The debate around technology transfer is proving to be critical in addressing shortages in the production of vaccines. We wanted to know from developing country manufacturers on the challenges they face in making vaccines for COVID-19. Geneva Health Files brings you an interview with Abdul Muktadir, Chairman and Managing Director of the Dhaka-based company Incepta Pharmaceuticals Limited.

Established in 1999, Incepta specialises in biosimilars and vaccines, employing nearly 10,000 people and producing about 1000 different medicines and vaccines – including oral cholera vaccines, vaccines for influenza, measles, rubella, and Hepatitis B. Incepta exports to 67 countries across the world, has 3 manufacturing sites, and 17 factories and research facilities.

Geneva Health Files (GHF): What, according to you, are the real impediments for technology transfer in the process of production of vaccines in the developing world? 

Abdul Muktadir (AM): The innovator companies are preoccupied with the supply commitments to the governments from which they have taken advance payment. They have successfully transferred the technology to all the Contract Research Organizations (CROs) so the technical difficulties that are often referred to may not be a big impediment. The innovator companies are at ease working within their comfort zone and do not want to deal with unknown companies.

This is the real barrier that the innovator companies do not feel comfortable working with many companies from the developing world.

Abdul Muktadir, an industrial pharmacist by training, who is Chairman & Managing Director for Incepta Pharmaceuticals Limited

GHF: In policy debates in Geneva, developed countries argue that intellectual property has not been a barrier for the production of vaccines. What are your thoughts on this? 

AM:  In the current context, the IP right is not the impediment as the companies from the developing world would act either as a CRO or as a license holder. The innovator companies should utilize as many manufacturing bases as possible and then increase their production. In this case there is no issue of IP violation.  

GHF: It has also been argued that developing country manufacturers may not have the skills and equipment to engage in technology transfer. What are your views on the expertise and manufacturing capacities in the developing world?

AM: There are several technological platforms for production of currently approved COVID-19 vaccines, and for each platform there are differences in upstream and downstream processes. The vaccine manufacturing is not very widely distributed but the companies that manufacture vaccines – they understand the process fairly well.

So, the capacity and expertise are available with the manufacturers of the developing world – otherwise Serum Institute and other Indian manufacturers would have faced difficulties. The equipment might require some re-tooling to accommodate the new process but certainly it is possible. 

GHF: As a developing country manufacturer, what in your view is a preferred way for technology transfer: non-exclusive licensing or bilateral arrangements? And why?

AM: Here, the primary objective is to increase the volume of production. My argument is: if a company can deliver 1 billion doses a year then we should try to increase that capacity to 4 billion using the same principle. No company was prepared to deliver 1 billion doses a year, but the companies are doing this now. The task of manufacturing should be distributed based on the capability of each manufacturing partner.

The best way should be to mass manufacture antigen [vaccine active ingredient] bulk in a few places and then the antigen could be distributed for fill/finish wherever the capacity is available. 

We are referring to any licensed Covid-19 vaccine such as Moderna, Pfizer, Astrazeneca, Johnson & Johnson. If we receive the active bulk ingredient, we have the capacity to fill and finish.

This way we can involve many companies in many different countries. This would also eliminate impediments on cross border transportation. We observe now that most of the manufacturing countries are putting barriers in previously agreed supply commitments. 

The above process would involve both non-exclusive licensing and bi-lateral arrangements. We can avoid non-exclusive licencing if the innovator company can make the agreements through multi-party contract manufacturing. In such a case the technology transfer requirement would be as per the requirement of each task. If the bulk antigen can be produced in a few places then the requirement of tech transfer would be very minimal, and the innovator company’s technology can remain very well guarded.

The current technology of manufacturing the COVID-19 vaccine is probably known to many vaccine companies, including companies from the developing world like ours. The biggest challenge in introducing a new vaccine is to successfully conduct an efficacious clinical trial and this remains the main barrier for a new vaccine. So, our best option would be to manufacture the already-approved vaccines on a massive scale and provide them fair reward for their innovation.

GHF: Can you share specific details on your operations in Bangladesh in terms of capacity for technology transfer? What would be the easiest vaccines to produce and what are the potential areas for improvements in your manufacturing plants?

Incepta Pharmaceuticals has full-scale vaccine manufacturing facilities – including antigen production lines, bioreactors, and fill-and-finish capacity.

AM: We have full-scale vaccine and biosimilar manufacturing facilities. We can manufacture bulk antigen using almost all technology platforms. 

We have the bulk antigen production facilities which could be utilized to adapt almost all technology platforms (e.g. mRNA, DNA, adenoviral & insect/baculoviral etc ) available for COVID-19 vaccine. 

For example, we have developed a meningococcal polysaccharide subunit vaccine (ACYW135), hepatitis B sub-unit vaccine (VLP based), and whole cell oral cholera vaccine from our own bulk, and obtained licensure for these vaccines in Bangladesh. Moreover, a cell culture-derived rabies vaccine that we developed is in a clinical trial now. A pre-clinical study for typhoid conjugate vaccine is on-going. In addition, we have more vaccines in the pipelines.

Depending on a particular process we have to re-tool the facility to accommodate the manufacturing of a new vaccine. Once we have a process in hand, then we would know the extent of re-tooling requirements. Once the facility is ready then we have to optimize the manufacturing process and it requires some time.

For us the easiest COVID vaccine technologies  would be the protein subunit vaccines [such as the one produced by Novavax] and mRNA vaccines [such as those produced by Pfizer/BioNTech and Moderna]. We would also be able to manufacture adenovirus vaccines.

We have the bulk antigen production facilities which could be used to adapt technology related to mRNA vaccines and protein subunit vaccines for COVID-19. 

We have a 500L bioreactor which could be used to produce insect cells/baculovirus based protein sub-unit vaccines like the one from Novavax. 

At the moment, we have a licensed protein sub-unit vaccine for hepatitis B which we developed using the yeast technology platform. 

If we have access to mRNA technology, we believe we can easily adapt this technology. We have all the reactors and purification tools required for mRNA vaccine production.

If we get the antigen then the production can start immediately, as we have two and a half production lines sitting idle. In one line we can handle multiple dose vials, and with 20 doses a vial, we can deliver about 500 million doses a year. If we re-tool the other two lines for larger, multiple vial capability then we would be able to deliver another 600 million doses. But this would require a lead time for the supply of tools from machine manufacturers, and this may require a lead time of 6-8 months. But we now have one line fully ready to deliver about 500 million doses a year in multiple dose vials (the lines we have are suitable to fill any type of vaccine).

At the moment we don’t have any deals with any innovators.

Priti Patnaik is the founding editor of Geneva Health Files – a reporting initiative that tracks power and politics in global health. This interview is a part of a series under a collaboration arrangement between Geneva Health Files and Health Policy Watch.

Image Credits: Incepta.

Dr. Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Thursday.

The World Health Organization (WHO) is hopeful that all healthcare workers can be vaccinated by mid-April, but the clock is ticking away, leaving rich countries only nine days to donate surplus COVID-19 vaccines to the global COVAX facility – which has run out of doses at a crucial time.

So far, the WHO has not received any donations since it called on countries last week to donate surplus doses they have accumulated, said Dr. Tedros Adhanom Ghebreyesus at a press conference on Thursday. 

“Last week, I made an urgent request to countries with surplus vaccines that have WHO emergency use listings to share 10 million doses with COVAX,” said Dr. Tedros. “This challenge has been heard, but we’re yet to receive commitments for those. I’m still hopeful that some forward looking and enlightened leaders will step up.”

COVAX Facing “Serious Challenges” 

Although the global COVAX facility has already delivered 35 million doses to more than 78 countries across the globe, it is facing “serious” shortfalls in doses – mainly because of India’s recent move to halt vaccine exports to the rest of the world as it attempts to fend off an outbreak that has grown to some 70,000 cases a day from only 15,000 since early March – an increase in cases by a factor of four in just a month. 

Despite the WHO’s call on rich countries and vaccine manufacturers to donate surplus vaccine doses last week, a whopping 100 countries still lack adequate access to vaccines, said Turkey’s Health Minister Fahrettin Koca, who also spoke at the press conference. Of those, two dozen countries that have signed up to the WHO co-sponsored COVAX initiative are ready to begin vaccinating healthcare workers – but they lack the supplies to begin before the 100th day of 2021 – the target date WHO had said for vaccine campaigns to start everywhere in the world. These include Cameroon, Haiti, Congo, Burkina Faso, Niger, Vanuatu, Papua New Guinea, Kyrgyzstan, the Dominican Republic and Mauritania, among others. 

“I know this is a challenging time for many countries as cases and hospitalization are spiking, but conversely, it’s when cases are spiking that it’s the most important time to share vaccines equitably and protect our workers, and at-risk communities,” Dr Tedros said.

Going forward, the concerning gaps in equity “could be addressed” by increasing local and regional vaccine production capacity and by moving forward on the intellectual property waiver spearheaded by South Africa and India, said the WHO Director General. 

“I think we should be able to produce vaccines everywhere, all over the world without intellectual property rights being a problem,” added Koca. “So that’s why I think we need to be taking concrete steps about this issue.”

Turkish Health Minister Fahrettin Koca at the press briefing on Thursday.

Turkey Announces Digital Platform To Commemorate Healthcare Workers

Meanwhile, in celebration of the International Year of Health and Care Workers, Koca announced the creation of a digital platform to tell the stories of the heroic and essential work carried out by healthcare workers since the pandemic began. The platform will be run in collaboration with WHO. 

“The whole of humanity is grateful to you right now,” said Koka. “[Your] stories need to be told in the common language of humanity. For this purpose, as a first step, we are working on creating a digital platform with WHO, to serve as a memorial dedicated to health and care workers.”

Since the start of the pandemic, millions of healthcare workers have been infected with the coronavirus and thousands have died. Those that have survived are struggling with a range of mental health issues, including heightened stress, anxiety, depression, insomnia, and exhaustion. 

That toll, said Dr Tedros, has been far too great – but it can be reversed by strengthening the capacity of the healthcare workforce, improving salaries, and ensuring healthcare workers are equipped with adequate personal protective equipment so they can do their job safely and effectively. 

“Far too many health and care workers have died in the pandemic,” he said. “As we work to end the pandemic and recover together….We must ensure that they are trained, protected, and supported to do their job safely and effectively.”

Image Credits: Our World In Data, WHO.

A man with symptoms of the deadly NTD African trypanosomiasis (sleeping sickness), is examined by Dr Victor Kande in the Democratic Republic of Congo (DRC). Kande was principle investigator for clinical trials of fexinidazole, the first oral sleeping sickness treatment approved by the European Medicines Agency (EMA) in 2018. Developed by DNDi, it is being rolled out in  DRC.

Global health experts expressed their frustration with the lack of research and attention towards neglected tropical diseases (NTDs) and vulnerable populations, calling for health systems to address NTDs in a more sustainable and holistic way.

Speaking at the launch of a new strategic plan for the Geneva-based Drugs for Neglected Diseases initiative (DNDi) on Tuesday, DNDi Executive Director Bernard Pécoul said greater emphasis should be placed on expanding access and developing treatments for patients in low- and middle-income countries (LMICs) affected by neglected tropical diseases (NTDs), as well as neglected viral diseases like HIV/AIDS, and also pandemic-prone and climate-sensitive diseases.

“Treatments were abandoned for years or decades because they fell outside commercial markets,” said Pécoul, at the launch of the plan that charters an eight-year journey to 2028, aiming to deliver 15 – 18 additional treatments, in addition to eight already developed, for a total of 25 new or improved, and highly effective, NTD treatments. 

“The frustration is where the idea was born – from the experience of humanitarian doctors, frustrated, while treating patients with vaccines that were ineffective, unsafe, or unaffordable, or never developed at all because the research and development was abandoned,” Pecoul added, speaking of his own experience in the past working with Medecins Sans Frontieres (MSF). 

DNDi, a WHO-supported organization of private and public sector actors, has committed to five strategic imperatives for the next eight-years: to deliver new treatments and expand access for neglected patients of NTDs and related viral diseases; join with public health leaders and Research and Development (R&D) stakeholders in low- and middle-income countries to advance sustainable health systems; contribute to building a proactive agenda for maternal, child health, and gender-responsive R&D; champion open science and transparency; and leverage new technologies to accelerate R&D. 

“It is our hope that we will identify safe, effective, and affordable medicines to help countries fight the health and social burden put on them by COVID-19. While all global attention is focused on development and purchase of COVID-19 vaccines, we should not forget about treatment and diagnostics,” said Marie-Paule Kieny, Director of Research, INSERM and DNDi Board Chair, at the Tuesday DNDi launch.

Challenging The Status Quo

DNDi
DNDi’s Strategic Plan launch event panel: clockwise: Patricia Amira, moderator; Dr Somya Swaminathan; Dr Marie-Paule Kieny; Dr Jeremy Farrar; Dr Bernard Pecoul; Dr Berhards Ogutu

Also appearing at the event, Jeremy Farrar, director of the Wellcome Trust. also expressed frustration with the ‘status quo’ that has defined R&D for global health, and called for more attention to be brought to three areas that would ‘define the 21st century’ – neglected and infectious disease, climate change, and mental health. 

“These three things are going to define our time – which have a focus on youth, and which have an inequitable impact on societies around the world. [DNDi is committed to] not just doing the science, but making sure that science is shared equally with everybody in the world,” he said. 

Over the next decade, DNDi will work to accelerate sustainable disease elimination in diseases with existing treatments, such as sleeping sickness and Chagas disease, and increase access to lifesaving and safer treatments for HIV and leishmaniasis. 

DNDi –  founded in  2003 to discover, develop, and deliver safe, effective, and affordable treatments for neglected and marginalized patients –  will also work with leaders and institutions in LMICs to bolster research capacity and generate more sustainable production and supply of NTD treatments. 

The initiative has grown into a network of over 200 partner institutions, and has so far delivered eight new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, and malaria.  

Clinical Trials for Mild COVID Cases Launching in 13 African Countries

Africa launches largest COVID clinical trial

COVID-19 has highlighted the need to prioritize and finance research in LMICs, as well as government preparedness to ensure both transparency and equitable access.  

In addition to working on NTDs and viral illnesses, DNDi will also address unmet medical needs, utilizing its ‘dynamic portfolio’ approach to explore new interventions in diseases with clear R&D gaps, including snakebite, dengue fever, schistosomiasis, and pandemic-prone diseases. 

At the start of the strategic planning period, DNDi also is coordinating ANTICOV – the largest African-led clinical trial testing for mild-to-moderate COVID-19. 

The ANTICOV platform  deals with the outpatient population, which is the majority of people with COVID, and is trying to answer the question of how to treat people to prevent them from getting ill and needing hospitalization, said Dr Soumya Swaminathan,  WHO Chief Scientist.

Carried out by a group of 26 prominent African and global R&D organizations in 13 countries, ANTICOV will simultaneously test and adjust treatments for COVID-19, and identify new treatments, fast-tracking research for patients and health systems in resource-limited settings. 

Swaminathan said that the high costs of the COVID-19 pandemic should not come at the expense of cutting or reducing budgets for NTDs, saying that the ‘collaborative science’ seen over the past year as proof that knowledge could be shared openly and freely. 

“Because of this vision, and the collective mission to solve the problem of COVID and develop new tools, it is possible to [share knowledge more widely].”

Though DNDi is primarily focused on R&D, the organization will also identify gaps in access to care, and build the partnerships needed to overcome them, laying the groundwork for more affordable care.  

Said Swaminathan: “When there’s a new technology, which can make a big impact, especially when it’s related to health and disease, it should be considered a global public good, and be made available to people who need it, regardless of their ability to pay.”

Image Credits: DNDi, DNDi, ClimateWed/Twitter.

A patient getting tested for COVID-19 at the Paris Charles de Gaulle Airport in January 2021. French President Emmanuel Macron imposed strict lockdown measures amid of surge of new coronavirus cases.

France is going into its third national lockdown since the start of the COVID-19 pandemic, after a deadly third wave hit Europe, causing soaring infection and death rates. With an average of more than 37,000 daily new cases over the past week, tougher restrictions have become inevitable. 

French President Emmanuel Macron announced the new restrictions in a televised address on Wednesday, saying that the government had waited “until the last moment” to impose the latest lockdown. 

The daily death toll reached 355 on Wednesday and health authorities recorded 569 new intensive care patients in 24 hours on Tuesday, the highest since April 2020. Over 5,000 COVID-19 patients are currently in intensive care units.

Infections have doubled since February, likely due to the spread of the more transmissible B.1.1.7 SARS-CoV2 variant, first detected in the United Kingdom. France “risks losing control” without strict measures, said Macron. 

France is approaching the grim milestone of 100,000 total COVID deaths, with 95,798 deaths recorded as of Wednesday. 

Lockdown Measures Put in Place

Lockdown restrictions include classes being taught remotely for the next three weeks, non-essential businesses will be closed, and travel within the country will be banned for a month after the Easter weekend (2-4 April). Residents will be limited to a 10 kilometer radius from their homes and will be subject to a curfew between 7pm and 6am. 

“We must limit all contact as much as we can, including family gatherings. We know now: these are where the virus spreads,” said Macron. 

Some 3,000 additional intensive care beds will be added to hospitals in the hardest-hit regions in an attempt to prevent health systems from becoming overwhelmed. 

The national lockdown will begin on Saturday and will last four weeks.

Emmanuel Macron, the French President, in a televised address on Wednesday announcing the country’s third COVID-19 lockdown.

Over a dozen regions were put under partial lockdown in early March with night-time curfews. The regional restrictions avoided closing schools or stores in an effort to keep the economy open. 

The existing restrictions at the regional level, which were implemented in early March in an attempt to avoid stricter measures, were unable to curb the spread of the virus. Macron was hesitant to impose nationwide restrictions, resisting calls from experts for tougher measures since January.  

“The outlook is worse than frightening. We’re already at the level of the second wave, and we’re quickly getting close to the threshold of the first wave,” said Jean-Michel Constantin, head of the intensive care unit at the Pitié-Salpêtrière hospital in Paris, in an interview on RMC radio on Monday. 

According to the French Health Minister, Olivier Veran, France could reach the peak of the epidemic in seven to 10 days, “then we need two extra weeks to reach a peak in intensive care units (ICUs) that could occur at the end of April,” he told Inter radio on Thursday.

“We have endured a year of suffering and sacrifice, but if we stay united and organized, we will reach the end of the tunnel,” said Macron. “April will be a critical month.” 

France’s vaccination campaign is seen as the path out of the pandemic and will be accelerated in the coming weeks, according to Macron. France, along with the rest of the European Union, was plagued by a slow rollout of vaccines due both to shortages as well as a lack of a well-coordinated health sector response in many countries, with systems that are either highly fragmented or else too centralized to permit for smooth and efficient rollouts at the local level.   

WHO Calls Europe’s Vaccination Program “Unacceptably Slow”

Amidst rising infection and death rates in the WHO European region, which encompasses 53 countries, the region’s vaccine “rollout is unacceptably slow,” said Hans Kluge, the WHO Regional Director for Europe, in a statement released on Wednesday.

Europe has recorded 1.6 million new cases and close to 24,000 deaths in the last week, quickly nearing one million total deaths. It is the second most affected region by SARS-CoV2 in the world. The B.1.1.7 variant has a greater public health impact and requires numerous measures in place to control it, said the statement. 

Currently, 27 countries in Europe are under partial or nationwide lockdown and 23 have tightened restrictions over the past two weeks. However, some 13 countries have ease measures and nine plan to follow suit. 

“My message to governments in the region is…that now is not the time to relax measures. We can’t afford not to heed the danger,” said Kluge. “We must keep reining in the virus.”

Hans Kluge, WHO Regional Director for Europe.

“Vaccines present our best way out of this pandemic,” Kluge said. However, “as long as coverage remains low, we need to apply the same public health and social measures as we have in the past to compensate for delayed schedules.”

In addition to implementing public health measures to limit transmission, efforts must be made to scale up vaccine production and administer as many jabs as possible, as quickly as possible. 

“We must speed up the process by ramping up manufacturing, reducing barriers to administering vaccines, and using every single vial we have in stock, now,” said Kluge. 

Only 10% of the region’s population have received one dose of a COVID-19 vaccine. While there has been a shortage of vaccines, countries must avoid vaccine nationalism and hoarding supplies, the statement said. 

Once a nation’s healthcare workers and vulnerable individuals have been vaccinated, Kluge urged governments to “share excess doses of WHO-approved vaccines with COVAX or with countries in need” in order to ensure that healthcare workers and older individuals in every country are inoculated. 

This message was echoed by Dr Tedros Adhanom Ghebreyesus, WHO Director-General, at a press conference on Thursday, who made an “urgent request to countries with surplus vaccines that have WHO emergency use listings to share 10 million doses with COVAX.”

In order to reach the goal of vaccinating all healthcare workers in the first 100 days of 2021, rich countries have nine days remaining to to donate excess doses to the COVAX facility, which has run out of doses at a critical time.

WTO Head Says Pharma Companies Should Either Scale Up Manufacturing Or Share Know-How with LMICs

Meanwhile, the new Director-General of the World Trade Organization (WTO), Ngozi Okonjo-Iweala, called it “unacceptable” that low- and middle-income countries (LMICs) were being left at the “end of the queue” for COVID-19 vaccines. 

“The kind of inequities we see in vaccine access are really not acceptable, you can’t have a situation in which…10 countries have administered 70% of vaccine doses in the world, and there are countries that don’t have one single dose,” said Okonjo-Iweala at a WTO trade forecast press conference on Thursday. 

Ngozi Okonjo-Iweala, Director-General of the WTO, at a press conference on Thursday.

She urged pharma companies to follow AstraZeneca’s lead in making deals with production facilities in LMICs to expand the manufacturing capacity for their vaccines. 

“Let’s have the same kind of arrangement that AstraZeneca has with the Serum Institute of India,” the world’s largest vaccine manufacturer and the main source of COVID-19 vaccines for LMICs, Okonjo-Iweala said. 

Voluntary licensing of technology could begin to address the inequity in access to vaccines, she said. 

While an intellectual property waiver for certain COVID-19 tools and technology – designed to allow more drug manufacturers to make the vaccines and improve access – is under consideration by WTO member states, Okonjo-Iweala said this was an issue for the next pandemic. 

Instead of pursuing the WTO TRIPS waiver, the focus now to meet the threat from COVID should be put on enlarging manufacturing capacity, she said.

Image Credits: France24, Flickr – International Monetary Fund, BBC.

The obesity pandemic is in “the same room” as the COVID pandemic in terms of its threats to health – putting people at greater risk of premature death from multiple causes, including SARS-CoV-2, the virus that leads to COVID-19. And ever since stay-at-home measures became routine, people have gained even more weight – up to 1.5 pounds a month according to one recent US study. Yet countries have the tools to address obesity, note Trish Cotter and Dr. Nandita Murukutla at Vital Strategies, a global public health NGO. We spoke to Ms. Cotter and Dr. Murukutla to find out more: 

Health Policy Watch (HPW): A third of the global population now suffers from overweight, and rates of obesity are growing across the world, including in poor countries. How can we explain these trends? 

Vital Strategies (VS): Over the last 40 years, obesity rates around the world have ballooned. High-income countries, like the United States, were the first to experience substantial weight gains of their populations, but the 21st century has seen that phenomenon spread to all parts of the globe. Now, the average adult is three times as likely to be overweight as the average adult in the 1970s.

There are a number of reasons for this alarming trend, which began well before COVID-19, starting with the environments in which people live, as well as poverty, discrimination, increasing availability of unhealthy foods in schools, dwindling levels of physical activity, and a lack of knowledge of unhealthy diets and products.

However, the fundamental reason is the rapid change in our diets and the broader food environment. Ultra-processed products or “junk food”, such as soft drinks, ice creams, or prepared frozen dishes, are one of the key drivers of growing obesity worldwide. They are high in sugar, salt and fat and, unfortunately, widespread in most societies. Yet their harmful effects are poorly understood.

One in three people worldwide are overweight

HPW: Why are ultra-processed foods so ubiquitous? 

VS: They are cheap, easily available, and because of additives and preservatives, they have a long shelf-life. They’re made to feel and look attractive, and they’re made to taste good. Importantly, they’re also hyper-marketed by the food industry. 

Advertising campaigns are very good at making unhealthy products seem part of the fabric of society: unhealthy foods are made to seem crucial to family gatherings and entertainment, so they become part of the social norm that normalizes unhealthy foods. And much of the advertising around unhealthy foods is so enticing that it gets children hooked at a young age.

In what ways is advertising of ultra-processed products misleading? 

Unhealthy products are often marketed cleverly as convenient substitutes for healthy, minimally processed options that include whole grains, fruits and vegetables. They are marketed as convenient breakfast foods, snacks, juices, and sometimes they are also marketed as being more sanitary than fresh fruits and vegetables. But that’s misleading, because current evidence demonstrates that ultra-processed products result in worse diets and ultimately overweight and obesity, which exacerbates the risk of contracting a range of chronic diseases as well as suffering poorer outcomes from infectious diseases like COVID-19. Claims that ultra-processed products are healthy alternatives are untrue. 

 Can you give a concrete example of a strategy that misleads customers into thinking they’re buying healthy products? 

Labels on the front and back of food packages are often really hard to accurately decode. And many of these labels use clever algorithms to hide unhealthy levels of sugar, salt, and saturated fat. Customers may not always realize that the product they are buying is unhealthy.  

Late last year, you co-authored a guide to help policymakers introduce clear, yet highly effective warning labels on foods and beverages to nudge customers away from unhealthy foods. How do these warning labels work?

Front-of-Package (FOP) nutrient labels, sometimes called warning labels, tell consumers immediately, on the front of products, and simply when a product contains high levels of unhealthy nutrients. That means customers don’t need to spend several minutes trying to work out whether each product is healthy or not. This system is simple, visual, and easy to understand. And it is effective, as seen from studies across the world, in triggering immediate behavior change.

The front-of-package labels serve as behavioral nudges, protecting people from making unintended unhealthy purchases. In other words, the warning labels work by reminding consumers that the products they are purchasing are unhealthy, thus nudging them to make healthier choices. But they also have important knock-on effects: they help change social norms around unhealthy eating.   

Example of warning labels on food products in Chile to nudge customers away from unhealthy foods. Translation from top-left to bottom-right: high in calories; high in sugars; high in sodium; high in saturated fats. Source: Ministry of Health of Chile.

You mentioned that warning labels can help change social norms that promote the consumption of unhealthy foods. Can you unpack that?

One study found that children pestered their parents to buy healthier products that did not have warning labels, partially because teachers at school would not accept unhealthy snacks. In some cases, teachers would even confiscate unhealthy snacks brought by children. This suggests that something as simple as a warning label can challenge the idea that ultra-processed products are desirable, and start to change the social norm.  

It’s also important to reiterate that warning labels are a highly cost-efficient approach because you’re able to target consumers rapidly, constantly, and at the point of decision making to make a purchase or not, with little to no cost to the government. 

And the costs of not addressing obesity during the pandemic could amount to $US 7 trillion by 2025, according to the latest review by the World Obesity Federation. Furthermore, out of a total of 2.5 million deaths from COVID reported as of February, 2021, 2.2 million were in countries where over half of the population is overweight. 

Countries with high proportions of overweight people had coronavirus death toll that were ten times higher than those with low proportions of overwheight people

So far, six countries including Chile have legally mandated warning labels, although many have put in place “voluntary” systems. How well do the voluntary systems work ?

The voluntary systems, which do not legally mandate warning labels on every single food product, are not effective. As warning labels may reduce sales of unhealthy foods, the food industry is unlikely to take them up. That’s why mandatory regulations on warning labels are crucial if we want to make a real dent into obesity and overweight. We’ve seen these warning labels work very well in Chile where they contributed to a decrease in the consumption of sugar-sweetened beverages by almost 25%. This was achieved through a comprehensive approach to addressing obesity, which also included: restrictions on child-directed marketing of unhealthy foods and beverages on the radio, television, cinema, and internet; a ban of unhealthy foods and beverages in schools and daycare; and a tax on sugary drinks.

 What kinds of labels work best?  

There are two broad categories of labels. The first category, the so-called “reductive” labels, outline how much of each nutrient is contained in foods, but they don’t help the consumer decide whether the product is healthy or not. These labels are less effective. The second category of labels, the so-called “interpretive” labels, are much more effective. They draw attention to the nutrients of concern or summarize the overall healthfulness of the product. Thus, they can help consumers distinguish between healthy and unhealthy products immediately through clear visual cues. 

The so-called “interpretive” labels can help consumers quickly identify nutrients of concern in food products to make healthier decisions

What are the challenges to getting countries to act? 

Although a number of high-level commitments have been made to fight obesity, including the inclusion of a target in the SDGs , The UN High-Level Meetings on NCDs as well as the UN Decade of Action on Nutrition, a lot more can and needs to be done. But that said, there is very strong industry pushback, and that’s also not surprising. We have seen decades of this with regard to other issues like tobacco control. Industry pressure cannot be underestimated and industry interference is often what holds governments back. However, governments should not feel powerless to take on food policy. The tools are out there to help them do this effectively and cheaply.  

Are there any other policies that can be used alongside mandatory warning labels to cut obesity and overweight?  

Sugary drinks taxes are among the most effective and cost-efficient ways to reduce access to unhealthy foods. Marketing restrictions and the removal of misleading advertising, especially in schools and environments in which children reside, is crucial. Bans on unhealthy products in schools can also help. 

We also need to ensure that healthy food becomes the default option by making sure that it’s easily available and cheap enough to buy – and at the same time ensure that unhealthy foods like ultra-processed foods are less available. 

And as mentioned earlier, it’s important to change those social norms around unhealthy foods so that they’re not associated with what marketers want you to associate them with – families, warmth, love, sports –  and all of the things that bring people together. 

Where do we go from here? And let’s be honest that food labels are not a panacea – what about access to healthier diets generally, which are often more expensive than unhealthy diets. And what about environments where people can be physically active?

With more than one-third of the world’s population overweight or obese, and the COVID-19 pandemic revealing deep structural inequities in food environments, the push to combat obesity has become more urgent than ever. Many individuals are powerless in the face of food shortages and the over-availability of cheap ultra-processed foods. The onus is on governments to act, and to act now. There were a number of factors, from environmental, structural to social, that brought us where we are today, and we will likewise need a concerted and cohesive set of actions to reverse these trends. FoP warning labels are a strong place to start.

Read more here on Vital Strategies’ new guide to help policymakers design and implement warning labels on foods and beverages.

Trish Cotter, MPH, Global Lead, Food Policy Program and Senior Advisor, Vital Strategies
Dr. Nandita Murukutla, Vice President for Global Policy and Research, Vital Strategies

Image Credits: University of Michigan, World Obesity Federation, Vital Strategies, Food Standard Agency, Vital Strateggies, Vital Strategies.

The most important takeaway about the just-released WHO report on the origins of the SARS-CoV2 virus that has infected over 100 million people to date may not be its initial findings, which need to be held under the microscope, but the fact that it has been issued at all. 

Speaking at a press conference on Tuesday, WHO’s Peter Ben Embarek, who coordinated the politically fraught WHO mission to Wuhan, China in January and the report produced after the visit  – stressed that it was the beginning of a process  – and a quest. It will take much more time for the 17 members of the international expert committee – and the world – to unravel.  

Glass Half Full – Half Empty 
WHO press briefing Tuesday with members of the international team tasked with tracing the origins of SARS-CoV2

The weaknesses of the report are already apparent, say experts, whose views were shared confidentially with Health Policy Watch.  The committee’s methodology for ranking some scenarios, like transmission through food products, as very likely, while ranking others, like a laboratory biosafety incident, as “extremely unlikely”  was foggy, with no real objective criteria measurement cited.  

The team discounted too rapidly the possibility that the virus could have emerged from a lab biosafety accident at the Wuhan Virology Institute – world-famous for its study of bat coronaviruses that are the closest known relatives of SARS-CoV2.  

WHO’s Peter Ben Embarek, head of the SARS CoV2 origins task team.

Asked at the press briefing, how the team decided to rank the probability of the four different theories it considered, Ben Embarek said that the method was debate and discussion among the team members until they reached a consensus. 

And so it was also no surprise that WHO DIrector General Dr Tedros Adhanom Ghebreyesus, was already walking back on one of the report’s key conclusions.  In a closed-door briefing to WHO member states, that preceded the report’s public release, the WHO Director General stated:

“Although the team has concluded that a laboratory leak is the least likely hypothesis, this requires further investigation, potentially with additional missions involving specialist experts, which I am ready to deploy… I do not believe that this assessment was extensive enough. Further data and studies will be needed to reach more robust conclusions.”

Significantly, Tedros himself also did not appear at the WHO media briefing – but rather let Ben Embarek, a WHO food safety expert who coordinated the mission by the international expert team to China, appear as the single WHO interlocutor on the public stage. 

And not long after the press conference was finished, some 14 governments led by the United States, Australia and Canada, but also including Denmark, Japan, Norway, Korea and the United Kingdom, issued a joint statement expressing, “shared concerns regarding the recent WHO-convened study  in China, while at the same time reinforcing the importance of working together towards the development and use of a swift, effective, transparent, science-based, and independent process for international evaluations of such outbreaks of unknown origin in the future.”

The group of 14 member states complained about the fact that the study was “significantly delayed and lacked access to complete, original data and samples”, stating that going forward, there is a need for “further studies of animals to find the means of introduction into humans.

“Going forward,” the member states added,”it is critical for independent experts to have full access to all pertinent human, animal, and environmental data, research, and personnel involved in the early stages of the outbreak relevant to determining how this pandemic emerged. With all data in hand, the international community may independently assess COVID-19 origins, learn valuable lessons from this pandemic, and prevent future devastating consequences from outbreaks of disease.”

Half Empty -missing and incomplete data

Among the specifics being raised by experts and observers in the wake of the report’s release are the following: 

  • Weak rationale for the team’s dismissal of a coronavirus laboratory escape.  As the international team members admitted themselves in the WHO press briefing, they lacked the competencies to carry out a ful-fledged laboratory investigation.  The Wuhan Virology Institute staff, told the WHO team that although researchers at the institute had sequenced the genome of the RaTG13 horseshoe bat virus, which is the closest known relative to SARS CoV2, researchers did not maintain live samples of the virus on hand at the institute.  that claim sounds disingenuous, because such samples were indeed collected by the institute in 2013 from a horseshoe-bat colony in Yunnan province, where a group of miners had died in 2012 from a mysterious SARS-like illness.  And the institute’s research into those same coronaviruses is a matter of scientific record. In addition, the WHO team did not have access to raw data on the virology institute’s inventory samples or to data on the health status of institute employees, or serological testing, was made available to the investigators.    
  • Early spread of the coronavirus in Wuhan – the WHO-mandated team did not get full access to clinical patient data from the earliest known patients, or to the genomic sequences of the viruses with whch they were infected.  Serological data available from blood banks, which could have been examined in retrospective studies similar to those carried out on Italy to identify asymptomatic virus carriers, also was not made available by the Chinese authorities. Such data would be critical to understanding where and how widely the virus was circulating prior to December 2019.  Despite that, as team member Marion Kooperman’s noted at the WHO press briefing – data that the team did access suggested that as of December, there were already several coronavirus strains circulating in the city. 
  • Spread through the food cold chain – the theory touted by the Chinese government of virus spread through imported frozen food products is termed as a “possible pathway” in the report – when in fact little real evidence exists that such contamination could have triggered the Wuhan pandemic, and the conclusion that it is even “plausible” lacks analytical rigour.   
  • Evidence about spread through an intermediate wild animal host -while highly plausible as a theory, remains very incomplete, with the mapping of animal supply chains and products only at the initial stages. 
Half Full – Key insights gleaned 
Dr. Peter Daszak – President of the EcoHealth Alliance

Despite the shortcomings, committee members at the briefing stressed the new evidence that they had gathered, which provides a basis to push ahead with more studies. 

Chief among those is a direct line of supply chain provision of wild animal products from regions such as Yunnan province, which are known to harbour bat coronaviruses similar to the SARS-CoV2 – to the Huanan Market in Wuhan – where the most intensive cluster of initial cases first appeared. 

virus
Mapping of stalls in Wuhan’s Huanan market that sold farmed wildlife products from rural regions that are coronavirus hotspots.

“Some of the market stalls in the (Huanan Seafood) market in Wuhan were selling [wild animal] foods foods originating from wildlife farms in known coronavirus hotspots” elsewhere in China, said Ben Embarek, citing what is perhaps one of the most important findings of the study. 

“From the animal side, … the events began to fit together when we looked at the molecular data the epi data and the animal data – they all seemed to fit to form a big picture story about what likely happened, and I think that’s quite exciting,” added Peter Daszak, a leading team member and president of the EcoHealth Alliance.   

“From the outside, it would have been incredible to have a bat with the exact same lineage of viruses, we didn’t see that yet –  that will come in the future I think.

“What we did see on the animal side is clear evidence… that there was a pathway to that market and animals that we know are Coronavirus carriers, from places where the nearest related viruses are. What that does is it shows you there is a pathway, that this virus could have taken to move  800-1000 miles from the rural parts of South China, Southeast Asia, into this market, that was exciting to see.” 

Those insights are all the more critical as the world grapples with a rapid pace of ecosystem deterioration, and more industrialized forms of animal food production, which present considerable risks of virus emergence that need to be better understood by the public at large.

Dr. Marion Koopmans, Dutch virologist and epidemiologist

On the patient side, despite the Chinese authorities’ fragmented provision of patient and epidemiological data, the evidence culled by the team still remains clear. Already in December 2019, there were diverse strains of the SARS-CoV2 virus already circulating in the city – suggesting that that the infection had already made its way into the city’s population some time before. 

Said Marion Koopmans, a Dutch virologist and epidemiologist: “The SARS CoV-2 virus was circulating in the Wuhan market market in December 2019, but it was also circulating elsewhere in the city, in cases unrelated to each other,” she noted at the press briefing. .

The team also noted that despite the multiple restrictions and barriers put up by Chinese governmental authorities – the atmosphere between scientists remained positive – creating what Ben Embarek called a “space” for the scientists to do their work.  And despite considerable pressure from China to point the finger abroad, the team’s testimony makes it clear that the next research steps on the virus trail must be taken in Wuhan, China as well as in rural areas that harbor bat coronaviruses – rather than more far-flung parts of the world. 

Moving Ahead – Balancing Political and Scientific Pressure  

What remains is a long road ahead, requiring investment in more rigorous, and as some team members rightly noted – more expensive studies – based upon evidence-driven demands and requests to Chinese authorities for more detailed data – on both the food safety as well as the human epidemiological side of the virus coin. 

In light of the WHO Director General’s comments about the inadequate analysis of the laboratory biosafety risks – it is also likely that WHO member states in Europe or the Americas (read USA), may demand a fresh query into that hypothesis – involving actual biosafety experts who were not members of the original virus origins team.     

Ultimately, It will be up to the WHO member states that mandated the report, informed by outside, independent experts and observers, to nurse the origins study  – or studies – through to more significant, and final conclusions. In that quest, Europe, the United States and their allies will need to steer a delicate course between exertion of the right amount of political pressure on the one hand – and alienating attacks that only foster anger and geopolitical tensions of the kind visibly on display during the era of former US President Donald Trump. 

And from the point of view of scientists – It is a process that may require months, if not several years – WHO’s Ben Embarek warned. 

“”How long will it take? That is always difficult to predict.” he said, pleading with the world to “please be patient.”   Although, despite the heat that the WHO team has received, his appeal was shadowed with appreciation for the fact that a certain amount of vigilance – may also be constructive:  

“It’s an exciting adventure that I hope the whole world will continue to follow.. it’s a fascinating journey and a critical one because it’s the only way we can understand what happened, and more recently tried to prevent something similar for happening again.”  

Image Credits: Sputnik, WHO.

Charles Michel, President of the European Council

After the COVID-19 pandemic exposed fundamental flaws in the global health architecture, a proposal for a new pandemic treaty that could strengthen the world’s capacity to contain the current pandemic and prepare for future ones, is gaining momentum.  

That was a key message at a World Health Organization (WHO) launch of an open letter by 25 global leaders calling for the world to negotiate such a treaty, featuring Charles Michel, President of the European Council, and two dozen other global leaders that are now backing the treaty initiative. 

Other signatories now include the United Kingdom’s Boris Johnson, Germany’s Angela Merkel, France’s Emmanuel Macron, along with the leaders of Indonesia, Kenya, Rwanda and South Africa’s Cyril Ramaphosa. But China, the United States and Russia have yet to sign the call. 

“Today, we are calling for an international treaty on pandemics [to] foster a comprehensive approach to better predict, prevent and respond to pandemics,” said Michel, who has championed the treaty since late last year saying that the treaty would support the principle of “health for all”.

If ratified, the treaty will give the WHO the political clout to better carry out part of its mandate in terms of improved pandemic alert systems, better investments in coronavirus research, and sharing of crucial data on infectious pathogens, vaccine supply chains and vaccine formulas.

WHO’s director-general Dr. Tedros Adhanom Ghebreyesus echoed Michel’s sentiments, saying: “The time to act is now”.

“The world cannot afford to wait until the pandemic is over to start planning for the next one. We cannot do things the way we have done them before and expect a different result. Without an internationally coordinated response…we remain vulnerable,” said Dr Tedros.

Pandemic Treaty Rooted In WHO Constitution 

The treaty “would be rooted in the constitution of the World Health Organisation, drawing in other relevant organizations key to this endeavour,” said the letter, also signed by the heads of: Albania, Chile, Costa Rica, Greece, Korea, Trinidad and Tobago, the Netherlands, Senegal, Spain, Norway, Serbia, Indonesia, and Ukraine.

“Existing global health instruments, especially the International Health Regulations, would underpin such a treaty, ensuring a firm and tested foundation on which we can build and improve.”

The Pandemic Treaty Will Strengthen WHO’s Mandate 

According to Michel, “Such a treaty [could] play an interesting role in order to make sure that we have more transparency on the supply chains [and] on the level of productions of vaccines and of tests; it will mean more rust and better cooperation.” 

Michel suggested that the treaty could also be used to expand vaccine production by facilitating  technology transfer in low- and middle-income countries, referring to the “third way” initially proposed by the World Trade Organisation’s (WTO) new chief Ngozi Okonjo-Iweala. 

“Certainly there is a debate in the international community about how to improve our vaccine production capacities to improve vaccine coverage, particularly in the African continent,” said Michel, adding that “we are closely following the debate at the WTO for the ‘third way’ voiced by Ngozi”.

 US and China Didn’t Sign Call – But Sent Positive ‘Comments’   

WHO’s director-general Dr. Tedros Adhanom Ghebreyesus

Although China and the US did not sign Tuesday’s op-ed, Dr Tedros said that that both countries had voiced “positive” comments during informal discussions with Member States – and that it was not necessarily an issue that the op-ed had only been signed by two dozen countries.

“It doesn’t need to be all 194 countries [to write an op-ed],” said Dr. Tedros. “I don’t want it to be seen as a problem, it wasn’t even a problem. When the discussion on the global pandemic treaty starts, all Member States will be represented.”

The Pandemic Treaty Will  Synergize With The International Health Regulations

Meanwhile, Mike Ryan, WHO’s Director of Emergency Programmes, emphasised that the treaty would “by no means” undermine the existing global framework that governs WHO countries’ behaviour during health emergencies – the legally binding International Health Regulations (IHRs). These regulations set out the mandates under which countries are obliged to report on disease outbreak risks, and share epidemic information, with WHO and other member states.

Rather, the pandemic treaty would generate the necessary political commitment to ensure that the IHRs are implemented; and bolster global pandemic preparedness and response by covering a broader set of issues than those covered by the IHRs, such as the sharing of crucial data.  

“The IHRs…is a really really good instrument,” said Ryan. “But in itself [it] is a piece of legislation that is without meaning unless countries are fully committed to its implementation.”

“IHR only works if we have trust, if we have transparency, if we have accountability. Such a treaty would provide that political framework in which we in public health can do our work much more effectively.”

“The proposed treaty will definitely bring strong political commitment and support for the IHR implementation,” added Jaouad Mahjour, WHO Regional Director for the Eastern Mediterranean region, who also spoke at Tuesday’s press conference.

In an initial response to the initiative, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that pharma partners should play a role in shaping such a treaty. The statement reflected IFPMA concerns over preserving what it described as the patent “incentive system” for developing new vaccines and medicines.

“The discussions around a possible International Pandemic Treaty need to take into account the important role played by the innovative biopharmaceutical industry and its supply chain in fighting the virus,” said the IFPMA statement.  

“It will be important to acknowledge the critical role played by the incentive system in developing tests, therapeutics, and vaccines to contain and defeat the coronavirus. We hope that the discussions on an International Pandemic Treaty will address enablers for future pandemic preparedness – the importance of incentives for future innovation, the immediate and unrestricted access to pathogens, and the importance of the free flow of goods and workforce during the pandemic – in addition to continuing the multi stakeholder approach undertaken in ACT-A and COVAX.”

WHO’s Peter Ben Embarek, head of the origins task team, at the release of the report on Tuesday.

The international team assembled by the World Health Organization (WHO) to investigate the origins of SARS-CoV-2 has identified animal transmission – through an elusive ‘Animal X’ – as the most likely route of infection.

The long-awaited report was released on Tuesday after the 17-person expert team, together with a 17-person team of Chinese scientists, visited Wuhan and its surroundings during January and February to examine evidence about the virus, which was first identified in 174 people in Wuhan in December 2019, and has since infected over 128 million people and caused 2.7 million deaths.

WHO Director-General Dr Tedros Adhanom Ghebreyesus said that the report advances the world’s understanding in important ways, but it also raises questions that will need to be addressed by further studies. 

“As far as WHO is concerned, all hypotheses remain on the table,” said Dr Tedros. “This report is a very important beginning, but it is not the end. We have not yet found the source of the virus, and we must continue to follow the science and leave no stone unturned as we do.” 

Tedros added that no single research trip could provide all the answers, as “finding the origin of a virus takes time and we owe it to the world to find the source so we can collectively take steps to reduce the risk of this happening again”. 

What follows is a summary of the report’s key points, which the team described as a “work in progress”.

The team examined four main scenarios for introduction: 

  1. Direct zoonotic transmission from a host animal to humans
  2. Indirect zoonotic transmission, involving the virus first infecting a host animal, then adapting through an intermediate host animal, before infecting humans
  3. Introduction through the cold/ food chain, particularly frozen wild animals sold at Wuhan markets
  4. Introduction through a laboratory incident.
Horsehoe bats carry viruses most similar to SARS-CoV-2

1. Direct zoonotic introduction:

Finding: possible to likely. 

Hypothesis: Transmission of SARS-CoV-2 (or very closely-related progenitor virus) moves from an animal reservoir host to human, and is followed by direct person-to-person transmission.

Arguments in favour 

  • The majority of emerging diseases originate from animal reservoirs and most of the current human coronaviruses have originated from animals. 
  • Surveys of the bat viromes conducted after the SARS epidemic in 2003 found SARSr-CoV in various bats, particularly Rhinolophus (horseshoe) bats. 
  • Viruses with a high genetic similarity to SARS-CoV-2 have been found in these bats in China, Japan, Thailand, and Cambodia. 
  • Two distinct types of SARSr-CoV were recently detected in Malayan pangolins. 
  • Minks have shown to be highly susceptible to SARS-CoV-2 and cannot be ruled out as the primary source of SARS-CoV-2. 
  • Antibodies to bat coronavirus proteins have also been found in humans with close contact with bats. 

Arguments against 

  • Although the closest genetic relationship to SARS-CoV-2 was a bat virus, more detailed analysis found “several decades” of evolutionary space between the viruses. 
  • Few of the identified bat virus genomes showed the ability to bind to human cells. 
  • Contact between humans and bats or pangolins is not as common as contact between humans and livestock or farmed wildlife. 
  • Despite the consumption of bats and other wild animal meat in some countries, there is no evidence for transmission of coronaviruses from such encounters. 

Information still needed: Detailed trace-back studies of the animal supply chain of Wuhan markets have provided some credible leads to survey potential reservoir hosts. 

2. Introduction through intermediate host followed by zoonotic transmission 

Finding: possible to likely 

Hypothesis: SARS-CoV-2 is transmitted from an animal reservoir to an animal host, followed by spread within that intermediate host (“spillover host”), and then transmitted to humans. 

Arguments in favour

  • Although the closest related coronaviruses have been found in bats, SARS-CoV-2 has evolved by an estimated “several decades”, which suggests a missing link. 
  • Similar viruses have also been found in pangolins, suggesting cross-species transmission from bats, but again with considerable genetic distance. 
  • Bats and pangolins have infrequent contact with humans, and an intermediary step involving an “amplifying host” has happened in a number of viruses, including influenza and MERS. 
  • SARS-CoV-2 adapts relatively rapidly in susceptible animals (such as mink). 
  • The increasing number of animals shown to be susceptible to SARS-CoV-2 includes animals that are farmed in sufficient densities to allow the potential for viral circulation. 
  • There was a large network of domesticated wild animal farms, supplying farmed wildlife to Wuhan. In high-density farms, there often are connections between farms, leading to complex transmission pathways that may be difficult to unravel. 

Arguments against 

  • SARS-CoV-2 has been identified in an increasing number of animal species, but genetic and epidemiological studies have suggested that these were infections from humans, rather than other animals. 
  • There is no evidence of repeated early SARS-CoV-2 strains of animal origin in humans in China. 
  • There was no genetic or serological evidence for SARS-CoV-2 in tests of a wide range of domestic animals (where large-scale screenings took place) and wild animals, where screening was more limited. 

Information still needed: Further surveys, including a wider geographic range. Studies of the supply chain of Wuhan markets have not found any evidence of infected animals but provided information for follow-up studies, including targeting supply chains from wild-life farms in provinces where the higher prevalence of SARSr-CoVs have been detected in bats. 

Animal products from outside Southeast Asia, where more distantly related SARSr-CoVs circulate, should not be disregarded.

A market in Wuhan, Hubei, China

3. Introduction through the cold/ food chain 

Finding: Possible

Hypothesis: SARS-CoV-2 is introduced or amplified through the cold/ food chain. This could involve direct zoonotic transmission, or spillover through an intermediate host. 

Arguments in favour 

  • The arguments are similar to those listed for zoonotic introduction, but with an emphasis on the potential for initial introduction through food animals or cold/ food chain products or the contamination of food and food containers (for instance by animal waste). 
  • Since the near-elimination of SARS-CoV-2 in China, the country has experienced some outbreaks related to imported frozen products in 2020. 
  • Screening programmes have found limited evidence for the presence of SARS-CoV-2 by nucleotide acid tests in different batches of unopened packages and containers in different cities. For example in an outbreak in Qingdao, the live virus was isolated from the outer package of imported frozen products. 
  • Foodborne outbreaks with enteric viruses are common, but contamination of food with human viruses usually comes from sewage or contaminated water for irrigation. 
  • Sewage treatment typically does not remove all infectious viruses prior to the release of wastewater in the environment. These processes have been investigated widely for non-enveloped viruses but far less for enveloped viruses in the food chain, but there is widespread evidence of  SARS-CoV-2 nucleic acid in sewage. 
  • There is some evidence that the oral route could lead to infection for SARS-CoV-2 from hamster infection experiments, and the virus replicates in gut organoids. 
  • Food animal handlers had an increased prevalence of SARS-CoV-specific antibodies. 
  • Humans infected with SARS-CoV-2 shed virus through faeces and can have gastrointestinal symptoms, suggesting the involvement of the gastrointestinal tract. 
  • Humans can also be exposed to contaminated objects. 

Arguments against 

  • There is no conclusive evidence for foodborne transmission of SARS-CoV-2 and the probability of cold-chain contamination with the virus from a reservoir is very low. 
  • While there is some evidence of the possible reintroduction of SARS-CoV-2 through handling imported contaminated frozen products in China since the initial pandemic wave, this would have been extraordinary in 2019 where the virus was not widely circulating. 
  • Industrial food production has high levels of hygiene criteria and is regularly audited. 
  • Most viruses have been found in 2020 in low concentrations and are not amplified on cold-chain products. It is not clear what the infection route would be (possibly oral, touch, or aerosol). 
  • There was no evidence of infection in animals tested following the Wuhan outbreak. 
  • The risk of foodborne transmission of SARS-CoV-2 through pathways such as objects is very low in comparison with respiratory transmission. 

Information still needed: Case-control studies of outbreaks, in which the cold chain product and food supply are positive, would be useful to provide support for cold chain products and food as a transmission route.

There are some preliminary reports of SARS-CoV-2 positive testing in other parts of the world before the end of 2019. 

There is also evidence of more distantly related SARSr-CoV in bats outside Asia. Some producers in these countries were supplying products to the markets. 

If there are credible links to products from other countries or regions with evidence for circulation of SARS-CoV-2 before the end of 2019, such pathways should be followed up. 

If there are leftover frozen products from the Huanan market from December 2019, particularly frozen animal products from farmed wildlife or linked to areas with the early circulation of SARS-CoV-2, these should be tested. 

4. Introduction through a laboratory incident 

Finding: Extremely unlikely.

Hypothesis: SARS-CoV-2 is introduced through a laboratory incident, reflecting an accidental infection of staff from laboratory activities involving the relevant viruses. We did not consider the hypothesis of deliberate release. The deliberate bioengineering of SARS-CoV-2 for release has been ruled out by other scientists following analyses of the genome. 

Arguments in favour 

  • Although rare, laboratory accidents do happen, and different laboratories around the world are working with bat CoVs. 
  • Humans could become infected in laboratories with limited biosafety, poor laboratory management practice, or through negligence. 
  • The closest known animal coronavirus strain (96.2%) to SARS-CoV-2 detected in bat anal swabs have been sequenced at the Wuhan Institute of Virology. 
  • The Wuhan CDC laboratory moved on 2 December 2019 to a new location near the Huanan market. Such moves can be disruptive for the operations of any laboratory. 

Arguments against 

  • SARS-CoV-2 from bats and pangolin are evolutionarily distant from SARS-CoV-2 in humans. 
  • There is no record of viruses closely related to SARS-CoV-2 in any laboratory before December 2019, or genomes that in combination could provide a SARS-CoV-2 genome. 
  • Prior to December 2019, there is no evidence of circulation of SARS-CoV-2 among people globally and therefore the risk of accidental culturing SARS-CoV-2 in the laboratory is extremely low. 
  • The three laboratories in Wuhan working with coronavirus diagnostics, isolation and vaccine development all had high-quality biosafety level (BSL3 or 4) facilities that were well-managed. 
  • A staff health monitoring programme showed no reports of COVID-19 compatible respiratory illness before or during December 2019, and no serological evidence of infection in workers through SARS-CoV-2-specific serology-screening. 
  • The Wuhan CDC lab which moved on 2 December 2019 reported no disruptions or incidents caused by the move. They also reported no storage nor laboratory activities on CoVs or other bat viruses preceding the outbreak. 

Information still needed: Regular administrative and internal review of high-level biosafety laboratories worldwide. Follow-up of new evidence supplied around possible laboratory leaks. 

At the end of the report, the team called for “a continued scientific and collaborative approach to be taken towards tracing the origins of COVID-19”, something that has been echoed by WHO.

 

Image Credits: CGTN, Arend Kuester/Flickr.

CAPE TOWN – Johnson & Johnson (J&J) will deliver its COVID-19 vaccine to Africa from October after reaching an agreement with the African Union to supply the continent with up to 400 million doses over the next two years. 

However, Africa may still be struggling to obtain vaccine supplies for some months following last week’s decision by the Serum Institute of India (SII) to scale back its delivery of the AstraZeneca vaccine to the WHO co-sponsored COVAX global vaccine facility – in order to address domestic demand as COVID-19 cases soar in India. 

To date, the AstraZeneca vaccine has been the backbone of the COVAX facility’s ambitious roll-out of vaccines to dozens of low- and middle-income countries. But the SII suspension would interrupt the planned March and April delivery of some 90 more vaccine doses at a time when some countries have already used up their allotted supplies, and another 10 countries in Africa and 20 worldwide have yet to receive any vaccines at all.    

J&J CEO Alex Gorsky

 J&J CEO Alex Gorsky announced the deal with the AU’s “African Vaccine Acquisition Trust (AVAT)” on Monday saying that his company has been “committed to equitable, global access to new COVID-19 vaccines” from the start of the pandemic.

“Our support for the COVAX Facility, combined with supplementary agreements with countries and regions, will help accelerate global progress toward ending the COVID-19 pandemic,” he added.

AVAT can order up to 220-million doses this year and an additional 180 million doses in 2022, according to the company.

Single Dose and Efficacious Against Variant

The J&J vaccine only requires one dose, it can be stored in a normal fridge for up to three months.  It has been tested in diverse populations and it has shown be able prevent death and severe illness – even in the case of the more infectious B.1351 (501Y.V2) variant first identified in South Africa. 

J&J has also committed to providing its vaccine on a not-for-profit basis for emergency use during the pandemic.

The vaccine was granted Emergency Use Listing from the World Health Organization (WHO) on 12 March, Conditional Marketing Authorization from the European Commission on 11 March and Emergency Use Authorization by the US Food and Drug Administration on 27 February. The single-shot COVID-19 vaccine has also been granted Interim Order authorization in Canada on 5 March.

It is also being used to vaccinate South African health workers as part of an implementation study. The country abandoned its original plan to roll out the AstraZeneca vaccine after a small trial showed that vaccine was ineffective in preventing mild and moderate infection by the B.1351 variant.

South Africa announced on Sunday that it expected 2.8 million J&J doses at the end of April to expand its vaccination programme. It also announced that it had secured an order of 30 million doses from the company but did not divulge the expected delivery date of the bulk of its order.

J&J Tested on Diverse Populations

So far, the J&J vaccine is in fact the only vaccine to have been rigorously clinically trialled on the B.1.1351 variant that first emerged in South Africa and has now reportedly spread to some 16 other countries. 

Those states reporting on the presence of the B.1.351 variant, namely Angola, Botswana, Cameroon, Comoros, DR Congo, Eswatini, Gambia, Ghana, Kenya, Malawi, Mauritius, Mozambique, Namibia, Rwanda, South Africa, Zambia and Zimbabwe, according to the Africa Centers for Disease Control (CDC).

“The availability of the vaccine candidate is subject to its successful approval or authorization by the national regulatory authorities of AU member states,” according to the company’s press statement.

The J&J vaccine has been tested on almost 44 000 people from four continents, including 7,000 South Africans, most of whom were exposed to the B.1351 variant. The vaccine showed 57% protection against moderate disease, 85% protection against severe disease and 100% protection against death.

Globally, the J&J vaccine demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. 

In addition, South Africa’s Aspen Pharmacare will assist to manufacture the vaccine and support shipments to the AU member states, according to the company.

Gavi in Talks With Indian Government Over SII supplies

Meanwhile, lat last week the global vaccine alliance, Gavi, announced that COVID-19 vaccines produced by the Serum Institute of India to lower-income economies that as part of COVAX “will face delays during March and April as the government of India battles a new wave of COVID-19 infections”.

“COVAX and the Government of India remain in discussions to ensure some supplies are completed during March and April,” added Gavi

According to the agreement between Gavi and SII, the company is contracted to provide COVAX with the SII-licensed and manufactured AstraZeneca vaccine to 64 lower-income economies participating in the Gavi COVAX AMC, alongside its commitments to the Government of India.

 

Image Credits: NBC News.

Pakistani health workers getting vaccinated with donated Chinese Sinopharm vaccines.

ISLAMABAD – (EXCLUSIVE) A controversial plan to sell Russia’s Sputnik V COVID-19 vaccine to wealthy citizens in Pakistan has been put on hold following a dispute between the government and the private pharmaceutical company involved over the vaccines’ sale price, Health Policy Watch has learned.

Meanwhile, Transparency International – Pakistan appealed to Prime Minister Imran Khan to “cancel” the private importation of COVID-19 vaccines altogether, citing concerns with price and the potential for corruption.

“Pakistan is one of the first countries to allow the private sector to import and sell COVID-19 vaccines and [this] will provide a window of corruption, as there are possibilities some of the government vaccines may be sold to …private hospital[s],” Transparency International stated in a letter to the Prime Minister’s office, also obtained by Health Policy Watch.

Public health experts have also expressed disquiet about how a two-tier system would deepen inequality, allowing wealthy citizens who can pay to move to the front of the vaccination queue. 

The arrangement would also enable private buyers to obtain a vaccine [Sputnik V] whose clinical trial results have significantly outperformed the donated Chinese Sinopharm vaccines that are currently being rolled out by Pakistan’s public health authorities to health workers and other priority groups.

And the vaccine deals set a precedent for other low- and middle-income countries. Along with Pakistan, Brazil, Indonesia, and the Philippines, as well as Thailand and the United Arab Emirates are also reportedly weighing, or in the process of creating, a private market vaccine channel.

Government Initially Gave Sputnik Sales Go-ahead

In early February, Pakistan health authorities granted emergency use authorization for Russia’s Gam-COVID-Vac (Sputnik V) vaccine and gave permission to Ali Gohar Pharmaceutical (AGP), a private pharmaceutical company, to import and sell the vaccine.

Last week, AGP brought the first shipment of 50,000 Sputnik V doses into Karachi – but disagreement over price has put the private vaccination rollout on hold.

Initially, the government had approved private importation without fixing a price. But it later classified COVID-19 vaccines in the “hardship” category of medicines, which enables the Drug Regulatory Authority of Pakistan (DRAP) to set a maximum price.

The government then fixed the sale price at around $55 for two doses. But AGP says this is too cheap, while Transparency International believes is too high.

According to Transparency’s letter to Prime Minister Khan, “the federal cabinet has fixed the maximum retail price of Sputnik-V Russian vaccine at PKR8449 (US$54.46) for two doses and China’s Conividecia at PKR4225 ($27.30) per injection”.

However, said Transparency, the global price set for the Sputnik-V is $10 per dose.

“This means that, internationally, the two doses of Sputnik V are available at $20. However, the approved price for its commercial sale in Pakistan is 160% higher than the international price,” said the letter.

The price cap came from the Ministry of National Health Services Regulations and Coordination (NHSRC). Confirming this, NHSRC secretary Aamir Ashraf Khawaja also defended the government’s decision of allowing the private sector to import COVID-19 vaccine.

Russian military personnel receive Sputnik V vaccine

In a letter written to Transparency, Khawaja said that Pakistan remains committed to fighting COVID-19 with “everything available” at its disposal, including private vaccinations.

“This is expected in a large country like Pakistan, with a population over 220 million. The government, therefore, as a deliberate policy tool, allowed private sector to import vaccines to cater to those segments of the society which were not on the immediate priority list of the government,” said Khawaja in his letter.

“Government is fixing the maximum retail price, leaving room for competition and free market dynamics. It may also be added that COVID-19 vaccine market dynamics entail the sale in large quantities, typically in millions, and it is not easy for small players to access small number of doses,” said the letter.

Company Has Reservations About Price Cap

When asked for its response to DRAP’s decision to cape the price on privately imported vaccines, the AGP official said that “obviously company has reserved some appropriate steps about it”. 

Sources close to the company said that it had been planning to sell the double-dose vaccine for at least $70 and it may not sell its current stock at all now.

Meanwhile, DRAP spokesperson Akhtar Abbas said that medicine prices are fixed by the federal government and DRAP can only recommend prices on technical grounds.

He said that the reconsideration of the Sputnik-V vaccine set price was possible only on the advice of the federal Cabinet and, as far as he knew, Cabinet had not passed any directions to the regulatory authority.

Abbas added that if the company had any reservations about the pricing of the vaccine, it must submit these to the pricing committee of the DRAP.

Ellen ‘t Hoen, from South Centre, said that although the World Health Organization (WHO) had not finished assessing Sputnik’s efficacy and safety, the vaccine has been approved for emergency use by certain countries.

She added that it was “only a matter of time” before COVID-19 vaccines became “big business”. She also said that now India is planning to impose export controls on vaccines, more countries will start to look at China and Russia for supply.

Pakistan has given Emergency Use Approvals to a number of vaccines, including the Pfizer, AstraZenca, SinoPharm and Conividecia vaccines, as well as Sputnik-V.  However, so far only the Chinese-donated SinoPharm is being administered to healthcare workers and people above age 60.

Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said its members were not focusing on selling vaccines to private companies.

 “The major international vaccine makers, who are members of our federation, fully appreciate the public health emergency and therefore are focusing all their efforts on meeting the requests of governments or their appointed health authorities; as well a COVAX,” said IFPMA Director General Thomas Cueni.

The manufacturer of Sputnik V has submitted dossiers to the World Health Organization (WHO) and the European Medicines Agency for approval.  In February, a peer reviewed study of Sputnik’s clinical trial reults in The Lancet  found it to be safe and effective.

Asked to comment on the reports of the private market vaccine arrangements being laid in Pakistan and other countries, neither WHO’s Pakistan country office, nor WHO’s global headquarters in Geneva, had replied as of press time.

Image Credits: Ministry of Defence of the Russian Federation.