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.

Locally fabricated plastic water containers with taps are making it easier for establishments and public spaces to set up handwashing stations.

Ibadan, Nigeria – The pandemic has brought to the fore Africa’s reliance on international support for its health sector – and it is also challenging the continent’s ability to build up its resilience when donors fall through. 

“There is a new public health order that is coming because of COVID-19. COVID-19 has opened our eyes to resetting lots of activities, relationships, strategies and actions,” Dr. Ahmed Ogwell Ouma, Africa Centres for Disease Control (CDC) Deputy Director, told Health Policy Watch, in an exclusive interview.  “What we are doing with COVID-19 is exactly what we need to do for all the other disease conditions and across the whole of healthcare. 

“We will own our space – Africans thinking for Africa and delivering for fellow Africans. This is the new public health order that is coming and COVID-19 is a way of delivering that public health order.”

WHO said the pandemic is not ending anytime soon. In Africa, the messaging has changed from describing the virus as one that needs to be eradicated quickly to one that the people can safely live with by following specific guidelines – including ones guiding the resumption of air travel. 

On 1 September 2020, the number of confirmed cases of COVID-19 in Africa exceeded 1.2 million, just two months after the WHO African Region announced that COVID-19 pandemic in sub-Saharan Africa had reached the major milestone of over 500,000 cases confirmed. 

While South Africa remains the epicenter of the pandemic in Africa with about 630,000 confirmed cases, there are also indications that cases are climbing elsewhere but obscured by limited testing capabilities. 

Africa’s COVID-19 Numbers Are Lower Than Expected – But Will Continue To Climb

At the outset of COVID-19, Microsoft founder, Bill Gates of the Bill & Melinda Gates Foundation, projected that the pandemic could claim as many as  10 million lives in Africa. But Africa has yet to become the pandemic’s epicentre, and governments across the continent have already reopened their countries extensively. While the global case fatality ratio is about 4.4%, it hovers around 2% in Africa.  

Ahmed Ogwell Ouma, Africa CDC’s Deputy Director

“The predictions were based on very wrong assumptions that Africa has no capacity or ability to look after itself. We’ve proven this assumption wrong as Africa has the commitment and capacity to be able to look after itself,” Ouma said. 

Ouma noted that African countries are “doing really great work keeping the virus under control”. While the numbers are rising, Ouma said the disease outlook would have been worse if the interventions did not come early. 

“The rising numbers are not an indication of failure. In fact, it is an indication that in Africa, we are seeking out those who have the virus and containing it. Africa is doing okay and much better than earlier predicted,” he said. 

Ouma said he is not worried that Africa’s COVID-19 numbers may continue to rise further, noting that the continent is not yet at the peak of the pandemic. 

“As long as we keep the number at a manageable level as we seek therapeutics and vaccines, then we are alright. I’m not worried that the numbers are going up. Indeed it’s our expectation,” he told Health Policy Watch. “But I will be worried if the graph is steep. We want the graph to stay gentle which means the numbers are not overwhelming.”

Absence of Global Leadership & The US’ Staunch Nationalism Have Pushed Africa To Be Proactive

With the entire world combatting COVID-19 at the same time, countries that had historically been supporting Africa understandably decided to prioritise their national interests. Moreover, the existence of a gap in global health leadership  is forcing a moment of reckoning that experts believe could compel African governments to begin taking more proactive roles. 

Africa countries historically been known for their weak health systems, but efforts to control COVID-19 have also been impacted by external factors. In Nigeria, for instance, the US.-based Abbott Laboratories, a major supplier of COVID-19 test kits, was accused of improper delays in filling orders from African governments, even when they were filed in a timely manner. 

The retreat from multilateralism by the United States, historically one of the continent’s biggest health donors, has signaled to African governments that they cannot afford to wait for traditional donors to step up in the COVID-19 pandemic response.

The Trump administration’s decision to withdraw the US from the World Health Organization has also distanced the continent, especially at a time when an African was leading the WHO for the first time.

“We are all very empathetic about the way Tedros (WHO Director Genera Tedros Adhanom Ghebreyesus) has been treated. We know Americans are being bullies. We don’t want that to happen anymore. What they are doing to him, they will do to Chikwe (Nigeria CDC’s Director General), and they will do to anybody,” Professor Moses John Bockarie, EDCTP’s Head of Africa Office told Health Policy Watch. 

The United States, along with other rich countries and regions such as the European Union, the United Kingdom, and Japan, have also been engaging in “vaccine nationalism” – preordering investigational COVID-19 vaccines, potentially buying up the world’s supply ahead of lower income countries. Along a similar vein, most of the world’s remdesivir, a drug that has been shown to speed up the recovery of some patients with severe COVID-19, had been bought up by the United States, leaving less than 15,000 treatment courses for countries that cannot buy generic remdesivir. 

Ouma thus described COVID-19 as a rallying moment where Africa needs to come first, African solutions should lead, and be propagated across the continent. He said Africa CDC is engaging programme officers across Africa, urging them to prioritise supply chain and capacity building on the continent. He added that COVID-19 has demonstrated why African countries should be sharing resources, particularly facilities for testing. By doing this, he said the continent will start achieving the integration and growth that is the aspiration of Agenda 2063 -The Africa We Want. 

Eswatini Builds On HIV/AIDS Capacity for Coronavirus Response
Ambrose Dlamini, prime minister of Eswatini

African countries are building on the extensive networks created for other diseases for the COVID-19 response. Ambrose Dlamini, prime minister of the Kingdom of Eswatini, told Health Policy Watch that while Eswatini is not currently fully ready nor fully-equipped to deal with pandemics, it has leveraged its HIV/AIDS response to expand capacity. 

“We’ve developed some capacity that we think we are going to leverage going forward. We are going to use the national response framework which has really done well, providing us with capacity over the years, we want to develop it to equip the country to deal with future pandemics,” said Dlamini. “That is the strategy going forward.

“Right now, it is responsible for HIV, malaria, and TB. Those are the diseases that are being managed by the framework. It is really doing quite well in all of these diseases and we hope future pandemics will be managed through that structure.”

Building on Local Capacities for Contact Tracing & Producing Equipment for Africa’s COVID-19 Response

Technology is also being deployed, to aid contact tracing in some countries – although this remains a controversial solution. Even though digital innovations have also been developed and deployed for the COVID-19 response in several African countries, Ouma said the core of Africa CDC’s strategy for contact tracing is not mobile apps.

“In developed countries they are using apps and technologies for contact tracing. In our own case, our technology is community health workers who will also educate the people on what they need to do to protect themselves,” he told Health Policy Watch. 

Handmade fabric facemasks

One very low-tech solution is the wearing face masks in public, as now recommended by the World Health Organization.

When the scarcity of PPEs hit the global market, local face masks and shield production systems soon emerged as African cities began to introduce and enforce mask policies, creating job opportunities for local tailors and entrepreneurs such as Abass Akinyemi.

“Before COVID-19, I was selling bread along the Lagos-Ibadan expressway (one of Nigeria’s busiest highways) but when COVID-19 hit Nigeria and the government introduced lockdown, I had to think of something else to do,” Akinyemi told Health Policy Watch.

He read about the state government’s plan to engage local tailors to produce one million face masks. Although he did not apply for the government project, he learnt how to make face masks, and began to sell them.

“The cost of production is very low, the profit margin is very wide and the demand for the face masks is high. Business has been good,” Akinyemi told Health Policy Watch in Ibadan, southwest Nigeria.

Different Contexts Require Different Solutions –  Some That Still Need To Be Found
Winnie Byanyima

But in many settings in Africa, some of the basic measures such as handwashing and lockdowns are difficult to successfully implement without backlash. Winnie Byanyima, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), told Health Policy Watch that the measures considered most basic, globally, are difficult to implement in many settings in Africa.

“Every day in Africa, a woman walks an average of 6 kilometer to fetch water. Now you’re saying wash hands every five/ten minutes. Who is going to fetch that water? It’s women and girls. Social protection came in so little and too late,” she said.

She noted that COVID-19 containment measures also increased vulnerability to other infectious diseases such as HIV, since people couldn’t get as easy access to prevention and treatment. But beyond the immediate impacts of COVID-19 measures on vulnerable Africans, Byanyima added that long-term impacts on relevant African programmes, which heavily rely on international donor funding. 

“For the low income countries in Africa, we have reasons to worry very much. They are funded, almost 90%, by aid money. This is disturbing because those aid countries (donors) have been hit very hard [and] they have to recover their economy and the revenue they will raise will not be what they expected. So even if we say we are going to keep the level of official development assistance (ODA) where it is – say 0.3 or 0.7%, or whatever the country has been giving, in terms of real volume of money, it will be less money,” Byanyima said. 

Next Priority Is Scaling Up Testing, Tracing & Treatment

With the pandemic not ending anytime soon, Dr. Nkengasong, Director of the Africa CDC said the priority for the response in Africa is to accelerate testing, tracing and treatment. On the continent, this is being driven through the PACT initiative (Partnership to Accelerate Covid-19 Testing). He described the initiative as the roadmap to safely unlock Africa’s economy.

“Africa is scaling up testing very rapidly. As a continent of 12 billion people we should have tested 1% of our people which is about 12 million tests. So, we have tested 2.7 million people, clearly there is a gap of 10 million that we should have tested to be ahead of the pandemic,” Nkengassong said at a recent press conference. A signature aim of the initiative is to conduct 10 million COVID-19 tests by October 2020.

But beyond testing, tracing and treatment, Ouma underlined that the COVID-19 response in Africa would still clearly benefit from the availability of new vaccines and more therapeutics. Early in July 2020, the Consortium for COVID-19 Vaccine Clinical Trial (CONCVACT) was launched to support the contributions of African scientists and healthcare professionals to the development and provision of safe vaccines. 

Ouma added that COVID-19 has also seen African countries working together to collaboratively overcome the challenges posed by the pandemic. Regarding treatment, he said African governments are being encouraged to ensure COVID-19 does not interrupt with the provision of other health services including maternal health, HIV/AIDS and malaria.

“Our intention is to ensure that Africa has local R&D, local field testing, clinical trials and production – not only vaccines but also therapies and any other supplies we may need, including equipment. It’s time for Africa to take its rightful position. A continent of 1.3 billion people must look after itself. This is our intention,” Ouma told Health Policy Watch. 

Image Credits: Paul Adepoju/Health Policy Watch.

Transmission electron micrograph of SARS-CoV-2 (red), the virus that causes COVID-19

AstraZeneca on Tuesday night suspended the Phase 3 trial of their experimental COVID-19 vaccine in order to investigate a a suspected severe adverse reaction in a volunteer reported in the United Kingdom.

The trial suspension follows just on the heels of AstraZeneca’s chief executive officer’s pledge to seek regulatory approval for a COVID-19 vaccine only after it has been proven to be safe and effective in large, randomized Phase 3 clinical trials. AstraZeneca’s CEO, along with the CEOs of eight other companies at the forefront of coronavirus vaccine development, signed the pledge on Tuesday.

“At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts,” CEO Pascal Soriot said in press release. “We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”

The pause is a sign that pharmaceutical companies are taking seriously routine clinical trial protocols to stop trials in the case of severe adverse reactions, even as pressure builds to get a safe and effective vaccine to market as soon as possible. Russia and China have already approved investigational COVID-19 vaccines for limited use, ahead of the completion of Phase 3 trials.

The Trump administration has indicated it’s looking to roll out a COVID-19 vaccine for wider use in late October, just ahead of the US presidential election on November 3rd. On Wednesday, the Administration issued new guidance to allow pharmacists and pharmacists in training to administer the vaccine, in preparation for a successful vaccine’s roll-out.

The World Health Organization and independent health experts have cautioned against prioritizing speed over safety; and are concerned that political pressure will lead to wider deployment of an investigational vaccine before large, final-phase trials have proven the vaccine to be safe and efficacious. It is unlikely that Phase 3 trial results will be available before early 2021.

Participant Who Experienced Suspected Adverse Reaction Is Doing Well

The trial was suspended because one participant was diagnosed with transverse myelitis – an inflammatory condition of the spinal cord that can be brought on by viral infections – according to the New York Times. However, it’s still unknown whether the condition was related to the investigational COVID-19 vaccine, although Soriot confirmed in a private call with investors that the patient had been enrolled in the arm that received the COVID-19 vaccine. However, he also told investors that the patient is doing well and will likely be released from the hospital as early as today, according to STAT News.

Such pauses are not uncommon, according to the director of the US National Institutes of Health Francis Collins.

“To have a clinical hold, as has been placed on AstraZeneca as of yesterday, because of a single serious adverse event is not at all unprecedented,” Collins told a Senate panel on Wednesday. “This certainly happens in any large-scale trial where you have tens of thousands of people invested in taking part, some of them may get ill and you always have to try to figure out: Is that because of the vaccine, or were they going to get that illness anyway?”

However, Collins added that should the review of the safety data find that the adverse event was related to the vaccine, all doses already manufactured would be disposed. The Trump administration signed a deal in May with AstraZeneca to produce 300 million doses of their investigational vaccine by January 2021, to be ready for mass rollout should the vaccine prove to be safe and effective.

“This ought to be reassuring to everybody listening when we say we are going to focus first on safety and make no compromises,” said Collins.

The massive trial – which has enrolled participants in dozens of study sites across the United Kingdom, Brazil, South Africa, and the United States – is one of the largest Phase 3 trials currently underway in the COVID-19 vaccine race, and the length of the trial’s suspension has not been confirmed. However, sources familiar with the trial told the Financial Times that the trial may resume in the next week.

Novel Technology Put To The Test In COVID-19 Vaccine Trials

In the private call with investors on Wednesday, Soriot also confirmed that the trial had been paused once in July due to a suspected adverse reaction. It resumed shortly after the suspected case was cleared to not be related to the vaccine candidate.

The vaccine, AZD1222, was co-developed by the University of Oxford, and uses a weakened version of a chimpanzee adenovirus – a common cold causing virus – to carry the genetic material of the SARS-CoV-2 spike protein. Once injected, cells inside the body produce the spike protein, a harmless but discrete marker of the SARS-CoV-2 virus, priming the immune system to recognize the virus and attack if the body is later infected.

There is no licensed vaccine with an adenovirus backbone on the market yet. However, this is in large part due to the novelty of the technology, according to Barry Bloom, an infectious disease epidemiologist and former dean of Harvard School of Public Health.

“No one had the genetic tools to be able to make them and make them quickly. So, the revolution in molecular biology and genetics and the ability to replace one gene with another rapidly easily and effectively, and has really speeded things up tremendously,” Bloom told Health Policy Watch. 

So far, results from a Phase 1/2 trial of the AstraZeneca/Oxford vaccine candidate published in July found that in 1,000 people, about 60% experienced “mild or moderate” symptoms after vaccination. These symptoms included pain at the injection site, feeling feverish, chills, muscle aches, and malaise. In that trial, no serious adverse reactions were reported.

Image Credits: NIAID.

Electron microscope image of SARS-CoV-2, the virus that causes COVID-19

The chief executive officers of nine biopharmaceutical companies at the forefront of the COVID-19 vaccine development race have signed a pledge to fully test the safety and efficacy of an investigational vaccine before rolling it out for mass use.

The top executives of AstraZeneca, BioNTech, GlaxoKlineSmith, Johnson&Johnson, Merck, Moderna, Novavax, Sanofi, and Pfizer signed the safety pledge on Tuesday, following reports that the CEOs were preparing such a safety pledge on Saturday.

News of the safety pledge coincided with reports Tuesday evening that AstraZeneca, which is one of the leading pharma companies in the race to develop a COVID-19 vaccine, was suspending it’s Phase III trials underway in four countries in collaboration with Oxford University, to investigate a report of a possible severe adverse reaction in one UK participant.

The AstraZeneca move was made out of “an abundance of caution,” a person familiar with the trials told STAT News – noting that such pauses are not uncommon. The trial may be resumed once the cause of the reported reaction is investigated, and if the vaccine is still deemed to be safe. However, it’s unclear how long the suspension will last.

“We voluntarily paused vaccination to allow review of safety data by an independent committee. This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” an AstraZeneca spokesperson said in a statement to STAT News.

Amidst pressure from the Trump administration to begin wider roll-out of a vaccine before the US presidential election in November, pharma companies have taken the initiative to reassure the public that any potential COVID-19 vaccine will be properly tested before it receives regulatory approval.

“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the companies wrote in the pledge.

Pharma Pledge Comes Amidst Pressure to Speed Up Approval

The pledge comes as countries’ regulatory authorities have faced pressure to release an investigational vaccine for wider use, even as large final phase clinical trials are still ongoing. Phase 3 clinical trials for the coronavirus vaccine candidates, which closely monitor the safety and efficacy of an investigational product in thousands of people, will not be complete before the end of the year.

However, the United States CDC notified US state officials in late August that a vaccine could be available for wider use by late October, just in time for the US presidential election on November 3rd, according to the New York Times.

And Russia approved a vaccine, aptly named “Sputnik 5,” before Phase 3 trials had concluded in mid-August. The move has drawn criticism and offers to collaborate by governments seeking new ways to combat the pandemic.

China in July approved a SinoVac’s vaccine candidate for emergency use, and media reports have found that nearly all of SinoVac’s employees and many of the employees’ family members have received the experimental vaccine.

The Gamaleya Institute, the developer of Russia’s approved vaccine, and SinoVac are not among the companies who have signed the pledge. However, Phase 3 trials for both companies’ vaccine candidates are currently underway.

The rapid approval of COVID-19 vaccines has drawn criticism from a number of researchers and public health specialists, who have warned governments against prioritizing speed over safety in releasing a vaccine. The World Health Organization has also recommended that countries wait for results from Phase 3 clinical trials before attempting to roll out a COVID-19 vaccine en masse.

Companies Pledge To Seek Regulatory Approval Only After Phase 3 Studies Show Safety And Efficacy

Key to the nine companies’ pledges is the promise to seek any regulatory approval, even emergency use approval, only after the vaccine demonstrates safety and efficacy in large scale, final phase clinical trials. The trials used to test the vaccine must also be designed to the highest clinical research standards, and ensure the vaccine is safe and effective in a large and diverse group of people.

“Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to..only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA,” the companies wrote in the pledge.

Additionally, the companies made three further promises:

  • Always make the safety and well-being of vaccinated individuals their top priority.
  • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
  • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

Together, these nine companies represent some of the biggest vaccine developers in the world, and some of the most promising biotech firms. All companies are invested in investigational COVID-19 vaccines that are currently in Phase 3 trials.

Image Credits: National Institute of Allergy and Infectious Diseases, NIH.