthur Caplan, founding head of the division of medical ethics at NYU School of Medicine, notes that right now, there may be sufficient numbers of people ready to volunteer for the classically designed randomized controlled trials (RCTs) which need 30,000 to 50,000 participants to determine whether infection rates are really lower in those receiving the vaccine than those who received a placebo, without subjecting anyone deliberately to extra risks. That may soon change.

What happens, he asks, after the first vaccine hits the market? People may be far less willing to sign up for such trials en masse. And at that point, Human Challenge trials may become more critical to tease out the benefits of different types of COVID-19 vaccines, particularly in light of the more than 40 vaccines are currently in various stages of R&D. Caplan:

“As vaccines get approved for emergency use or licensed many [clinical] trials may collapse as subjects demand unblinding, or refuse to sign up for new studies and seek access to an approved, albeit not great vaccine.

“Challenge studies will enable comparator trials among promising vaccines to help determine which is best… Challenge studies may be the only way forward if large RCTs are not feasible for next in line vaccine candidates. Risks and unknowns are real but if brave volunteers consent the benefit to the world will be enormous.”

Nir Eyal, head of the Rutgers Center for Population-level Bioethics and author of a recent paper on the ethics of human challenge trials, is even more emphatic.

He calls the planned British studies “very important”, saying that they can eventually provide more nuanced data, more rapidly, on what vaccines are safer and more effective:

“Even if and when a vaccine like the ones currently being tested is proven safe and efficacious, we would still need to test others. These others may yet prove even more efficacious (e.g. for blocking infections and reaching vaccine-derived herd immunity, and thus helping us end this pandemic), as well as safer, easier to deliver, cheaper, or simply available outside a few countries that are hoarding the global vaccine supply. “A challenge trial would provide fast, reliable answers, much more than more rounds of slower conventional trials.

“Challenge trials save some time compared to conventional trials when all goes well in the latter, because in challenge trials, there is no need to wait for enough natural infections to accrue. When all does not go well, and specifically when the outbreak moves elsewhere, challenge trials can save a lot of time.”

That, he says, is what we are seeing with COVID-19, which is proving to be a moving target with infection rates rising, declining and hotspots constantly shifting.

And what about the risks to the brave volunteers?

Any benefits, Eyal he asserts, would still far outweigh the risks:

  • It is true, he concedes, that a challenge trial carries risks to volunteers, but those risks can be dramatically reduced by selecting volunteers at low risk. And compared to the dramatic humanitarian value of a challenge trial, these risks to volunteers are “ethically acceptable.” Some other common medical practices such as live kidney donation involve commensurate risks.
  • Crucially, just like live kidney donation, challenge trials (and the dose-escalation study that will precede them) must be performed only with the “truly informed consent of the study volunteers, who prove their comprehension of all risks and uncertainties,” he underlines. “Just as the consensual nature of kidney donation helps justify risks to kidney donors, so does the challenge volunteer’s autonomous consent to being put at risk, for the greater cause of ending the pandemic earlier.”

“If a challenge trial helps shorten the pandemic by a mere one month (and it may shorten it more), it will have averted the loss of at least 720,000 years of life and 40 million years in dire poverty worldwide (an estimate by development economist Pedro Rosa Dias, global health leader Ara Darzi, and myself),” Eyal concludes.

Eyal’s big regret, in fact, is that the US didn’t pursue such studies early on, as was proposed at one stage to the National Institutes of Health.

“Such an early study would have saved even more time and accelerated vaccine development even more than the UK study will do.” He says an ill-informed report to the National Institutes of Health put the US public authorities off of the idea, saying it would take one to two years to set up, “an impression that will be refuted when the Brits conduct a challenge study earlier.”

The World Health Organization’s Take

Like many other thorny pandemic issues it has faced, WHO doesn’t exactly endorse challenge trials. But it’s fairly obvious that the organisation sees them as a potentially legitimate mode of research – even in the COVID-19 context – having drawn up two weighty volumes of guidance about the issue.

In a press briefing this week, WHO Spokesperson Margaret Harris said that the organisation’s guidance includes a report by a WHO working group on the key criteria for the ethical acceptability of COVID-19 human challenge studies and another draft document by a WHO Advisory group on the feasibility, potential value and limitations of challenge studies.

In a nutshell, says Harris:

“There are very important ethical considerations to take into consideration if you are planning to do such a trial. We have developed guidance on this… We have identified eight principles that need to be followed, one of them being that they must be overseen by an ethics committee. They must also have full consent. You will be challenging people with a virus that we don’t have a treatment for. Generally, these were done in the past when we had a specific treatment… You must ensure that everybody involved understands what is at stake… and the informed consent is rigorous.”

That’s not an unqualified ‘‘yes’’. But it isn’t a ‘‘no’’ either.

__________________________

Published as part of a collaboration with Geneva Solutions, a new platform for International Geneva focusing on constructive journalism about climate, humanitarian affairs, sustainable business, and digital technology, as well as health.

Image Credits: KEYSTONE/Gaetan Bally, Kerry Cullinan , R Santos/HP Watch.

The COVID-19 pandemic will end at some point. But TB, tobacco use, air pollution and other lung diseases will continue to “steal the breath and life of millions of people every year”, unless we reimagine the future, said WHO’s director-general Dr Tedros Adhanon Ghebreyesus, appearing at the opening of the 51st Union World Conference On Lung Health in an all-start lineup with former US President Bill Clinton and Crown Princess Akishino of Japan .

“COVID-19 is reminding us all that life is fragile, and health is the most precious commodity on Earth. Together, we must harness the same urgency and solidarity with which the world is fighting COVID-19 to make sure everyone everyone can breathe freely and cleanly,” he said.

Bill Clinton, former US President

As COVID-19 shatters livelihoods, cripples economies and claims the lives of over a million people, the conference comes at an “important time” to redefine the future of the planet, said Clinton, another keynote speaker at The Union’s 100th anniversary event.

It was exactly a century ago that the Paris-based organization was founded in 1920 to end all suffering from tuberculosis (TB) and other lung diseases. Even today, despite the progress made since, TB remains the world’s largest infectious disease killer, claiming 4,000 lives a day.

“This crisis also gives us a chance to totally reimagine what our future will look like, what our societies, our economies and our healthcare systems [will] look like and how we relate to one another,” Clinton said Tuesday, at the weeklong event. Despite being on a virtual platform, this year’s conference features speakers from 82 countries around the world. 

“The path to an optimal post-COVID world is unlikely to be simple and quick. But we cannot simply revert to the status quo,” Clinton said.

The Union’s executive director José Luis Castro`

On a positive note, the world still has the capacity to deliver the Sustainable Development Goals (SDGs) by 2030 despite the pandemic, emphasized The Union’s executive director José Luis Castro. Achieving SDG targets in time is especially feasible for TB, which is still the leading cause of death worldwide, even though it is preventable, treatable and curable. According to Castro, the SDGs are not ideas, but commitments world leaders must uphold “no matter what”. 

“Today, we have more knowledge, more technology, more resources and more connectivity than humanity has had at any other time in history,” said Castro. “We have the power to see that the Sustainable Development Goals are not just good ideas that get put aside when a crisis arises. But that these are commitments that we have made to each other, no matter what. It is up to us.”

Now is not the time to slow down, added Shannon Hadder, deputy executive director of UNAIDS, in her call for more aggressive investments in preventive therapy, infection control, health worker safety, scaled and modern contact tracing, and sufficient social and economic support to achieve it.

Given that HIV is the leading cause of death in TB patients, testing for TB in HIV patients and maintaining HIV treatment is particularly important, said Hadder. Even before COVID-19, 50% of TB cases in HIV-positive people were under the radar, she said, adding that a mere six month interruption in HIV treatment could trigger half a million additional TB deaths in Sub-Saharan Africa alone.

Building Back Better – Governments Must Foster Honesty & Integrity  

Dr Tedros Adhanom Ghebreyesus, WHO director-general

Apart from transforming health care towards a more inclusive, affordable and equitable model, heads of state must restore their citizens’ trust through honesty, integrity and evidence-based decision-making, said Dr. Tedros. 

Fostering trust in the general public seems quite urgent given that almost 30% of the world is unlikely to accept a coronavirus vaccine – even if it were proven to be safe and effective – concluded a Nature survey just this Tuesday. The survey was based on responses from over 13,000 randomly selected adults across 19 countries that were heavily affected by COVID-19.

Governments must also be held accountable for the decisions they make, added Castro, noting that by March 2021, world leaders will only have two years left to deliver their pledge to ensure that 30 million people have access to TB treatment. According to Castro, there is still time to turn these promises into reality. 

“We cannot allow the pandemic to become an excuse for failing to deliver on the commitments we have made to end tobacco and air pollution,” added Dr Tedros. “Quite the opposite. The pandemic is showing us why we must work with even more determination, collaboration and innovation to meet those commitments.”

Image Credits: The Union.