SARS-CoV-2 (red), the virus that causes COVID-19, attacking a dying cell (blue).

Preliminary results of a clinical trial released by the US National Institutes of Health (NIH) found that in patients who received remdesivir recovered faster than those who did not receive the treatment.

The largest trial to date, which followed 1063 patients, found that patients who received the drug recovered on average 4 days earlier than those who did not. Additionally, the death rate was 8% in the group that received remdesivir compared to 11.6% in the control group, although this result was not statistically significant.

“What [this trial] has proven is that a drug can block the virus,” Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID), told reporters in a rare show of optimism on Wednesday. Fauci has emerged as the most reliable expert voice on the US national coronavirus taskforce.

He reflected that the moment he saw the results were reminiscent of the moment the NIAID reviewed preliminary results from the first large-scale study on the use of antiviral combination therapy for HIV/AIDS – the first in a series of technological breakthroughs against that virus.

“We think it’s really opening the door to the fact that we now have the capability of treating [COVID-19],” he said.

In seemingly contradictory news, a new study published Wednesday in The Lancet found that remdesivir did not significantly speed recovery or reduce deaths in patients suffering from severe COVID-19 in Wuhan, China. 

Some 14% of patients in the remdesivir treatment group died after 28 days, compared to 13% in the group that did not receive the treatment. The Lancet study followed 237 adult patients with severe COVID-19 in Wuhan, China, the original epicentre of the pandemic.

“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo”, says lead researcher Bin Cao from China-Japan Friendship Hospital and Capital Medical University in China, in a press release. The formal publication in the Lancet confirmed initial reported findings that were accidentally leaked on the World Health Organization’s clinical trials registry last week.

Independent experts have urged for continued research in order to create a larger pool of conclusive evidence to judge remdesivir’s effectiveness on COVID-19. The Wuhan study had been terminated early due to lack to new patient enrollment, resulting in a much smaller sample size.

“Each individual study is at heightened risk of being incomplete [in a pandemic situation],” wrote John Norrie, professor of Medical Statistics from the University of Edinburgh, in a separate Lancet comment. “Pooling data across several such ‘underpowered’ but high-quality studies looks like it will be our best way to obtain robust insights into what works, safely, and on whom.”

Remdesivir, a failed Ebola antiviral developed by Gilead Sciences, was tapped as one of a handful of promising COVID-19 treatments for a global Solidarity trial coordinated by WHO. It has only been available to patients under emergency or compassionate use protocols, which allow patients to access experimental medications in the absence of any known treatments for COVID-19.

WHO experts declined to pass judgement on remdesivir in a press briefing Wednesday. Maria Van Kerkhove, WHO’s Technical Lead on the COVID-19 crisis, remarked, “Typically you don’t have one study that will come out that will be a game changer. Once we look at all of the studies, and we judge them collectively we can come away with some kind of a conclusion of ‘yes we see an effect’ or ‘no we don’t.’”

WHO Executive Director of Health Emergencies, Mike Ryan, said that he had not yet read the full study, but “fervently hoped” that one of the many drugs under investigation around the world would help improve clinical outcomes. 

In a parallel move, Gilead unveiled early results from a trial exploring the efficacy of different durations of remdesivir treatment on Monday. The so-called SIMPLE trial found that treatment outcomes were similar in patients with severe COVID-19 receiving a 10 day course and those receiving a 5 day course. However, the Gilead trial results fail to assess remdesivir efficacy against a control group, making The Lancet study the first published RCT to explore whether remdesivir has any overall benefit to COVID-19 patients.

Findings from the Lancet Study – Small Sample Size a Major Limitation
3D molecular structure of remdesivir, an antiviral drug

The Lancet study found no significant differences in the death rate or amount of virus in the body between patients who received remdesivir and those who did not. 

Overall, 22 of 158 patients died in the remdesivir group compared with 10 of the 78 in the placebo group after 28 days. Treatment with remdesivir did not reduce the amount of SARS-CoV-2, the virus that causes COVID-19, in the body or respiratory tract compared to the control group.

However, patients who were treated within 10 days of illness onset had a slightly lower mortality rate at 11% compared to 15% in those who did not receive remdesivir. Similarly, patients who were on invasive mechanical ventilation were weaned off an average of 8.5 days earlier compared to those who did not receive the drug. No significant differences were noted between the groups in overall length of oxygen support, length of hospital stay, or time to discharge or death.

Still, the authors say that the results must be interpreted with caution due to the small sample size in the study.

“This is not the outcome we hoped for, but we are mindful that we were only able to enroll 237 of the target 453 patients because the COVID-19 outbreak was brought under control in Wuhan,” said Cao. “What’s more, restrictions on bed availability resulted in most patients being enrolled later in the disease course, so we were unable to adequately assess whether earlier treatment with remdesivir might have provided clinical benefit.”

Despite the limitations, independent experts praised the study’s protocol, including the use of a well-designed control group. All patients enrolled in the study received standard care including treatment with lopinavir–ritonavir, interferons, and corticosteroids.

“Most other released data did not have a proper comparison group, while this trial has a group given standard treatment but no remdesivir, allocated at random. The description of the methods makes it clear that this was a well-conducted trial,” said Stephen Evans, a professor in the Department of Medical Statistics at the London School of Hygiene & Tropical Medicine, in a separate comment.

WHO Director-General to Reconvene Emergency Committee for COVID-19

WHO Director-General Dr Tedros Adhanom Ghebreyesus will reconvene the emergency committee under the international health regulations on Thursday to reassess the status of the COVID-19 pandemic.

The meeting will take place three months after Dr Tedros declared COVID-19 a ‘public health emergency of international concern’ (PHEIC) on 30 January. The group of experts was deadlocked over whether COVID-19 constituted a PHEIC, the highest level of alarm the WHO can raise, in late January, meeting several times to debate the issue. 

“WHO is committed to transparency and accountability in accordance with the International Health Regulations. I will reconvene the emergency committee tomorrow,” said the Director-General on Wednesday.

However, Dr Tedros refrained from making public comment on the plans for the 74th World Health Assembly, WHO’s largest and most important annual meeting of Member States, usually planned for mid-May. Sources told Health Policy Watch on Tuesday that the Organization was considering for the first time a one-day virtual World Health Assembly on 18 May – focusing only on COVID-19. 

European Countries and US States Slowly Unwind Lockdown Restrictions – Even as the US Surpasses 1 Million Infections

The US crossed the threshold of 1 million coronavirus cases on Tuesday, confirming 1,013,168 cases and 58,368 deaths as of Wednesday morning.

Even so, many states are gearing to reopen – Alabama will replace its stay-at-home order with a safer-at-home mandate beginning Thursday, allowing employers and beaches to reopen “subject to good sanitation and social distancing rules,” Governor Kay Ivey said. Florida Governor Ron DeSantis stated on Wednesday that he will outline reopening plans during an Oval Office meeting with President Donald Trump.

Still, public health experts fear a second, deadlier wave of coronavirus in the fall. Anthony Fauci said, “I’m almost certain it will come back, because the virus is so transmissible and it’s globally spread,” during an Economic Club of Washington webinar.

Meanwhile, several European nations are eyeing a gradual end to their coronavirus lockdowns as infection rates slow and death rates decline. Swiss councillor Alain Berset announced in a Federal Council press conference on Wednesday that the country’s three-step re-opening will be sped up due to a dramatic decrease in the infection curve. The council has now authorized the reopening of more businesses than was previously allowed for 11 May, also authorizing restaurants and gyms to reopen, with appropriate sanitation and social distancing methods. Switzerland has recorded 29,407 coronavirus cases with 1408 deaths.

Spain is hoping for a return to relative normality by the end of June, said officials in Madrid, announcing a four-phase plan on Tuesday to lift the toughest set of restrictions as the daily death toll fell to 301, less than a third of a record high of 950 in early April. Meanwhile in France, widespread coronavirus testing will be launched on 11 May so that the country can slowly unwind its lockdown to avoid an economic meltdown.

Still, Europe remains the worst-affected continent, with over 1.2 million confirmed cases and more than 125,000 deaths. Spain, Italy, France and the United Kingdom are the most affected countries with 236,899, 201,505, 169,053 and 162,350 cases respectively; each has recorded over 20,000 deaths.

Total cases of COVID-19 as of 8:30PM CET 29 April 2020, with cumulative case distribution globally.

Gauri Saxena contributed to this story

This story was updated 4 May.

Image Credits: NIAID, ChiralJon – Remdesivir 3D, Johns Hopkins CSSE.

Colorized electron micrograph of a human cell (green) heavily infected with SARS-COV-2 virus particles (purple)

For the first time ever, the World Health Assembly appears set to meet in a one-day virtual session on May 18, which would be devoted largely to debate the global COVID-19 pandemic, sources told Health Policy Watch on Tuesday.

European Union member states are hopeful that a draft WHA resolution to create a voluntary patent pool of new COVID-19 health technologies could be approved in the rapid-fire session – and they are holding daily worldwide consultations with WHO member states online, with the hopes of sealing a deal on the potentially game-changing resolution in time for the WHA meeting.    

In the 73rd session of the one-day virtual WHA, 10 new members of the WHO’s 34 member governing body, the Executive Board (EB), will be elected, sources said.  

“The current COVID-19 pandemic and related public health restrictions preclude the feasibility of holding the governing body meetings scheduled for May 2020 in their traditional format,” states an excerpt of the draft proposal for the WHA meeting, obtained by Health Policy Watch. “At the same time, convening WHA73 in May would afford Member States the opportunity to collectively address the single most pressing global health issue in a moment of crisis and effectively build global solidarity and strengthen the response.”

The proposed agenda would “provide crucial international focus on Covid-19, while recognizing that consideration the nearly 60 items on the full WHA73 agenda would not be appropriate at this time,” states the proposal by the WHO senior leadership for the virtual meeting. The proposal, has been under review by the WHO Executive Board  – and would become operative by tonight, if no EB member opposition has been expressed.  

In anticipation, informal EU-led consultations with Member States already began yesterday to hammer out the nuts and bolts of the patent pool resolution, with over 130 member states getting online for the first remote debate. The closed-door country negotiations will attempt to reach a polished agreement on the controversial issues associated with access to medicines and patent rights – to avoid airing disputes publicly at WHA. 

Following on calls from Costa Rica and other countries, the EU first tabled the draft resolution on the COVID-19 patent pool to the World Health Assembly (WHA) about two weeks ago. On May 4, the European Commission will also host a fundraiser that aims to raise 7.5 billion Euros to support broad access to COVID-19 health products as well as to prop up the WHO’s efforts to coordinate and lead the response. 

Carlos Alvarado Quesada, President of Costa Rica

The EU draft WHA resolution calls on Member States to “work collaboratively at international level to develop, test and produce safe, effective, quality diagnostics, medicines and vaccines for the COVID-19 response, and to facilitate the equitable and affordable access of people to them, including through voluntarily pooling their intellectual property for all COVID-19-related medical interventions…under the leadership of the WHO.”

Other key sections of the resolution are directed at the WHO Director-General to draft a plan to achieve equitable access to COVID-19 health products for consideration of the WHO Governing Bodies, in consultation with Member States, the United Nations Secretary-General, as well as from “relevant international organizations including WIPO, GAVI, UNITAID, the Medicines Patent Pool, CEPI, the Global Fund to fight Aids, TB and Malaria, and UNICEF.”

The patent pool, which aims to share any information, data or intellectual property rights (IPRs) for innovations, would enable competitive and rapid production of needed technologies, and thus supposedly increase their affordability. 

Civil society groups have also welcomed the initiative overall 

However, some groups have leveled criticism that the proposal needs to be strengthened considerably to give it teeth.

Notably, Médecins Sans Frontières (MSF), Drugs for Neglected Disease initiative (DNDi), Health Action International (HAI), and Knowledge Ecology International (KEI) – all civil society groups in “official relations” with WHO have submitted comments to the EU and member states about WHA proposals, making some key recommendations with respect to the draft. 

Their amendments aim to strengthen key provisions around:  the WHO’s leadership role;  the specific definition of the IP rights to be pooled;  funding of government “buyouts” of essential patent rights on existing products; and “market entry rewards” or other financial inducements for innovators that openly access new drugs or vaccines; and price transparency for products. 

Among the most key points, they proposed: 

  • Definition of IP rights to be pooled, which should include regulatory test data, know-how, cell lines and other biologic resources, copyrights, blueprints and designs for manufacturing diagnostic tests, devices, drugs, or vaccines.
  • Creation of an innovation reward fund, or other market entry incentives, to compensate innovators that create open-source products. 
  • A global database of prices paid for COVID-19 diagnostic, drugs and vaccines and public contributions to new product R&D.

The KEI proposal also calls for more explicit reference to other existing legal avenues that can facilitate access to therapeutics, notably, the so called “TRIPS flexibilities” created by the World Trade Organization, in the Doha Declaration. These provide mechanisms, like compulsory licenses, that can be used lawfully by countries, to locally produce or import patented health products at a reduced price when a justifiable need exists.

The WHO could also be mandated to help build IP capacity of Member States to ensure that they make more effective use of TRIPS ‘flexibilities’, and gain timely and affordable access to technologies, KEI suggested.

“The WHO could organize a series of virtual workshops to share expertise and best practices on various technical and practical aspects of compulsory licenses and other related topics [like] the ability of Member States to implement limitations on remedies for patent infringement,” said the KEI proposal.

As for other comments, the Netherlands-based Health Action International (HAI) also issued a statement on Tuesday, commending the EU draft proposal. HAI also recommended that WHO undertake  a feasibility study of the proposed patent pool.

Access to medicines is not the main policy challenge right now, says WIPO 

While the World Health Assembly prepares to debate the Draft Resolution from the EU, the World Intellectual Property Organization (WIPO) has said that intellectual property law is not the key barrier to accessing essential medicines, and breaking patent law principles could “disincentivize innovation. 

The WIPO statement last Friday also comes on the heels of a joint statement by the WHO and the World Trade Organization (WTO) which sounded a more positive note on the need to exercise available legal flexibilities in patent law to ensure equitable access to COVID-19 health technologies.

WIPO’s statement argues that the key policy challenge right now is the total absence of proven therapeutics for COVID-19, as well as limited manufacturing capacity for essential medical equipment, or even disrupted supply chains. 

“The main policy challenge is to encourage the innovation that may lead to a vaccine and treatments and cures, as well as innovation that assists in managing the crisis,” said the WIPO assessment. 

“At the present time, it may be noted that there does not appear to be any evidence that IP is a barrier to access to vaccines, or to treatments or cures.”  

Given that the pharmaceutical industry contributes over 70% of the funding for R&D, WIPO also notes that access-focused initiatives, particularly at this stage, could even harm the private sector’s incentive to innovate. 

“Focusing on access, rather than the encouragement of needed innovation, at this stage, may not only represent a misunderstanding of the sequencing of innovation and access, but also create a disincentive to investment in needed innovation.”

Ursula von der Leyen, European Commission President, co-leading ACT fund-raiser May 4 with WHO

WIPO’s statement also seems to run against the current not only of the European Union draft WHA resolution, but also initiatives like last Friday’s European Commission and WHO-led COVID-19 Tools (ACT) Accelerator, which commits to equitable global access to innovative tools for COVID-19 for all, observed Ellen ‘t Hoen, from Medicine Law & Policy, in an interview with Health Policy Watch. 

The ACT Accelerator, together with the European Commission, aims to raise some 7.4 billion Euros in support of broad access to COVID-19 technologies. It will hold a major fundraising on 4 May. The ACT Accelerator has been backed by prominent global health organisations, like the Bill and Melinda Gates Foundation, as well as 11 heads of state, including Germany, France, South Africa, as well as other leaders across Africa, Asia, and the Americas, and Europe. 

The statement also appears to diverge from recent legislative measures that various countries have taken, like Israel, Germany, Canada, Chile, Colombia and Ecuador, to promote emergency access to potential COVID-19 technologies by facilitating the use of compulsory licenses, as well as other legal flexibilities allowed by TRIPS.

WIPO’s assessment also does not acknowledge the huge public sector investment in R&D, including for potential coronavirus drugs, noted, Yuanqiong Hu, Senior Legal and Policy Advisor of MSF’s Access Campaign, in an interview with Health Policy Watch.

“R&D for remdesivir [an antiviral candidate for COVID-19] was almost entirely funded by the government and performed by university scientists and affiliates. You cannot claim that R&D initiatives like remdesivir are mostly funded by the private sector,”  she said. 

–Updated 29.04.2020

Image Credits: National Institute of Allergy and Infectious Diseases.

A young boy sits by an open sewer in Kibera slum, Nairobi, Kenya, where COVID-19 prevention recommendations such as social distancing and frequent handwashing are difficult to maintain.

“Epidemics, such as this one or any other, by their very nature, feed off existing inequalities and make them worse. And that’s what we see COVID-19 doing to inequalities between countries and within countries.” – Winnie Byanyima, executive director of UNAIDS. 

As the COVID-19 crisis unfolds and the global economy grinds to a halt, how has this pandemic exposed inequalities in access to medical care, employment, and countries’ abilities to protect their citizens? A panel of global health leaders and international experts tackle this question in the first ‘Global Pandemics in an Unequal World‘ webinar on Tuesday, co-sponsored by The New School and Health Policy Watch.

“As this pandemic unfolds, it has made one thing very clear. It’s unprecedented in reach and reinforcing inequality,” said moderator Sakiko Fukuda-Parr, professor and director of the Julien J. Studley Graduate Programs in International Affairs at The New School. “Not only are low income and more marginalized populations more exposed, it’s likely to deepen inequalities between countries.”

Global inequality has left entire countries’ health systems exposed to the virus. African countries, saddled by debt, are particularly vulnerable.

“30 African countries are paying more towards debt repayments today than to their health sector,” said Winnie Byanyima, executive director of UNAIDS. “That’s the situation African countries have found themselves in. Corona hits at a time when they have very little fiscal space to address a new epidemic, or even to address the existing health needs of their people.”

But the inequality can be felt within countries as well. As low-wage essential workers continue to risk exposure to the deadly virus while celebrities and CEOs retreat to private mansions and islands for self-isolation, gaps between the “haves” and the “have-nots” were brought into stark relief by the coronavirus pandemic. 

“In Italy, we have clearly seen the poisonous combination of two pandemics: the new coronavirus and the pandemic of inequality,” said Nicoletta Dentico, Italian journalist and director of the Global Health Program at the Society for International Development. “The decades of social spending cuts and the very serious problems that we’ve had with austerity measures, since the financial crisis, have devastated completely the health system.”

Likewise in New York City, the pandemic has disproportionately hit the poor, immigrant, and other marginalized communities. Over 1 million people have lost their jobs – and health insurance – during the coronavirus lockdown in the city, according to James Parrott, director of Economic and Fiscal Policies at The New School. Additionally, crowded housing in the lowest income neighborhoods in the city have elevated the risk of COVID-19 transmission in those communities.

As such, any policy solution to the pandemic must focus on the most vulnerable people at the core, said Mandeep Dhaliwal, director of HIV/AIDS and human rights at the United Nations Development Programme.

“Those most vulnerable who don’t have a right to quality basic services, health, education, social protection, social safety nets; who don’t have adequate standards of living living conditions; who don’t have access to medicines or vaccines; who don’t have access to food or don’t have access to water, how can they possibly protect themselves from [COVID-19]?” she asked. 

Manjari Mahajan, co-director of the India China Institute at The New School, added that solutions must be multi-sectoral. 

“Health has to really be embedded firmly within larger social, economic, political governance systems,” said Mahajan. “We have to stop thinking about health… as a stand alone sector where the [COVID-19] response has to be determined by health specialists, health experts, health systems and hospitals alone.”

(top, left-right) Winnie Byanyima, Sakiko Fukuda-Parr, James Parrott
(Bottom, left-right) Manjari Mahajan, Mandeep Dhaliwal, Nicoletta Dentico

Here are some more key comments from the panelists, touching on debt relief, tension between the US and WHO, and next steps to address inequality:

Winnie Byanyima, executive director of UNAIDS

Corona hits Africa at a time when they have the very little fiscal space to address a new epidemic, or even to address the health needs of their people. More than half of the Sub-Saharan African countries have some form of user fees that people have to pay to go to the clinic. So we have a situation where we have user fees that are themselves now an obstacle to diagnosis because people want to offer themselves to be tested. 

We have a situation where country debt repayments have been deferred by the G20, but not canceled. It’s a good start, but it’s not enough, because you just have a little space now in six months to spend a little more. The World Bank, the Regional Development Banks, they too need to take action.

We will win this battle on the ground. We must empower communities, center them in shaping and leading responses. We must be data-driven and evidence-based; we cannot win when we are not focusing on what works. And I add global coordination – strong coordination and sharing of resources. Lastly, we must tackle these inequalities that existed before in order to build a better world afterwards. As Antonio Guterres said, in our interconnected world, we are only as strong as the weakest health systems.

Mandeep Dhaliwal, director of HIV/AIDS and Human Rights at the United Nations Development Programme

The crisis of COVID-19 also comes crashing into the crisis of inequality and the climate crisis. The policy solutions need to address multiple crises. but not in the way we’ve done them in the past where we trade off a health benefit for an economic benefit, or we trade off an economic benefit for an environmental sustainability benefit. We need solutions that actually address the drivers and the consequences of three profound crises coming together.  

I imagine in refugee camps, these COVID solutions of ‘shelter in place,’ and ‘wash your hands’ and physical distancing are meaningless in many ways. I think solutions need to really be adaptable to the most vulnerable. And this is not impossible. This is not our first pandemic; the HIV pandemic showed us that global solidarity, led by the people who are most vulnerable and most effective can drive incredible positive change and policy solutions. So I think we need integrated solutions. 

Nicoletta Dentico, journalist, director of the Global Health Program at the Society for International Development (SID)

We are now in the midst of a very delicate and very thorny, complex transition…of exiting the national lockdown. We lost 27,000 people – which is something totally unheard of. The elderly people have been abandoned where the hospitals could not absorb the affected people anymore. There will be a long term effect on the younger generations who have lost their grandmothers and grandfathers without saying goodbye. This is an intergenerational shock that we will have to coexist with.

In Italy I think one of the most difficult issues has been that we have a national health system, but it is the regions that are in charge of their people at the regional level. There is a disparity already between those regions that are wealthy enough to maintain a health system and those that cannot. So, the disease has hit the hardest where health was most systematically placed in the hands of the private sector. The fragmentation of the health system has created a lot of inefficiencies, a lot of delays, a lot of problems that finally resulted in losses of lives. 

Manjari Mahajan, associate professor of International Affairs & Starr professor and co-director of the India China Institute at The New School

Emergency discourse around any epidemic makes it seem as though the response has to be about short term measures, whereas what really determines outcomes is the investments in resilient egalitarian health systems, over a long term. The second thing is that we have to stop thinking about health as a standalone sector – health has to really be embedded within larger social, economic, political governance systems. This kind of cross-sectoral response really determines the long term success of various countries.

In India for example, a very strict lockdown was announced with four hours notice, without taking into account the wage laborers who need to earn money on a daily basis to buy food, making hunger a big issue. It did not take into account that people live in extremely congested, cramped quarters without access to clean water and sanitation systems, or how populations need to invest in harvest and planting today to ensure their livelihoods tomorrow.

James Parrott, director of Economic and Fiscal Policies, Center for New York City Affairs at The New School

In the United States we’ve been tremendously affected by the incapable leadership that we’ve had at the national level. What our president has done is inadvertently made the UN a lot more relevant. In a normal period, the United States might be providing international leadership on this or any crisis. It’s just totally not doing that right now, it’s doing the opposite. 

It’s been very clear that the healthcare system is so inadequate in the United States, despite all of the resources we heaped upon it. The pandemic has played out in very polarizing ways, both in terms of the economy and the health effects. The response of the federal government has not been to assure employers that they should keep their workers fully on the payroll, so that when the public health crisis eases, they can return to work. The response takes the form of laying workers off so they become economically displaced. And the hospitalization impact of this pandemic has been very concentrated in the poorest neighborhoods in under-resourced public hospitals. Hopefully out of this, we will have a spirited national conversation about a sort of health care system we need, as well as a thorough response to the raft of inequities that we’ve seen exposed.

New Webinars in the ‘Global Pandemics in an Unequal World’ Series

The Tuesday event was the first in a series of four webinars, co-sponsored by The New School and Health Policy Watch, with the Centre for Development and Environment at the University of Oslo joining as a partner. The following webinars will be covering these themes:

27 May –  Inequality and access to diagnostics, vaccines, and medicines for COVID-19

24 June – Digital technology and Inequality in the COVID-19 response

22 July – COVID-19 inequalities and the environment

 

Image Credits: Wikimedia Commons.

Dr Tedros speaks at the 27 April WHO COVID-19 press briefing

When the World Health Organization sounded the alarm by declaring a ‘public health emergency of international concern‘ on 30 January, “the world should have listened,” said WHO Director General Dr Tedros Adhanom Ghebreyesus, in his strongest response to date, to repeated allegations by the United States that WHO failed to act quickly enough in the early days of the coronavirus pandemic.

“The world should have listened to WHO carefully then, because the highest level of global emergency was triggered. This was on January 30 when we only had 82 cases and no deaths in the rest of the world,” said Dr Tedros, repeating even more adamantly messages he delivered on several occasions last week, “We advised the whole world to implement a comprehensive public health approach; find, test, and do contact tracing.

“You can take for yourselves countries who followed [our advice] are in a better position than others. This is fact,” he added.

Although the Director-General refrained from pointing fingers at specific nations, his response was clearly aimed at  US President Donald Trump, who bitterly attacked the agency for allegedly being China-centric and failing to provide sufficiently early warnings, and then suspended nearly US$ 500 million in funding – which represents some 15-20 percent of the WHO’s 2020-2021 budget. The US has now become the new epicentre of the COVID-19 pandemic – after Trump initially downplayed the risks posed by the virus and even praised China’s management.

“We don’t have any mandate to force countries to implement what we advise them,” Dr Tedros said. “WHO gives the best advice we can based on science and evidence, and it’s up to the countries to reject or accept.

“But what we have seen so far is that some countries accept [our advice] and some may not. At the end of the day, each country takes its own responsibility.”

Some 75% Of All COVID-19 Deaths Reported in Just Six Countries – Led by United States
United States tops the list of six countries with the most COVID-19 fatalities. (University of Oxford, CEBM). Orange bar indicates initial dates of state lockdowns.

In fact, some 75% of all COVID-19 deaths were reported in only 6 countries – with the United States at the top of the charts – a new analysis from researchers at the University of Oxford found. 

As of 24 April, there had been some 54,941 deaths in The United States, which suffered the biggest toll,  followed by Italy, Spain, France, the United Kingdom, and Belgium. 

These six countries together accounted for 155,457 of the 206,008 global deaths reported in the period – although they comprise only 7.5% of the global population. The sobering numbers come even as countries are slowly easing lockdown measures as new infections decrease, hoping that they have weathered the peak of the epidemic. 

New Drug Trial Results Sparks Hopes for Tocilizumab Therapy; Outcomes for Hydroxycholorquine and Remdesivir Less Positive 
How Tocilizumab may calm the “cytokine storm” provoked by immune overreaction to COVID-19

An antibody therapy used to treat inflammatory conditions associated with rheumatoid arthritis – tocilizumab – showed promising results in small, preliminary trials on COVID-19 patients in France, researchers at the Assistance publique – Hôpitaux de Paris, reported on Monday.

Given the pandemic context, “the investigators and sponsor felt ethically obligated to disclose this information,” said the investigators in a press release from the Assistance publique – Hôpitaux de Paris.

“These results should be confirmed independently by additional trials,” said a statement from the hospital press release, which was initial posted and then blocked, after having been widely reported in French media. 

The drug, produced by Roche Pharmaceuticals, is rapidly gaining attention as a potential COVID-19 therapeutic, with another Phase III clinical trial, approved by the US Food and Drug Administration, underway in the United States.

In the French trial, a 14 day course of tocilizumab was found to significantly reduce the proportion of moderate or severe COVID-19 patients who required more intensive ventilator support, or died.  

The drug works by preventing IL-6 cytokines from binding to immune cell receptors. In many severe COVID-19 cases, an overreaction of the immune system to the SARS-CoV-2 virus unleashes a wave of cytokines and immune cells, causing massive damage to the lungs that can lead to acute respiratory failure. Some scientists have posited that blocking the so-called “cytokine storm” could prevent massive lung damage. 

The trial observed 129 patients with moderate or severe COVID-19 in a multicenter randomized control trial conducted across several French hospitals. The specifics of the study will be submitted to a peer review journal pending longer follow-up in the patients.

The new US FDA-approved study on tocilizumab will enroll 330 patients in a randomized controlled trial run by Roche, the company that produces the drug, and the US government entity, Biomedical Advanced Research and Development Authority (BARDA), a branch of the US Health and Human Services Department.

Meanwhile, new results on hydroxychloroquine and remdesivir, two of the therapeutics tapped for the World Health Organization’s Global Solidarity Trial, have not so far made strong showings, in the preliminary results of human trials which have recently been reported – although these studies also have have significant limitations. 

Preliminary results of a small remdesivir study in China, accidentally posted by the World Health Organization last week, showed no significant differences in mortality after 28 days of treatment, among patients who received the drug and those who did not. In a screenshot captured by STAT News, the trial results also reported that 11.6% of the patients who had received remdesivir also stopped the drug early due to adverse effects. The trial results were quickly removed from the Clinical Trials Registry site, with WHO saying that the results were not yet conclusive. 

Screenshot of WHO Clinical Trial Registry capturing remdesivir trial results, captured by STAT News

In a statement released on Thursday, Merdad Parsey, chief medical officer of Gilead said the trial had been terminated, but expressed hopes that other studies might yield a more positive picture: “The study was terminated early due to low enrollment and, as a result, it was underpowered to enable statistically meaningful conclusion,”  Parsey said.  He claimed that “trends in the data” could indicate that remdesivir may have clinical benefit when given to patients in earlier phases of the disease.

In early February, remdesivir showed promising results against the COVID-19 virus, SARS-CoV-2, in a Chinese cell culture study. However, these results have not been replicated in human studies.

As for hydroxychloroquine, a number of recent studies and warnings have emerged to the effect that the high doses required to combat the virus may also prove fatal to some patients.  Those include a study in Brazil, which was terminated early due to adverse effects.

Last Thursday, a retrospective analysis of outcomes among some 368 US patients treated with the drug, or with the drug in combination with azithromycin,  found “no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with COVID-19.”  The study of patients treated in US Veterans Health Administration medical centres, also found an association of increased overall mortality in patients treated with hydroxychloroquine alone.

At the same time, researchers have not given up on the drug. A 400-person Phase III Clinical trial was announced last week by Swiss authorities for the hydroxychloroquine as well as the HIV drug lopinavir/ritonavir. The trial is to be run by the Geneva University Hospitals, Basel University Hospital and the Swiss Tropical and Public Health Institute. There are currently over 60 clinical trials of various drug combinations underway in Switzerland.

Global Trends

Switzerland began today its first phase of a three-stage re-opening. Hospitals resumed all medical procedures, including elective surgeries. Caps on funerals, which were restricted only to close family members, were lifted. Businesses offering low levels of direct contact, such as hairdressing salons, massage practices, tattoo and cosmetic studios, florists, garden centres, and DIY stores, were reopened. 

Similarly New Zealand’s Prime Minister Jacinda Arden, who has been praised for her handling of the pandemic, announced Monday that the country was deescalating from a level four to level three emergency as new infections dropped into the single digits.

Yesterday, the Italian Prime Minister Giuseppe Conte announced that the country will deescalate into phase two. From May 4th, businesses such as catering services, manufacturing, construction, real estate, wholesale trade, and sports activities can resume operations. An additional $55 billion is pledged to support families, workers, and businesses struggling due to the pandemic. 

Meanwhile a new Swiss biosensor could be used to detect the COVID-19 virus, SARS-CoV-2, in public spaces like hospitals or train stations, Swiss authorities reported last Thursday. The biosensor, which was developed by the Swiss Federal Laboratories for Materials Science and Technology (EMPA) in collaboration with Zurich’s Federal Institute of Technology (ETHZ), can help contain outbreaks in public spaces by detecting ‘hotspots’ of viral genetic material floating in the air.

In the United States, the nursing home industry sought immunity from lawsuits after lawmakers  appealed to the CDC and CMS to disclose information on infections in nursing home facilities. Nursing homes have emerged as outbreak hotspots in most hard-hit countries. Hans Kluge, Regional Director for WHO Europe, told reporters last Thursday that almost half of the COVID-19 deaths across the WHO European region were in nursing homes.

In an interview with Financial Times, Bill Gates announced that the Bill and Melinda Gates Foundation (BGMF) would “almost entirely shift” to work on COVID-19 related problems, even in the non-health sectors such as education, where the Foundation has become involved in online learning.

Meanwhile, the CDC added six more symptoms to COVID-19, including chills, repeated shaking with chills, new loss of taste or smell, sore throat, headache, and muscle pain. 

In a video conference today with the Chief Ministers of the Indian states, Prime Minister Narendra Modi claimed that ‘the lockdown has yielded positive results’ and that ‘the country has managed to save thousands of lives in the past 1.5 months.’ 

Modi’s remarks coincide with the Indian Ministry of Health and Family Welfare’s new guidelines for home isolation of very mild/pre-symptomatic COVID-19 cases released today. The recommendations include mandating that caregivers and patients wear a triple-layered medical mask and disinfecting the used marks with 1% sodium hypo-chlorite solution before discarding.

Total cases of COVID-19 as of 6:31PM CET 27 April 2020, with active case distribution globally. COVID-19 cases exceed 3 million mark.

Tsering Lhamo and Svet Lustig Vijay contributed to this story.

Image Credits: University of Oxford/CEBM , Journal of Translational Medicine, WHO Clinical Trials Registry, captured by STAT News.

Soweto, South Africa. Poverty and crowded conditions make lockdowns doubly difficult.

As the COVID-19 pandemic unfolds, it continues to reveal and reinforce deep inequalities within and between countries, where low income and marginalized populations pay the highest price and suffer the most.

On Tuesday 28 April, a Panel discussion on ‘COVID-19 And Global Inequality’ will zoom into the issues even more deeply, with featured speakers including Winnie Biyanyima, executive director of UNAIDS, Mandeep Dhaliwal, of the UN Development Programme (UNDP), as well as voices from academia and civil society. The event is being hosted by the New-York based Julien J.Studley Graduate Program in International Affairs, in collaboration with Health Policy Watch.

The event, at 3 p.m. GMT time (11 EDT/17 CET), is the first in a series on Global Pandemics in an Unequal World webinar, which will address how public policymakers and civil society can change the dominant discourse of many policy debates by prioritizing health, sustainability and egalitarianism.

“Inqualities are deeply driven by the entrenched structures of health systems and the global economy. And after this pandemic is over, these are likely to be even more riveted onto the social fabric of societies – unless we get the right policies in place,” said Sakiko Fukuda-Parr, Professor and Program Director of International Affairs at the New School in New York, who will moderate the webinar. The series will continue over the summer, looking at other themes related to COVID-19 and health inequalities.  

Along with Biyanyima, and Dhalilwal, director of HIV/AIDS and human rights at UNDP, Tuesday’s panel will also include:

  • Nicoletta Dentico, journalist and director of the Global Health Program at the Society for International Development (SID) and;
  • Manjari Mahajan, associate professor of international affairs & Starr professor and co-director of the India China Institute at The New School

Link here to register for the event. Follow the livestream here:

Image Credits: Matt-80.

Sky clears up in New Delhi, India.

“I am not celebrating the fact that people can see the Himalayas or that the air quality is better in Madrid coming out of this virus, but what might come out of it is an awareness of how much human beings have contributed to the ongoing damage to people’s lungs, to our ability to drink clean water, to the harmful algae blooms in the Great Lakes, to the hurricanes and intense storms in the Midwest. Maybe it’ll be a wake-up call,” – Gina McCarthy, president and CEO of the Natural Resources Defense Counsel (NRDC) and former US Environmental Protection Agency Administrator.

As skies clear and waterways clean up due to widely adopted lockdowns and quarantines all over the world, three prominent environmental health scientists and policy experts, Maria Neira, the World Health Organization’s Director of Environment, Climate Change and Health; Gina McCarthy, administrator of the US Environmental Protection Agency under Barack Obama; and Aaron Bernstein, Director of the Center for Climate Health and Global Environment at the Harvard T. Chan School of Public Health, explored how environmentally unsustainable policies have predisposed vulnerable communities to COVID-19, at a webinar hosted by Harvard University last Monday in recognition of Earth Day.

Air pollution, mainly due to fossil fuel burning, makes people more vulnerable to serious illness from respiratory infections. In the case of COVID-19, emerging evidence is also revealing far higher death rates among people infected with COVID-19 and living in highly polluted cities. 

As economies start to open up, the experts urged governments to take time to rethink their priorities and offered a roadmap to invest in more sustainable transport, energy and urban policies that would make societies healthier as well as more resilient. 

“We have to use [the pandemic] to create a healthier society better prepared for emergencies, no doubt, more investment on our epidemic preparedness and response capacities at all levels,” said Maria Neira.

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

The pandemic has also underlined how both health, climate and environmental hazards in one part of the world can affect people on the other side of the planet, said Bernstein, a paediatrician by training.  

He described how he visited a family’s home, fully suited in protective gear, to examine a child suspected of being infected in the early days of the US epidemic. 

“As I walked into the room, dressed in my alien suit, and touched that child’s hand through the barrier of a synthetic rubber glove. It occurred to me – that child’s hand could connect me to a bat living in Asia. By the way, I work in Boston.” 

In looking forward into the future, the panelists emphasized that this pandemic, despite its devastation, does present a ‘shock’ that could change our economic system. Here, the Bernstein emphasized a transition into a green economy, and considered the present inequities between not just the global South and the global North, but within countries where the poor and marginalized often share an unequal burden of disease. 

“We cannot get out of this crisis at the same level of environmental pollution that we went in. Even before the crisis we were having 7 million primitive deaths caused by air pollution and we were very much vulnerable today. Our health was very vulnerable to climate change and the responses we need to provide are more important than ever,” said WHO’s Maria Neira.

Boys play on a beach in Kiribati, an island nation threatened by rising sea levels due to climate change.

As part of a Health Policy Watch’s continued coverage on COVID-19 and climate, here are some key excepts from the Q&A:

Air Pollution Predisposes Vulnerable People to Negative COVID-19 Outcomes

Q – Is there a link between air pollution and the severity of coronavirus? Do most polluted cities experience more severe coronavirus epidemics?

Aaron Bernstein – “For every small increment in air pollution [in long-term studies], there’s a substantial increase in death from COVID-19…This kind of air pollution makes people more vulnerable to respiratory infections and makes them more likely to die. You could pick any city in the world and expect to see an effect of air pollution on people’s risk of getting sicker with coronavirus.”

Maria Neira – “The evidence we have is pretty clear. And on top of that, of course, within those cities [that are more polluted], the people who are most at risk are people who are already sick, people who are poor, and in the United States, the evidence is strongly suggesting minority communities of color.”

Gina McCarthy – “We have to look at low income [groups] and we have to look at people of color, who are in this COVID-19 exposure. Actually, we’re seeing African Americans die at much higher rates than others in part because of their exposure to air pollution…they are already predisposed [due to high air pollution levels]; this is adding another layer of burden on their bodies. And they just can’t fight equally.” 

 Q – Considering that the southern hemisphere is moving towards winter shortly, could a colder climate be expected to increase the transmission of COVID-19 and /or its lethality? And if so, what would be the recommendation to scientists and policymakers?

Aaron Bernstein – “We don’t have clarity about what temperature means for the virus. It’s been thriving and warmer temperatures and colder temperatures as it is. And so I think the best thing we need to do is to have surveillance in place and the ability to test people at a broader scale as possible. And particularly in many cases among the poor.”

Aaron Bernstein, Director of the Center for Climate Health and Global Environment at the Harvard T. Chan School of Public Health

Addressing Climate Change To Better Mitigate Public Health Crises – A Holistic Approach Is Key

Q – If the coronavirus shows how effectively we can mobilize to confront a public health crisis, what does framing climate change as a public health crisis look like? 

Gina McCarthy – “We have to figure out how we can live healthy lives. We know now that we have a problem, not just with our ability to treat, but with our ability to prevent and that needs to be invested in. We have to get people to understand that…if you invest in stopping people from getting sick, which is what all environmental protection is about, then you save enormous money in lives, from having to spend the money to treat them on the back end.”  

Maria Neira – “Climate change is creating the conditions for the population to be extremely vulnerable and we cannot leave this crisis by not joining forces between all the efforts: the law, the legislation, the enforcement, the demands by the environment community and [through community mobilization]…We need to prove to the population that this is not a completed agenda….Our lungs have been made very vulnerable by the levels of exposure to pollution that we had for many years.” 

The COVID-19 Pandemic: A Strategic Opportunity To Promote A Green Recovery

Although it is “very difficult” for humans to learn lessons from the past, Maria Neira is “very optimistic” that the “new society” can do the right thing.

Q – How should countries limit air pollution to reduce the impact of coronavirus?

Maria Neira – “We need to avoid the temptation [of going back to] intensive use of fossil fuels or again intensive use of traffic, private cars, or going back to activities that will be considered as important to recover the economy…It has to be a green recovery, it has to be an investment, this time on maintaining the commitments for tackling climate change, on moving into a green and renewables and stopping the use of fossil fuels, and working as well on healthy cities, better urban planning and in the mobility of the new society….One of the most important benefits of this type of healthy planning on this new transition will be by the reduction of air pollution. So, this will require a lot of work from the scientific community, from the climate change, air pollution, energy, and sustainable development community, a community. We need to have a common narrative. We need to be very strategic.”

Q – What steps should governments take to reduce air pollution and prevent future pandemics like COVID-19? 

Gina McCarthy – “My biggest concern has been the stimulus dollars [to address the economic effects of the pandemic in the USA]. How you spend this money is going to be usually important. We know climate change and the challenges we face on air pollution are going to cost money, but they are also going to prevent public health damages, and we have to invest in a better future, and not go backwards.”

Gina McCarthy, president and CEO of the Natural Resources Defense Counsel (NRDC) and former US Environmental Protection Agency Administrator.

Investment in Education, Science and Prevention: An Awakening For Governments ?

Q – Clearly, climate friendly policies can provide long term improvements to public health, but what would you say to local officials and governors coming out of COVID-19, what should be the first priority of local official and governance? Where should the priorities be in the first 12 to 24 months to address both COVID-19 and climate change?

Gina McCarthy – “[Governments] need to make science-based decisions, and they need to look at what healthy air and clean water looks like. And they need to use the laws that are in the books and create more to make sure that we’re protected.”

Maria Neira – “One of the lessons of this horrible shock is that the investment on the health systems, investment on education, investment on researchers and scientists is definitely a non-regrets investment. I mean having a very strong health system, well prepared to respond to this type of public health crisis has proved to be fundamental…This crisis is once again demonstrating how much the government needs to take the right decisions to protect people’s health…[we need to] invest in primary prevention [and build] a very good health system, trying to reduce as much as possible those horrible inequalities that are bad for the population, for the health of the people, but they’re very, very bad for the economy of the country as well.”

This story was published as part of Covering Climate Now, a global collaboration of more than 250 news outlets to strengthen coverage of the climate story, co-founded by The Nation and Columbia Journalism Review.

Image Credits: Maria Neira, WHO.

Ursula von der Leyen, European Commission President, speaking at the virtual launch of the Access to COVID-19 Tools (ACT) Accelerator virtual launch

In the largest global collaboration to address the COVID-19 crisis so far, the World Health Organization, European Commission, and other partners including the Bill and Melinda Gates Foundation (BMGF), launched a new campaign to accelerate development of COVID-19 diagnostics, drugs, and vaccines – and just as critically ensure that they are affordable and accessible worldwide.

The European Commission will be hosting a rolling pledging campaign, beginning 4 May, to raise the 7.5 billion Euros to bankroll the massive effort, said Ursula von der Leyen, EC President.

In a striking display of multi-lateral unity, launch of the new ‘Access to COVID-19 Tools’ (ACT) Accelerator was made in a WHO public webcast featuring UN Secretary General Antonio Guterres, Melinda Gates, 11 heads of state, including Germany’s Angela Merkel, France’s Emmanuel Macron, and South Africa’s Cyril Ramaphosa, as well as other leaders across Africa, Asia, and the Americas, and Europe.  

Strikingly absent were the United States and China, which have been locked in bitter dispute with each other over the management of the COVID-19 crisis. But Macron specifically addressed the political tensions, saying he hoped to “be able to reconcile this initiative” with both superpowers.

“I hope that both of these countries will be able to fight against COVID-19 by developing vaccines together,” said Macron. “There should not be any divisions between countries, we need to join forces.” Clinical trials for five of the seven leading vaccine candidates identified by the WHO are being conducted in either the United States or China. 

“Human health is the quintessential global public good, and today we face a global public enemy like no other. COVID-19 requires the most massive public health efforts,”  said Guterres in prepared remarks. “For too long we have undervalued, underinvested in global public goods. Data must be shared, production capacity prepared, resources mobilized, and politics set aside.”

UN Secretary-General Antonio Guterres calls into the ‘Access to COVID-19 Tools’ (ACT) Accelerator launch event.

“The ACT Accelerator brings together the combined power of several organizations to work with speed and scale,” added WHO Director-General Dr Tedros Adhanom Ghebreyesus at a 90 minute virtual launch, co-hosted with French President Emmanuel Macron and the BMGF. “Each of us are doing great work, but we cannot work alone. We’re coming together to work in new ways to identify challenges and solutions.” 

Leaders of other global health organizations echoed Guterres’ and Tedros’ calls urging countries to collaborate in the pandemic response.

Melinda Gates, co-founder of the BMGF, said “COVID-19 knowns no borders, and defeating it will require action across sectors and countries.”

“Beating coronavirus will require sustained actions on many fronts,” said von der Leyen, president of the European Commission. “This is a first step, only, but more will be needed in the future.” 

Search for a Vaccine Dominates

As new COVID-19 cases continue to rise in newly affected hotspots, and some states begin to weigh the risks of a resurgence as cases plateau, there was wide agreement among the leaders that developing and deploying an effective COVID-19 vaccine was the priority. Von der Leyen and Chancellor of Germany Angela Merkel called for such a vaccine to be treated as “a universal public good.”

Hope of curbing the pandemic was pinned on a vaccine just as early COVID-19 drug trial results, revealed that remdesivir, the most promising therapeutic so far, may not be as effective as initially suspected. The pre-print study was accidentally posted by WHO and obtained by STAT News.

“COVID-19 is not a human endemic infection, this will not disappear. The only true exit strategy is science,” said Jeremy Farrar, director of the Wellcome Trust.

“Finding and distributing the vaccine is the only way to win this battle,” said Guiseppe Conte, president of the Council of Ministers of Italy. “The role of governments is to promote good governance, transparency, and mutual accountability to ensure universal, equitable access to the vaccines.”

Guiseppe Conte, president of Council of Ministers of Italy, speaking at a virtual ACT Accelerator launch

So far, vaccine developers have reported that an acceleration of funding is required to bring candidates through later clinical trials and market approval. The Coalition for Pandemic Preparedness and Innovation (CEPI), which has been supporting three of the six vaccine candidates that have entered clinical trials around the world, is still facing a US $1 billion shortfall to bring a successful vaccine candidate to market.

“The establishment of the ACT Accelerator is a watershed moment in the world coming together to develop a global exit strategy from the COVID-19 pandemic,”  said Richard Hatchett, CEPI CEO. “Everyone must have access to the tools and countermeasures, including vaccines, that we will develop through the Accelerator.”

Hatchett’s comments were echoed by several heads of state and leaders of global health organizations from around the world, who stressed the importance of making any new COVID-19 tools accessible in an equitable way.

“We must commit to a system of clear global access goals as long as the virus is active somewhere. We are all at risk. The fight against COVID-19 must leave no one behind,” said Prime Minister of Norway, Erna Solberg.

Erna Solberg, PM of Norway, speaking at a virtual ACT Accelerator launch

But while the search for a vaccine dominated the discussion, other speakers reaffirmed the importance of supporting a holistic COVID-19 response, focusing on providing equitable access to diagnostics, therapeutics, and strengthening the public health system for future pandemic threats. The standing president of the G20 group of most called pandemic preparedness the “smartest investment for us to make today.”

“We might face a similar threat in the future,” said G20 president and Minister of Finance of Saudi Arabia, Mohammed bin Abdullah Al-Jadaan. “In order to deal with future pandemics effectively, we have to invest in strengthening our preparedness  and response systems. G20 is working with relevant organizations to assess that gaps with the view to establish a global mechanism for response.”

Key Commitments Under the ACT Accelerator

Under the ACT Accelerator, 11 major global health agencies, organizations, and pharma industry representatives made five major commitments in a statement released Friday:

  1. Aim to ensure equitable global access to innovative tools for COVID-19 for all;
  2. Commit to an unprecedented level of partnership to proactively engaging stakeholders and existing collaborations to align and coordinate efforts;
  3. Commit to create a strong unified voice to maximize impact;
  4. Build on past experiences towards achieving this objective;
  5. Stay accountable to the world, to communities, and to one another.

Some 11 heads of state including the United Kingdom’s first Secretary of State Dominic Raab, Spain’s President Pedro Sánchez Pérez-Castejón, Chairperson of the African Union Commission Moussa Faki Mahamat, Malaysian Prime Minister Muhyiddin Mohd Yassin, and Rwanda President Paul Kagame, among others spoke at the launch event to support the collaboration. Costa Rica President Carlos Quesada Alvarado, who called on WHO to create an accessible pool of COVID-19 intellectual property rights, also called in to support the launch. 

The initial group of collaborators includes the Bill & Melinda Gates Foundation (BMGF); the Coalition for Epidemic Preparedness and Innovations (CEPI), Gavi, the Vaccines Alliance; the Global Fund for HIV/AIDs, Tuberculosis and Malaria; UNITAID; the International Red Cross and Red Crescent Movement, and the Wellcome Trust.

Pharma industry representatives including the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA); the Developing Countries Vaccine Manufacturers’ Network (DCVMN); and the International Generic and Biosimilar Medicines Association (IGBA) have also joined as founding members of the Accelerator.

The combined impact of Covid-19 and malaria in regions where malaria is widespread “could be catastrophic,” warned David Reddy, CEO of Medicines for Malaria Venture (MMV), the Geneva-based product development partnership, just ahead of World Malaria Day, which is celebrated on Saturday, 25 April.

His commment to Health Policy Watch,  came in the wake of WHO’s publication of a new study that forecast malaria deaths could double in sub-Saharan Africa in 2020 – effectively winding the clock back to levels seen two decades ago – if the delivery of core malaria control tools, including bednets and antimalaria drugs, is interrupted due to the pandemic response.

Under the worst-case scenario, in which all insecticide-treated net (ITN) campaigns are suspended and there is a 75% reduction in access to effective antimalariala,  malaria deaths in sub-Saharan Africa in 2020 would reach 769 000, nearly twice the number of deaths reported in 2018 and comparable to levels seen at the turn of the millennium, the new WHO study warned.

“Having witnessed the devastating impact of the pandemic on health systems around the world, we know this intuitively to be the case, and this study backs that up with modelling data,” Reddy said. “We need to act now and do all we can to avoid this catastrophic loss of life. Among other measures, this means ensuring bednets and antimalarials are available and accessible to people that need them – especially children under 5 years of age and pregnant women who are at greatest risk of malaria morbidity and mortality.”

Children and Pregnant Women Among the Most Vulnerable

According to the World malaria report 2019, sub-Saharan Africa accounted for approximately 93% of all malaria cases and 94% of deaths in 2018. More than two-thirds of deaths were among children under the age of five.  Altogether, there were an estimated 228 million cases of malaria worldwide and 405 000 malaria-related deaths.

Malaria was also one of the top 5 killers of adolescent girls and young women aged 15-19 in 2019.  Due to physiological changes that reduce natural immunity during the first pregnancy,  pregnant teenagers and young women may become seriously ill and even die from malaria, experts point out. In 2016, malaria caused some 10,000 maternal deaths, mostly in sub-Saharan Africa, where there is moderate to high transmission of the parasite, according to expert reviews.

“Across the world, this pandemic has surfaced a deep anxiety for the loss of lives of our loved ones,” Reddy said, noting that was also “an anxiety that echoes the deep, unheard concern of millions of parents of malaria-infected children every day. ”

The new WHO analysis considers nine scenarios for potential disruptions in access to core malaria control tools during the pandemic in 41 countries, and the resulting increases that may be seen in cases and deaths.

In a press release issued ahead of World Malaria Day, WHO urged countries to move fast and distribute malaria prevention and treatment tools at this, still early, stage of the COVID-19 outbreak in sub-Saharan Africa, and to do their utmost to safely maintain essential malaria control services even if the regional epidemic accelerates.

COVID-19 Cases Comparatively Small – But Rapidly Rising In Africa 

At 17000 cases and 748 deaths as of Thursday, the number of reported COVID-19 infections in WHO’s African Region has represented a comparatively small proportion of the global total, though hundreds of new cases are now being reported every day.

But countries across the region still have a critical window of opportunity to minimize disruptions in malaria prevention and treatment and save lives at this stage of the COVID-19 outbreak, WHO says.

The organization advised that mass malaria vector control campaigns be accelerated, while ensuring that they are deployed in ways that protect health workers and communities against potential COVID-19 transmission. WHO and partners commend the leaders of Benin, the Democratic Republic of the Congo, Sierra Leone and Chad for initiating ITN campaigns during the pandemic. Other countries are adapting their net distribution strategies to ensure households receive the nets as quickly and safely as possible.

Preventive therapies for pregnant women and children must be maintained. The provision of prompt diagnostic testing and effective antimalarial medicines are also essential to prevent a mild case of malaria from progressing to severe illness and death.

WHO and its partners have developed guidance on maintaining malaria services in COVID-19 settings.  The document, Tailoring malaria interventions in COVID-19 response includes guidance on the prevention of malaria infection through vector control and chemoprevention, testing, treatment of cases, clinical services, supply chain and laboratory activities.

 

 

Image Credits: UNICEF USA , Elizabeth Poll/MMV.

The World Health Assembly in Geneva, Switzerland.

In the wake of the COVID-19 pandemic, there could be “a window of opportunity… that would be suicidal to miss” to revise the International Health Regulations that govern countries’ behaviour during health emergencies, said Gian Luca Burci, former World Health Organization head legal counsel and now professor of international law, at a panel hosted by the Geneva Graduate Institute and Global Health Centre.

The present system may have led to delays in ramping up levels of alert at key points in the crisis to an international health emergency, Burci suggested at Tuesday’s panel entitled “What’s law got to do with COVID-19.”

“The system of alert right now is either we have an emergency or we have nothing. There is a growing consensus [that this system must be replaced by] something much more incremental,” Burci said.

The International Health Regulations (IHR), the legal framework for WHO’s emergency coordination and countries’ response, also has a “very weak” system for commanding sovereign states’ compliance with its provisions to prevent, prepare and respond to infectious disease outbreaks, Burci underlined.

But it remains up to Member States of the World Health Assembly to decide whether the WHO should wield more power, said Steven Solomon, principal legal officer for governing bodies at the World Health Organization.

As the only binding international law that governs international and member state response, and last updated in 2005 under very different global conditions, it is time for IHR to be revised, agreed Solomon and Gian Luca Burci. The question is how? 

The World Needs The WHO For Leadership And Coordination 
Top: Steve Solomon, current WHO Principal Legal Officer.
Bottom: Gian Luca Burci Former WHO Principal Legal Officer and Professor of International Law.

“To respond with two words, what can be done now [by WHO within the IHR system]…is leadership and coordination”, said Solomon.

Yet despite WHO’s attempts to coordinate such outbreak response for the world, countries have not always complied.

Export restrictions, which can block critical supply chains for essential products like personal protective equipment or medicines, have been adopted by 28 countries despite WHO guidance that such barriers impede efficient emergency allocation of resources, said Sueri Moon, Co-Director of the Geneva-based Global Health Centre.

“While many recommendations by the WHO have been implemented at the national level,” said Burci, the same level of adherence has not been observed in the international arena, with regards to trade, travel and related areas, “and we have to wonder why,” said Burci.

Countries have not complied because they simply do not have the incentive to do so under the current IHR rules, he added. 

“The system of accountability is weak. States can do whatever they want, without much accountability and with impunity,” Burci said. “There is resistance [by the WHO] to naming and shaming. There is no system of assessment of compliance [decreasing incentive for members to comply]”, he added.

Needed: “Agile” System For Resolving Trade Desputes

To address some of the trade barriers that have emerged during the emergency, the IHR would also requrie an ‘agile’ mechanism for settling trade disputes. The current system is “very weak”, and with countries shutting down their exports in a desperate attempt to prioritize sovereign supply, such revisions have become more important than ever. 

“There is no system of dispute settlement. The one we have is very weak. Look at what’s happening now, with border closures and trade limitations. These are the seeds of major dispute…There are evident gaps in travel restriction and trade restriction policies,” said Burci. 

At the broader level, a stronger compliance assessment system, integrated into the IHR, could make Member States more likely to comply with WHO recommendations because their responses to outbreaks would be evaluated and communicated to the public, agreed Solomon and Burci.

Public scrutiny, or ‘naming and shaming’, could be a useful tool to improve the WHO’s capacity to lead and coordinate an effective response at an international level.

An enforcement compliance mechanism can be created if Member States were interested in creating one, suggested Solomon. The WHO would also be ready to support countries if they decided on a new Mandate for that within the IHR context.

“Member states or countries decide…[if] something needs to be changed; that’s certainly an area where WHO would support, but that mandate has to come from Member States. That mandate can only be provided from the countries themselves,” he said.

The IHR revisions mentioned by Solomon and Burci, ranging from a compliance assessment to an improved trade dispute resolution mechanism, are not, however, compatible with the current architecture of WHO financing.  When most of its budget is controlled by a handful of large stakeholders, WHO’s hands are often tied in terms of inspecting, auditing or compelling countries to adopt emergency measures. 

Legal Experts Call For Sustainable WHO Financing Mechanism 

Top contributors to WHO’s Budget (2018)

Funding was dramatically highlighted last week when US President Donald Trump decided to suspend US funding, which amounts to about 15% of WHO’s annual budget. In addition, the regular annual “assessed” contributions of member states comprise only about one-fifth of the total WHO budget, while the rest comes from national “voluntary” commitments, which may be short-lived and are often earmarked for specific purposes.  

Solomon and Burci advised Member States to invest in a “sustainable financing mechanism” with a view to strengthening public health systems in the long-run.

“It’s irrational to have an organization like the WHO funded at 82% with voluntary contributions. You cannot have a fire brigade that has to raise money when it catches fire, that is irrational.”

Furthermore, it is important that funding be directed more strategically toward long-term strengthening of core capacities of public health systems like prevention, surveillance and response to disease outbreaks, the two legal experts said.

“Investments cannot immediately respond to a short term profit or political gain…Long term investment in public health care [is needed]…I hope that the WHO would play a role in that”, said Burci.

“It is not a do it once and it’s done”, said Solomon. “Maintaining core capacities is much more like brushing your teeth. It needs to be done every single day in a determined way”.

Image Credits: WHO/L. Cipriani, WHO .

Polio eradication is on WHO program that will likely take a big hit in light of US funding suspension.

Essential health programmes such as polio eradication and trauma management, and programmes in the World Health Organizations’ Emergencies program, will be hit hardest by the suspension of US funding to the WHO. 

“The reality is for my programme, a lot of that US funding is aimed at direct life saving services to people in the most destitute circumstances in the world,”  said Mike Ryan, WHO’s Executive Director of Health Emergencies. “We have a huge operational, technical, and financial relationship with the USA, and we’re very grateful for that relationship… I very much hope that it will only be a 60-day stay [on funding].”

Ryan made the statement in response to a line of questioning regarding whether WHO would be hard hit by a loss of US funding. A WHO spokesperson had previously told reporters that approximately 81% of WHO’s 2020-2021 budget had already been funded, and the Health Emergencies program had been allocated an additional US $1billion for the global COVID-19 response.

Approximately a quarter US funds would have been directed towards ‘core’ health programs outside of the COVID-19 response, and over US $650 million had been pledged to support other specific health areas such as polio eradication, immunization, and nutrition programmes. In Iraq and Syria for example, WHO programs there were concerned about the impact of loss of funding on health services, not as much on the COVID-19 response, according to Ryan.

“I hope that the US believes funding WHO is an important investment not just to help others, but for the US to remain safe itself,” added WHO Director General Dr Tedros Adhanom Ghebreyesus. “As former Minister of Health for Ethiopia, I am a living witness to appreciate the US support at the country level, and now as Director-General I am a living witness to appreciate the support the US gives the WHO. I hope the freezing of the funding will be reconsidered, and the US will once again support WHO’s work and continue to save lives.”

However, it’s unclear whether the US president has broad authority to put a moratorium on all funding WHO receives. However, the President could instruct US agencies to scale back funding for the organization. 

Ryan added that the WHO team is focusing on the health work on the ground, instead of “where the next paycheck will come from.”

“We’re concerned about supporting our friends and colleagues in the frontline who risk their lives every day, every single day to deliver life saving interventions to people around the world,” said Ryan. 

Just two days ago, one staff member, Pyae Sone Win Maung, was killed and another critically injured while transporting COVID-19 samples in Myanmar. “I don’t think their families are that concerned about the overall funding situation,” Ryan said. WHO Southeast Asia Regional Director Poonam Khetrapal Singh also condemned the attack on Twitter, saying, “As they deliver essential lifesaving services, our health workforce deserves gratitude, respect, appreciation and support for their selfless services.”

“But one thing we would like to assure to the world is that we will work day and night. And we will not be deterred by any attacks,” Dr Tedros said. “And as our colleagues say, attacks like this only strengthens our resolve.”

Africa at the Beginning of the Infection Curve

The WHO Health Emergencies Executive Director additionally warned today that many countries in the WHO Africa region were at the beginning of the COVID-19 infection curve. But leveraging innovation and agile public health systems could help countries “avoid the worst of the pandemic.”

“We’ve seen an almost 250% fold increase in cases in Sudan. In the last week, in Tanzania,Mali, Congo, Gabon, Guinea, Cabo Verde and Eritrea we saw increases of more than 100% in the last week. In many other countries in Africa, cases increased somewhere between 30 and 90%. So, we are at the beginning in Africa,” Ryan said on Wednesday. There are currently 15,394 confirmed cases and 716 deaths in the WHO Africa region. 

But some African nations have rapidly rose to meet the COVID-19 challenge – South Africa has so far tested 120,000 people with a 2.7% positivity rate. The country focused on a prevention and surveillance based strategy, rapidly training 28,000 community health workers in case detection and rolling out 67 mobile lab units across the country. 

“That much testing for that return, it’s incredible,” said Ryan. “We need to leverage the capacities that exist in Africa. The innovation, the science. We need to connect scientists and laboratories across Africa.”

For a number of African countries the case load remains under 100, and most of them are imported cases according to WHO COVID-19 Technical Lead Maria Van Kerkhove.

As such, Ryan said, countries across the continent must keep focused “on preparation, on surveillance, on community mobilization.”

WHO DG Urges Eastern Mediterranean Countries to Step Up Response

Dr Tedros urged Health Ministers from WHO Eastern Mediterranean countries to strengthen their COVID-19 response as infections accelerated in countries across the region. The WHO Director-General met online with Minister of Healths from the Eastern Mediterranean Region on Wednesday, just a day before the holy month of Ramadan.

“The epidemic in the Islamic Republic of Iran now appears to be waning, but most other countries in the region are seeing increasing numbers of new infections every day,” said Dr Tedros in prepared remarks.

“We have been impressed by the progress being made across many EMRO countries. The active outreach to almost 70 million people in Iran through the national campaign; the rapid scaling up of testing in United Arab Emirates; the commitment to establishing temporary isolation units in Pakistan; the use of polio assets in Afghanistan and in Somalia.

“In spite of this clear progress, I am of course asking you to do more. First, the response to COVID demands a whole-of-government approach. As Ministers of health, you play a vital,  central role, but you cannot do it alone so continuing with the whole of government approach will be very important to beating this virus.

“Second, we call on countries to implement proven public health measures aggressively: detect, test, isolate and care for every case, and trace and quarantine every contact.

“And third, we urge you to pay careful attention to ensuring that essential public health services continue safely and effectively.”

Dr Tedros further affirmed WHO’s support and highlighted resources available at countries’ disposal, including a United Nations Supply Chain System, launched last week to ramp up the distribution of essential supplies to countries in need. The Organization is also coordinating global Solidarity Trial to explore therapeutic options for COVID-19, monitoring healthcare worker infections and prevention, and updating technical guidance.

Total cases of COVID-19 as of 10:00PM CET 22 April 2020, with active case distribution globally. Numbers change rapidly.

Regional Trends in Europe, the Americas, and Southeast Asia

Following a downward trend in new COVID-19 cases, the federal council has released a three-step re-opening plan, starting from April 27. In Switzerland, the Federal Office of Public Health (FOPH) has confirmed 28,268 positive coronavirus cases with 1217 deaths.

In conjunction with this plan, the FOPH has also widened the criteria for coronavirus testing, now allowing for asymptomatic people at risk of spreading infection to be tested. This measure comes as a study shows that the current testing regime in Geneva has confirmed only one of every six cases and calls for increased testing to avoid a second wave of infections. 

The European Council is drafting a recovery plan to bolster corona-hit economies. A roadmap released on Tuesday emphasizes strengthening Europe’s “strategic autonomy” to reduce reliance on foreign suppliers, as the EU leaders prepare to endorse a 540 billion euros ($587 billion) package that would help pay lost wages, keep companies afloat and fund health care systems. The European Centre for Disease Prevention and Control currently records 1,101,681 cases of coronavirus in Europe, with 107,453 deaths.

United States President Donald Trump will be signing an executive order today implementing a 60-day ban on issuing permanent residency cards to immigrants. A bipartisan $484 billion coronavirus relief package was passed by the Senate on Tuesday, which would replenish a depleted loan program for distressed small businesses and provide funds for hospitals, states and coronavirus testing. 

Public health officials in the US have been retracing the path of the virus across the country and have found that the earliest deaths occurred in early February in California, almost three weeks before the first officially confirmed coronavirus death in Seattle – indicating the virus may have begun circulating in the community much earlier than expected.  A second wave of COVID-19 may occur in the fall, coinciding with seasonal flu to cripple the weakened healthcare system, warned Robert Redfield, director of the Center for Disease Control and Prevention in an interview with the Washington Post. The United States of America has the world’s highest number of positive coronavirus cases and confirmed deaths, with 825,306 cases and 45,075 deaths.

In Latin America, WHO PAHO is dispatching an additional 1.5 million PCR tests this week, followed by another 3 million next week to strengthen laboratory surveillance networks across member states, PAHO Director Carissa F. Etienne said in a press briefing Tuesday. As cases started to ramp up across the region, countries have faced increasing difficulty keeping up with the demand for testing.

“We need a clearer view of where the virus is circulating and how many people have been infected in order to guide our actions,” Etienne said in a press release.

In Southeast Asia, India’s central government has approved an amendment to the Epidemic Diseases Act, 1897 that aims to end violence against health care workers. Anyone found guilty of attacking a healthcare worker could be imprisoned for 6 months to 7 years, according to Union Minister Prakash Javadekar. The move comes after several complaints from the medical fraternity on the acts of violence against doctors and other medical staff during the COVID-19 crisis in India, which has now bloomed to more than 20,000 confirmed coronavirus cases and over 600 deaths.

Gauri Saxena contributed to this story

Image Credits: WHO Africa Regional Office, Johns Hopkins CSSE.