DNDi

Nairobi, Kenya – Africa is trailing the rest of the world in  conducting clinical studies on COVID-19 vaccines and drugs. Less than 70 registered studies for drugs and vaccines are currently taking place in Africa, out of more than 1000 studies being conducted globally.

Only 8 of 102 clinical vaccine trials were being conducted in Africa. And out of 1098 clinical studies on potential drugs underway around the world, a mere 56 of them were being done on the continent, data presented to an African Science journalists forum in Nairobi last week showed.

According to Dr Borna Nyaoke, senior clinical project manager for the Drugs for Neglected Diseases Initiative (DNDi)-Africa, part of the reason for the low number of trials was due to lack of government funding for the studies.

Nyaoke noted that successful treatments or vaccines for COVID-19 largely relied on the breadth of trials conducted, with large experiments being more likely to succeed compared to ones enrolling fewer study participants. Yet enrolling, finding, and monitoring a large number of study volunteers is a costly and time-consuming endeavor.

“We need to see African governments committing additional funding for drugs and vaccine trials, finance more international collaborations and engage pharmas for more research to happen on our continent,” she told a virtual pre-conference event hosted by the Media for Science Health and Agriculture (MESHA).

Vaccine studies were only taking place in seven countries, five of them in South Africa. Trials for drugs were more widely distributed, happening in 13 different countries. Egypt has 36 trials for potential COVID-19 treatments underway, followed by South Africa with eight.

More Research Into Mild & Moderate COVID-19 Treatments Required
Dr Borna Nyaoke, senior clinical project manager

And most of the drug and vaccine experiments currently taking place in developed countries of the global north and parts of Asia are concentrated on severe and advanced cases of the disease, Dr Nyaoke observed. But more research was required to understand how to treat mild and moderate cases to help benefit places like Africa, which has a comparatively higher rate of mild and moderate disease.

“Right now only a few studies are happening in the Global South, and as such, trials may not be as conclusive. We have large populations in these regions of the world with over 1 billion people in Africa for example that can provide an adequate sample size for a trial,” she said.

There was therefore a great need for COVID-19 clinical trials in “Africa led by Africans” given the continent’s unique genetic diversity, and existing capacity for conducting such trials. Many efforts by organisations such as DNDi have helped set up a rich research ecosystem across the continent.

“Africa displays genetic diversity which if not represented, trial findings cannot be generalised to our large populations. Responses to drugs or vaccines can be influenced by, among other things, human genetics,” she said.

Conducting clinical studies in Africa would have many advantages besides benefiting from the most genetically diverse population in the world, as such trials also need to be well designed and “adequately powered to generate evidence” – meaning they must enroll massive numbers of people.

In addition, Dr Nyaoke said large, well-conducted clinical trials are urgently needed to support guidelines on prevention and clinical management of COVID-19 in “resource-constrained settings” such as Africa.

Local Trials Will Help Build Local Trust

Local trials would also help influence policy change since policymakers are more apt to trust local evidence. Trials can help support faster adoption of new tools into policy, access to new tools, and development of potential life-saving innovations.

Besides, Nyaoke opined, locally developed disease remedies easily gained trust of communities as local researchers were more likely to win and maintain trust of their communities.

To increase the number of clinical trials in the poor regions of the world, the DNDi and its partners have formed the COVID-19 Clinical Research Coalition, a global partnership aimed at accelerating clinical research in resource-limited settings.

Founded by a coalition of organizations, which include the DNDi and Infectious Diseases Data Observatory (IDDO) among others, the group aimed to advance research in therapeutics, preventive medicines, vaccines, diagnostics, social science, epidemiology and modeling.

Some 22 African countries have so far joined the group.

The partnership formed in March also hoped to establish a vibrant dialogue within a network of research and allied institutions around the world, to facilitate and accelerate research adapted for resource-limited settings, and facilitate prompt sharing of findings to ensure accelerated learning for speedy review of evidence and its adoption into guidelines.

Members of the partnership include research institutions, universities, Non-Governmental Organisations (NGOs) and governments from all regions of the world.

Image Credits: DNDi.

European Health and Food Safety Commissioner, Stella Kyriakides, speaks to the G-20 virtual session of Health and Finance Ministers

Against the backdrop of Thursday’s G-20 Health and Finance Ministers meeting on the COVID-19 pandemic, UN and Global health leaders were escalating their pleas to the world’s industrialized countries and global financial institutions for billions of dollars in immediate funding to fight the COVID-19 pandemic.

The calls echoed statements issued earlier this week by the World Health Organization and UN Sectretary General Antonio Guterres – to the effect that the world needs some US$ 35 billion to ensure wide global access to vaccines, tests and treatments – without which pandemic containment may be impossible.

The sense of urgency was growing as WHO said that Europe was facing a worrisome surge in cases – “weekly cases have now exceeded those reported when the pandemic first peaked in Europe in March,” said the WHO’s Regional Director for Europe, Hans Kluge, at a press briefing on Thursday.

Speaking at the virtual G-20 meeting, hosted by Saudi Arabia, European Commissioner of Health and Food Safety, Stella Kyriakides called upon the world’s most industrialized countries to create new financial mechanisms to raise the funds – including some €15 billion that is needed almost immediately.

This year’s series of virtual G20 meetings, hosted by Saudi Arabia
‘Think out of the Box’, Urges EC Health Commissioner

While welcoming the G-20 statement of support for a coordinated global pandemic response, she emphasized that world leaders need to commit to more than declarations in order to make a real difference.

“More funding is needed to speed up the development, manufacturing and distribution of COVID 19 diagnostics, therapeutics and vaccines,” Kyriakides said in her published remarks.

“The UN tells us about a budget shortfall of €35 billion for the ACT-Accelerator, of which €15 billion will be needed in the next three months,” she said referring to the WHO-co-sponsored Access to COVID-19 Tools (ACT) Accelerator, which aims to raise funding to produce and equitably distribute two billion vaccine doses, 245 million treatments and 500 million tests.

“We, as G20, must develop a vision to attract new funding by thinking outside the box. What about a private fund to which the pharmaceutical industry, or philanthropic organisations could contribute? Or a crowd funding initiative? Let us work on creative solutions to keep the momentum and bring an end to COVID-19.”

Similar notes of worry and warning were sounded among philanthropies such as the Wellcome Trust, which has invested millions into R&D support for new Covid vaccines and treatments.

Said Wellcome Trust Ddirector Jeremy Farrar on Thursday. “we’re running out of time and these warm words must urgently turn into the real investment and global leadership that is needed.

“The ACT-Accelerator urgently needs $35 billion to develop and provide tests, treatments and vaccines for the world and to have the health systems to deliver them,” said Farrar. ” So far, less than 10% of this been raised. $35 billion is a tiny figure when compared to the trillions the world economy has already lost and will continue to lose as this pandemic continues to reverberate around the world.

“Securing this funding now will prove to be the wisest investment humanity has ever made. Putting it off will only prolong the pandemic and all its dreadful consequences. The actions leaders take today will affect how the world spends the next decade. This needs a moment of historic political and financial leadership.  Leadership that will change the world.  Leadership that will be remembered in a 100 years’ time. But we need it now through actions not words.”

G-20 Finance Ministers Still Pass The Buck on COVID Finance – Suggesting “Voluntary Funds” and “Multilateral Development Bank” Initiatives

The G-20 Health and Finance Ministers’ statement, issued at the close of today’s virtual meeting, expressed strong support for the global pooling efforts, even noting them explicitly by name as the “Access to COVID-19 Tools Accelerator and its COVAX [vaccine pool] facility.”

“We recognise the role of extensive immunization against COVID-19 as a global public good for health in preventing, containing, and stopping transmission,” said the ministerial statement.

But the finance leaders of the world’s most powerful nations made no further commitments that their countries would cough up more funds directly, saying only that they supported “further voluntary contributions to relevant initiatives, organizations and financing platforms”.

The G-20 statement also appealed to multilateral development banks to “swiftly consider ways to strengthen the financial support for countries’ access to COVID-19 tools.”

In his keynote address to the UN General Assembly on Tuesday, UN Secretary-General António Guterres appealed for “a quantum leap in funding”  for the Acces to COVID-19 Tools (ACT) Accelerator, the WHO-co-sponsored funding mechanism which aims to pool capital to finance equitable global distribution of new COVID vaccines, tests and treatments.

“We now need $35 billion more to go from set-up to scale and impact. There is a real urgency in these numbers. Without an infusion of $15 billion over the next three months, beginning immediately, we will lose the window of opportunity”, he warned.

According to the latest data, the ACT Accelerator has received only US$2.7 billion of the hoped-for US$35 billion – although some 170 countries have made commitments in principle to pooling vaccine or treatment resources through the “COVAX” vaccine and tools treatment pools.

Meanwhile, the global economy is expected to contract by trillions of dollars this year.  “Fully financing the ACT-Accelerator would shorten the pandemic and pay back this investment rapidly as the global economy recovers”, said Gutteres in his remarks to the UN GA.

One note of progress last week came as the WHO announced a “Facilitation Council” for the ACT-Accelerator pools, co-chaired by South African President Cyril Ramaphosa and Norway’s Prime Minister, Erna Solberg.

But the thorny work of a legal framework under which the Act Accelerator’s “COVAX” vaccine pool would operate is yet to be completed, sources have told Health Policy Watch. And this is needed in order to satisfy a wide range of  national regulatory rules and requirements that would allow high- and middle-income countries to “join” the pool voluntarily, effectively committing funds to pay in advance for vaccines produced later, is yet to be finalized.  Another track of funding would support the vaccine needs of low-income countries, through overseas development assistance. However, traditional ODA mechanisms, which were designed to provide assistance on the order of “millions” of dollars, are ill-suited to generate the billions now needed for a truly world-wide COVID-19 vaccine effort, seasoned observers say.

European COVID-19 Resurgence Should Be ‘Wake-Up Call’

In the WHO/Europe media briefing today, Kluge declared: “We do have a very serious situation unfolding before us. More than half of European countries have reported a greater than 10% increases in cases in the past two weeks. Of those, seven countries have seen newly reported cases increase more than two-fold in the same period,” he said.

“In the spring and early summer we were able to see the impact of strict lockdown measures. Our efforts, our sacrifices, paid off. In June cases hit an all-time low. The September case numbers, however, should serve as a wake-up call for all of us,” he said.
“Although these numbers reflect more comprehensive testing, it also shows alarming rates of transmission across the region,” he continued. “While we did see an increase in cases among older age groups, 50 to 64 and 65 to 79 years, in the first week of September, the biggest proportion of new cases is still among 25- to 49-year-olds.”
“This pandemic has taken so much from us,” Kluge said, referring to the fact that the region has already seen nearly 4.9 million Covid-19 and more than 226,000 deaths. “And this tells only part of the story,” he said. “The impact on our mental health, economies, livelihoods and society has been monumental.”

In response to the resurgence, a growing swathe countries across the 53-member-state region, which had been easing lockdowns and reopening their economies, are now pulling back and implementing new restrictions and quarantine measures.

New hotspots have been declared and restrictions imposed in countries and cities across the region that had gotten the virus under good control in early June and July – from the northeast of England to Paris, Lyon and Nice in France; Germany’s Bavaria region; as well as Spain’s Madrid, and even Italy.

Travelers arriving from many central and southern European countries such as Greece, Croatia and the Czech Republic, which saw relatively few cases in the first wave and had thus become particularly popular European tourism destinations over the summer after EU borders reopened, have now been slapped back onto the quarantine list of certain other European countries and the United Kingdom.  Cases are also rising steadily in Switzerland, where new cases have risen from a few dozen a day as the lockdown was lifted in June to over 500 new cases a day presently – placing it in the “red” list category of some other Euroepan countries as well – although borders with neighboring France and Italy have remained open to passage by cross-border workers without quarantine requirements.

Kluge called for more coherent regional efforts, saying “the response to the crisis has been very effective whenever the actions were prompt and resolute, but the virus has shown merciless whenever partisanship and disinformation prevailed.  Where the pandemic goes from here, is in our hands. We have fought it back before and we can fight it back again.”

He also said that countries need to find ways to combat the pandemic “fatigue that is now setting in.”

Image Credits: G20.org, @SKyriakidesEU.

A volunteer receives an injection of an investigational mRNA COVID-19 vaccine, developed by Moderna Inc, with US government support.

Geneva, Switzerland – Moderna, Inc., one of the leaders in the race to develop a new COVID-19 vaccine, has come home — again.

The biotech startup, which raised a significant chunk of its initial US$ 100 million amongst a group of far-sighted Swiss investors and private bankers a decade ago, announced Wednesday that it would be establishing its first commercial hub outside of North America in Basel. The new Swiss hub, located alongside the company’s European headquarters, will be led by Dan Staner, as vice president and managing director, Switzerland.

“Switzerland has a leading biotech and pharma sector. All the conditions exist for a new leading edge technology, such as the mRNA platform, to attract leading vaccine talents from around the world to join us in Switzerland,” Staner told Geneva Solutions.

“By the end of December, we will have around 20-30 specialists at our Swiss headquarters in Basel, where the hub for the whole of Europe is also located. By the end of 2021, we expect to have between 50 and 60 employees, mainly people who already have experience in regulatory affairs, medical, quality, manufacturing or commercial roles,” said Staner, a former executive for Eli Lilly and a Swiss national with a degree from the University of Lausanne.

Dan Staner, vice president and managing director of Moderna, Switzerland
Paving way to Swiss Medic Approval

One of the key missions of the new office will be to ease the way to Swiss regulatory approval for the company’s novel messenger RNA (mRNA) vaccine candidate, currently undergoing Phase III clinical trials, Staner added. Recently, the Swiss Federal Government concluded an agreement with Moderna for the procurement of 4.5 million vaccine doses of the mRNA-1273 candidate, one of nine worldwide at the advanced Phase III trial stage. However, the national regulatory agency, Swiss Medic, operates independently of the European Medicines Agency.

“My goals are firstly to work closely with the Swiss Regulatory Authorities to deliver a high quality, approved vaccine as soon as possible for the Swiss population, secondly, to build a highly effective and professional Moderna team in Switzerland; and thirdly to work closely with key healthcare stakeholders in the country, to ensure we defeat the pandemic together,” said Staner

In an interview with the Swiss business journal Bilan, Moderna CEO Stéphane Bancel predicted that the company’s vaccine could be ready for market approval as early as October, but “without a doubt” by December or January 2021. He noted that the Moderna Phase III trial had already enrolled some 21,000 participants – nearly reaching the 30,000 target set by the United States Food and Drug Administration (FDA) for participation.

Fears of ‘Vaccine Nationalism’

The United States, where the company is based, also has huge political and financial investments in Moderna’s development, with a pre-order of 100 million vaccine doses, announced by US President Donald Trump in an August deal, said to be worth US$ 1.5 billion. The big pre-orders have fueled fears amongst global health officials that once a safe and effective Covid-19 vaccine does become available, rich countries will have already bought up the lion’s share of available supplies – making it harder to get access to low and middle-income countries.

The US Biomedical Advanced Research and Development Agency (BARDA) also had provided Moderna with nearly US$ 1 billion in public funds for Covid-19 vaccine R&D, with the US Defense Advanced Research Projects Agency (DARPA) investing lesser amounts. Recently, that support became the focus of controversy after a medicines access group charged that Moderna had failed to report the public funding, as required, in its US patent applications – something both BARDA and DARPA said they are now investigating. Evidence of public funding is often key to leveraging lower prices among drug and vaccine manufacturers.

Lonza manufacturing agreement also key to Moderna’s Swiss choice. According to Moderna, another reason for the decision to open a Swiss commercial hub, is the agreement announced in May 2020, with the Swiss manufacturing firm, Lonza, for the large scale global manufacture of the vaccine candidate in Switzerland “and additional Moderna products in the future.”

Deep roots in Switzerland. But the strategic decision to develop a commercial outpost in Switzerland, continues a romance with the Confederation that began long before the Lonza agreement. Almost a decade ago, Bancel, head of what was then an unknown startup, Moderna Therapeutics, began raising capital along the shores of Lac Leman among a small group of private Swiss investors as described in an exclusive Geneva Solutions story.

Bancel, who had previously headed BioMérieux in nearby Lyon, won over the hearts and minds of the Swiss financiers, who were shrewd enough to see the potential in the new technology – which went on to yield a number of infectious disease vaccine candidates even before the SARS-CoV-2 virus came along and dramatically changed the company’s trajectory.

“Switzerland is a leader in life-sciences, with a dynamic pool of industry talent, scientists, research organizations, investors and global health policymakers,” said Bancel. “Since Moderna’s founding, Switzerland has played an important role in Moderna’s development thanks to the long-term support of our Swiss investors and their business advice. Opening our first subsidiary outside North America in Switzerland is a natural step for Moderna.”

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Health Policy Watch is partnering with Geneva Solutions, a new non-profit journalistic platform dedicated to covering International Geneva, for a health news stream. Sign up for the daily brief, and follow Geneva Solutions at @GenevaSolutions on Twitter and Facebook. 

Image Credits: Keystone/ Hans Pennick.

Secretary General Antonio Guterres speaks at a virtual event just ahead of the opening of the 75th UNGA

As the 75th United Nations General Assembly opened in an unprecedented virtual session on 15 September, WHO issued a plea to the world’s leaders for funding to fight the COVID-19 pandemic – saying that US$ 35 billion is needed to fast-track development, procurement and distribution of 2 billion vaccine doses, treatments and tests over the coming year.

The call by WHO came on the heels of a pre-session vote last week by the General Assembly on an “omnibus” bill pledging to advance multilateral cooperation in the quest for solutions to the global health crisis and reaffirming WHO’s leadership role.

However WHO leaders stressed that countries need to put their money on the table to fulfill those commitments.

“Pooling investments globally, the ACT-Accelerator provides a chance for all countries to access a greater number of tools more quickly, sharing the risks and costs together.

The ACT-Accelerator needs US$35 billion to fast-track the development, procurement and distribution of 2 billion vaccine doses, 245 million treatments and 500 million tests over the next year,” said a WHO statement, issued as the UN GA was convening.

The WHO framed the call for funds as part of a three-pronged message to the GA, including a call to world leaders to support the ACT-Accelerator mechanism for pooling and more equitable distribution of COVID-19 medicines, tests and vaccines; maintain the momentum on sustainable development goals, despite COVID threats, and invest more in preparing for the next pandemic now.

“According to a recent WHO survey, 90% of countries are experiencing disruptions to essential health services due to the pandemic. The most frequently disrupted areas reported include routine immunization, non-communicable diseases diagnosis and treatment, family planning and contraception, treatment for mental health disorders, and cancer diagnosis and treatment,” said the WHO statement.  “COVID-19 offers a stark reminder of why we need to invest in stronger health and data systems, rooted in primary healthcare, to achieve universal health coverage and to meet the health-related targets of the SDGs.”

In terms of preparing for the next pandemic, WHO pointed to the findings of a report issued on Monday by the UN-sponsored Global Preparedness Monitoring Board, noted that it would take some 500 years to spend as much on preparedness as the world is losing economically as a result of COVID-19.  The report “World in Disorder” also noted that it had warned last year of the likelihood a pandemic could erupt, killing millions and disrupting economies, but nothing was done.

Said the WHO statement, “The investment needed in a global solution aimed at equitable access pales in comparison to the economic impacts of COVID-19 and the domestic stimulus packages designed to keep economies afloat.”

The first high level meeting of the 75th UN General Assembly will convene next Tuesday, 22 September 2020, during New York City’s 2020 Climate Week.

Image Credits: UN/Loey Felipe.

(left-right) Mike Ryan, Dr Tedros, Maria Van Kerkhove at the September 15 2020 WHO press briefing

Countries may be able to reopen schools safely if adults strictly observe masking and social distancing measures, and show restraint in leisure activities, said World Health Organization Health Emergencies Executive Director Mike Ryan.

“We have to reduce transmission at community level in order to lower the risk to those older and vulnerable people, and to maintain an environment in which children can continue to attend school,” Ryan told reporters on Tuesday. “The only way to do that is that the adults separate themselves enough to drive transmission downwards.

“So what is more important? Are children back in school? Or are the nightclubs and bars open? I think these are the decisions that we have to make coming into the winter months.”

Ryan’s comments came as WHO, UNCESCO, and UNICEF released updated guidelines for policymakers to consider when deciding the safest way to reopen schools during the COVID-19 pandemic.

“Keeping children safe and at school is not a job for schools alone, or governments alone or families alone. It’s a job for all of us, working together,” added WHO Director General Dr. Tedros Adhanom Ghebreyesus.

“With the right combination of measures, we can keep our kids safe and teach them that health and education are two of the most precious commodities in life,” he said.

More Research Into COVID-19 Effects in Children is Required

Since the start of the pandemic, understanding how the virus affects children has been a top priority, said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

But “nine months into the pandemic, many questions remain,” he added.

It’s clear so far that children seem to be spared the worst of the virus, with comparatively fewer children than adults getting infected or experiencing severe illness. Less than 10% of reported cases and less than 0.2% of deaths are in people under the age of 20, according to the WHO. However, there have been reports of specific rare COVID-19-related complications in children, and it’s still unclear what role children play in the virus’ spread.

And WHO COVID-19 Technical Lead Maria Van Kerkhove admitted that they were still learning about the “role that schools are playing” in transmission. It is suspected younger children transmit the virus less than adolescents.

Taking public health measures such as ensuring desks are properly spaced, or all students and staff wear masks may help reduce transmission.

However, the key to ensuring safe school reopenings is to make sure that “transmission is under control in the community,” said Van Kerkhove.

Staying Out Of School Has Devastating Effects On Children

The decision to close schools in the wake of COVID-19 outbreaks was a “last resort,” Dr Tedros said. But as the fall semester begins, many countries are struggling with the decision to reopen schools, or pursue distance learning opportunities.

However, half of the global student population is still not yet back in school, said UNICEF Executive Director Henrietta Fore.

A recent UNICEF survey of 158 countries found that 1 in 4 countries have not put a date in place for allowing children back to the classroom, added Fore. And for at least 463 million children whose schools closed in the spring due to the coronavirus, remote learning was never a feasible option. Some 11 million children are at risk of never being able to return to school, most of them being girls.

Schools represent a safe haven for many students, and students from disadvantaged backgrounds often also rely on schools for healthcare and meals, according to UNESCO Director-General Audrey Azoulay.

“Supporting the safe reopening of schools must be a priority. In particular, supporting the return of the most disadvantaged. And while this return to school is crucial, it must be done in a safe manner,” said Azulay.

Monitoring diabetes in Honduras

A new Lancet Commission reports shows for the first time that the main killers of the poorest billion people in the world aren’t traditional “diseases of poverty” such as tuberculosis or neglected tropical diseases, but are non-communicable disease such as heart diseases and stroke, and injuries.

The Lancet NCDs and Injuries (NCDI) Poverty Commission found that these conditions cause over a third of all annual deaths among the poorest billion, killing 800,000 a year in those under the age of 40. In this group, NCDs and injuries kill more people every year than HIV, TB, and maternal deaths combined.

And care for managing these conditions is out of the reach of the poorest billion, with between 19 to 50 million people every year spending a catastrophic amount of money in out-of-pocket healthcare payments.

“The pandemic has exposed the myth that extreme poverty was disappearing,” said Commission Co-Chair Gene Bukhman of Harvard Medical School, Partners In Health, and Brigham and Women’s Hospital. “We need a cross-border movement with a common sense of humanity to serve people living with NCDs in poor countries, whose economic and health status makes them doubly vulnerable to COVID-19.”

In the midst of the coronavirus pandemic, those struggling with preexisting NCDS such as heart diseases and diabetes are at even higher risk of experiencing severe disease or death if infected by COVID-19.

Richard Horton, editor-in-chief of the Lancet, called the syndemic of NCDs, COVID-19, and inequity a “terrifying intersection of forces.”

“We’re seeing that COVID-19, as do all pandemics, strike the poorest people hardest. Here we have a terrifying intersection of forces, a systemic combination of three concurrent epidemics,” said Horton at the launch of the Commission’s report on Tuesday. “That is COVID-19, the epidemic of non communicable diseases, and an epidemic of inequality disparities within countries and between countries.”

NCDs Need A Massive Infusion of Funding

But despite the high burden of NCDs in the poorest billion, many of whom live in Southeast Asia or Sub-Saharan Africa, only US $100 million in development aid is directed towards NCD programs every year.

“Out of the total development assistance for health; the Commission finds just 0.3% goes to the non communicable diseases and injuries,” said Bukhman on Tuesday.

“No disease should practically be a death sentence in one country but treatable, preventable or curable in another,” said Commission Co-Chair Ana Mocumbi of Universidade Eduardo Mondlane and Instituto Nacional de Saúde in Mozambique.“Universal health coverage is unobtainable unless the global health community broadens the geographies and conditions covered by action on non-communicable diseases.”

The report also found that in a number of countries, national plans for NCDs and for poverty reduction fall along separate tracks. Even in national poverty reduction plans published after the UN High-level meeting on NCDs in 2011, NCDs are usually referred to as an “emerging problem.”

But this new report could help turn the assumption that rich countries are affected most by NCDs on its head.

The release of the Commission’s report also marks the launch of the NCDI Poverty Network, which will be dedicated to mobilizing greater funding and political commitment for tackling NCDS as a problem in the poorest billion.

 

Image Credits: WHO/INADI, The Lancet NCDI Poverty Commission.

Tijjani Muhammad-Bande, President of the seventy-fourth session of the United Nations General Assembly, submitted the omnibus COVID-19 resolution that ultimately passed.

The United Nations General Assembly adopted an omnibus resolution urging Member States to mount a coordinated global coronavirus response on 11 September.

The resolution (Document A/74/L.92), submitted by the President of the Assembly Tijjani Muhammad-Bande, was almost passed unanimously, with only two countries voting against and two abstaining.

United States & Israel Vote Against the Majority

In a blank break from multilateralism, the United States and Israel voted against the adoption of the resolution – which clearly acknowledged the key leadership of the UN agency the World Health Organization in coordinating the response. Ukraine and Hungary abstained.

The Trump Administration in July had formally announced to the UN and the US Congress that the US intended to withdraw from the WHO by July 2021, following weeks of Trump criticizing the agency for allegedly mishandling the early days of the pandemic and catering to Chinese pressure.

The US representative on Friday repeated claims that China’s Communist Party had concealed the truth about the COVID-19 outbreak, resulting in innumerable needless deaths. Those responsible must be held accountable for their actions and inactions, he said, adding that WHO must reform, including by declaring its independence from China’s Communist Party.

China’s representative responded by declaring that the United States’ claims were “well past their sell-by date,” and urged the country to focus on fighting the virus within its borders, and lift unilateral sanctions that may violate international law.

The United States currently has the highest number of coronavirus cases and deaths in the world, with more than 6.5 million cumulative cases and nearly 200,000 deaths. Israel saw a sharp spike in new coronavirus cases after lifting restrictions in late June, and now has more than 150,000 cumulative cases.

Resolution Passed After Debate on Key Amendment Discouraging Sanctions

The resolution was passed after 19 Member States submitted a controversial amendment to the resolution that discouraged nations from enacting unilateral sanctions on states that were not in accordance with international law – a thinly veiled reference to the US sanctions against Iran.

The 19 sponsors of the amendment – including Cuba, the Islamic Republic of Iran, and Myanmar – amended operative paragraph 20 of the text to:

“Strongly urges States to refrain from promulgating and applying any unilateral economic, financial or trade measures not in accordance with international law and the Charter of the United Nations that impede the full achievement of economic and social development, particularly in developing countries;”

In contrast, the previous text referred had vaguely referred to the “unjustified obstacles” to the “efficacious” and “fair distribution” of all health products.

Israel says last-minute amendment on sanctions forced it into opposition

While the United States expressed multiple objections to the resolution – ranging from its language affirming sexual and reproductive health rights to the expressions of support for the WHO, Israel said its vote was largely due to the last minute addition of the language on sanctions.

Said an Israeli source at the Geneve Mission to Health Policy Watch: “The original text put forward by the facilitators (Afghanistan and Croatia) was comprehensive and balanced.

“We had serious concerns about a few amendments that were put forward on OP20 of the draft. For us, they threaten the delicate balance of the text that was achieved by the facilitators. It is very unfortunate that a few delegations decided to put these amendments, knowing that by doing so, they prevent the resolution from being adopted by consensus.

“While we support the rest of the resolution, we couldn’t agree with the attempt to use this important document to promote narrow political agendas. I would also note that in the room, many more countries objected these additions.”

The source added that Israel remained “very committed to working together with the international community in the fight against COVID-19. We are also strong believers in the importance of multilateralism in this regard.”

Resolution calls for science-based aproaches and climate sensitive recovery

The all-encompassing resolution called on Member States and the UN to combat the pandemic through a science- and evidence-based, cooperative approach, allocating resources based on public health needs, and partnering with relevant stakeholders to accelerate development of COVID-19 drugs, diagnostics, and vaccines.

It also called on Member States to drive recovery through climate- and environment-sensitive approaches, reflecting growing support and recognition within the UN of the importance of combatting the threat of climate change.

Cuba, in introducing the tough sanctions amendment, said that the original text failed to reflect countries concerns about the impact of such measures on national efforts to deal with the COVID-19 crisis.

The amendment was adopted by a recorded vote of 84 in favor and 13 against, with 60 abstentions.

Image Credits: UN Photo/Eskinder Debebe.

SARS-CoV-2 (yellow) attacks a dying human cell (red)

AstraZeneca resumed clinical trials for its investigational COVID-19 vaccine Saturday, after briefly pausing the trial globally to investigate reports of a potential severe adverse in a patient in the United Kingdom.

In a brief press release, AstraZeneca announced that Phase 3 trials for the vaccine, AZD1222, have resumed in the UK on 12 September following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so. The trial was paused on 6 September.

No further medical information can be disclosed at this time, according to the press release. However, AstraZeneca CEO Pascal Soriot had last week told investors that pausing the trial to investigate the potential safety signal was a routine move, and the patient in question was doing well.

The pause on the trial came just a day after the CEOs of nine major biopharma companies currently involved in COVID-19 vaccine trials pledged to follow standard safety protocol and delay seeking regulatory approval until final phase clinical trials showed their vaccines were safe and effective, amidst political pressure to speed up development.

AstraZeneca’s experimental COVID-19 vaccine, co-developed with Oxford University, is one of the frontrunners in the COVID-19 vaccine race. The company has already committed at least 300 million doses to the COVAX Facility, an initiative co-led by the World Health Organization and its partners to leverage global demand for the vaccine and ensure equitable distribution.

The company has also bilaterally signed deals with the United States, and the European Union to supply 300 million and 400 million doses of their vaccine respectively, should it prove to be safe and effective in Phase 3 trials. The company has committed to selling the vaccine at a “no-profit” price, although it is still unclear what the exact cost will be.

Image Credits: NIAID.

Minister Jackson Mthembu assesses government’s response to COVID-19 at Harry Gwala District Municipality, South Africa 5 September 2020

Cape Town, South Africa – Dire predictions of Africa being overwhelmed by a tsunami of COVID-19 infections and deaths have not materialized – yet – and this is confounding many researchers.

So whether the reason is the continent’s youthful population,  a certain level of  “herd immunity” gained from prior exposure to other coronaviruses, or simply a lack of adequate disease surveillance, experts are trying to understand the reasons why.

In early August, when the continent recorded one million COVID-19 cases  Dr Matshidiso Moeti, the World Health Organization’s regional director for Africa, described the pandemic as a “slow burn” – and that still seems to be the case as the world marks a full six months since the global health emergency was declared to be a “pandemic” by WHO.

Officially, Africa accounts for a mere 4% of the world’s cases and 3% of deaths, according to the latest statistics from the World Health Organization (WHO).  In contrast, Africa represents some 17% of the world’s population.

As encouraging, the rate of new infections has slowed in the continent’s worst affected countries, including South Africa and Egypt.

But on a more sober note, the pandemic is gaining momentum in some countries, notably Congo Brazzaville, Burundi, Central African Republic, Mali, Angola, Cameroon and South Sudan.

Warning Against Complacency

Scientists have warned against complacency, saying that a second wave is possible and that the continent’s health services could still easily be overwhelmed by COVID-19.

The total number of deaths reported in 45 countries of the region was 22 150 as of the first week of September, for an overall case fatality rate (CFR) of 2.1% – which is half the global average and way lower than the UK (11.7%) and Italy (12,7%).

But two important studies point to Africa’s infection rate being much higher than the official figures.

In the first study, researchers tested the blood samples of Kenyan blood donors between the end of April and mid-May and found that 5.6% had SARS-CoV-2 antibodies. Almost 10% of donors in the popular tourist of Mombasa, Kenya were positive. Yet  at the time, Kenya’s official infection rate was only 2093 cases and 71 deaths.

“This contrasts, by several orders of magnitude, with the numbers of cases and deaths reported in parts of Europe and America when seroprevalence was similar,” concluded the Kenyan researchers.

South Africa – More COVID infections and deaths than officially reported – but mortality still below European levels?
Total cases and coronavirus deaths on 14 Sept 2020. Numbers change rapidly

Last week, South African researchers told a media briefing that a whopping 40% of the pregnant women, as well as people with HIV, who visited Cape Town’s public health facilities had SARS-CoV-2 antibodies.

The samples were collected during the country’s pandemic peak in late July and early August from 2 700 people who had no symptoms and were simply at facilities for routine care, according to Professor Mary-Ann Davies, director of the University of Cape Town’s Centre for Infectious Disease Epidemiology and Research.

Meanwhile, the South Africa Medical Research Council, which conducts robust surveillance into mortality trends,  recorded 41,424 “excess deaths” between 6 May and 25 August in comparison to last year.

If the evidence of much higher infection rates is combined with these “excess deaths”, then South Africa’s pandemic trajectory is in line with global trends, according to Professor Andrew Boulle, a public health specialist with the Western Cape health department.

“Crudely, African and other poorer countries ought to have seen about a quarter of the mortality of Europe, given the same incidence and age-specific infection fatality ratios because of the much younger populations,” says Boulle, who is also public health medicine professor at the University of Cape Town.

Serology from overcrowded slums in South Africa and India shows that “seroprevalence is much, much higher than in Europe and North America,” says Boulle. This indicates that South Africa’s hospital cases the mere tip of the infection iceberg.

“I have seen some articles questioning why Africa was not harder hit but, to be honest, I think lower morbidity and mortality was entirely predictable,” he added.

In African countries with less rigorous mortality data, the true extent of COVID-19 deaths may never be known. There is anecdotal evidence that hospitals are filling up in Uganda, as well as reports of delays in tests and poor hospital infection control practices in a country that was once praised as a model for COVID containment.  Meanwhile, funerals have increased in places like Somalia.  Even so,  given the global research community’s scrutiny and measures put into place to track diseases such as cholera, measles and Ebola,  it is unlikely that African countries would be able to conceal abnormally high deaths over a long period of time.

South African Researchers Explore Possible Protective Factors: Youth, Prior Exposure to other Coronaviruses, Vaccine History
The relative youth of Africa’s population may be one reason why coronavirus death rates are lower across the continent.

So how is Africa keeping its hospital cases and deaths lower than predicted? There are a few popular theories.

The first is the relative youth of Africans. Around 60% of Africa’s population is under the age of 25 and only 3% of people living in sub-Saharan Africa are over the age of 65. In contrast, over 20% of the Italian and French populations are over this age and this is where the biggest deaths have occurred globally.

While there are likely to be many more cases than recorded, a high proportion of people infected would have few symptoms and could recover without treatment, simply because of their age.

The second is that some regions or communities already may have developed some kind of “herd immunity” thanks to earlier exposure to other coronaviruses that manifest, such as  the common cold.

Professor Shabir Madhi, head of vaccinology at the University of the Witwatersrand, posited this idea at a symposium hosted by his university and Columbia University last Friday:

Referring to the Cape Town study where 40% of people were seropositive, Madhi said that “there was a huge infection rate in urban areas and quarter of those who tested positive for virus were completely asymptomatic”.

“One of the factors for why so many people are asymptomatic is that here may be some herd immunity underpinning the response, possibly as a result of people being exposed to other common cold coronaviruses over two or three years, ” said Madhi.

Professor Marc Mendelson is head of infectious diseases at the University of Cape Town, and oversees the COVID-19 response at Groote Schuur Hospital, which was at the epicentre of South Africa’s pandemic about six weeks back.

He says that the country’s true infections are “probably somewhere in the region  of six to 15 million”.

“Why South Africa was better off than expected is still in the realms of hypothesis,” adds Mendelson. “I think it is a combination of factors. My top three most likely factors are cross-immunity relating to pre-existing infections with humbler coronaviruses; younger age of the population meaning that less mortality and more asymptomatic or pauci-symptomatic cases, (most of which would have been undocumented); and high transmission rates in high density areas, which drove herd immunity, while compliance with social distancing, masks, and hand hygiene reduced transmission in low density areas”.

He added that these factors may apply to other African countries, but there were also “a number of unknowns” including a lack of testing and laboratory capability.

Professor Helen Rees, who is chair of the WHO Africa Regional Immunisation Technical Advisory Group, said researchers were also examining whether the childhood vaccinations for measles, mumps and rubella (MMR) and tuberculosis – the BCG (bacillus Calmette-Guérin) jab  – offered any protection.

Prevention Policies May Be Keeping Death Rates Low – But ‘Slow Burn’ Still a Threat
South African peacekeepers are distributing awareness-raising pamphlets in a school in North Kivu, Democratic Republic of the Congo

Scott Dowell, an infectious diseases specialist at the Bill and Melinda Gates Foundation, believes that there are “several reasons for why the impact is so low in Africa”.

“The first is that African leaders identified COVID-19 early and their response was robust and quick,” Dowell told the Columbia-Wits symposium. “Then there is age. Very few Africans are over the age of 65 relative to other parts of the world. Over 50% of Africans are between the ages of five and 25 and at low risk of mortality.”

However, Dowell’s final reason was “the 50-fold lower rate of testing” on the continent due to lack of tests and restrictions on who can get tested – meaning that many more cases of infection, and by implication deaths, are really being caught and tracked.

A briefing note by  Resolve to Save Lives, the initiative led by former US CDC director Tom Frieden, concludes that, “a younger age distribution, lower overall population density, warmer temperature, less urbanization and other factors common in Africa tend to favor less transmission and less severe disease.”

But Resolve continues: “Conversely, larger households, high rates of malnutrition, high rates of infectious diseases and other factors may lead to additional burden in comparison to other regions. The balance of these factors will drive trends in the number of people who become sick and the number who die, regardless of whether disease surveillance is optimal.”

Boulle says that, given higher death rates from other illnesses – tuberculosis and HIV in South Africa – “it is possible that the mortality experience due to COVID-19 is less noteworthy and probably largely undocumented.”

However, while the “slow burn” development of the pandemic might be less immediately devastating, it will require sustained resources over a longer period of time and there is a high risk of health-worker fatigue.

Image Credits: Government of Zambia , WHO, Grassroots Soccer/Karin Schermbrucker , MONUSCO/Force.

(left-right, top-down) Clemens Martin-Auer, Frederik Kristensen, Thomas Cueni, Kate Elder, Ilona Kickbusch

COVID-19 has the potential to change how vaccines are sold and distributed, but industry leaders, academics, policymakers, and advocates are still struggling to decide the direction those changes should take.

A successful COVID-19 vaccine should only be sold by companies to countries if it fits within an equitable distribution platform made by a neutral third party, such as the World Health Organization, said Kate Elder, senior Vaccines Policy Advisor at the Médecins sans Frontières Access Campaign, at a webinar hosted by the European Health Forum Gastein. This year’s European Health Forum Gastein will be hosted virtually from 30 September – 2 October.

“Equitable allocation needs to be done based upon public health criteria,” Elder said. “All countries need to agree that that might mean that they’re not first in line for a certain number of doses, and pharmaceutical corporations most certainly also need to cooperate with that and not sell in a priority manner those future doses to any one country or bloc of countries.”

But Thomas Cueni, director-general of the International Association of Pharmaceutical Manufacturers and Associations, said that it is unlikely that a successful COVID-19 vaccine will follow only one global distribution method.

“The notion of a global public good means that if you can get it, I can get it. But it’s simply not the case when you have limited doses,” said Cueni. “Ideally you would have one global allocation mechanism, but unfortunately that is not likely to happen…Of course, vaccine manufacturers have to respond to where do they get the support, where they get the orders from.”

The debate around allocation of a COVID-19 vaccine comes just a day after the first meeting of the Facilitation Council for the Access to COVID-19 Tools (ACT) Accelerator, which includes a key pillar working on COVID-19 vaccines access. The COVAX Facility, an initiative within the ACT Accelerator, aims to pool global demand for a vaccine from rich and poor countries alike, pooling the risk of investing in the wrong vaccine candidate for rich countries, and providing poorer countries more negotiating power and financing.

Supply Will Definitely Not Meet Demand – Proposed COVAX Facility Design May Introduce ‘Inequity’

There will certainly be a shortage of COVID-19 vaccine in 2021, even after it receives regulatory approval, according to Cueni.

“We talk about the need for 12 to 16 billion doses of COVID-19 vaccine based on the phase 1 clinical trials,” said Cueni. “[Within the COVAX Facility], somebody told me that he is optimistic that 3 billion doses should be possible by the end of next year.

“We’re delighted to [be able to] vaccinate the health professional frontline workers. That’s 1% of the global population.”

But expanding vaccination to include all people over 65 years old, a high risk group for COVID-19 severe disease and death, then proportion of the global population that requires the vaccine increases to 8%. And vaccinating all people with comorbidities and pre-eixisting conditions, such as diabetes, which predispose them to severe COVID-19 will increase the proportion of the world population in need to 20%.

However, Cueni added that he was “optimistic” that many rich countries would join the COVAX Facility, even after signing bilateral deals outside the Facility guaranteeing millions of doses of vaccine. Compromises had to be made to attract more donors to the Facility, said Cueni.

Japan is one example so far – the country has preordered vaccines directly from Moderna and AstraZeneca, and has pledged to participate in the COVAX Facility.

But medicines access advocates say that the terms of the COVAX Facility still lean in favor of rich countries, who can pay more to choose which of the dozen vaccines in the Facility’s portfolio that they want to back, and opt out of purchases of vaccines they may not want or need.

“We now have a new option that was pushed by high-income countries for how self -financing countries can join the COVAX facility,” said Elder. “By the terms of that new option, if they pay more money up front, they get to opt out of certain deals. They get to pick and choose which deals they want to benefit from now.

“I think we do need to honestly acknowledge that by giving the initial opportunity to countries to pay more upfront and give only them the choice to pick and choose which doses they’re going to benefit from, it is introduces inequity by definition.

“If you cannot afford that upfront, then you don’t get those choices.”

Still, the COVAX Facility may be the largest ever multilateral effort to coalesce global demand for any vaccine. And the pooled procurement mechanism can be a powerful strategy to negotiate lower prices, with the European Union already negotiating deals outside of the COVAX facility as a bloc of 27 countries, according to Clemens Martin-Auer, lead negotiator for COVID-19 deals for the European Union.

Commitment Made To Mobilize Political Interest for the ACT Accelerator, but Finer Details Around Distribution Are Still Unclear

South Africa and Norway co-chaired the meeting, pledging to both galvanize political leadership to support the Accelerator and motivate countries to mobilize funds. However, details such as the governance structure of the COVAX Facility, or the exact distribution plan of a successful vaccine candidate, have not yet been hammered out.

The deadline for countries to make a binding financial commitment to the COVAX Facility is fast approaching on September 18th. So far, some 170 countries have expressed interest in joining the facility, including 92 lower-income countries that qualify for development assistance. Some large traditional global health donors, including the European Union, Germany, and Japan, have also made commitments to the COVAX Facility to help fund procurement of vaccine doses for poorer countries.

However, the United States, historically the world’s largest global health donor, has said that it will not join the COVAX Facility because it it is in part led by the World Health Organization. The Trump Administration in March began criticising the agency for allegedly bowing to pressure from China and moving slowly in the early days of the pandemic. Since then, Trump has suspended funding to the Organization, and has notified Congress and the United Nations of the US’ intent to withdraw from the WHO by July 2021. The US currently has the world’s highest coronavirus caseload, and the highest number of coronavirus deaths.