Opening ceremony for the second meeting of the Protocol to Eliminate Illicit Trade in Tobacco Products (MOP2) at WHO headquarters in Geneva.

While the world was focused last week on the Glasgow Climate Conference (COP26), officials from 160 countries and the European Union gathered virtually to address another urgent global crisis – the crisis in tobacco consumption that is one of the largest causes of death worldwide, year after year.

Otherwise known as COP9, the ninth Conference of Parties to the WHO Framework Convention on Tobacco Control (FCTC), made significant strides with comparatively little attention – apart from partisan campaigns that denigrated the WHO and the global health treaty.

The fact that such negative messages align with the interests of cigarette companies should come as no surprise. There is clear urgency for this work: tobacco use kills more than 8 million people every year. The FCTC is central to ending the global tobacco epidemic.

At the same time, progress is a threat to the rich and powerful vested interests of tobacco companies.  As with efforts to address climate change, advancing proven policies to save lives from tobacco is a hard-won battle.

Worryingly, in the week before COP9, new research published by industry watchdog STOP, suggested that big tobacco – cited by governments as the main barrier to treaty implementation – had taken advantage of the COVID-19 crisis to advance its interests. Industry efforts during the pandemic delayed and weakened health policies to reduce tobacco use in several countries.

Influence of vested interests is key theme at both COP meetings

Global tobacco industry interference ratings (STOP). Countries in yellow and light green experience the least interference – those in red and burgundy, the most.

The influence of vested interests was a key theme at both COP meetings – the one addresing the climate crisis and the one addressing the public health crisis of tobacco use. Industry rhetoric aimed to portray health policies as part of a ‘nanny state’ or even ‘authoritarian.’ Even more insidious were disingenuous claims that regulating industry harms the poorest in our society, when this group often bears the brunt of unhealthy and unsustainable policies – whether they are related to climate change or tobacco use.

The virtual format for COP9 meant there was a shorter, pared-down agenda, with several issues deferred to COP10 in 2023 when they can be discussed and agreed upon in person. These include topical issues like more systematic regulation and disclosure of the contents of tobacco products, including products like waterpipes, smokeless tobacco and heated tobacco products.

Some delegations were understandably concerned that the industry could use this deferral to further influence policy between now and the next meeting in 2023, although expert reports on the key issues, which were published at COP9 could be used to help guide national policy development in the interim.

In a first-ever COP that was fully open to accredited media, news reports also noted how some countries’ interventions appeared to be designed to delay discussions at COP9, reflecting the interests of powerful tobacco companies.

For example, delegations from the Dominican Republic and the Philippines, which included officials from departments such as trade & industry, finance, agriculture and foreign affairs, argued that tobacco is a positive force in their country, while not fully addressing the costs or harms of tobacco use. Such industry-aligned activity was so pronounced within the Philippines delegation that the Philippines’ Department of Health was compelled to issue a statement disassociating itself from statements made by its other delegates.

Virtual pro-vaping event on COP9 sidelines tried to divert attention

The tobacco industry is using deceptive advertising to promote its products, according to WHO.

Industry-friendly rhetoric was abundant on the virtual sidelines of COP9 too. One group created a virtual pro-vaping event it tried to cast as an alternative to COP9; it was amplified by a flurry of social media activity and press releases.

Despite all this chatter, however, the more than 1,200 delegates present made progress, and the results represent a global consensus.

Included in these positive decisions was an agreement to establish a new sustainable funding mechanism to support countries’ and global FCTC implementation, with a hoped-for $2-3 million annually in additional resources. There was also explicit support for the FCTC Secretariat’s efforts to increase transparency: as per the agreement by delegates to open the meeting to accredited media in addition to accredited non-state observers (as well as countries and territories that are not formal FCTC parties). Opening and closing sessions also were broadcast live.

At a regional level, nearly all the delegates from the Americas region issued a joint statement to confirm that they had voluntarily signed and submitted Declaration of Interest forms, in line with a decision at COP8 to help reduce industry interference. Delegates from across Africa called out tobacco industry tactics and called for the tobacco industry to be held liable for the harm it has caused. Both regions are strategic targets for tobacco companies working to expand their markets and grow their profits in emerging economies.

COP9 Declaration – protecting policy from industry influence

Global tobacco industry interference ratings (STOP). Countries in yellow and light green experience the least interference – those in red and burgundy, the most.

The culmination of the week was the approval of the COP9 Declaration, in which Parties agreed to accelerate implementation of the Framework Convention, and make efforts to protect policy from industry influence to support COVID-19 recovery. Governments were also encouraged to implement parts of the treaty that protect policy from industry interference.

This will not, of course, stop tobacco companies from trying to recast themselves as a solution to the problem they created. This is an issue that echoed through this week, at the subsequent Meeting of Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products (MOP2). Evidence shows that, even while the tobacco industry promotes flawed, proprietary solutions to address tobacco smuggling, it may be complicit in the illicit trade of its own products.

We are reminded, meanwhile, by WHO’s latest report on tobacco trends, also published this week, that there are still more than a billion tobacco users around the world, not including e-cigarettes and heated tobacco products. Tobacco companies are producing and selling trillions of deadly cigarettes every year, while their rhetoric steers public conversation away from that inconvenient fact.

As Health Policy Watch said in its report on COP9, it’s a David and Goliath struggle. Taking action in line with the COP9 declaration would be a true win-win for health. With political will and support from the FCTC Secretariat and other organizations, governments can make real progress to reduce tobacco use before COP10 in 2023. The time to act is now.

Gan Quan is the Director of Tobacco Control at The Union, and a partner in STOP, a tobacco industry watchdog, funded by Bloomberg Philanthropies. He has over 17 years of experience in tobacco control advocacy and research in Asia, North America and globally. Gan Quan has a PhD in Public Health from the University of California – Berkeley.

Gan Quan, director of tobacco control at The Union, a Partner in STOP

Image Credits: City of Bengaluru, WHO/Pierre Albouy, Global Tobacco Industry Interference Index 2021 (STOP), STOP: Global Tobacco Industry Interference Index 2021.

First long-acting injectables to treat HIV approved by NICE.

People living with HIV in England and Wales may be eligible for injectable antiretroviral treatment every two months, rather than daily pills.

Two injectable drugs, cabotegravir and rilpivirine, were recommended for use by the UK National Institute for Health and Care (NICE) on Thursday after trials proved they work as effectively as daily tablets, according to their draft guidance. 

To be eligible for cabotegravir with rilpivirine, people must already have a low and stable viral load. 

The Scottish Medicines Consortium has also approved the injections for adults living with HIV in Scotland.

Cabotegravir (also called vocabria), which is made by Viiv Healthcare, and with rilpivirine (also called Rekambys), made by Janssen, are the first long-acting antiretroviral injections available for HIV. 

“Clinical trial results show that cabotegravir with rilpivirine is as effective as oral antiretrovirals at keeping the viral load low,” according to NICE.

“Both cabotegravir and rilpivirine are administered as 2 separate injections every 2 months, after an initial oral (tablet) lead-in period.”

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Assessment at NICE, said that while  HIV is still incurable, the virus “can be controlled by modern treatment”.

“For some people, having to take daily multi-tablet regimens can be difficult because of drug-related side effects, toxicity, and other psychosocial issues such as stigma or changes in lifestyle,” added Boysen.

“The committee heard that stigma remains an issue for people living with HIV and can have a negative impact on people’s health and relationships,” he added.

“We are pleased therefore to be able to recommend cabotegravir with rilpivirine as a valuable treatment option for people who already have good levels of adherence to daily tablets, but who might prefer an injectable regimen with less frequent dosing,” added Boysen.

Pill fatigue 

antiretroviral
People living with HIV typically have to take daily pills to lower viral load.

“HIV unfortunately remains a stigmatised condition. Although we’re working hard to tackle the stigma surrounding HIV, this new injectable treatment option could help people in house-shares for example who do not wish to share their HIV status and will no longer have to worry about hiding their medication,” said Debbie Laycock, head of policy at HIV charity, Terrence Higgins Trust.

“Pill fatigue is also an issue for some people living with HIV who struggle with the idea of taking antiretroviral drugs every day,” added Laycock.

“Long-acting injectable treatment is also a better option for those who have difficulty swallowing medication. Therefore, the institute’s approval provides a welcome additional treatment option for people living with HIV across England and Wales.”

The United Kingdom has a relevantly small, concentrated HIV epidemic, with an estimated 101,600 people living with HIV in 2017. An estimated 13,000 people will be eligible for the injectable treatment in England

Added Laycock: “This is a great step forward as we work towards ending new cases of HIV by 2030. The institute’s decision brings great potential for HIV prevention including long-lasting pre-exposure prophylaxis (PrEP) in the future.”

Image Credits: PharmacyMagUK/Twitter, Flickr.

Dr Ali Ahmed Yahaya, WHO Africa lead on antimicrobial resistance.

Over four million Africans a year could die as a result of antimicrobial resistance (AMR) by 2050, according to WHO’s Africa Region at the start of World Antimicrobial Awareness Week on Thursday.  And if global action isn’t taken to head off risks, nearly nine million of the estimated 10 million people dying around the world from AMR by 2050, will be either Africans or Asians. 

Drug-resistant tuberculosis is a growing phenomenon, while malaria parasites also are becoming resistant to once-effective first-line anti-malarial treatments.

“Antimicrobials – including antibiotics, antivirals, antifungals, and anti parasites – are the backbone of modern medicine,” explained World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus.

“They allow us to treat deadly infections successfully, and make essential health services safer for everyone. However, the overuse and misuse of antimicrobials are the main drivers of drug-resistant pathogens,” he warned in a recorded message as events were held all over the world to draw attention to the threat posed by the growing trend of “superbugs” resistant to existing drugs and treatment.

In light of the growing threats, six global and regional organisations on Wednesday issued an appeal for stronger policies to fight AMR. They included the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), the World Organisation for Animal Health (OIE), the UN Environment Programme (UNEP),  the Africa Centres for Disease Control and Prevention (Africa CDC), and the African Union Inter-African Bureau for Animal Resources (AU-IBAR).

The FAO’s Regional Representative for the Near East and North Africa, Dr Abdulhakim Elwaer, said that his organisation, together with the WHO and OIE were establishing AMR multi-stakeholder partnership platforms across all sectors to implement an AMR global action plan.

FAO’s Dr Abdulhakim Elwaer

COVID-19 illustrates ease of infection spread

Projection of deaths annually from AMR by region as of 2050 in business-as-usual scenario, show Africa and Asia bearing the brunt of the burden. Source: Review on Antimicrobial Resistance: Wellcome Trust & HM Government, 2014

“The COVID 19 pandemic has shown the ease with which infections can spread, threaten global health security, and destabilise economies, lives and livelihoods,” Elwaer told an African regional AMR meeting on Thursday.

“Trans-boundary animal diseases and zoonotic diseases have a devastating impact on animal production, food security, trade, public health, and economy,” he warned, calling for the responsible use of antimicrobials in animal and plant health.

The estimate of 4.1 million deaths annuall in Africa by 2050 is part of a broader assessment of global health risks that concluded some 10 million people a year could die from AMR by 2050 – mostly in Asia and Africa.  The estimates from the review, conducted in 2014 by an independent commission, co-sponsored by the UK government and the Wellcome Trust, were also highlighted in a major UN assessment of AMR trends and risks, No Time to Wait, published in 2019 just before the COVID pandemic took off.

Worldwide, agriculture is one of the biggest users of antibiotics alongside human health – and in some developed countries like the United States animals may even be the largest consumers of these life-saving drugs.

Dr Yahaya Ali Ahmed, the WHO’s Africa Team Lead for AMR, said that routine administration of antibiotics to animals as a prophylaxis against disease, and to promote growth, is now also a growing practice on the continent – and that is driving resistance too.

In addition, inadequate treatment of sewage, particularly emissions from health care facilities that use and inevitably discharge medicine residues in their waste, provides a media where resistant microbes may breed and multiply.

“Animals might also acquire resistance from water contaminated with human sewage. We have several issues in our region, specifically inadequate hospital sewage systems,” added Ahmed.

“These examples highlight that there is really an interface between humans, animals, plants and the environment,” said Ahmed. “If a single sector tries to work alone, it will fail and this is why we really need to adopt an integrated and holistic multi-sectoral, ‘One-Health’ approach in combating AMR.”

Wildlife and aqua-culture

OIE Africa representative Dr Karim Tounkara Africa said that his organisation was working to integrate environmental, aquatic and wildlife issues into the region’s One Health approach.

“OIE developed a wildlife health framework in 2020 aiming at reducing the risk of disease emergence and protecting wildlife health,” said Tounkara.

The wildlife framework aimed to “improve member states’ capacity to manage the risk of pathogen emergence in wildlife and at the human animal ecosystem interface, whilst taking into account the protection of wildlife”, said Tounkara.

“The second objective is about enabling OIE members to improve surveillance systems, early detection and the reporting and management of wildlife of diseases,” he added.

Antibiotic shortages may also drive inappropriate use – leading to AMR

While drug resistance develops from overuse and incorrect use in both people and in animals, it can also be an outcome of antibiotic shortages – when an antibiotic that is already vulnerable to resistance is routinely prescribed because a better one is unavailable.

“In Uganda, doctors write prescriptions based on availability rather than suitability,” according to a report from the Center for Disease Dynamics, Economics & Policy (CDDEP) published in 2019. 

In addition, poor medicines regulation in Africa also drives a black market trade – including fake medicinal treatments.  Widespread use of fakes, which may contain weakened formulations of antibiotics or other inappropriate treatments, also enable drug resistant microbes to flourish, leading to more AMR.

Despite the pandemic, Europe sees reductions in antibiotic use between 2019-2020

There has been widespread concern that the COVID-19 pandemic may be stimulating AMR trends – in light of the widespread administration of antibiotics to COVID patients to prevent secondary infections – even in cases when the risks were very low.

Nonetheless, Europe saw a net decline in antibiotic use in 2019-2020, according to a recent report by the European  Centre for Disease Prevention and Control (ECDC). The report, showcased at ann event sponsored by the ECDC and the European Union, found that virtually all of the member states of the European Economic Community (EEC) had reduced their antibiotic consumption by 18% in 2019-2020. Bulgaria was the only country that reported increased antibiotic use.

This decrease could be explained by a reduction in respiratory tract infections, thanks to the use of masks, phyical distancing and other measures introduced to curb COVID-19, reported the ECDC.

Even so, the risks of AMR in most regions of the world are mounting – and with them the risk that AMR will lead to the routine loss of more and more lives – if not the next pandemic.

“The World Bank has estimated that, if nothing is done to address the factors driving AMR, it will have the same impact and cost as much as COVID-19, not once, but annually, year after year,” warned Hans Kluger, the WHO’s European Regional representative, at the EU event.

Image Credits: WHO / M. Edwards, Source: Review on Antimicrobial Resistance: Wellcome & UK Govt. .

Pfizer’s COVID-19 vaccine during the manufacturing process.

In a bid to better respond to both domestic and global needs, as well as future threats, the Biden Administration plans to spend billions of dollars to expand US vaccine manufacturing capacity enabling production of 1 billion vaccine doses a year by mid-2022, two top White House officials told US media on Wednesday. 

The announcement comes just ahead of another move whereby the US Food and Drug Administration is expected to approve booster shot doses of the Pfizer-BioNTech Covid vaccine for all adults later this week. 

Currently, boosters are only recommended for Americans age 65 and older, but as US infection rates begin to rise again, leading experts such as Anthony Fauci, chief White House Medical advisor, have said that they think booster doses for most people will be inevitable to head off a mid-winter virus surge.  

Despite rising infection rates in many countries – WHO continues to oppose boosters 

In most African countries, less than 15% of people have received even one vaccine dose, and in many countries, less than 5%.

WHO and health equity advocates have continued to strongly oppose the administration of booster doses by rich countries, saying that these rob poorer nations of doses for their first and second vaccines. 

On Sunday, WHO repeated its call for a “moratorium on COVID-19 boosters until the end of 2021” so that other countries could get first shots. 

“No more vaccines should go to countries that have already vaccinated more than 40% of their population until COVAX has the vaccines it needs to help other countries get there too,” said WHO, citing earlier remarks by WHO Director General Dr Tedros Adhanom Ghebreyesus.

“No more boosters should be administered except to immunocompromised people. Most countries with high vaccine coverage continue to ignore our call for a global moratorium on boosters at the expense of health workers and vulnerable groups in low-income countries who are still waiting for the first dose.

White House manufacturing expansion – focused on domestic producers  

Dr David Kessler, chief science officer for White House COVID-19 response

The White House moves to expand manufacturing should help ease supplies abroad, officials pointed out. 

However, while Africa and other low- and middle-income regions have called for more investments on the continent and in other LMICs, the planned new US new investments will be based around manufacturing by US domestic suppliers:

“This effort is specifically aimed at building U.S. domestic capacity,” White House vaccine czar Dr David Kessler was quoted as saying. “But that capacity is important not only for the U.S. supply, but for global supply.”

Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, is the White House Chief Science Officer for COVID Response – the initiative the former Trump administration had called ‘Operation Warp Speed’.

Speaking with reporters at a briefing on Wednesday, White House COVID-19 Response coordinator Jeff Zients said that along with battling COVID, the programme would help prepare the US and the world for a future pandemics, enabling production:  “within six to nine months of identification of a future pathogen.”  

Initiative expands government partnerships with private sector

Insufficient progress on delivering pledged doses to COVAX – across most high-income countries

The investment in vaccine manufacturing capacity is happening in the context of a thrust by the Biden administration to both challenge and woe industry. 

On the one hand, the government has waged a high-profile battle with Moderna, contending that three scientists at the National Institutes of Health should hold co-inventor rights over Moderna’s core mRNA vaccine patent – a demand that Moderna now seems to be conceding, at least partially. 

On the other, the need for expanded collaboration with the private sector was also a theme of statements last week by US Secretary of State Anthony Blinken after a virtual COVID-19 ministerial conference with about 40 other foreign ministers from around the world.

The investments would focus on US vaccine manufacturers with experience in producing mRNA vaccines – who need more help to scale up their capacity rapidly.  

As a first step, Biomedical Advanced Research and Development Authority (BARDA) will issue a call for inputs from experienced vaccine manufacturing companies, asking for responses within the next 30 days, Zients and Kessler said. 

Funding for the scale-up, estimated to cost “several billion” according to Kessler in an interview with the New York Times, which first reported on the initiative.  

The funding would come from the $1.9 trillion coronavirus relief bill that President Biden signed into law in March.

Biden has pledged to donate more than 1 billion coronavirus vaccine doses to other countries in order to vaccinate the global population as the international community struggles to overcome the pandemic, including 800 million doses through the WHO co-sponsored COVAX global vaccine facility initiative.  However only a fraction of those donated doses – or others promised from high -income countries, have so far been delivered. 

Zients said at the COVID-19 briefing that the administration has now shipped 250 million doses to 110 countries as of Wednesday.  A little more than 100 million US doses have been delivered through COVAX, while the rest were donated in bilateral arrangements.  

Some observers say that it is stockpiling of unused doses by wealthy countries, rather than boosters, remains a bigger factor foiling attempts to distribute vaccines more equitably.

In either case, it’s clear that vaccine hoarding is also a powerful driver.  According to independent reports by both civil society groups like Medicins Sans Frontiers, as well as industry observers such as AirFinity, between 600-900 million excess vaccine doses are currently languishing in rich country stockpiles – after existing vaccine priorities and boosters are considered. At least 241 million of those doses will also expire by the year’s end.

The excess doses of COVID-19 vaccines by the end of 2021 after vaccinating people ages 16 and up in ten high-income countries.

 

Image Credits: NBC, Pfizer, Twitter , https://covid19globaltracker.org/, MSF.

The number of tobacco users globally has dropped from 1.32 billion in 2015 to 1.3 billion, and is expected to decline to 1.27 billion smokers by 2025, according to the fourth World Health Organization (WHO) global tobacco trends report.

The report, released on Tuesday, revealed that 60 countries are now on track to achieving the global target of a 30% reduction in tobacco use between 2010 and 2025. Two years ago, only 32 countries were on track. 

WHO Director-General Dr Tedros Adhanom Ghebreyesus described the findings as  “encouraging” but noted that the world still had a long way to go. 

“Tobacco companies will continue to use every trick in the book to defend the gigantic profits they make from peddling their deadly wares,” said Dr Tedros. “We encourage all countries to make better use of the many effective tools available for helping people to quit, and saving lives.”

Tobacco kills an estimated 8.1 million a year, 7 million smokers and another 1.2 million people from second-hand smoke, according to the most recent WHO numbers. 

While the WHO report covers use of smoked tobacco, such as cigarettes, pipes, cigars, and smokeless tobacco products, such as oral and nasal tobacco, the use of electronic cigarettes was not analyzed in the report. This could distort the data provided, as e-cigarette use is on the rise, particularly among young people. 

To further reduce the number of people at risk of becoming ill and dying from a tobacco related disease, the report also urges countries to accelerate the implementation of measures outlined in the WHO Framework Convention on Tobacco Control (FCTC). 

Investment in cessation could help 152 million tobacco users quit 

Investing a mere $1.68 per capita each year in evidence-based cessation interventions such as brief advice, national toll-free quit lines, and SMS-based cessation support, could help 152 million tobacco users successfully quit by 2030, according to the new WHO Global Investment Case for Tobacco Cessation. 

WHO called for cessation services to be scaled up, along with strengthening tobacco control measures, and subsequently established a tobacco cessation consortium, which will bring together partners to support countries in scaling up tobacco cessation.

Currently, only about 30% of the world’s population has access to appropriate tobacco cessation services, with many countries still lacking a national tobacco cessation strategy and only a few countries dedicating both personnel and budgets to cessation programs. 

Implementing cessation measures has been shown to result in a 2 – 15% increase in the proportion of tobacco users who quit tobacco use for 6 months or more, as opposed to no intervention. 

Notably, over 60% of smokers report that they want to quit, and over 40% have attempted to do so in the past year – though the report notes that many will fail without much-needed cessation assistance. 

Americas, Africa and SE Asia on track for 30% tobacco reduction

Key findings from the report show that reductions in tobacco have been seen across the Americas, Africa, and Southeast Asia.  

The WHO Americas region reports the steepest decline in tobacco prevalence rate, which has gone down from 21% in 2010 to 16% in 2020. 

The WHO regions of Africa and South-East Asia have also joined the Americas region to be on track to achieve a 30% reduction by 2025. 

However, the WHO Western-Pacific region is projected to become the region with the highest use rate among men, with more than 45% of men still using tobacco in 2025. 

Additionally, the WHO European region has more women using tobacco than any other region – 18%, with women in Europe the slowest to cut tobacco use. 

Approximately 231 million women used tobacco in 2020, with the highest use seen among women aged 55 – 64. 

All other regions are on track to reduce tobacco rates among women by at least 30% by 2025. 

In 2020, 22.3% of the global population used tobacco – accounting for 36.7% of all men and 7.8% of all women. 

E-cigarette research missing from report 

E-cigarettes
Observed estimates show e-cigarette use among young people is increasing.

While e-cigarettes were notably left out from the report, observed estimates did reflect the rise in use among adolescents, with the most startling prevalence rates found in Monaco of 41% of children aged 15 and 16 years old, followed by Lithuania (31%) and Poland (30%). 

Trends in the use of e-cigarettes and other nicotine delivery devices were not included in the report due to the lack of country data. But the data that does exist reveals the need to address a fast-growing and relatively unregulated market that continues to influence children and adolescents. 

Newer tobacco and nicotine products, including e-cigarettes, have evaded regulation, with the tobacco industry using deceptive advertisements to market these products to children and teens.   

Children who use these products are up to three times more likely to use tobacco products in the future, according to a WHO 2021 report on the tobacco epidemic released in July. 

Approximately 28 million children aged 13 – 15 currently use tobacco, despite the fact that most countries have made it illegal for minors to purchase tobacco products. 

Aggressive tobacco control needed

Although the report indicates notable progress in many regions of the world, Ruediger Krech, WHO Director of the Department of Health Promotion, emphasizes the need to push ahead in moving aggressively with tobacco control. 

“It is clear that tobacco control is effective, and we have a moral obligation to our people to move aggressively in order to achieve the Sustainable Development Goals,” said Krech.

“We are seeing great progress in many countries, which is the result of implementing tobacco control measures that are in line with the WHO FCTC, but this success is fragile. We still need to push ahead.” 

While one in three countries are likely to achieve the 30% reduction target, especially in low-income countries, upper-middle countries, on average, are making the slowest progress in reducing tobacco use. 

Some 29 countries lack sufficient data to know tobacco trends and need additional monitoring. 

WHO Meeting of the Parties to address illicit trade in tobacco products  

Starting also this week, in line with the release of the report and the investment case, is the Second Meeting of the Parties (MOP2) to the Protocol to Eliminate Illicit Trade in Tobacco Products.  

Up to $47 billion is lost globally to illicit trade in tobacco products. To further reduce this loss and improve the effectiveness of tobacco control legislation, representatives at MOP2 will consider ways of implementing the protocol, including securing the supply chain of tobacco products through tracking and tracing technologies.

Eliminating illicit trade could reduce cigarette consumption by almost 2% and increase tax revenues by an average of 11%. 

Ahead of MOP2, Head of the WHO FCTC Secretariat Adriana Blanco Marquizo highlighted the need to address illicit trade in tobacco, which has undermined global tobacco reduction efforts. 

“We have serious work to conduct at this meeting. Not only does the illicit trade in tobacco products undermine progress being made on taxing tobacco products, but illicit trade is linked to cross-border organized crime and other activities which threaten our security, ” she said. 


Discussions at MOP2 will be held from 15 – 18 November, days after the close of the Ninth Conference of the Parties (COP9), which convenes every two years to discuss ways in which the FCTC and its implementation can be improved. 

 

 

Image Credits: Johannes Zielcke, Mahdi Bafande/ Unsplash, Bastien Hervé / Unsplash.

Opening ceremony for the second meeting of the Protocol to Eliminate Illicit Trade in Tobacco Products (MOP2) at WHO headquarters in Geneva.

While it pales in comparison to tobacco industry marketing, two new capital investment funds worth some $75 million to support low- and middle-income countries in their fight against tobacco are being created by signatories to the Framework Convention on Tobacco Control and a related Protocol on illegal sales.  Together, the funds would yield an estimated $3 million a year for developing new systems to regulate, track and reduce tobacco use.

While all eyes last week were on the Glasgow Climate Conference (COP26), another Conference of Parties – on the Framework Convention on Tobacco Ccntrol (FCTC) was taking place in Geneva and virtually. 

The FCTC’s COP9 is being followed this week by a Meeting of Parties to a new FCTC protocol that aims to eliminate illicit trade in tobacco products.  That trade, including both physical and online sales,  is a growing concern of countries – because of its potential to undermine new tax laws and other measures that curb tobacco’s harmful influence. 

The first fund, for $50 million, was approved by the FCTC’s COP9 last week, at the close of the week-long meeting of the Convention’s 181 member states.  

The second fund, for $25 million, is being considered during this week’s meeting of signatories to a related FCTC Protocol to Eliminate Illicit Trade in Tobacco Products, which has now been ratified by 64 FCTC member states. 

The new capital investment funds, aim to recruit investors from beyond the health sector, and create annual yields of earned revenues that may be put at the disposal of countries to help them refine and adapt their policy and regulatory tools in the tobacco control battle, Samuel Compton, FCTC spokesperson, told Health Policy Watch.

The funds will bolster the long-term stability of FCTC activities – which currently rely upon a biennial budget of some $19.1 million, covered by assessed contributions to FCTC signatories, and extra budgetary support.

In terms of managing the funds it is likely that the World Bank make take over the task, Compton said, supported by a board of experts in financial and investment management representing the six World Health Organization Regions, as well as civil society.

Tobacco kills an estimated 8.1 million people a year, according to the most recent WHO numbers, including 7 million smokers and another 1.2 million people from second-hand smoke. 

And market projections show that industry continues to expand – with expected growth of over  % 2.7 this year.  This expansion is occurring despite evidence that consumption of traditional tobacco products, according to a 2019 WHO report. Although those reports have not included e-cigarette use in their tracking.  

Illicit trade driving market expansion

Illegally manufactured or trafficked tobacco products also driving market expansion.

Along with e-cigarettes, another one of the drivers of expansion is the illicit trade in tobacco products – which is easier than ever before thanks to online trade, says FCTC spokesperson Samuel Compton, told Health Policy Watch. 

“WHO estimates that eliminating illicit trade could reduce cigarette consumption by almost 2% and increase tax revenues by an average of 11%,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus, in his opening remarks to the meeting of members of the protocol (MOP2) the second such meeting to take place.

“The global tax revenue potential from eliminating illicit trade in tobacco is about 47 billion US dollars annually,” he added, noting that the illicit tobacco trade is rooted in a wide range of driving forces, including, “weaknesses in governance and regulation, corruption, insufficient enforcement capacity, and organized crime networks.”

It includes both the black market sale of legally produced tobacco products – as well as black market production of tobacco products.

Both types of products are marketed and sold in informal markets, and online, at prices that undercut legal, taxed tobacco sales.  Under the terms of the FCTC, such tobacco taxes are supposed to designed and use in a way that deters tobacco consumption as well as providing funds to support public health programmes to fight tobacco addiction and use.  

Added Adriana Blanco Marquizo, Head of the Secretariat of the WHO FCTC, in her opening remarks at Monday’s MOP: 

“We know the tobacco industry tries to mislead governments, using the illicit trade argument to oppose the adoption of highly effective tobacco control measures, like increasing tobacco taxes. Refraining from increasing taxes is not the solution. But implementation of the Protocol is. Parties should respond with a comprehensive strategy to fight illicit trade by fully taking up its provisions.

David and Goliath struggle with tobacco – parallels that of fossil fuels

All tobacco products, including electronic cigarettes, increase the risk of heart disease

Other than timing, there are other comparisons between the David and Goliath battle against big tobacco seen at COP9 and the battle to phase out fossil fuels waged at Glasgow’s COP26. 

While the oil and gas sector will earn about $2.1 trillion in 2021 – and were said to have the largest contingent of lobbyists at this year’s COP26 – climate conference participants failed to come up with a clear way forward to raise the estimated $100 billion annually in finance that low- and middle-income nations say that they need to fight climate change effectively – and wind down fossil fuel dependency more rapidly. 

Similarly, as compared to the tens of billions spent on marketing by the tobacco industry, which will earn revenues of $786 trillion in 2021, global and national budgets to fight big tobacco remain miniscule. 

Only about $66.2 million of international development assistance for health was dedicated to tobacco control activities in 2019, according to a 2020 analysis published in the peer-reviewed journal, Tobacco Induced Diseases. 

Considering that, along with the roughly $9.55 million annual FCTC budget, still leaves an estimated $27.4 billion funding gap in monies urgently needed to fight tobacco use, according to a 2019 report by the Framework Convention Alliance, FCA. 

Tracking and reporting on progress

And in the world of tobacco control, there are also challenges in tracking and reporting progress against global goals – comparable to those faced by countries tracking fossil fuel phase-out, or “phase-down” – as per the final language adopted by the Glasgow Climate Conference on Saturday.

For instance, while WHO says tobacco use worldwide is declining, recent WHO reports have tracked only smoked tobacco products – excluding the growing market in e-cigarette sales. 

And there are clear signs that e-cigarette use is on the rise, particularly among young people.

That raises questions about how much of the decline in tobacco use is real – and how much is merely a shift to another form of tobacco dependency?

At the same time, WHO points to progress made by countries in adopting more health-conscious tobacco legislation, regulation and taxing.  

“Even during the COVID-19 pandemic, there has been progress on tobacco control,” said Dr Tedros Adhanom Ghebreyesus, in his remarks to the MOP.

“5.3 billion people are now covered by one of the best practice tobacco control measures, including increased taxes on tobacco,” he said, referring to the WHO basket of best practices for health, tax and educational that countries can adopt to stop tobacco use. 

Image Credits: WHO/Pierre Albouy, Chris Vaughan, WHO.

A protest banner highlighting COP26’s exclusion of indigenous communities from talks.

While China and India’s last-minute refusal to commit to an end to fossil fuel at COP26 has caused depression and despair amongst many developing country delegates and climate activists, the mental health of millions is already severely affected by what climate disasters have done to their lives.

Humidity and heatwaves are linked to increased suicides, according to a new report released on Monday. Almost one-third of people caught in floods experience post-traumatic stress. Predicted massive climate-related conflict and increased climate migration are also triggers for mental distress.

“When we talk about the mental health impact of climate change, many people think I am talking about eco-distress and eco-anxiety but that’s not really what I’m talking about,” said psychiatrist Dr Lisa Page, co-chair of the UK Royal College of Psychiatry’s Planetary Health and Sustainability Committee.

Instead, said Page, she was referring to the direct and indirect impacts of climate crises on mental health.

“A systematic review that was published recently showed that around if you’re flooded, around 30% of people will develop post-traumatic stress disorder (PTSD) and probably around 20% of people will develop either depression or anxiety,” Page told a meeting hosted by the UK Royal College of Psychiatrists, Royal College of Paediatricians and Child Health Workers and Royal College of Physicians on the sidelines of COP26 last week.

Turning to heat, Page pointed to statistics from the UK Office for National Statistics for summer 2020 which showed that all-cause mortality went up during each of the three recorded heatwaves, with over 2500 excess deaths in England alone.

“That’s mostly in the over 65. But we know from other evidence that it’s not just the frail elderly. It is also people with major mental illness, examples being dementia, severe and enduring illnesses like psychosis, and people with substance misuse problem,” said Page.

Monday’s report in Nature, based on data from 60 countries between 1979 and 2016, found statistically significant increases in suicide – but related to more to humidity than heatwaves. Women and younger people were particularly affected, and the countries affected were as varied as Sweden and Guyana.

One of the scientific reasons advanced for this is that some medicines for mental health inhibit the body’s ability to effectively thermoregulate. This results in heat stress and the exacerbation of certain mental health conditions, including bipolar ‘disorders’, schizophrenia, dementia and developmental ‘disorders’ including autism.

Page cited indirect impacts such as loss of land, forced migration, and changes patterns in infectious diseases as possibly more significant than heat and floods.

“Forced migration, particularly migration that might involve unexpected migration, or migration after conflict, has very significant and very serious effects on mental health, and can  lead to higher incidence of psychosis, for example, in migrating populations,” said Page.

“There have been recent dire predictions about increases in conflict as a result of climate change and I can’t think of any other human activity that leads to more mental disorder than conflict,” said Page. “And finally, we get to eco-distress and eco anxiety.”

What about grief and loss?

Child psychiatrist Dr Lynne Jones, has been establishing and running mental health programmes in conflict areas and after natural disasters since 1990, including Iraq, Sierra Leone, Ethiopia, Uganda, post-tsunami Indonesia, post-Earthquake Haiti and with migrants in Europe and Central America.

“For millions of people, climate change is not a future threat but a current catastrophe,” said Jones, speaking from Bosnia where she is working with migrants. 

“Climate-fuelled disasters were the number one driver of internal displacement in the last decade. The word climate change is totally inadequate. These disasters are the result of climate breakdown and ecological collapse and I prefer the term planetary crisis to encompass both.”

In 2020, Central America suffered the worst Atlantic hurricane season ever recorded, which displaced more than half a million people, while Madagascar has been in a climate-induced famine for the past four years, said Jones.

“The developing brain needs adequate nutrition, maternal love, play and stimulation. And if any of these absent, there’s likely to be lifelong damage and an enormous loss of human potential,” stressed Jones.

Jones worked in a refugee camp in Chad following a climate-induced conflict and was struck by how mothers were too depressed and lacking in energy to interact with their babies.

“I know that PTSD and traumatic stress and acute stress problems are a major issue of the conflict. But what doesn’t get talked about, as a direct effect of conflict and disaster, is grief and loss. It is the most important mental health effect. It’s not a disorder,” said Jones.

“The problem is how do you mourn if you can’t hold a funeral because your house has been destroyed? Or all the neighbours are also mourning and feel they can’t come because they’re dealing with their own grief so you don’t have that community connection? And what if there’s no body because it was lost at sea, or buried in a mass grave, or abandoned in flight? These are the problems of grief and loss that I don’t see discussed?”

Image Credits: Disha Shetty .

A French official checks a woman’s COVID-19 certificate, providing evidence of vaccination or a recent PCR test.

It may be too late for many European countries to avoid harsh measures to try to curb the intense transmission of COVID-19, according to World Health Organization (WHO) officials on Friday.

“Almost two million cases of COVID-19 were reported in Europe last week, the most in a single week in that region since the pandemic started,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s media briefing.

“Almost 27,000 deaths were reported from Europe, more than half of all COVID-19 deaths globally last week.”

High rates of infections are being experienced both in more vaccine-hesitant countries in Eastern Europe, as well as in countries with some of the world’s highest vaccination rates in Western Europe – reflecting the fact vaccinations alone are not enough to halt the virus, according to the WHO.

A number of European countries have already started to clamp down on public activities. The Netherlands is poised to introduce a three-week partial lockdown including a 7pm closing time for restaurants this weeked, while Austria expects to introduce more restrictions on unvaccinated people.

Last month, Russia – part of the WHO Europe region – ordered all unvaccinated people over 60 and with underlying conditions to stay at home until February as it battles its worst case load amid vaccine hesitancy.

At least 12 European countries including Italy, France, Germany, Portugal, Greece and Belgium now require people entering public places such as restaurants, museums and concernts to show proof of vaccination or a recent test with a COVID digital certificate, with Denmark being the most recent to introduce such a measure this week. Some countries are also applying the passes in workplaces, particularly schools and health facilities.  

Restrictive measures

“Quite frankly, some countries are in such a difficult situation now that they’re going to find it hard not to put in place restrictive measures at least for a short period of time to reduce the intensity of transmission,” said Dr Mike Ryan, WHO’s head of health emergencies.

“Other countries can re-engage with communities around masks, around avoiding crowded spaces, around limiting their contact with others, work from home and many other initiatives and very importantly increasing vaccine coverage in high-risk populations,” stressed Ryan.

However, each country would have to assess their own unique situations – weighing vaccination levels and “what level of compliance can be expected from the implementation of personal measures versus government-mandated measures”, he added. 

Predictable surge after curbs lifted

WHO’s COVID-19 lead, Dr Maria Van Kerkhove described the surge in Europe as “predictable” given that most restrictions on social mixing and masks had been lifted.

However, the European surge was also showing “quite strongly how effective vaccines actually are in terms of reducing hospitalizations and reducing deaths”, she added.

New research from the UK has shown that an unvaccinated person has a 32 times higher risk of death than a vaccinated person, said Ryan, but these vaccines had to reach the most vulnerable people.

Places with high vaccination rates of vulnerable people were seeing cases increase but this had not translated into pressure on health systems. But in countries where there were significant pockets of vulnerable people unvaccinated, the same incidence or even lesser incidence of disease will lead to pressure on the health system, added Ryan.

WHO remains opposed to boosters in Europe

Despite the stiff WHO warnings about the possible need for stricter lockdown measures, WHO officials have continued to recommend against the wider uptake of booster shots in Europe or other high-income countries.

WHO has maintained that there is insufficient evidence for boosters, which also divert vital vaccine supplies from countries that haven’t even yet had one jab.  And on Friday Tedros once again appealed for a moratorium on boosters until the end of 2021, so that available doses can be channelled to countries that have not yet reached the WHO goal of 40% vaccination coverage.  He pointed out that, every day, there are six times more boosters being administered globally than first or second doses in low-income countries.

Even so, it appears that boosters are being administered with ever increasing frequency in high-income countries seeing surges – with 92 high- to -middle income countries initiating booster programmes for at least some population groups.

US Chief Medical Officer Anthony Fauci recently hailed the successful Israeli booster campaign as a model that others will have to follow. Israel was one of the first countries to initiate mass administration of boosters in August after it became clear that vaccine immunity from the first two shots had waned significantly after five month. The campaign  drove down new infections from one of the word’s highest levels to levels below that of almost any country in Europe or North America today.

There are now signs that boosters are helping to reduce new infection rates and hospitalizations in the United States, although they are only available to people over age 65, and at least stabilise persistently high rates in the United Kingdom, where people over age 50 can now get a third jab.

According to WHO, 25% of the doses administered every day worldwide are now booster doses, as compared to only 5% two weeks ago.

WHO remains mum on COVID-passes requiring proof of vaccination or testing

Resistance to both lockdowns, as well as much milder measures “COVID pass” rules, is strong in a number of European countries. Large protest rallies have taken place recently in a number of Swiss, German and French cities.

In Switzerland a national referendum is planned for 28 of November to vote on whether to maintain the new system of COVID passes required in almost any indoor venue outside of a private home.

Scope of Switzerland’s COVID Pass

In anticipation of the vote, a series of large demonstrations have been underway – protesting the COVID certificates that are the main focus of controversy. French and Italian opponents of COVID certificates also are eyeing the Swiss debate and the precedent that may take shape on referendum day.

WHO has largely recommended against the use of COVID vaccine or PCR test passes for international travel – pointing to the inequalities between rich and poor countries in accessing vaccines.

But it has refrained from entering into the fray over domestic use of COVID certificate in countries where vaccines are universally available.

Asked about the issue by Health Policy Watch, a WHO spokesperson responded Friday evening saying that the organization was “still checking” for a response.

–Elaine Fletcher contributed to this story

  • Updated 14.11.2021

Image Credits: Mat Napo/ Unsplash, https://www.ge.ch/en/covid-19-certificate/scope-covid-certificate.

moderna

Moderna has fired back against claims made by US National Institutes of Health (NIH)  that its scientists at the National Institute of Allergy and Infectious Diseases (NIAD) helped to invent the crucial component of the pharma company’s COVID-19 vaccine, stating that the mRNA sequence was “selected exclusively” by Moderna scientists. 

“We do not agree that NIAD scientists co-invented claims to the mRNA sequence of our COVID-19 vaccine,” a tweet from a thread on intellectual property by the company said on Thursday.

The thread continued: “The mRNA sequence was selected exclusively by Moderna scientists using Moderna’s technology without input of NIAID scientists, who were not even aware of the mRNA sequence until after the patent application had already been filed.” 

However, Moderna does recognize the “substantial role that the NIAID has played in helping to develop Moderna’s COVID-19 vaccine,” and has said that it has, in fact, included NIAID scientists as co-inventeres on published patent applications where they have made inventive contributions.  

Genetic sequencing dispute; Moderna turned ‘people’s vaccine into rich people’s vaccine’ 

In a story first reported by the New York Times on Tuesday, Moderna had excluded three NIH scientists as co-inventors of a central patent for the company’s COVID-19 vaccine in its application filed in July. 

But the NIH has asserted that three of its scientists at the NIAD, Dr John Mascola, Dr Barney Graham, and Dr Kizzmekia Corbett, helped design the genetic sequence used in Moderna’s vaccine, and should be included on the patent application. 

Had federal researchers been named as co-inventors in the patent, the government would have almost exclusive right to license the vaccine to other manufacturers, opening access to low- and middle-income countries who are still lagging behind in vaccination rates. 

“Recognition as the vaccine’s joint inventor can help the U.S. government finally responsibly steward the vaccine’s use, including by helping secure access for the billions of people still awaiting a safe path out of the pandemic,” said Peter Maybarduk, director of US-based advocacy group Public Citizen’s Access to Medicine, in a statement.

“But Moderna has turned this people’s vaccine into a rich people’s vaccine; refusing to share technology with WHO or developing country manufacturers and sharing very few doses with COVAX while overcharging poor nations.”

Both Moderna and Pfizer have been lambasted by WHO’s Director General Dr Tedros Adhanom Ghebreyesus in the past for offering and planning COVID boosters while billions in LMICs await their first jab.

NIH not backing down from claims

Speaking to Reuters, NIH Director Dr Francis Collins made clear that the NIH, the government’s biomedical research agency, was not backing down. 

 “I think Moderna has made a serious mistake here in not providing the kind of co-inventorship credit to people who played a major role in the development of the vaccine that they’re now making a fair amount of money off of.”

Advocacy group Public Citizen has pointed out Moderna’s failure to name NIH scientists as joint inventors, imploring NIH to “ensure the contributions of federal scientists are fully recognized,” in a letter to Director Collins last week.  

“NIH is showing a modicum of verve at last, suggesting it will not allow federal scientists’ role in the invention of the NIH-Moderna vaccine to be erased,” said Maybarduk. 

Moderna has received around $10-billion in US government money to develop its vaccine but has not responded to US government pressure to share the vaccine technology with low and middle-income countries.

Image Credits: Gavi .

covaxin
Covaxin

Following World Health Organization approval last week, interim data from a phase 3 trial of BBV152, a COVID-19 vaccine developed in India, reports 77.8% efficacy against symptomatic COVID-19. 

The study, published in The Lancet, indicated that BBV152 induced a robust antibody response, with the majority of adverse events, including headache, fatigue, fever, and pain at the injection site, were mild and occurred within seven days of vaccination. 

BBV152, also known as Covaxin, is an inactivated whole virion vaccine developed by India-based Bharat Biotech. The vaccine has recently received emergency use approval (EUL) from WHO for people aged 18 and older, and is administered in a two-dose regimen, 28 days apart. 

The trial conducted an efficacy analysis of 24,419 randomly-assigned participants across 25 hospitals in India who received either two doses of the vaccine or a placebo between 16 Nov 2020 – 17 May 2021.

Vaccine cold-chain requirements make it suitable for low- and middle-income countries

covaxin
Covishield and Covaxin Drive in India

Covaxin’s ability to be stored and transported between 2-8 degrees Celsius has made it suitable for  low- and middle-income countries.

Jing-Xin Li and Feng-Cai Zhu of the Jiangsu Provincial Center for Disease Control and Prevention in China, who were not involved with the study, say “the roll-out of BBV152 might ease the ultra-cold chain requirements of other SARS-CoV-2 vaccine platforms, increase the finite global manufacturing capacity, and improve insufficient supply of vaccines which disproportionately affects low-income and middle-income countries.” 

Bharat Biotech said the WHO EUL approval will help countries “expedite their regulatory approval processes to import and administer Covaxin.” 

“It allows procurement by UNICEF, the Pan-American Health Organization (PAHO), and the GAVI COVAX for distribution to countries in need,” a company press release said. 

The Gavi managed COVAX global vaccine facility has not  yet  signed an agreement with Bharat Biotech, with India delaying committing supplies to the COVAX global sharing effort, sources told Reuters.  

The world’s biggest vaccine maker resumed exports of COVID-19 doses in October, for the first time since April. It has sent about 4 million doses to countries such as neighboring Bangladesh and Iran, but none to COVAX.  

The vaccine has, however, been distributed widely already in India, with 121 million doses administered since the beginning of the country’s big COVID surge in the spring of 2021. 

Covaxin gears up for major distribution abroad 

Airfinity’s COVID Vaccines Revenue Forecasting predicts 545 million Covaxin doses to be sold to low-middle-income countries in 2022.

Following the WHO approval and publication of its Phase 3 results, Covaxin is gearing up for major distribution abroad.

Airfinity’s COVID-19 Vaccine Market Forecast 2021 – 2022, which covers global demand scenarios, supply and production, and revenue of COVID vaccine, has predicted 545 million Covaxin doses will be sold to low-middle-income countries in 2022.

As many as 96 countries have already recognized Covaxin, with Hong Kong the latest to approve the vaccine for international travelers. 

Canada, the US, Australia, Spain, the United Kingdom, France, Germany, Belgium, Russia, and Switzerland, are among the 96 nations to recognize both Covaxin and Covishield, another India-manufactured vaccine. 

Further research needed against COVID-19 variants 

The next step for studies of BBV152, noted Li and Zhu, should be long-term monitoring of vaccine efficacy against COVID-19 and its efficacy against variants. 

This is to “identify whether the vaccine provides ongoing protection when any variation of concern replacement (other than the variants of concern investigated in the study) has occurred,” they said. 

Preliminary analysis of efficacy found Covaxin to be 65% effective against symptomatic COVID-19 from the delta variant. 

Additionally, there was no decrease in efficacy against the alpha variant (B.1.1.7) and marginal reductions in efficacy against other variants of concern, including delta and gamma variants.

Image Credits: Mohammed Naseeruddin/Twitter, Airfinity.