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.

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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.

Mock album cover for ‘We Are Family’ campaign, featuring WHO DG Tedros Adhanom Ghebreyesus, Mike Ryan and Maria Van Kerkhove of the Health Emergencies campaign.

WHO is launching a collaboration with R&B Vocalist Kim Sledge of “We Are Family” fame to reproduce her signature album in a campaign aimed to promote global solidarity for COVID-19, and raise funds to battle COVID-19.  

The campaign, which will be coordinated by The World We Want Foundation, is to feature a special edition cover of the classic song “We Are Family” in a worldwide viral video that would include versions of the song by people ranging from  celebrities to frontline health heroes, political leaders and members of the public  – singing together to support global public health needs, including COVID-19. 

American singer Kim Sledge

“Together we are unity strong, and we can do this as a family because we are one big global family,” Sledge, of the legendary music group Sister Sledge, said, speaking at a WHO press conference on Monday. Sledge said that she embarked on this initiative after being motivated by those around her who are looking for ways to end the crisis, including her husband and daughter, who both work as doctors on the COVID-19 frontlines. 

The video campaign invites people to star in the music video by recording themselves with their close family and friends singing the song and sharing on their social media channels. In order to submit sing-along videos to the special edition of the We Are Family song, members of the public can:

  • Record yourself singing We Are Family either alone, or with friends and family, whilst observing physical distancing guidelines.
  • Share the video on your favourite social media channel, with the hashtag #WeAreFamily #COVID19 #HealthforAll and tag @WHO, @The_WorldWeWant and @thewhof.
  • Upload your video to www.unitystrong.com.
  • If you want your video to be considered for inclusion in the global We Are Family video, you will need to share your video by Monday, 30 November 2020.
  • Video clips will be selected based on age, geographical diversity, and appropriate physical distancing if the video includes groups of people beyond immediate family members and correct handwashing if singing along to the song while washing hands.
  • More details including Terms & Conditions can be found here www.unitystrong.com. 

Part of the proceeds from the new song, to be released on November 9, are to be donated to the WHO Foundation to support the response to COVID-19, as well as to other health promotion initiatives worldwide. 

Video Release To Coincide With World Health Assembly Autumn Session  

The release will coincide with the resumption of the 73rd session of the World Health Assembly, November 9-14. The WHA began in a two-day special virtual session in May to discuss the COVID-19 crisis, and then was adjourned until the autumn. 

Sledge is also scheduled to perform for the WHA alongside singers from New York to Tonga. 

Sledge is collaborating with Natasha Mudhar, founder of The World We Want Foundation, and another driving force behind the #WeAreFamily campaign. 

Natasha Mudhar, Founder of The World We Want

Said Mudhar: “We Are Family is one of the most instantly recognizable anthems in the world. The song carries such an inspiring message of unity and solidarity.

“What is so powerful about music and what we feel will be so powerful about this particular campaign, the song, and the video is that it will not only just entertain, but inspire action. And that’s just really bringing everybody together.”  

Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, emphasizes in his closing remarks, “This campaign is more than a song. It’s a call to action for collaboration and kindness, and the reminder of the strength of family and the importance of coming together to help others in times of need. 

“It represents that to heal the world from this pandemic, we must come together like never before in national unity and global solidarity with a family, and as humankind. We have more in common with one another, than we would ever dare to believe.” This comes after his announcement that 184 countries have now joined the COVAX initiative, Ecuador and Paraguay having joined this weekend. Tedros reiterated the importance of sharing vaccines equitably around the world by safeguarding high risk populations and working together to share life-saving health supplies globally. 

“Let us use this anthem as a family, to help unite us, unite the world, and together, we wouldn’t just beat this pandemic. We will take on, and successfully tackle other global challenges like air pollution and the climate crisis. So join us in the We Are One Family campaign. Because together we can do anything we put our minds to: national unity and global solidarity. We are one family.”

Image Credits: R Santos/HP Watch.

Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria.

Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria, says a new WHO position statement. Genetically modified mosquitoes are designed to suppress mosquito populations and reduce their susceptibility to infection and their ability to transmit disease-carrying pathogens.

WHO announced their support for the continued investigation into genetically modified mosquitoes as an alternative to existing interventions to reduce or prevent vector-borne diseases.

“These diseases are not going away,” said John Reeder, Director of TDR, the Special Program for Research and Training in Tropical Diseases. “We really do need to think about new tools that could make an impact.”

Each year 700,000 people die from vector-borne diseases and over 80 percent of the global population live in areas with higher risks of contracting a vector-borne disease, including malaria, dengue, yellow fever, and others. Major vector-borne diseases account for 17 percent of the global burden of communicable diseases.

Genetically modified mosquito approaches use recombinant DNA technology to introduce heritable traits to reduce the transmission of mosquito-borne diseases. WHO raised concerns about the ethics, safety, and governance of this new potential vector-borne disease control strategy.

The statement advised for the implementation of oversight mechanisms, risk assessment, and community engagement for further research and field trials of genetically modified mosquitoes. Guidance on vector-borne disease prevention and control was released by the WHO to respond to key ethical issues involved.

Image Credits: Flickr: Tom.

GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high blood sugar  levels, and high body mass index (BMI).

The COVID-19 pandemic, along with the continued global rise in chronic illness and related disease risk factors, such as obesity, high blood sugar, and outdoor air pollution exposures, seen over the past 30 years has created a ‘perfect storm’, fueling COVID-19 deaths, says a new study published Thursday in The Lancet .

The global disease estimates provide insights into how rising chronic disease, along with public health failures, is fueling excess deaths from SARS-CoV-2 among people with pre-existing conditions.

Led by the Institute of Health Metrics and Evaluation, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) is a comprehensive global study, analyzing and ranking 286 causes of death, 369 disease and injuries, and 87 risk factors in 204 countries and territories.

The GBD study, covering 204 countries, also tracks a population’s social and economic status on the basis of socio-demographic index (SDI). SDI combines information on average income per capita, educational attainment, and total fertility rates. 

Increased COVID-19 Illness and Death Associated With NCDs & NCD Risk Factors

The study found that increased illness and death from COVID-19 is associated with several risk factors and non-communicable diseases, including obesity, diabetes, and cardiovascular disease, as well as outdoor air pollution exposures. 

But these diseases don’t just interact biologically, they also interact with socioeconomic factors, the study highlights. Underlying social inequities that perpetuate chronic diseases need to be addressed through policy and research in order to prevent the burden of disease from worsening and leaving populations vulnerable to increased risk of COVID-19, the study concludes.

Said Dr Richard Horton, Editor-in-Chief of The Lancet: “The syndemic nature of the threat we face demands that we not only treat each affliction, but also urgently address the underlying social inequalities that shape them—poverty, housing, education, and race, which are all powerful determinants of health.”

He continues, “COVID-19 is an acute-on-chronic health emergency. And the chronicity of the present crisis is being ignored at our future peril. Non-communicable diseases have played a critical role in driving the more than 1 million deaths caused by COVID-19 to date, and will continue to shape health in every country after the pandemic subsides. As we address how to regenerate our health systems in the wake of COVID-19, this Global Burden of Disease Study offers a means of targeting where the need is greatest, and how it differs between countries” .

An accompanying Lancet editorial “Global Health: time for radical change” also states: “The message of GBD is that unless deeply embedded structural inequities in society are tackled and unless a more liberal approach to immigration policies is adopted, communities will not be protected from future infectious outbreaks and population health will not achieve the gains that global health advocates seek. It’s time for the global health community to change direction.”

The study also reveals that the rise in exposure to key risk factors (including high blood pressure, high blood sugar, high body-mass index [BMI], and elevated cholesterol), combined with rising deaths from cardiovascular disease in some countries (e.g., the USA and the Caribbean), suggests that the world might be approaching a turning point in life expectancy gains.

The authors stress that the promise of disease prevention through government actions or incentives that enable healthier behaviours and access to health-care resources is not being realised around the world.

“Most of these risk factors are preventable and treatable, and tackling them will bring huge social and economic benefits. We are failing to change unhealthy behaviours, particularly those related to diet quality, caloric intake, and physical activity, in part due to inadequate policy attention and funding for public health and behavioural research”, says Professor Christopher Murray, Director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, USA, who led the research.

“Double Down” on Development Promotes Health – Address NCDs in Low & Middle Income Countries 
Since the 1990s, the health burden has shifted towards NCDs and away from communicable, maternal, neonatal, and nutritional (CMNN) disease

The report also contains some good news. Over the past two decades, since the adoption of the UN Millennium Development Goals, low and low-middle income countries have chalked up faster progress in their socio-demographic index (SDI), in comparison to rich countries, the report finds. Such progress is “highly correlated” with better health outcomes as well.  

“Given the overwhelming impact of SDI on health progress, doubling down on policies and strategies that stimulate economic growth, expand access to primary and secondary schooling, and improve the status of women should be our collective priority,” adds Murray.

However, LMICs are not prepared to handle the growing transition in the disease burden from communicable diseases to non-communicable diseases (NDCs), the report also finds. 

Indeed, most global health policy discussion, including that of WHO, still focuses on communicable diseases, “even though there is an inevitable shift of disease burden to non-communicable disease.” 

‘Functional Disorders’ – A Growing Problem

Another challenge low- and middle-income countries may face, in particular, is the loss of so-called “functional health” capacities, which may not be well represented in classic health metrics characterizations of so-called “premature disability (DALY’s)”, the report notes. 

This can include issues such as: musculoskeletal disorders, mental disorders, substance misuse, vision loss, and hearing loss – issues which also become more acute as people live to older ages. Instead, current policy discussion is primarily focused on cardiovascular diseases and cancers, with low investment in research towards understanding underlying causes and therapeutic solutions for functional health loss.

Health of Children Has Seen Steady Improvement; Not So for Older Age Groups 
Since 2000, lower SDI countries have improved in the index faster when compared to higher SDI countries

While global health has still steadily improved over the past 30 years, especially for children under 10 years old, thanks to improvements in prenatal care and efforts to tackle infectious diseases, the same cannot be said for older age groups. 

Worldwide health loss, measured in disability-adjusted life-years (DALYs), is increasing. Six of the causes primarily affect older adults (ischaemic heart disease, diabetes, stroke, chronic kidney disease, lung cancer, and age-related hearing loss) and the other four are common from teenage years into old age (HIV/AIDS, other musculoskeletal disorders, low back pain, and depressive disorders). 

Though the number of DALYs hasn’t increased, there are a greater number occurring at old age. There has been a global shift towards non-communicable diseases and injuries, with them being half of the disease burden for 11 countries in 2019. However, global public health has focused more on primary causes of death rather than the systemic disparities of health, such as inequalities in access to preventative and curative services for lower socioeconomic groups.

As said in the GBD: “Policy makers should remain aware that the number of DALYs represents the burden of disease that the world’s health systems must manage.” Health relies on more than just health systems. 

Air Pollution among the Fastest Increasing Health Risks 
Risk factors that have had the largest increases in exposure are high BMI, ambient particulate matter pollution, and high fasting plasma glucose

GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with  drug use, high fasting plasma glucose, and high body mass index (BMI) by more than 0.5% per year. Many health risks are considered preventable and can be slowed down and reversed through public health action and policy. 

Risks that are strongly linked to social and economic development were the largest declines in risk exposure from 2010 to 2019. These included household air pollution; unsafe water, sanitation, and handwashing; and child growth failure. This correlates to increasing global SDI. Global declines were also reported for tobacco smoking and lead exposure. 

The decrease in tobacco smoking, down 1-2% per year since 2010, is a partial success due partly to the governmental interventions and policy on tobacco control. In comparison, there has been inadequate policy and attention dedicated to BMI, one of the leading causes to contributable DALYs. 

Speaking about the findings, Murray says, “Governments should invest more funding in research and action to tackle these stagnating or worsening risk exposures. A core obstacle to accelerating progress on behavioural risks is the notion of individual agency and the need for governments to let individuals make their own choices. 

“This concept is naïve, given that individual choices are influenced by context, education, and availability of alternatives. Governments can and should take action to facilitate healthier choices by rich and poor individuals alike. When there is a major risk to population health, concerted government action through regulation, taxation, and subsidies, drawing lessons from decades of tobacco control, might be required to protect the public’s health.” 

Image Credits: Igbarrio, The Lancet/IHME.

Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial.

Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. 

The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer.  

“These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.”

Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results

The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. 

In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear:

“Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. 

“For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. 

WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals

Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead  in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.”

The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19.  

Even so,  clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products.  Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process.

The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system.  

Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States 

With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread.  

Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan.  But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context.  Some excerpts: 

Mike Ryan, Executive Director of WHO Health Emergencies Programme

Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed.  

Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.”

Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding:

“We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.”

“Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.”

Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. 

Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.”

“We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” 

Maria Van Kerkhove, WHO Health Emergencies Technical Lead

Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.”

Travel precautions  – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice.  

Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. 

“It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.”

COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere

Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing.

Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020.

“Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove.

Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19.  

“Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. 

Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. 

Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries.  

However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. 

Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds

Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint  study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. 

The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to  2% of those who did not get the vaccine.

Image Credits: European Medicines Agency, WHO, Johns Hopkins.