Microplastics from a river in Maryland, collected by the National Oceanic and Atmospheric Association Marine Debris Program. Recent research have now found microplastics in human blood samples.

DAVOS, Switzerland – The presidents of Switzerland and Ecuador led a call here at the World Economic Forum (WEF) Tuesday for greater international cooperation to fight plastic pollution, urging passage of a global treaty with tough regulations to confront a burgeoning environmental and health crisis from the ubiquitous material once seen as a symbol of modernity. 

Swiss President Alain Berset, heading a panel discussion hosted by Switzerland, told a packed room that an international treaty and new “regulatory framework” is needed to get rid of plastics that are clogging the world’s ecosystems, choking oceans and poisoning fish and wildlife – with severe human health consequences. 

“We are facing a major plastic crisis. The world cannot deal with the amount of plastic it produces,” he said. “If we continue on this path there could be more plastic than fish by 2050.”

Berset said the plastic crisis is not only an environmental crisis, but also a health and socioeconomic challenge, “and Switzerland is ready to do its part.”

Plastic pollution
Switzerland’s President Alain Berset at the WEF panel on plastic pollution.

Ecuador’s President Guillermo Lasso Mendoza noted that his nation and Switzerland are “united by a historic commitment” to work together to end plastics pollution as two of the five countries joining the United Nations Security Council this year.

Japan, Malta, Mozambique are the other three countries elected to a two-year term on the 15-nation Council, the world body’s most powerful arm, based in New York.

“With our commitment we are indeed making history. We must find a solution to the global crisis of plastic waste,” said Lasso Mendoza. “In just a few years, there will be more plastic in our oceans by tons than there is fauna.”

Plastic pollution
Ecuador’s President Guillermo Lasso Mendoza at the WEF panel on plastic pollution.

In a historic moment in March 2022, the world’s environment ministries agreed to negotiate a treaty on plastics pollution. The decision by some 175 UN member states was reached at the United Nations Environment Assembly in Nairobi.

But the road to approval and ratification of a legal instrument that has teeth promises to be a major lift in light of the powerful oil and gas interests that will oppose it every step of the way.

Political leadership by countries such as Switzerland and Ecuador, in the Security Council and in other UN Fora, will thus be key to making progress in treaty negotiations.  

Fossil fuel producers scale up plastics production

Currently, an estimated 5% of global total goods trade is in plastics, Lasso Mendoza said, citing UN data. But even as knowledge about the enormous environmental and health risks of plastics grows, fossil fuel producers are scaling up their plastics production, with plans to double the production of virgin plastic resin by 2040. 

At current rates, plastics are on track to account for 20% of oil and gas consumption by 2050, according to the UN Environment Programme.

“Political will and leadership are the foundations upon which we must build,” Lasso Mendoza said. “Ecuador takes the fight against plastic very seriously. We need a globally binding treaty. We should reach agreement by the end of 2024.”

 

Over the past 30 years, plastics production increased fourfold, with growth rates still rising exponentially.

Already over the past 30 years, plastic consumption increased four-fold. Although global production of recycled plastics more than quadrupled over the same period, recycled plastics only represent about 6% of global plastics production, while 94% are “virgin” plastics, according to the OECD.

Burgeoning health and environmental impacts 

Plastic waste from an informal landfill litters a rural seascape in Albania while goats graze nearby.

Of the majority of plastic waste that doesn’t get reprocessed and reused, 19% is incinerated, 50% ends up in landfills, and 22% is burned in open pits, with the remainder winding up in uncontrolled dumpsites, scattered along roadsides, farmlands or littering coastal beaches and waters of poorer countries.

A 2021 report by the Food and Agriculture Organization (FAO) found that plastic contamination of farmland from single-use soil and plant coverings, tubing and other materials, poses an increasing threat to soil quality, food safety and human health.  In 2022, a new study identified microplastics in human blood samples for the first time. 

On the high seas, a recent Nature study found that the blue whales, which typically feed upon krill, may consume some 10 million pieces of microplastics a day, a taste of what other large fish like tuna and salmon are likely eating as well.

Human exposure to plastic additives such as DEHP and Phthalates, which are used to soften polyvinyl chloride (PVC), leads to higher risks of cancer and hormonal disorders that cause reproductive health problems, research has shown.   

Not only are phthalate additives health harmful, but the production of PVC out of fossil fuel-derived ethylene, generates considerable mercury emissions, which are toxic for humans and to wildlife. Along with its uses in waterproof garments and building materials, PVC is ubiquitous in healthcare settings where it is a key component of basic medical devices like IV tubes.

‘Dangerous for all living things

Rwanda’s Environment Minister Jeanne d’Arc Mujawamariya, whose nation has teamed with Norway to eliminate plastic pollution by 2040, told the panel that “plastic pollution is not only dangerous for nature but for all living things, including human beings.”

“No one country can solve the problem alone, she emphasized.

Marco Lambertini, a special envoy for Gland, Switzerland-based World Wild Fund for Nature (WWF), said that negotiations on an international treaty need to be inclusive of governments, businesses, investors and citizens.

“Without everybody, we won’t get anywhere,” he said. “We also need to look at the plastic value chain in its entirety, from production to disposal.”

Plastic pollution
(Left to right): At the WEF panel on plastic pollution, the Graduate Institute’s Carolyn Deere Birkbeck, moderator; WHO’s Dr Tedros Adhanom Ghebreyesus; Rwanda’s Environment Minister Jeanne d’Arc Mujawamariya; Kristin Hughes of WEF; and Marco Lambertini of WWF.

Developing countries that lack the infrastructure for waste management will need special help, he added, and recycling must be increased globally from its current “outrageous” low of less than 10%.

“I see a real parallel between the phasing out of fossil fuels and the phasing out of fossil fuel- based plastics,” he said. 

Kristin Hughes, director of WEF’s Global Plastic Action Partnership, added: “you don’t just need business, you also need the government component. And they need to work together.”

WHO – ending plastics pollution critical to healthier environment

The World Health Organization’s director-general, Dr Tedros Adhanom Ghebreyesus, said ending plastics pollution is a critical part of creating a healthier environment for everyone, but more study is needed to determine the range of biological and human health impacts that plastics can and do have.

“I don’t think plastics pollution and health – that connection – has been given the attention it needed,” Tedros said.  “And not only that, we don’t have research that documents well how plastics affect human health throughout the [product] lifecycle. 

“They do actually.”

Image Credits: John Heilprin, Will Parson/Chesapeake Bay Program, Plastics Atlas, 2019, @Antoine Giret/ Unsplash.

The existing international framework for sharing pathogens is ‘transactional’ and undermines global health security, according to research commissioned by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

Produced by legal consultancy Covington, the research was developed partly from interviews with 82 public health experts.

There were drawn from the pharmaceutical companies (44% of respondents), the World Health Organization (17%), public health institutions including the US Center for Disease Control, (23%), biobanks (7%), academia (1%), NGOs (7%), and other stakeholders (1%).

“The research “points to an increased ‘politicization’ of access to samples of pathogens, as well as access to sequence information on pathogens,” according to a statement released by the IFPMA on Tuesday.

“This is due to countries’ adoption of national access and benefit-sharing (ABS) rules under the Nagoya Protocol  and potentially, the future draft Pandemic Accord,” 

The Nagoya Protocol “employs a transactional model”, requiring almost 100 countries to get a permit “each time a researcher wishes to access that nation’s biodiversity for R&D”, according to the IFPMA. 

“In return for the permit, benefit-sharing in the form of a payment on the result from R&D is usually required.”

While this was meant to attach value to and protect biodiversity,  “there is a broad consensus among stakeholders interviewed by Covington that the transactional model of the Nagoya Protocol applied to pathogens is not logical, and undermines global health security”. 

A possible solution, it adds, would be to unlink “access” to pathogens from “benefits” derived from such access. This would “ensure rapid and free sharing of pathogen samples and sequence data, while addressing equity concerns separately”, it adds. 

“Coming on the heels of the COVID-19 pandemic and as negotiations commence on the so-called pandemic accord led by the WHO, our report demonstrates the need to secure free, rapid and unhindered access for scientists to pathogen samples and sequence data,” said Bart Van Vooren, who led the Covington team. 

‘Held hostage to deals’

“Currently, pathogens are being held hostage to deals on benefit-sharing through the Nagoya Protocol.  This represents a grave risk for humanity when the next pandemic hits,” he added.

The report provides examples of how ABS laws have blocked or delayed researchers’ access to pathogen samples of seasonal influenza, SARS-CoV-2, Zika, mpox, Japanese Encephalitis, Foot and Mouth Disease, Ebola, and African Swine Fever. 

It also shows that delays or refusals for pathogen-sharing have led to “sub-optimal vaccine composition, including lack of regional representativeness”; diagnostics that were not tailored or tested against original or new variants of pathogens and “skewed and non-representative epidemiology in genomic surveillance”.  

Thomas Cueni, Director General of IFPMA, said: “Investments in global health security, especially improved and expanded pathogen and disease surveillance, will not achieve the ultimate goal of protecting people and saving lives, if immediate and unfettered access to pathogens and their genetic information is constrained.”

Image Credits: Paul Owere/Twitter .

Smriti Zubin Irani, India’s Minister of Women and Child Development,

Diminishing democracy, growing nationalism, widening social inequality, growing climate-related crises and debt are part of the “unprecedented” trends of 2023, according to world leaders at the World Economic Forum (WEF) on Tuesday.

“Our generation has reached a turning point confronted by truly existential problems: climate change, exploitation of nature, nuclear possible incidents or even worse, extreme poverty and violence. They all can lead to the extinction of large parts of our global population,” warned WEF founder Klaus Schwab.

Swiss president Alain Berset warned that “extreme inequality undermines social cohesion, creates resentments, causing us to seek scapegoats and it is politically toxic, eating away at our faith in democracy”.

Only 20% of the world’s population lives in democracies, down from 50% 30 years ago, said Berset.

Inequality was exacerbated by climate change, the Ukraine war and the COVID-19 pandemic, added Berst, pointing out that 300 million people faced “acute risk of hunger”.

Investment in women’s health

 

UNFPA executive director Natalia Kanem

But investment in basic healthcare for women still offers one of the best returns on investment.

UNFPA executive director Natalia Kanem said that “there are still 300 million women who would want to access family planning that are knocking on the door of a clinic and nobody is there.

“We’ve seen the wisdom and the high return of almost $10 for every dollar you invest in family planning and maternal health,” Kanem added.

Smriti Zubin Irani, India’s Minister of Women and Child Development, said her government’s introduction of health insurance for the country’s poorest families had resulted in the “unprecedented number “ of 120 million Indian women being scanned for cervical and breast cancer.

Irani said that there is “a conscious effort on behalf of the government to ensure that the whole life cycle needs of a woman’s health are looked after by every government entity”.

After a 40-year wait, a Bill allowing abortion from 24 weeks “passed both houses of parliament without a whimper”, said Irani.

In addition, 703 emergency and crisis centres for women had helped 220 million women in distress, and “given them medical, psychological and police help so that they can transition from challenges towards solutions”. 

“When you invest in the health of a woman, you invest in the health of community. When you empower her financially, she tends to spend more on health and education.”

Bio-pharmaceutical company Organon is focusing on “femtech” solutions to address women’s health, said CEO Kevin Ali.

In the 18 months since it was listed on the New York stock exchange, Organon has “done eight deals’, said Ali. “Two are in the medical device space, one to solve the issues of postpartum haemorrhage, and one to solve some of the issues around minimally invasive hysterectomy,” said Ali.

His company is also investing in “new mechanisms of action for endometriosis, preterm labour and polycystic ovary syndrome”.

Nutrition and pregnancy

Mark Suzman, Gates Foundation CEO

“Nutrition is such a critical enabler for healthy pregnancies and healthy birth,” said Gates Foundation CEO Mark Suzman.

“An area where we are prioritising investment right now is treatments for anaemia, which is actually one of the most fundamental challenges facing women and particularly women in pregnancy.”

While a number of companies were researching the microbiome “to figure out how to do better weight loss”, the Gates Foundation was focusing on “what elements of treating the microbiome can actually be most important in the antenatal and postnatal period for women and children”, added Suzman.

“We were also able to do some research as a public good which showed the efficacy of a single dose of HPV vaccine [to prevent cervical cancer] was as good as multiple doses. That basically allowed you to vaccinate twice as many children,” he added.

The “cost-of-living crisis” and failure to mitigate climate change are the most acute global risks, according to the World Economic Forum (WEF) which opened in Davos, Switzerland, on Monday.

The forum’s risk assessment report 2023 released last week identifies a “polycrisis” of risks, most of which relate to environmental and societal issues, such as biodiversity loss, ecosystem collapse, and large-scale involuntary migration.

However, despite the prominence of environmental concerns, environmental activists have already called out WEF leaders for hypocrisy.

On Sunday, protestors blocked a number of private jets from landing at Davos airport – over 1000 jets are expected to bring the rich and powerful to the meeting, causing significant carbon emissions.

Protestors block private jets at Davos’s airport.

In addition, a social media campaign was also launched by climate activists Thunberg, Vanessa Nakate and Luisa Neubauer, demanding that energy company CEOs “immediately stop opening any new oil, gas, or coal extraction sites, and stop blocking the clean energy transition we all so urgently need” or face legal action and protests.

‘Tax the rich’

Meanwhile, Oxfam also called for new measures to tax the world’s super-rich, releasing research on the eve of the meeting showing that, since the COVID-19 pandemic started in 2020, the richest 1% had “grabbed nearly two-thirds of all new wealth” – almost twice as much money as the bottom 99% of the world’s population.

“A billionaire gained roughly $1.7 million for every $1 of new global wealth earned by a person in the bottom 90%,” according to Oxfam, which calculated that a tax of up to 5% on the world’s multi-millionaires and billionaires “could raise $1.7 trillion a year, enough to lift two billion people out of poverty”.

The WEF, the first in-person meeting of the annual event since 2020, was set up to promote public-private collaboration, and has become a marketplace for world leaders to promote investment in their countries and for businesses to court government support.

However, the annual risk assessment frankly acknowledges the dire economic conditions faced particularly by people in poorer countries thanks to the pandemic and Russia’s war in Ukraine.

Cost-of-living crisis

Based on interviews with key leaders, the cost-of-living crisis is ranked as the most severe global risk over the next two years.

“We have seen a return of ‘older’ risks – inflation, cost-of-living crises, trade wars, capital outflows from emerging markets, widespread social unrest, geopolitical confrontation and the spectre of nuclear warfare – which few of this generation’s business leaders and public policy-makers have experienced,” it warns. 

“These are being amplified by comparatively new developments in the global risks landscape, including unsustainable levels of debt, a new era of low growth, low global investment and de-globalization, a decline in human development after decades of progress, rapid and unconstrained development of dual-use (civilian and military) technologies, and the growing pressure of climate change impacts and ambitions in an ever-shrinking window for transition to a 1.5°C world.”

Taking all these factors into account, the WEF warns of a “unique, uncertain and turbulent decade” ahead.

Nine risks are featured in the top 10 rankings over both the short and the long term, including “geoeconomic confrontation” and “erosion of social cohesion and societal polarisation”, alongside “widespread cybercrime and cyber insecurity” and “large-scale involuntary migration”.

Health is the focus of a number of sessions of the forum, which runs midday on Friday These include sessions on pandemic preparedness, women’s health, tuberculosis and equity.

Electricity
One-eighth of the global population does not have access to health facilities with reliable electricity. The resulting treatment gaps threaten the health and lives of nearly one billion people around the world.

Nearly one billion people in low- and middle-income countries lack access to health facilities with reliable electricity, a joint report by the World Health Organization (WHO), World Bank, and International Renewable Energy Agency (IRENA) found.

Electricity is essential for the functioning of medical equipment like ventilators, incubators, and cold-chain storage for vaccines, as well as basic hospital needs like computers and air circulation systems required to keep them running smoothly. Without a steady supply of electricity, healthcare services like childbirth, emergency care, and vaccinations cannot be adequately provided.

Despite its importance, the electrification of healthcare infrastructure has long been overlooked, leaving one-eight of the global population in danger of not being able to reliably access the care they need. In total, over 430 million people are served by medical facilities without any electricity at all.

The report is the first to map electricity access in low- and middle-income countries worldwide, and revealed large gaps in electricity access in the world’s poorest countries. In South Asia and Sub-Saharan countries, only half of health facilities reported having reliable access to electricity, while 12-15%, or 25,000 facilities, reported having no electricity whatsoever.

“It is simply unacceptable that tens of thousands of clinics in rural areas of Asia, Africa, and Latin America are equipped with little more than kerosene lanterns and rapid diagnostic tests,” the report said. “The image of health care providers bent over a patient’s bedside, hand-holding his or her pulse under a fading kerosene lamp – needs to be relegated once and for all to the annals of history.”

$4.9 billion to bring facilities up to a minimal standard 

Energy Access in Health Facilities
Central and eastern Africa have the highest proportion of health facilities with no electricity access at all – 50% or more in some regions.

At least 912 million people across Latin America and the Caribbean, Middle East and North Africa, South Asia, and sub-Saharan Africa rely on medical facilities with no electricity access or an unreliable energy supply. An analysis by the World Bank included in the report found that nearly two-thirds of facilities across these regions are in need of urgent intervention to improve their access to reliable electricity. 

With over 100,000 facilities requiring new off-grid electrical connections and over 230,000 others needing a backup energy system, the World Bank estimates $4.9 billion will be required to bring them to a minimal standard of electrification. 

But the cost-estimate limits itself only to the most basic level of energy needs required to operate essential health services, set at 15 kilowatts per hour for clinics and 500 kilowatts per hour for hospitals, and does not reflect the same standard present in hospitals in rich countries. 

Expanding health clinics’ energy access to 32 kilowatts per hour, to allow for the provision of a broader range of healthcare services, also increases the price tag to $8.9 billion.

Importantly, the estimates also do not include costs related to the acquisition of new medical equipment. Electrification without a parallel investment in such equipment, the report found, would be an incomplete strategy, meaning the real amount of investment needed is higher than the figures set forth in the report.

 “This required amount is much lower than the social cost of inaction,” the report said.  

No need to “wait for the grid”

Sub-Saharan Africa and East and Pacific Asia, the two regions with the highest rates of non-electrified health facilities, are ideally situated to take advantage of advances in solar technology.

Centralised grid extension has long served as the go-to strategy for expanding energy access. But this approach often falls short when trying to reach rural and remote regions of low-income countries due to the distance the grid needs to expand to reach the populations living in their farthest reaches. 

Technological advances and price drops in renewables, especially solar, have triggered a rethink of the grid-based approach. Instead, the report found decentralized sustainable energy solutions are often “the most technically and economically viable solution” to reach people living in areas with challenging terrain for traditional infrastructural expansion.

In a presentation delivered at the report’s launch event, Dr Maria Neira, acting assistant-director general of Healthier Populations at the WHO, said there are “no excuses” for not making progress on increasing access to decentralized, sustainable energy sources given the availability and affordability of these technologies.

“No need to wait for the grid. IRENA has pointed out the role of centralized renewable energy to increase electricity access,” she said. “It’s cheap and more resilient to climate change. This is a major development priority as it saves lives.”

Decentralized approaches have the added benefit of allowing healthcare facilities to be energy independent, insulating them from the risks of fuel shortages or price shocks inherent to a reliance on fuel generators. The higher reliability of renewable energy solutions, in turn, means higher uptime for life saving medical equipment, and essentials like clean water access, particularly in regions vulnerable to water insecurity or extreme weather events. 

“Solutions are available and rapidly deployable,” the report added. “The impact on saving lives and improving the health of vulnerable populations would be huge.”

Electricity access is a story of inequalities

Stark inequalities in accessing reliable electricity in healthcare facilities emerge when comparing different countries based on income, facility type, and location.

Generally, facilities in low-income countries have less access to reliable electricity than those in lower-middle-income countries. Sub-Saharan Africa and South Asia have the lowest rates of electrification, followed by the Pacific and East Asia regions. 

Low rates of medical facility electrification are often symptoms of a wider lack of development of energy infrastructure. In South Sudan, for example, overall energy access – let alone that for medical facilities – was estimated at just 7.24% nationally. 

Disparities in access to electricity are also pronounced within countries. Non-hospital healthcare facilities, like primary health centers, which often serve poorer regions due to their lower operating costs, tend to have less access to reliable electricity supplies than hospitals. A divide can also be seen between urban and rural areas, with urban healthcare facilities reporting better access to than rural facilities in the same country. 

Until the electrification gap can be bridged, one eighth of the world’s population, equal to the populations of the United States, Pakistan, Indonesia and Germany combined, remain in a medical no man’s land. 

“Electricity access in healthcare facilities can make the difference between life and death,” Neira said.

Image Credits: WHO, World Bank.

A patient sits outside Lok Nayak Jai Prakash Narayan Hospital in New Delhi, which was one of India’s largest COVID treatment facilities.

Most long COVID symptoms are resolved within a year of diagnosis, according to the results of a retrospective Israeli  study published last week in the peer-reviewed BMJ medical journal. 

“Our study suggests that mild COVID-19 patients are at risk for a small number of health outcomes and most of them are resolved within a year from diagnosis,” according to researchers.

The clinical definition of long COVID is still evolving. So far, it has been defined as persistent symptoms or appearance of new symptoms beyond four weeks from the diagnosis of COVID-19, which cannot be attributed to another condition.

More than two million people in the United Kingdom are living with long COVID, according to various studies published over the summer. Similarly, a report by the US Centers for Disease Control and Prevention showed in June that more than 40% of US adults have COVID-19 and one in five of those (19%) had long COVID symptoms. 

Long COVID symptoms can vary from loss of smell and taste, concentration and memory impairment and breathing difficulties to weakness, palpitations, streptococcal tonsillitis and dizziness.

The main objective of the Israeli study was to compare the long-term incidence of long COVID symptoms between uninfected people and people who were diagnosed with mild cases of the virus. To do so, the Israeli team analyzed electronic health records from the database of the country’s second-largest health fund, Maccabi Healthcare Services

Difficulty breathing

Some 299,885 members with complete data were eligible for the study, all of who had tested positive for COVID-19 between 1 March 2020 and 1 October 2021 but had not been hospitalized within 30 days of diagnosis. The eligible cohort was matched with 299,870 similar people who tested negative.

Potentially influential factors, such as alcohol intake, smoking status, socioeconomic level and a range of pre-existing chronic conditions were also taken into account.

Because of the study time period, the results covered all of the earliest COVID-19 waves, including the Delta wave, but did not include patients diagnosed with the Omicron variant. 

Over 70 long COVID conditions were analysed, comparing these during early (30-180 days) and late (180-360 days) time periods after infection. Conditions in vaccinated versus unvaccinated people with COVID-19 were also compared over the same time periods.

Chest pain, cough, hair loss, muscle and joint pain and respiratory disorders were significantly increased only during the early phase, the research showed. In contrast, brain fog, breathing problems, dizziness and weakness, heart palpitations, loss of smell and taste and strep throat remained risks in both the early and late time periods.

However, even for most of these symptoms, the risk difference between the people who tested positive for the virus and those who did not was less dramatic in the second six months of follow-up.

Difficulty with breathing was the most common complaint. The study found that vaccinated people were at lower risk of breathing difficulties compared with unvaccinated people.

In general, children had fewer long COVID symptoms than adults and recovered from most of them well within a year.

A separate study published by the UK Office of National Statistic in January found that around one-third (30%) of people who self-reported long COVID symptoms as of December 2022 reported experiencing symptoms for at least two years.

Nonetheless, “these findings suggest that, although the long COVID phenomenon has been feared and discussed since the beginning of the pandemic, the vast majority of mild disease cases do not suffer serious or chronic long-term illness,” the researchers said.

Image Credits: Flickr.

The World Health Organization (WHO) has called for stricter masking policies and reduced isolation time recommendations for people with COVID-19 isolation, the organization announced on Friday.

Patients who test positive for COVID-19 but do not have signs or symptoms are now recommended to isolate for five days in the absence of testing, WHO suggested – compared to the 10 days it previously recommended.

“Patients without symptoms are much less likely to transmit the virus than those with symptoms,” WHO said.

The organization advises that COVID-19 patients who test negative on an antigen-based rapid test may leave isolation early. People who have symptoms but do not test should isolate for 10 days from the date of symptom onset. This is an update from WHO’s previous recommendation that these individuals isolate for at least three additional days after their symptoms have been resolved.

In contrast, WHO has called for stricter masking policies, recommending the use of masks irrespective of the local epidemiological situation.

“Masks are recommended following a recent exposure to COVID-19, when someone has or suspects they have COVID-19, when someone is at high-risk of severe COVID-19, and for anyone in a crowded, enclosed or poorly ventilated space,” WHO wrote in a release.

At the same time, WHO did say there are instances when masks might be suggested based on a high-level of risk, such as being in a place with increased infection and hospitalization levels or lower levels of vaccination.

Finally, WHO stressed that it recommends the use of Pfizer’s Paxlovid or its generic equivalent, Hetero’s COVID-19 oral drug Nirmacom, for patients with mild or moderate COVID-19 who are at risk of developing severe disease or being hospitalized.

It does not recommend two other treatments – sotrovimab and casirivimab-imdevimab – because these monoclonal antibody medicines “lack or have diminished activity against the current circulating virus variants.”

Image Credits: Flickr/Nicolò Lazzati, IPPR.

Uganda’s Health Minister, Jane Ruth Aceng

There is no clear path to test the three candidate vaccines developed to combat the Ebola Sudan strain now that Uganda’s outbreak is over.

The three candidate vaccines – produced by IAVI (called SUDV), Sabin (ChAD3) and Oxford (ChAdOx1) – were delivered to Uganda with much fanfare in mid-December. But scientists attending a meeting convened by the World Health Organization (WHO) on Thursday could not agree on how to test them now, and discussed options including regulatory approval based on animal-only studies and “immunobridging”.

Candidate vaccines for Ebolavirus Sudan.

So far, only one vaccine, BioThrax, developed to protect against anthrax, has been given US Food and Drug Administration approval based solely on animal studies

BioThrax had already been licensed in the 1970s to prevent anthrax inhalation but received a futher FDA approval as post-exposure prophylaxis for anthrax exposure in 2015, based on the FDA’s Animal Rule.  

Under the Animal Rule, efficacy is established based on “adequate and well-controlled studies in animal models of the human disease or condition of interest, and safety is evaluated under the pre-existing requirements for drugs and biological products”, according to the FDA.

‘Immunobridging’

There was much discussion about the possibility of immunobridging, an approach that allows scientists to infer a vaccine’s effectiveness to conditions other than those proven in a clinical trial. It has been used during COVID-19 to approach vaccines for different demographic and age groups.

It can also be used to change dose levels and formulation. In some cases, conclusions from animal trials have been extrapolated to humans – including to approve Ebola vaccines and treatment.

 

Given how lethal Ebola is, the WHO’s Ana Maria Hanao-Restrepo asked participants whether anything could be done with the thousands of doses of the three candidate vaccines currently in Uganda in order to prepare for the next outbreak.

More non-human primate efficacy data, testing the effects of one vaccine dose or two, which vaccine gave rapid protection and which gave long-term protection, and whether efficacy was affected by malaria were some responses.

CEPI’s Bill Dowling said that while efficacy studies in mice and guinea pigs were “not very applicable”, non-human primate studies, particularly in cynomolgus macaques, were similar to human progression and had been used extensively for Ebolavirus Zaire studies.

But having the assays in place to support trials was missing, said Dowling, including reagents for Sudan virus.

Dowling also noted that certain correlates of protection established during trials of the vaccine for Ebolavirus Zaire might be applicable to Sudan.

WHO’s Ana Maria Henao-Restrepo

Pathways to regulatory approval

Several pathways are open to regulatory approval for a vaccine for Sudan, Dowling added.

These include an accelerated approval pathway where efficacy is based on a surrogate endpoint likely to predict clinical benefit, conditional approval, where the benefit of the vaccine’s immediate availability to patients is deemed greater than the risk and an exceptional circumstances pathway, where it is recognised that the sponsor is unable to provide certain data.

“The US animal rule is very stringent, and does not apply if approval can be based on an efficacy standard elsewhere in FDA regulations,” said Dowling, and that it usually entailed “a large number of studies with a large number of animals, and was quite a lengthy process”.


Infectious disease expert Nancy Sullivan, director of Boston University’s National Emerging Infectious Diseases Laboratories, “efficacy data have to be generated in humans”.

“We have to be careful about trying to compare vaccines based on immunogenicity. I think we need those efficacy results and if it requires doing it over multiple trials, we should,” stressed Sullivan.

The University of Marburg’s Stephan Becker agreed: “The most important thing is really the efficacy trials that we can bring up very rapidly during an outbreak.

“Maybe this discussion about immunobridging studies does not help in a situation such as the Sudan Ebola outbreak,” he added. “I think it’s much more important to have all the vaccines ready to go at the beginning of an outbreak. These immunobridging studies are interesting to perform, but in essence, I think we need the efficacy trials.”

Erica Saphire from the La Jolla Institute agreed that “we don’t know a magic number that we need to hit in terms of binding antibody or neutralising antibody to know somebody will or will not be protected [against Sudan]. 

“But we do have the ability to generate useful and informative data on human samples and non-human samples in the meantime so that we have that at the ready for when we do need to deploy a Sudan vaccine during an outbreak,” she added.

Immediate vaccination?

Former FDA official Philip Krause challenged Sullivan and Becker: “If we’re saying the only way to evaluate these vaccines is efficacy trial, that means that a certain number of people are going to receive delayed vaccination versus immediate vaccination. And of course, everybody would rather have immediate vaccination [in an outbreak].”

If it was “reasonably likely” that a vaccine was efficacious, regulators could allow all trialists to get immediate vaccination, he added.

But Sullivan and Becker were convinced that immunobridging could assist to determine efficacy as the different vaccines behave so differently.

Given the lack of clarity and consensus about the way forward, the WHO is conducting further discussions with scientists and collaborators.

Genomic Surveillance
Lineage tree of Sars-CoV-2 strains according to genomic sequencing data.

British scientists have launched a new initiative to expand the sequencing of common seasonal respiratory viruses with the aim of developing an early warning system for new viral threats and help prevent future pandemics.  

At the height of the COVID-19 pandemic, labs around the world were sequencing tens of thousands of Sars-CoV-2 genomes a day. The data being shared from around the world allowed health authorities to keep pace with the evolution of the virus responsible for causing COVID-19, and identify where the next threat was coming from. 

The Respiratory Virus and Microbiome Initiative launched on Tuesday by researchers at the Wellcome Sanger Institute aims to build on these lessons. The project, run in collaboration with the UK Health Security Agency and other scientists, will track and sequence the evolution of respiratory virus pathogens like SARS-Cov-2, as well as other coronaviruses, flu families, and respiratory syncytial viruses (RSV) in order to establish a what it calls a “large-scale genomic surveillance system for respiratory viruses.” 

“It comes out of the simple idea that what we’ve done for Covid, we should now be doing for all respiratory viruses because if we can establish a better understanding of these viruses, we can be in a better place to understand their transmission and how to develop vaccines against them,” Dr Ewan Harrison, who is leading the initiative, told the Guardian.

Viral genome sequencing expanded significantly during the pandemic. The public release of the Sars-CoV-2 sequence by Chinese scientists in January 2020 allowed the world to start developing diagnostics and vaccines within days, saving millions of lives. To date, scientists have shared millions of Sars-CoV-2 sequences on public databases.

Influenza has attracted a lot of research interest over the years. However, many other respiratory bugs, like rhinovirus or adenovirus, are poorly monitored, leading to a gap in scientific understanding of their transmission dynamics.  By providing large amounts of data for academics and public health officials to use in their work, the program hopes to “supercharge” research efforts to fill these blind spots and improve scientific understanding of the particular characteristics of individual strains that make up respiratory virus families.

“Understanding which specific strains of each virus is causing disease in patients, and if there are multiple strains or multiple viruses present at any one time will hugely change our understanding of how viruses lead to disease, which viruses tend to coexist, and the severity of disease caused by each virus,” said Dr Catherine Hyams, an expert in respiratory viruses at the University of Bristol.

If the program succeeds, it could provide a blueprint for other countries to implement as part of their pandemic preparedness strategies – and become a cornerstone of global defenses against viral threats in the future.

Image Credits: MinMaj.

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WHO’s director-general Dr Tedros Adhanom Ghebreyesus.

The World Health Organization (WHO) has called for more data on China’s COVID-19 situation to better understand the transmission dynamics of the virus on the ground and  flagged China’s under-reporting of COVID-related deaths. 

“There are some very important information gaps that we are working with China to fill. First and foremost is to have a really deeper understanding of the transmission dynamics of Covid across the country,” Dr Maria van Kerkhove, WHO’s COVID-19 technical lead, told a media briefing on Wednesday.

She added that the WHO has an open communication channel with the Chinese authorities and has offered technical advisory support to the country’s authorities. 

China’s management of COVID-19has been a cause for increased global concern in the recent past. Since the country lifted its ‘zero-COVID’ measures in December 2022, it has seen an unprecedented surge in infections and deaths.   

China recently narrowed its definition of COVID-related death to indicate only those with a positive COVID test and died of respiratory failure or pneumonia. By definition, this excludes deaths caused due to underlying conditions worsened by Covid-19. 

WHO’s Director-General, Dr Tedros Adhanom Ghebreyesus, told the briefing that the number of COVID-19 deaths across the world has remained constant at between 10,000 and 14,000 per week since mid-September.

Describing these deaths as “unacceptable” since there are tools to prevent it, Tedros added that “this number is almost certainly an underestimate given the underreporting of COVID-related death in China”.

Need for more sequencing

Recalling that the first gene sequence of SARS-CoV2 had been shared with the world three years ago, Tedros stated that the number of sequences that are being shared globally has decreased by more than 90% since the peak of the Omicron infection, while the number of countries sharing sequences has fallen by a third.  

“It’s understandable that countries cannot maintain the same levels of testing and sequencing they had during the Omicron peak. At the same time, the world cannot close its eyes and hope this virus will go away.”

He added that only 53 out of 194 countries provide data on Covid-19 deaths that are disaggregated by age and sex.

Since the early days of the pandemic, China has been accused of downplaying the number of COVID-19 infections and deaths. As of 12 January, China has reported a little over 17,000 deaths.

Dr Maria van Kherkhove, WHO’s Covid-19 technical lead.

The data from China will help WHO understand the breakdown, increases and decreases in the hospitalisations, ICU capacity and COVID-related deaths in urban and rural areas across the provinces in China, Van Kerkhove explained. 

While underlining that the agency has received some sequencing information from China, Van Kerkhove said that further information is necessary. “We have requested further information to have those sequences be shared publicly so that a deeper analysis and more phylogenetic analysis can be done so that we could look mutation by mutation to really assess what is circulating there.”

Reiterating that WHO believes that the “deaths are heavily underreported from China”, Dr Mike Ryan, executive director of health emergencies at WHO, said that the agency does not have enough information to do a comprehensive risk assessment. 

“We will continue to try to encourage access to that data but also recognize in the same breath that China has done a lot in the last number of weeks,” Ryan said, acknowledging the country’s efforts to strengthen its own internal capacities like increasing the number of hospitals, ICU beds and fever clinics, and prioritising vulnerable groups in treatment and using antivirals early in the course of the infection. 

Urging countries to maintain higher levels of sequencing and data sharing, Van Kerkhove said that this would greatly help WHO’s risk assessments.

“We need to maintain surveillance. We need to maintain sequencing and sharing of sequences from around the world so that risk assessments can take place, and we can ensure that any changes to our response, any changes to our advice is done in a timely manner.” 

Image Credits: Screengrab from Wednesday's presser. .