Leading suicide prevention organizations highlighted the need to decriminalize suicide and invest in suicide prevention strategies, as suicide causes one in every 100 deaths globally.

The leading international organization for suicide prevention has called for the decriminalization of suicide – as well as greater investment by countries in suicide prevention, including greater restrictions on access to common suicide tools such as toxic  pesticides and firearms. 

The appeals, by the International Association for Suicide Prevention (IASP) and endorsed by the World Health Organization (WHO), come on World Suicide Prevention Day, observed every year on 10 September. 

Suicide is among the leading causes of death worldwide. The COVID-19 pandemic has exacerbated the risk factors associated with suicidal behaviors and highlighted the grave need for national prevention plans, said Dr Rory O’Connor, President of IASP, in a statement. 

“Raising awareness of suicide can help to strengthen our understanding and reduce the stigma surrounding suicide,” he noted. “This in turn helps to break down the many barriers to people seeking help… [and] can also help create a more accepting society.”

Globally, 703,000 people die by suicide every year – accounting for one in every 100 deaths. Suicide causes more deaths than malaria, HIV/AIDS, breast cancer, or war and homicide. 

Among young people aged 15 to 29, suicide was the fourth leading cause of death in 2019. 

Decriminalization can open up access to services 

But suicide also is currently a criminal offence in 20 countries and those who have attempted suicide can be arrested, prosecuted, and punished with fines and one to three years in prison, found a new report published by IASP and United for Global Mental Health on 8 September.

“Criminalizing suicide is counterproductive,” said IASP. “It does not deter people from taking their lives, but it does deter them from seeking help in a moment of crisis. Suicide must be decriminalized.”

Decriminalization plays a pivotal role in amplifying access to suicide prevention services – removing stigma associated with people with suicidal thoughts or behaviours. 

This, combined with investments in mental health services and measures that restrict access to suicide “weapons,” can enable people to receive emergency lifesaving treatment – and facilitate the longer-term diagnosis and treatment of mental health conditions. 

“We cannot – and must not – ignore suicide,” said Dr Tedros Adhanom Ghebreyesus, Director-General of WHO, in a statement  in June. “Each one is a tragedy. Our attention to suicide prevention is even more important now, after many months living with the COVID-19 pandemic, with many of the risk factors for suicide – job loss, financial stress and social isolation – still very much present.”

Banning pesticides, training healthcare workers, and decriminalizing suicide

Earlier this summer, WHO published a comprehensive implementation guide for suicide prevention to encourage countries to develop national prevention strategies.  

WHO’s LIVE LIFE approach to suicide prevention includes four strategies: 

  • Regulations restricting access to means of suicide – including firearms as well as deadly pesticides that are often used for self harm in the developing world; 
  • Early identification, assessment, management, and follow-up of people affected by suicidal thoughts and behaviors; 
  • Fostering adolescent social-emotional skills; 
  • Educating the media on responsible reporting on suicide. 
WHO’s LIVE LIFE approach to suicide prevention.

“Suicide is an urgent public health problem and its prevention must be a national priority,” said Renato Oliveira e Souza, head of the Mental Health Unit at the Pan American Health Organization, in a press release. “We need concrete action from all elements of society to put an end to these deaths, and for governments to create and invest in a comprehensive national strategy to improve suicide prevention and care.”

Currently only 38 countries have a national strategy for suicide prevention. 

According to suicide prevention activists, there is a historic opportunity to push for reforms in light of the commitments to achieving the Sustainable Development Goals – one of which is the reduction of suicide – and the WHO Mental Health Action Plan 2020-2030. 

In low- and middle-income countries, countries have been called to ban or severely restrict access to acutely toxic and highly hazardous pesticides, which are often widely available on the market, and cause 20% of all suicides worldwide.  Globally, restricting access to firearms, reducing the size of medication packages, and install barriers at jump sites after other critical measures. 

Training for healthcare professionals in early identification, assessment, management, and follow-up is necessary to support those at risk of suicide. 

Image Credits: WHO, WHO.

Integration of care is important for patients’ wellbeing.

Health services in low and middle-income countries have yet to adapt to their growing burden of non-communicable diseases (NCDs) and still prioritise infectious diseases, according to a new report launched on Thursday by the NCD Alliance.

Treatment “silos” for HIV and tuberculosis need to be transformed into integrated universal healthcare services to better serve people in LMICs, many of whom are living with both infectious diseases and NCDs, according to the report.

“COVID-19 has brought about a greater recognition that the long-held distinctions between infectious and non-communicable diseases are not as clear cut as once thought – those with chronic conditions have a significantly higher risk of hospitalisation or death from the virus,” according to the NCD Alliance. 

The vast majority of people who have become seriously ill or died from COVID-19 had an underlying condition, particularly hypertension, cardiovascular disease and diabetes, it notes.

Integrated care ‘is the future’

“We urgently need a reset of healthcare delivery in poorer countries that actually reflects the needs of those who need it most,” said Katie Dain, CEO of the NCD Alliance. 

“Integrated care is the future of healthcare. The reality today is that ever more people are living with multiple chronic conditions. This needs to be better recognised in health systems. 

Dain added that infectious diseases and NCDs were entwined: “People living with HIV have a significantly higher risk of cardiovascular disease and some cancers. People living with TB are much more susceptible to diabetes and vice-versa. 

“Hypertensive disorders and gestational diabetes affect many pregnancies, risking potential lifelong health impacts for both mother and child if not effectively treated.”

“LMICs are experiencing a rapid transition from population disease profiles shaped by communicable diseases and conditions impacting mothers and their children, to those dominated by NCDs and injuries. Today, 85% of people dying from NCDs between ages 30 and 70 are in LMICs,” according to the NCD Alliance.

One in three diseases among the poorest billion people in the world are NCDs, according to the Lancet NCDI Poverty Commission.

Cardiovascular diseases account for most NCD deaths (17.9 million people annually), followed by cancers (9.3 million), respiratory diseases (4.1 million), and diabetes (1.5 million). These four groups of diseases account for over 80 percent of all  NCD deaths before the age of 70.

“Health centres that reflect this changing epidemiology are the future,” said Dain. “But this will also mean that we have to change the way we do business. The COVID-19 pandemic has been catastrophic for people living with NCDs and it is clear we need a health infrastructure in LMICs that is fit for purpose if we are to build back better.”

HIV, TB funding influences health system

The report’s lead author, Dr Gill Schierhout from the George Institute for Global Health, said that many LMIC health systems were still influenced by funding for HIV, TB, malaria and maternal health.

“The shape of this [funding] has critical impacts on the health care available – or not available – for the growing number of people who are living with NCDs in LMICs,” said Schierhout.

The report was based on an online survey that was sent to health workers in LMIC. Survey respondents identified that there were particular challenges posed by staffing siloes, and organisational ambivalence around the integration effort.

In addition, specialist managers of global health initiatives are sometimes “well versed in disease-focused areas, but not as well versed in whole-of-person care or primary health care. Therefore, programmes often struggle to gain the necessary management support”, according to the report.

However, the report documents a number of integration  successes. In Zambia, for example,  a cervical cancer screening has been integrated into an HIV care programme. It modelled that, for every 46 HIV-positive women screened, a woman’s life was saved who otherwise would likely have died of undetected cervical cancer.

More than a decade ago Ministers of Health resolved at the first UN High-Level Meeting on NCDs to “encourage the development, integration and implementation of vertical programmes, including disease-specific programmes, in the context of integrated primary health care”. 

“However, progress in this area has been patchy at best,” noted the NCD Alliance.

 

 

Image Credits: NCD Alliance, WHO/A. Loke.

Ethiopia vaccines
AstraZeneca COVID-19 vaccine arrive at Bole International Airport in Addis Ababa, Ethiopia, in March.

As Africa prepares to get even fewer COVID-19 vaccines than expected in the coming months thanks to the supply shortage at COVAX, the continent is also battling with vaccine hesitancy – exacerbated by the lack of vaccinated role models.

Africa could receive 155 million fewer vaccines than expected this year from the global vaccine platform, COVAX, which announced on Wednesday that it has had to cut its supply forecast by 25% as it has been affected by export bans, particularly from India, bilateral deals between manufacturers and countries, production challenges and delays in vaccine regulatory approval. (COVAX had previously said it will provide 520 million doses to the WHO Afro region by the end of the year.)

As a result, said Dr Matshidiso Moeti, head of the World Health Organization (WHO) Africa, the continent would have to continue to rely on economically crippling lockdowns, and other public health prevention measures instead of vaccinations to control the pandemic.

However, Moeti also conceded that the continent was facing vaccine hesitancy in some countries, notably the Democratic Republic of Congo (DRC) – which is also battling a meningitis outbreak.

“It’s true that vaccine rejection, denial, has been a strong feature of the response in the DRC,” Moeti told a WHO Africa media briefing on Thursday. 

“The demand was so little that the country, at some point had to redistribute some vaccine supplies that it had been provided for to other countries.

“Some surveys have shown that [vaccine hesitancy] has started to shift in other countries as the vaccines have been rolled out more and more people are interested now in getting vaccinated,” she added.

This was partly because people who have already been vaccinated can act as “role  models” to show that vaccines are safe, can prevent severe illness and death, she said.

Dr Matshidiso Moeti, head of the World Health Organization Africa region.

Only 20 African countries may reach 10% target this month

But vaccinated Africans currently make up a tiny minority.

“As of today, Africa as a whole has received around 138 million doses only,” said Dr Richard Mihigo, WHO’s Program Area Manager for Immunisation.

 “Only around 40 million people have received the two doses that are required to be fully vaccinated, and this represents merely 3% of the African population.When you look at sub-Saharan Africa, it’s around 1.7%,” added Mihigo.

Fewer than 20 out of the 54 African countries were likely to reach the WHO target of 10% of their population vaccinated by the end of this month, he added.

However, Mihigo said that despite the COVAX shortfall, vaccine supply was fluid and the continent could still get the vaccines it needed to vaccinate 40% of Africans by the end of the year, WHO’s next target.

Meanwhile, Moeti stressed that increasing vaccine supply was the biggest priority for the country.

She noted that while COVAX had recently supplied around five million vaccines to Africa, three times as many doses – 15 million had been thrown away in the US due to wastage.

“This is enough vaccines to cover everyone over 18 years in Liberia, Mauritania, and the Gambia,” she observed. “Every dose is precious and has the potential to save a life.”

She noted that, while high-income countries have pledged to share one billion doses globally, and so far 120 million doses have been released.

Prioritize vaccine equity

“Manufacturers are now producing 1.5 billion COVID vaccine doses globally each month, and two billion doses are required to reach 40% of people in every country. If producing countries and companies prioritise vaccine equity, this pandemic, can be over quickly,” she noted.

However instead, COVAX had announced that its shipment forecast for the rest of the year had been revised downwards by 25% “in part because of the prioritisation of bilateral deals over international solidarity”, she said. 

“G20 Health Ministers this week expressed their support for the global 40% vaccination target. This goodwill needs to be accompanied by concrete actions and financing for the global fight against COVID-19, to succeed,” she added.

Image Credits: UNICEF, WHO.

COVID booster vaccines have gained traction in several countries – US, Israel, Germany, UK, and others, but low- and middle-income countries lag significantly behind in shots.

The World Health Organization (WHO) has called for its global moratorium on COVID-19 boosters to be extended until the end of the year to enable vaccines to be directed to countries that have not yet been able to reach their vulnerable citizens.

“A month ago, I called for a global moratorium on booster doses at least until the end of September to prioritise vaccinating the most at-risk people around the world who are yet to receive their first dose,” WHO Director-General Tedros Adhanom Ghebreyesus told the body’s media briefing on Wednesday.

“There has been little change in the global situation since then, so today I am calling for an extension of the moratorium until at least the end of the year, to enable every country to vaccinate at least 40 percent of its population.”

The WHO’s global target is for every country to vaccinate at least 10% of its population by the end of this month, at least 40% by the end of this year and 70% of the world’s population by the middle of next year – but the September target so far is likely to be missed due to the failure of rich countries to donate sufficient doses to low- and middle-income countries.  And current commitments to COVAX, the WHO co-sponsored global vaccine facility, are running several hundred million doses short of the 40% end-year goal. 

Dr Kate O’Brien

Dr Kate O’Brien, WHO’s director of immunisations, also stressed that there was neither scientific consensus nor enough evidence to support giving COVID-19 boosters.

“We’re not asking [countries] to withhold something for which there is a strong set of evidence,” said O’Brien. “The vaccines are holding up very, very well against the severe end of the disease spectrum. The actual focus of the vaccine programme is to prevent severe disease, hospitalizations and deaths, and we see in the evidence that, in fact, the vaccines are performing extremely well over time, and against the variants,” she said. 

According to a technical report issued by the European Centre for Disease Prevention and Control (ECDC) last week, “based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population” but that ”additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination”.

“We will continue to watch the evidence very carefully, but our expert advisory committees continue to see that there is not a compelling case to move forward with a generalised recommendation for booster doses,” added O’Brien.

No more promises, just vaccine delivery

Tedros hit out at high-income countries that have promised to donate more than one billion doses as “less than 15 % of those doses have materialised”. 

“Manufacturers have promised to prioritize COVAX and low-income countries. We don’t want any more promises. We just want the vaccines,” Tedros added.

Although 5.5 billion vaccine doses have been administered globally, 80% have been administered in high- and upper-middle-income countries, according to the WHO.

Reiterating his weekend appeal to G20 health ministers, Tedros said that “the world’s largest producers, consumers and donors of vaccines, the world’s 20 leading economies, hold the key to vaccine equity and ending the pandemic”.

They could do so by swapping their near-term vaccine deliveries with COVAX, fulfilling their dose-sharing pledges by the end of this month and “facilitating the sharing of technology, know-how and intellectual property to support regional vaccine manufacturing”, he added.

WHO’s Bruce Aylward

Dr Bruce Aylward, the WHO representative on COVAX, said that despite promises made by the G7 and others, the global vaccine platform had to reduce its supply forecast this week as there had been a 25% reduction in the number of doses that will go through COVAX – unless there is urgent action by the world’s G20 countries and vaccine manufacturers. 

“People have come out and said, ‘Well, it’s only 100 million doses if we do boosters’, but we’ve just had to downgrade supply by a few 100 million doses. It makes a real difference in the face of scarcity,” added Aylward.

“To get all the world to 40% [vaccination] coverage in every single country requires two billion doses of vaccine,” he added.  

According to its latest Supply Forecast, COVAX expects to have access to 1.425 billion doses of vaccine in 2021 “in the most likely scenario and in the absence of urgent action by producers and high-coverage countries to prioritize COVAX”.

COVAX supply forecast, 8 September 2021

COVAX added that its work was being hampered by “export bans, the prioritisation of bilateral deals by manufacturers and countries, ongoing challenges in scaling up production by some key producers, and delays in filing for regulatory approval”.

Tedros ‘appalled’ by IFPMA comments

Tedros also lashed out directly at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), for comments made in an media briefing on Tuesday.

He complained that the IFPMA was calling for dose-sharing with poorer nations – but only after rich countries had vaccinated virtually everyone who wanted a jab.

“Yesterday, the IFPMA said that G7 countries now have enough vaccines for all their adults and teenagers, and to offer booster doses to at-risk groups, and that manufacturing scale-up should now shift to delivering global vaccine equity, including dose sharing,” said Tedros.

“When I read this, I was appalled,” said Tedros. “In reality, manufacturers and high-income countries have long had the capacity to, not only vaccinate their own priority groups, but to simultaneously support the vaccination of those same groups in all countries.

“We have been calling for vaccine equity from the beginning, not after the richest countries have been lower-middle-income- and lower-middle income countries are not the second or third priority. Their health workers, older people, and other at-risk groups have the same right to be protected. I will not stay silent when the companies and countries that control the global supply of vaccines think the world’s poor should be satisfied with leftovers,” Tedros said.

In the IFPMA statement, the pharmaceutical body stated that: “The biopharmaceutical industry continues to call for dose sharing and renew its commitment to work with governments to support their efforts.

“From now on, G7 countries have sufficient stocks of doses to vaccinate adults, teenagers and roll out boosters programmes to protect the most at-risk groups as well as substantially increase the number of doses available to low- and lower-middle-income countries. Political leadership is critical to enable dose deliveries as quickly as possible.

“Reducing the toll of the pandemic on lives and livelihoods requires equitable access to vaccines and country readiness for vaccination.”

WHO Director General Dr Tedros Adhanom Ghebreyesus.

Aylward, meanwhile, took a less combative position, recognising that vaccine inequity was no longer an issue of supply constraints.

“We had the IFPMA came out yesterday and said ‘Look, global production is 1.5 billion doses a month now’. The absorptive capacity of the world is less than a billion right now… So, the volumes are there. This is a fixable problem, but it’s only going to get fixed if the political will and the will of the manufacturers come together to solve it,” he said.

Israel, currently facing one of the highest infection rates in the world due to a Delta variant surge, has already implemented boosters shots for any residents who got their jabs more than five months ago.  And the White House has also announced it would begin offering boosters in September for everyone immunised eight months ago or longer – although regulatory authorities are still debating authorization of the plan. Several other countries including France, Germany, Thailand and the United Arab Emirates are offering boosters.

But Aylward noted that many other countries had already consulted the WHO on whether booster policies can be delayed. 

“Some countries may be going ahead with [booster] decisions, others may not. But our role is to make sure that we put forward the strongest possible arguments for the way out of this pandemic, and the way out is an extended moratorium because, since the last time we called for it, the equity gaps have got greater, the amount of vaccine available in low-income countries has gone down,” he added.

Recognise all WHO-listed vaccines

Tedros also condemned the refusal of some countries to allow travellers who have been fully vaccinated with a vaccine that has WHO Emergency Use Listing (EUL) entry on the basis that their vaccines have not been approved by their national regulators.

“WHO Emergency Use Listing follows a rigorous process based on internationally recognized standards. All vaccines that have received WHO Emergency Use Listing are safe and effective in preventing severe disease and death, including against the Delta variant,” said Tedros, urging all countries to recognize all vaccines with WHO EUL.

This follows reports that some European countries are still not allowing travellers vaccinated with Covishield, the AstraZeneca vaccine produced by the Serum Institute of India, to enter their countries – even though the European Union has approved the AstraZeneca vaccine made elsewhere.

 

Image Credits: Marco Verch/Flickr.

Vials of the Pfizer-BioNTech COVID-19 vaccine.

COVID-19 vaccine manufacturers are expected to produce 12 billion doses by the end of the year – almost half made by China – and there could be a vaccine surplus by mid-next year.

In addition, by the end of this month, around 500 million doses should be ready for “redistribution” from wealthy to low-and middle-income countries.

This emerged at a media briefing organised by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Tuesday.

“By January 2022, there will be sufficient vaccines produced for every adult on every continent,” according to IFPMA.

“Modelling by Airfinity indicates that even if vaccine advisory committees and governments in G7 countries vaccinate teenagers and adults and decide to give boosters to at-risk populations, there would still be over 1.2 billion doses available for redistribution in 2021 alone. This means that each month for the foreseeable year, over 200 million doses would be, with effective planning, available for low- and lower-middle-income countries,” it added.

 

Describing the vaccine production increase as “absolutely extraordinary”, Rasmus Bech Hansen, CEO of research forecast group Airfinity, said that it had been “a surprise to pretty much everyone how fast China has scaled up vaccine production”.

Hansen added that, even when third booster shots for citizens in high-income countries were factored in, Infinity estimated that, “by the end of September, there will be around 500 million doses available in the US, UK, European Union and Canada that could be redistributed” through donations, swaps or reselling.

“In the last G7 summit, one billion doses were pledged [to LMIC] and it actually seems that these stocks will be available by the end of the year so G7 countries could meet those pledges,” he added.

IFPMA Director General Thomas Cueni told the briefing that ‘by June 2022, we expect that we will have more than 24 billion doses of COVID-19 vaccines available”.

IFPMA Director General Thomas Cueni

“At this point, vaccine supplies may actually outstrip global demand,” added Cueni. “Vaccine manufacturers are now producing 1.5 billion doses per month, and are expected to continue manufacturing at that scale on the basis of the most conservative protection projections.”

Hansen noted that 73% of the production increases were the result of pharmaceutical companies enhancing their in-house capacity, supported by an array of collaboration agreements within the industry – Affinity had counted 231.

Pfizer doses mostly allocated for next year 

Pfizer CEO Dr Albert Bourla said that his company had doubled its production capacity in the past six months and was on track to produce three billion doses by the end of the year, thanks to “sleepless nights, and a lot of effort from thousands of people”.

While it was testing a version of its vaccine that had been tweaked to combat the Delta variant, Bourla said this didn’t seem necessary as the current vaccine is highly efficacious.

One of the key challenges Pfizer faced in scaling up was access to raw material to make it’s mRNA vaccine.

“We literally created new suppliers” by giving companies financial, scientific and technical support, said Bourla.

However, in response to a Health Policy Watch question, Bourla dismissed joining the mRNA technology transfer hub established recently in South Africa by the World Health Organization (WHO) to assist Africa to develop its own mRNA vaccines.

Pfizer CEO Dr Albert Bourla

“I’m not sure what is the point of transferring technology that it is going to take years to transfer. And, by the way, this is what we do. I’m not sure I understand what they want, to give it someone else to do?” asked Bourla.

Pfizer expects to make four billion doses in 2022, but Bourla but urged all countries to place their vaccine orders as soon as possible.

“We have allocated doses already for this year and frankly, we have allocated a very big part of the doses that we are going to be producing next year also to countries that they have placed orders for these doses,” said Bourla, adding that 41% of this year’s production had been allocated to LMICs.

Bourla said most orders for 2022 were from high-income countries, with boosters fueling demand. While Pfizer would like to allocate at least one billion doses to LMIC for 2022, it had  yet to receive orders for this amount.

“When it comes to the ability to pay, we implemented tiered pricing. High-income countries were receiving one tier of pricing, mainly the cost of a meal in their country. Middle-income countries received half of this price, and the low-income countries received doses at cost,” said Bourla, who is also IFPMA’s vice-president.

Johnson & Johnson has policy of technology transfer

Dr Paul Stoffels, Chief Scientific Officer for Johnson & Johnson

Dr Paul Stoffels, Chief Scientific Officer for Johnson & Johnson, said that his company had established a global vaccine manufacturing network across four continents with 11 manufacturing  sites

“We made a commitment to equitable access and committed by putting a billion doses forward for low and middle-income countries in the next 12 to 18 months,” said Stoffels, adding that over half the company’s vaccines would go to LMICs in the coming year.

“Our strategy of focusing on technology transfer brought us to partnering with Aspen Pharmacare in South Africa. Aspen is now fully in production and we anticipate that all supplies produced by Aspen from now on will go to COVAX countries and African Union. And we are also transferring our technology as we speak to BioE in India,” said Stoffels.

This follows a recent report by The New York Times that Aspen, which has a ‘fill and finish’ contract with J&J, had been exporting millions of vaccines to Europe while lagging behind in its African deliveries. The EU recently agreed to send these vaccines back to South Africa.

However, Stoffels warned that technology transfers are “highly technical by nature and highly complex”. 

“We need to work with many partners. Multiple steps are needed, including biological manufacturing, quality testing and release, regulatory inspections and controls. Most critical is the training of workforce and new technologies,” he added. 

Progress in therapeutics

Cueni reported that “a handful of authorised COVID-19 treatments are becoming standard of care for COVID-19 patients that have been hospitalised and are saving lives”. 

“Monoclonal antibody treatments are beginning to offer promise as are novel antivirals,” said Cueni.

Some of the key treatments that have been authorised for emergency use include the anti-viral, Remdesivir (Gilead Sciences), Monoclonal IL-6 blocker, Tocilizumab (Roche), Monoclonal Casirivimab and  Imdevimab (REGEN-COV Roche Regeneron) and Monoclonal Sotrovimab (GlaxoSmithKline).

“Getting the therapeutic rollout right will be important for all countries to be able to benefit from future innovation, such as the anticipated oral outpatient COVID-19 therapeutic candidates,” he added.

Roche has been involved in 10 experimental treatments for COVID-19 “focused on preventing progression to mechanical ventilation and preventing death”– but testing these was complex and difficult, said its CEO, Bill Anderson.

Roche CEO Bill Anderson

One of these, tocilizumab (Actemra), is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor.

“As it suppresses the immune system, we thought, ‘you don’t want to give it to patients that are newly diagnosed’. It’s really for patients who’ve progressed to a severe illness where their immune system may actually be more doing more damage than good. So we had to run multiple studies. I think we’ve run ultimately, we’ve run seven pivotal studies,” said Anderson, adding that the first pivotal study had failed to show any results.

“Many people thought, well, that’s the answer. But we had seen enough to think, hmm, you know, I don’t think that’s a complete story. And ultimately, we’ve shown that Actemra does decrease need for mechanical ventilation and death quite significantly in hospitalised patients,” he added. 

But there are only so many facilities in the world capable of producing monoclonal antibodies, said Anderson, and the treatments needed large quantities.

“We ultimately did a partnership with Regeneron, which is a company that we compete with in many other fields, but we felt like they were farthest along,” added Anderson.

“We made an exceptional decision that we would not assert patent rights if companies could make a product of a biosimilar to Actemra and deliver it to LMICs, and that, in fact, it looks to be happening,” he added.

However, Anderson added that Roche was only prepared to support technology transfer to companies with the capacity to produce large amounts of monoclonal antibodies.

“Tech transfer is very laborious, and we can’t afford to take our people that are producing Actemra and that are also doing tech transfer with the existing external contracts, unless we have somebody who can produce large quantities.”

 

Image Credits: Twitter: @WHOAFRO, US Centers for Disease Control.

air quality

Over a third of the world’s countries – 37% – have either not created or are not enforcing legally mandated ambient air quality standards (AAQS), according to a new report released by the United Nation Environment Programme (UNEP).

The report, “First Global Assessment of Air Pollution Legislation” assesses national air quality legislation in 194 states and the European Union, and found  persistent policy, capacity, and implementation gaps to prevent more effective action against air pollution.

Approximately 60% of countries, accounting for 1.3 billion people, have no annual ground-based monitoring for fine particulate matter (PM 2.5), while at least 31% of countries with the ability to introduce sub-standards for ambient air quality standards (AAQS) have not done so. 

Unregulated air pollution continues to pose the greatest environmental threat to health. There are over seven million premature deaths every year due to the combined effects of outdoor and household air pollution – with millions more people falling ill from breathing polluted air, according to the WHO. More than half of these deaths are recorded in low- and middle-income countries.

UNEP calls for multi-sectoral action, in light of the report’s launch coinciding with International Day of Clean Air for Blue Skies, that can enable cleaner air for all. 

“Investments in air quality will [not only] enhance our health, but also job creation, energy efficiency, clean transport, sustainable agriculture, and green and resilient cities,” said UNEP Executive Director Inger Andersen, during a Tuesday launch event of the report. 

“We can’t clean the air overnight, and we can’t clean the air without the full engagement of every sector of society. But if we put the work in today, we can one day soon breathe easier.”

‘Lack of ambition’ in heterogeneous approach to air quality control

Eloise Scotford, one of the co-authors of the UNEP report

While the majority of countries (64%) embed AAQS in legislation, the global picture of national air quality is one of heterogeneity, with some cases of implementation masking a “lack of ambition”, said Eloise Scotford, Professor of Environmental Law at the University College London and one of the co-authors of the study.

Poor enforcement of air quality laws has led to 43% of countries lacking a legal definition of air pollution and only 51% of national air quality laws globally with explicit public health, or public and ecosystem health as their main objective.

“We found that processes for setting AAQS are often not transparent, or accountable, or accessible,” said Scotford, noting that standards could often be made more ambitious.

Although the heterogeneous approach to embedding air quality standards reflects specific air quality challenges and diverse legal cultures, in addition to acknowledging that there is no one-size fits-all approach to air quality control, this also risks masking weak ambition and legalizing unclean air.

In addition, only 33% of countries impose requirements on governments to achieve AAQS, indicating that the institutional responsibility on air pollution is quite weak and are the bare legal standards, added Scotford. 

The lack of level playing field for AAQS may keep the world at odds with the demanding requisites on global policies on climate change expressed in the 2015 Paris Agreement.

Legal standards need to be established

Figure 1 is a conceptual map explaining how legislative incorporation of AQS may sit within, and provide the foundation for a domestic “system of air quality governance”.

Regulating and controlling the different sources of air pollution remains a “coordination challenge”, according to Scotford, with the first step establishing legal standards for air quality. 

“Once you have legal standards for air quality, that’s really important. Ambition is important. But that is not enough. More needs to be done to have a full system of quality governance that is robust, to ensure the achievement of clean air.” 

The UNEP report notes that a robust system of air quality governance is one which: 

  • requires governments to develop and regularly review applicable air quality standards in light of public health objectives;
  • determines institutional responsibility for those standards;
  • monitors compliance with air quality standards;
  • defines consequences for failure to meet them;
  • supports the implementation of air quality standards with appropriate and coordinated air quality plans, regulatory measures and administrative capacity;
  • is transparent and participatory.

WHO air quality guidelines launching end of the month

Maria Neira, WHO Director of Environment, Climate Change and Health

In light of the launch of the UNEP report, WHO has announced that they will be launching their 2021 Air Quality Guidelines on 22 September.

These guidelines will serve as a global target for national, regional, and city governments to work towards reducing air pollution. 

WHO Director of Public Health, Environmental and Social Determinants of Health Maria Neira echoed UNEP’s calls for urgent and collective action in reducing air pollution.   

“It is time to stop with those fossil fuels. It is time to accelerate towards a very ambitious and quick transition to clean sources of energy. We need to do it for the economy, we need to do it for our society, but we also need to do it for our health. The more we postpone this transition, the more we will have death and disease on our shoulders.”

Image Credits: Flickr, UNEP, UNEP.

 

Climate change: A firefighter fighting a battle against a fire in South Africa

“The greatest threat to global public health is the continued failure of world leaders to keep the global temperature rise below 1·5°C, and to restore nature. Urgent, society-wide changes must be made and will lead to a fairer and healthier world,” according to an editorial published simultaneously in 200 journals world-wide.

The aim of the editorial is to help develop momentum for “urgent action to keep average global temperature increases below 1·5°C, halt the destruction of nature, and protect health” in the run-up to the UN General Assembly which starts on 14 September,  the biodiversity summit in Kunming, China, and the UN Climate Change Conference of the Parties (COP26) in Glasgow, UK. 

“The science is unequivocal; a global increase of 1·5°C above the pre-industrial average and the continued loss of biodiversity risk catastrophic harm to health that will be impossible to reverse. Despite the world’s necessary preoccupation with COVID-19, we cannot wait for the pandemic to pass to rapidly reduce emissions,” states the editorial, published in journals that are usually in competition with one another.

The editorial warns that temperature rises of above 1·5°C ”increase the chance of reaching tipping points in natural systems that could lock the world into an acutely unstable state” and “critically impair our ability to mitigate harms and to prevent catastrophic, runaway environmental change”.

It says that targets set by many governments, financial institutions, and businesses “are not enough”. 

“They are yet to be matched with credible short-term and longer-term plans to accelerate cleaner technologies and transform societies. Emissions reduction plans do not adequately incorporate health considerations.

“Concern is growing that temperature rises above 1·5°C are beginning to be seen as inevitable, or even acceptable, to powerful members of the global community,” states the editorial.

“Relatedly, current strategies for reducing emissions to net-zero by the middle of the 21st century implausibly assume that the world will acquire great capabilities to remove greenhouse gases from the atmosphere.

“This insufficient action means that temperature increases are likely to be well in excess of 2°C, a catastrophic outcome for health and environmental stability. Crucially, the destruction of nature does not have parity of esteem with the climate element of the crisis, and every single global target to restore biodiversity loss by 2020 was missed. This is an overall environmental crisis.

“Health professionals are united with environmental scientists, businesses, and many others in rejecting that this outcome is inevitable.”

 

Image Credits: Commons Wikimedia.

Italian health minister Roberto Speranza addresses a media briefing after the meeting.

G20 health ministers have agreed to share COVID-19 vaccine doses with low and middle-income countries (LMIC) and to support their capacity to produce their own vaccines, but failed to commit to numbers or a time frame.

The two-day meeting of G20 health ministers ended on Monday with the adoption of a health declaration that reiterated the group’s support for strengthening “the resilience of [COVID-19 vaccine] supply chains, to increase and diversify global, local and regional vaccine manufacturing capacity, and building expertise for LMICs, including for the raw materials needed to produce vaccines”.

But host Italian health minister Roberto Speranza told the media at a post-meeting briefing on Monday that the G20 countries would need to “consider the text as a starting point”.

“Some countries have bilateral arrangements to send vaccine doses directly to LMICs and COVAX,” Speranza told a meeting briefing on Monday. “But it is not enough to transfer doses. We really need to make sure that all areas are capable of producing their own vaccines by sharing methodology and personnel.” 

While the declaration acknowledges that “we need to also share more doses to meet the immediate need for safe, effective and quality and affordable vaccines building upon the commitments made at the COVAX Advanced Market Commitment (AMC) Summit”, only Germany was prepared to make a numbers-based commitment. 

German Health Minister Jens Spahn announced on the sidelines of the meeting that his country would make 100 million COVID-19 vaccine doses available globally before the end of the year.

WHO appeals for more support

Addressing the meeting on Sunday, World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus appealed to the group for support on three key issues.

First, he appealed for wealthier countries to swap “near-term [COVID-19 vaccine does] delivery schedules with COVAX, fulfilling your dose-sharing pledges by the end of this month at the latest, and facilitate the sharing of technology, know-how and intellectual property to support regional vaccine manufacturing”.

He also called for support for “a legally binding international agreement on pandemic preparedness and response” – the so-called ‘pandemic treaty’ – due to be discussed at a special session of the World Health Assembly at the end of November

Finally, Dr Tedros appealed for their support to strengthen the WHO, including financially through “a historic reversal of the current imbalance between assessed and voluntary contributions”. 

The COVAX AMC Summit, co-hosted by Japan and global vaccines body Gavi, secured commitments from G20 members to ensure the global distribution of 1.8 billion vaccine doses – enough to cover nearly 30% of the population of AMC eligible economies. However, most of these undertakings have yet to materialise, with Dr Tedros stating recently that only 10% of promised doses had actually been shipped.

The meeting also welcomed the COVID-19 mRNA vaccine technology transfer hub launched by the WHO recently, and supported “voluntary technology transfers on mutually agreed terms, market shaping and increase local production capacities worldwide”.

While the meeting did not embrace a pandemic treaty – G20 members US, Brazil and Russia are believed to be opposed to such a measure – the declaration supported strengthening the WHO’s ability to address global health emergencies 

“We look forward to the findings and proposals of the Special Session of the World Health Assembly in November 2021. WHO should be adequately, sustainably and predictable funded by its Member States to fulfill its mandate and live up to their expectations towards the WHO,” notes the declaration.

It also supported more research to “better understand the links between human, animal (both domestic and wild) and environmental health” and “improving systems for the coordinated surveillance of zoonotic pathogens, antimicrobial resistance (AMR) and environmental risks” inclding by establishing early warning systems for communicable diseases.

The G20 is made up of 19 countries and the European Union. The 19 countries are Argentina, Australia, Brazil, Canada, China, Germany, France, India, Indonesia, Italy, Japan, Mexico, the Russian Federation, Saudi Arabia, South Africa, South Korea, Turkey, the UK, and the US.

WHO Director General Dr Tedros Adhanom Ghebreyesus (speaking here in Berlin) has thrown his weight behind a new Pandemic Treaty – but the US thinks reform of existing rules, might be a better way forward.

While a “pandemic treaty” could take years to establish, the World Health Organization’s (WHO) International Health Regulations (IHR) could be revised more rapidly to significantly improve global disease outbreak response, top US officials are saying.  The statements coincided with a 3-day working group meeting of WHO member states to discuss ways to strengthen the global muscle behind pandemic preparedness and response. 

“Some major strides to advance global health security may take years to accomplish, for example, the creation of a new international instrument on preparedness and response, which the WHO and a number of other countries have endorsed,” US Secretary of State Antony J. Blinken and US Secretary of Health and Human Services Xavier Becerra wrote in JAMA.

“But it is not necessary to choose between a new instrument and a revised standing legal framework; immediate steps can make a meaningful difference. One is strengthening the WHO’s International Health Regulations (IHR), adopted by the World Health Assembly in 1969 and revised in 2005,” they argued.

The IHR, they add, “is the legal framework under which 196 States Parties are responsible for developing their capacities to prevent, detect, report, and respond to public health emergencies within their borders, to prevent them from spreading to other countries”. 

The COVID-19 pandemic has revealed the IHR weaknesses “that can be fixed, particularly around early warning systems, coordinating the response, and information sharing”, they added.

US Statements coincide with working group meeting on Treaty proposal

The US policy statement coincided with the second meeting of the working group on the proposed ‘pandemic treaty’ proposal, which is then due to be debated at a special session of the World Health Assembly (WHA) scheduled for 29 November to 1 December.

It prompted an immediate response from Professor Ilona Kickbusch, a member of the Global Preparedness Monitoring Board, who pointed out that there is no guarantee that transforming the IHRs would be easier than adopting a pandemic treaty.

Kickbusch’s comments also reflects the divide between Europe and the United States over the pandemic proposal. Germany,  along with the European Union, has strongly supported the treaty initiative as a measure that would raise the level of awareness and debate over pandemic response – which prior to COVID had been consigned to technical units in ministries of health, lacking authority to guide major policy choices.

Since last November, the European Union has been advocating for a pandemic treaty similar to the Framework Convention on Tobacco Control, but has faced opposition from the US, Russia and Brazil. (The tobacco convention provides signatories with evidence-based tobacco control strategies that they are obliged to implement, albeit incrementally.)

WHO Director-General Dr Tedros Adhanom Ghebreyesus has also spoken out repeatedly in support of a ‘pandemic treaty’ along the lines of the Framework Convention on Tobacco Control. 

“The vaccine crisis illustrates the fundamental weakness at the root of the pandemic: the lack of global solidarity and sharing – sharing of information and data, biological samples, resources, technology and tools,” Dr Tedros told a recent meeting of WHO’s African leaders.

“That’s why there is now an emerging global consensus for the idea of an international treaty or other legal instruments, to provide the basis for improved international cooperation to prepare for, detect and respond to epidemics and pandemics,” he said

WHO has lobbied heavily along with the European Union for support of the new pandemic treaty – but the United States says reform of existing IHR rules might be a better way forward.

Speaking at the WHA in June, Mike Ryan, WHO Health Emergencies Programme Executive Director, also spoke out in favour of the treaty despite the fact that WHO technical staff have historically avoided taking positions on controversial policy choices before member states. 

“My personal view is that we need a political treaty that makes the highest-level commitment to the principles of global health security — and then we can get on with building the blocks on this foundation,” Ryan told a briefing on pandemic preparedness.

Germany and allies want to make rules on pandemic response more binding

Whether a full-fledged treaty is adopted, or the IHR rules revised, another key debate has centered around how to make the rules more binding on member states. This has been sharpened over China’s reluctance to fully co-operate with the WHO-appointed group investigating the origins of the SARS-CoV2 virus – including unfettered access to data and destinations in China where the SARS-CoV2 virus, or its closest genomic relatives, may have first emerged and spread.

Germany’s Health Minister Jens Spahn has proposed on two occasions recently that sanctions should also be imposed against countries that hide information about future outbreaks.

Speaking at the launch of a WHO pandemics intelligence hub in Berlin, Spahn called on China “to finally become fully cooperative, and to make the explanation of the origin of the coronavirus transparent to the international community.”

He also added that “there must be something that follows” if countries failed to co-operate with the WHO on pandemics – noting that even transparent democracies like Germany might shirk from opening its doors to independent investigations unless they were bound to do so through a global mandate.

Meanwhile, Tedros said that a pandemic treaty should “have all the incentives, or the carrots” but acknowledged that “maybe exploring the sanctions may be important”.

Civil society complains of exclusion from discussions

Meanwhile, some civil society groups are also questioning the wisdom of a new pandemic treaty – while objecting to the marginal role they have been allowed to play in the discussions of the WHO Member State Working Group. 

According to the modalities established by WHO, “Non-State actors” are unable to attend or speak at open sessions of the working group but can provide inputs via an electronic portal, an open ‘hearing’, and/or a segment of a session.

Some civil society advocates support IHR reform rather than Pandemic Treaty

Civil society debate the pandemic treaty proposal in May – hosted by the Geneva Global Health Hub (g2h2.org).

Some leading civil society advocates have also supported the US position that devoting energy to the establishment of a pandemic treaty may be a waste of time – when existing IHR rules, which are part of a binding convention can also be strengthened.

In a blog published by the Third World Network on Thursday, Nithin Ramakrishnan and KM Gopakumar charged that the WHO administration (bureau) was prejudging the outcome of the member state discussions – which are supposed to consider whether a pandemic treaty would be useful in  the first place.   The authors claimed that a WHO analytical paper and draft programme of work for the meeting  had prejudged the outcome of discussions through a series of “leading questions” to working group members:

“The Bureau’s questions focus on the merits of developing new instruments straight away. Secondly, it asks what steps Member States would need to take in order to ascribe relative priority to a new instrument. Thirdly, it goes on to ask what criteria and scope should be included or excluded from the new instrument. Finally, the Bureau nails down the need for a “new framework convention” by asking whether the Member States share the idea for another “framework”.

These four questions sequentially are prejudging the outcome of the Working Group meeting and to be suggestive of a pandemic treaty,” the authors said.

A WHO background analysis also fails to provide a logic for why a new agreement would be needed to solve the problems that have surfaced during the COVID pandemic, they added.

“WHO Secretariat’s analytical paper has attempted to set the background …..by arguing that some of the proposed recommendations of the various [pandemic review] committees require new agreement/agreements. Not a single reason is provided in the analytical paper as to why some of these recommendations require a new agreement,” the authors said.

They pointed out that nine out of the ten key recommendations made by the series of independent reviews of the COVID pandemic’s emergency response mechanisms “could be realized effectively through the International Health Regulations (IHR), either by amending or by adding annxes to IHR.

Concluded the authors:  “The only point amongst the recommendations which requires a framework convention is the recommendation which states that there must be an establishment of a new framework convention. This has precisely been the problematic approach right from the beginning.

“None of the expert bodies which called for a new framework convention reasoned out why it is needed or how it will be more effective than the present regime. The WHO secretariat and the Bureau of the Member States Working Group are the latest to join such a pursuit.”

 

Image Credits: EU Council.

European Commission head Ursula von der Leyen has agreed to return to Africa millions of Johnson & Johnson  (J&J) COVID-19 vaccines that were imported from a South African manufacturer following a meeting with South Africa’s President Cyril Ramaphosa last week.

This was revealed by African Union envoy Strive Masiyiwa said at an Africa Centres for Disease Control (CDC) press conference on Thursday.

News that J&J had fallen behind in vaccine deliveries to African countries while the Aspen Pharmacare manufacturing facility in South Africa was busy exporting millions of the J&J/ Janssen vaccines to Europe was exposed by the New York Times in mid-August.

The report was met with outrage from civil society activists, African governments and the World Health Organization (WHO) – particularly as Aspen has been lagging behind in its J&J vaccines deliveries to African countries.

However, after Ramaphosa raised the issue with Von der Leyen at the G20 Compact with Africa event on 27 August, she agreed to reverse the imports, said Masiyiwa, who heads the African Vaccine Acquisition Trust (AVAT).

“All the vaccines produced at Aspen will stay in Africa and will be distributed to Africa,” said Masiyiwa on Thursday.

He added that J&J’s “finish and fill” contract with Aspen would be converted to a license agreement in which J&J would no longer control where the vaccines went. 

But Fatima Hassan, head of the South African Health Justice Initiative (HJI), said that the AU and South African government should not take credit for the EU’s U-turn.

“Civil Society shone a lone light with two New York Times investigative journalists. Mostly, governments were caught napping and unaware,” said Hassan, adding that she was reserving her celebrations until the J&J vaccines were actually returned to the continent.

Meanwhile, AVAT also facilitated the delivery of 12,000 J&J vaccines to the African Union Commission staff, AU embassy staff and their dependents in Addis Ababa this week.

Only a quarter of this group is vaccinated, according to AU Commission Deputy Chairperson Dr Monique Nsanzabaganwa.

“This figure is far below where we need to be, in order to be near normalcy and return to work.  It is therefore pertinent that all staff and supervisors should encourage colleagues to get vaccinated as this is the only way for us to return to our previous working environment”, she said.

The doses, which had been paid for by donors, were delivered by AVAT on Wednesday alongside the first batch of a large J&J order for Ethiopia.