The White House in Washington, DC

As the World Health Organization becomes the target of attack by President Trump, his administration and political allies for its alleged failures in response to the COVID-19 pandemic, the main points of critique are reverberating throughout the media in an escalating cycle.

After a week of mounting criticism, Trump announced on Tuesday night that he had instructed the administration to suspend funding while an investigation was conducted into WHO’s handling of the crisis.

His statement came a little more than 100 days after China first reported the mysterious outbreak of the pneumonia-like virus – even as the agency attempts to contain the pandemic’s spread to vulnerable low-income countries of Africa and South-East Asia.

“The WHO failed in its duty and must be held accountable,” Trump said in the daily White House Taskforce briefing.

While Legitimate evaluation and critique are important, a question that must be asked, however, is whether any shortcomings and mistakes made were uniquely WHO’s? Or is the global health agency also being targeted as the “fall guy” for errors made by its member states, including the United States – which is presently the epicentre of the pandemic.

A more critical question is: would the world be better off without the WHO?

Or is it an agency that we urgently need to coordinate the global response to outbreaks; to synthesize available evidence on effective responses – whether these are at national or hospital level; and to support those countries and health systems that lack sufficient resources to respond on their own?

Main Points of Criticism: Technical Errors & Pressure Politics

Donald Trump speaks at the daily White House Coronavirus Taskforce briefing

Boiled down to the essence, the main points of critique by President Trump, other US administration figures and political allies are running along two lines:

  • WHO leadership bowed to Chinese political pressure in making decisions – refraining from recommendations for more forceful measures such as travel restrictions. And it praised Chinese responsiveness while it avoided criticizing its initial concealment of the outbreak in Wuhan – what Trump described as “China-centric” policies.
  • WHO failed to properly assess and communicate the risks from the COVID-19 virus, particularly in the early days, with respect to a range of medico-technical issues, such as early determinations of whether the virus was being transmitted person-to-person. Trump criticized WHO’s early opposition to travel restrictions, calling it “one of the most disastrous decisions.” Although criticism of the technical decisions, as well, is enmeshed in politics – with Taiwan’s government asserting that it warned WHO early on about the person-to-person risks, only to be ignored.

Had these failures not occurred, the argument goes, the international community — and particularly the United States — would have been spared the scale of human suffering it has experienced. The criticism repeated by President Trump in White House press briefings, and echoed by key political allies, has been coupled with threats to suspend funding to WHO, which amounted to US$400 million in 2019. Congressional Republicans now appear poised to shortly follow up on those threats – even if cooler voices have pointed out that cutting funding during the pandemic might not be the best idea.

Crises and Pressure

It is not surprising that WHO is subject to political attack as deaths from the spread of the pandemic accelerate. National (and more local) political leaders are under great pressure. Their constituents are dying. The role of government is to protect the health and safety of its citizens. People will hold their governments accountable. If misguided actions, or omissions to act, have demonstrably contributed to the scale of suffering, the adverse political consequences loom large.

Almost inevitably, a national government that failed to heed warnings will seek to shift blame. The WHO is a made-to-order target. Its name is enough to suggest that the organization might be held responsible for the consequences of the pandemic. WHO officers and staff are not a voting constituency.

Regardless of what China did or did not do, there is a motive anchored in political expediency to blame the Chinese political leadership as this fits squarely with the Trump Administration’s agenda of portraying China as a bad actor and strategic threat to the United States (while episodically praising it).

The aim here is not to determine definitively what the WHO or China did or did not do. Rather, it is to point out that for his domestic political constituency these are the logical places for President Trump to re-direct responsibility in the COVID-19 crisis. Regardless of facts, there is nothing surprising about this from a political standpoint.

WHO Leadership

Dr Tedros speaking at WHO’s regular COVID-19 press briefing.

A substantial part of the US criticism of the WHO is directed toward its leadership and the “real-time” decisions that the leaders, especially Director General Tedros Adhanom Ghebreyesus, have made. The WHO Director General has a margin of discretion in terms of his decision-making. But he relies on input from many technical experts within and outside the organization.

In the case of a pandemic, and under the International Health Regulation, the Director General acts with the advice of an Emergency Committee. The Director General will have received technical input from scientists, logistics experts and so forth from around the world, including the United States, China and Europe. A WHO Director General will be responsible for weighing and balancing the technical opinions he or she receives, but those decisions are based on a body of evidence and opinion. At the same time, any WHO Director General understands that he (or she) will also be judged personally for decisions that were made.

WHO’s Global Role – Its Mandate is Limited by Member States

The WHO, governed by its member states in the World Health Assembly and Executive Board, is the forum where governments and other interested stakeholders discuss and agree upon policy and implementing measures to advance the promotion and protection of public health. The WHO provides the network framework for cooperation to address common challenges. In the counterfactual where there is no WHO – or it is “hypothetically defunded” — what is going to be the alternative? What will be different?

The WHO is deliberately designed with very limited autonomous authority. If a national government — China for the sake of argument — refuses or delays allowing WHO scientists to enter the country, the WHO cannot and does not send paratrooper virologists to stage a raid.

The WHO has powers of persuasion, but those are of debatable strength. In terms of budget allocation, WHO members have also deliberately pursued a system of earmarked funding in recent years that assures national control over the WHO work program.  This has made it difficult for WHO to establish its priorities based on global and regional assessments of public health needs, an issue that Dr Tedros has sought to address. The Gates Foundation is another major source of funding for WHO activities, and due to that, it also plays a substantial role in directing the work of the organization.

Is the new and improved WHO-alternative going to be given “sovereign authority” to act – even against the wishes of member states? Will it have its “own” budget controlled by that sovereign authority? Or, would any new WHO-alternative be even weaker from a political standpoint than “old WHO”?

The critical point is that we need an institution like the WHO because public health concerns such as pandemics are global. What happens in Burundi may very well affect people in Toronto. Leaving aside the ethical questions, high-income countries cannot permanently wall themselves off from the impact of pandemics by sealing their borders, refusing to trade and preventing their citizens from traveling. Or if they theoretically might do that, we would be living in a very different – and poorer – world than the one we are living in today. Only the most radical isolationists might be seeking such a result.

Technical Decisions – Ensuring Feedback Loops & Avoiding Politicization

Against this landscape, much has been made of the decisions made by WHO on medico-technical issues such as its initial uncertainty over whether there had been person-to-person transmission of COVID-19; whether and when to recommend travel bans; whether and when to declare the outbreak a pandemic; and whether to recommend wearing face masks.

These decisions have been made, and continue to be made, in situations of substantial uncertainty.

In hindsight WHO might have more quickly extrapolated the first few reports of facile person-to-person transmission into grounds for a major change in risk assessment. But the grounds were shifting here in light of initial reports coming out of China that human transmissibility was more limited.

With respect to travel bans, at the time that WHO resisted calling for such measures, a  preponderance of public-health specialists were also opining that travel bans were likely to be ineffective because borders are porous; they can restrict critical economic trade; and the imposition of bans may provoke precisely the type of infection-carrier exodus they are trying to prevent. Keep in mind, as well, that this outbreak has posed challenges unlike others seen in the past century, including SARS, Ebola and H1N1.

That said, there is strong evidence that travel bans, when they are used, need to be planned and prepared so that they don’t lead to unintended consequences that facilitate further virus transmission.

This was evident immediately after the United States announced a travel ban on passenger arrivals from Europe. This triggered a wave of departures from European airports, with thousands mobbing European and then US arrival terminals for many hours – creating a fertile ground for the virus to spread.

Travelers at Madrid-Baraja Airport, Spain’s largest international airport. The airport is nearly empty after an initial rush of travelers in mid-March, right after the US enacted travel bans for Europe.

The WHO and other public health authorities will certainly need to revisit the utility of travel restrictions in the wake of the COVID-19 pandemic based on experiences gained.

It is almost inevitable that some decisions made in the course of a pandemic will be in error. Everything is not foreseeable or pre-programmable. The question is not so much whether errors will be made — though obviously this should be kept to a minimum — but how well the feedback loop works so that mistakes are quickly corrected.

Many national (and local) governments, including the United Kingdom as well as large parts of the United States, initially elected to go about business-as-usual, avoiding business and school closures and stay-at-home orders. Once it became apparent that lockdowns of some sort were one of the most effective tools to contain the spread of the virus most of those governments corrected the mistake. The egregious failure is by the government entity that has the “better information” and refuses to act on it.

When the history of the COVID-19 pandemic is written, it is likely that some of the decisions at least initially made at WHO will be assessed as errors. Errors made in the course of a pandemic are likely to cost lives and they cannot be treated lightly. The main thing is that the appropriate lessons should be drawn so that they are not repeated.

The China Question – Did the US Listen to its own Intelligence Services?

Residents in Wuhan buy daily necessities and food across closed fence gates during the lockdown in China.

Perhaps the most politically fraught set of issues goes to the question “what did China know and when did it know it?”

I do not have the answer to that. It is “above my pay grade”. What seems clear based on current reporting is that the US government through various information channels became aware of an outbreak with potentially very severe consequences early on and that President Trump was apprised of this information. The President delayed domestic preparedness, even weeks later assuring the public that the virus was something over which we have “tremendous control”.

If the President chose to ignore information coming from US intelligence services and other presumably reliable sources, what difference would it have made if the WHO (or the Chinese government) conveyed information about person-to-person transmissibility a week or two earlier?

None of this would excuse the Chinese government if it deliberately withheld information critical to the international community at large, but it does go to the heart of the political dynamic within the United States and harsh criticism aimed at China (and indirectly at the WHO). Shouldn’t the United States President have trusted his own intelligence apparatus without confirmation from the Chinese government?

COVID-19 Reaffirms the Need for a Global Health Organization

(left) World Health Organization Headquarters in Geneva (Photo: WHO/P. Virot).
(right) White House in Washington, DC (Photo: Obama Whitehouse Archives)

The WHO was founded because the international community needed a forum where public health issues of collective concern could be assessed and addressed. It was not founded to host political debates and resolve strategic disputes — for which there are alternative fora. The COVID-19 pandemic reaffirms the continuing need for such an organization.

The circumstances of this pandemic argue in favor of increasing funding and strengthening cooperation and coordination mechanisms, not for weakening them.

There are no “perfect” international organizations, just as there are no perfect national governments. Judgments made in real time based on imperfect information will not always be optimal. In the case of the WHO, judgments are based on processes that filter incoming data through a range of scientific experts. A judgment by the WHO Director General may turn out to be incorrect, and it should be corrected promptly. The Director General and senior WHO leadership understand that what is done during an outbreak will be analyzed and assessed by history.

The WHO, however, should not be the place where national governments offload their own errors in judgment made with their own, and perhaps even better, information as well as (at times) resources.

Some countries that were just as vulnerable to the virus as the United States responded earlier, and in different ways, and have been spared its worst consequences. While the WHO is supposed to provide evidence-based guidance to national decision-makers, ultimately it is up to national governments to act – and that is what the WHO has urged them to do, more than anything, from the beginning – to get ready, to be prepared.

Will the US, or leaders of other WHO member states for that matter, acknowledge the mistakes they have made: the failures to prepare hospitals sooner; failures to acquire protective gear; failures to ramp up testing rapidly?

President Trump, like others, made decisions early in the crisis under circumstances of imperfect information – that needs to be acknowledged. The problem for President Trump is that he insists that his instincts are perfect, so that if errors were made they could only have been made by someone (or somewhere) else.

Acknowledging error undercuts a claim to perfection. And President Trump is not alone on the world stage today claiming that kind of instinct.

Director General Tedros has not claimed to be perfect, or to have made perfect decisions. His appeals have largely centered around another theme – solidarity.  He has called on world leaders to put politics aside while countries confront a bigger enemy than each other. That call goes increasingly unheeded. Like COVID-19, the accelerating pathogenic deterioration in international discourse needs to be contained so that the world can confront future pandemic threats with an even more effective WHO.

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Frederick M. Abbott is Edward Ball Eminent Scholar Professor of International Law at Florida State University College of Law, USA. He has served as expert consultant and legal representative for numerous international organizations (including the WHO), governments and NGOs, mainly in the fields of public health, intellectual property and technology transfer, trade, and sustainable development. He is Co-Chair of the ILA Committee on Global Health Law. He served as a member of the Expert Advisory Group (EAG) to the UN Secretary General’s High-Level Panel on Access to Medicines.  http://frederickabbott.com

Image Credits: WHO/Pierre Virot, Library of Congress/Carol Highsmith, White House/D. Myles Cullen, Wikimedia Commons: Nemo, Wikimedia Commons: Painjet, WHO/P. Virot; Obama Whitehouse Archives .

A common cause of death from COVID-19 is through a cytokine storm. Cytokines are chemical messengers released by the immune system.

New Delhi, India – COVID-19 has posed unique challenges for healthcare providers across the globe, as the world has been grappling with the pandemic with no approved treatments or vaccines for the disease. Researchers are searching everywhere for drugs that may help treat or prevent the spread of the deadly virus.

This has led to the assessment of a large number of already commercialized antiviral drugs, as well as new small molecule compounds currently in research and development. And as R&D advances, ensuring wide, equitable access to such drugs has also been thrust to the forefront of health policy debates, including frequent references to this pressing need by WHO’s Director-General Dr Tedros Adhanom Ghebreyesus, and his senior management.

Yet the robust biologic pipeline of candidates to treat COVID-19 or its symptoms – and the special role these drugs could play in the COVID-19 battle, has received far less attention. And should these prove effective, stiff barriers exist for the development of COVID-19 biosimilar compounds – beginning with WHO’s own guideline policies. In fact, access to potentially life-saving biosimilar products at an affordable price will remain a distant dream, unless WHO updates its Guidelines for the Evaluation of Similar Biotherapeutic Products (SBPs).

Biologics with Potential to Treat COVID-19  

So far, the drugs with the greatest potential include those aimed at host targets, such as interleukin-6 (IL-6) receptor inhibitors. Apart from this, many researchers and pharmaceutical companies are working to develop monoclonal antibody-based treatments.

In terms of IL-6, recent preliminary data on COVID-19 patients from China reported high plasma levels of cytokines, including IL-6, that are related to the severity and the prognosis of the disease with a clear implication for the occurrence of the deadly “cytokine storm” or Cytokine Release Syndrome (CRS).

Anti-IL-1 and anti-IL-6 drugs may therefore interfere with this cytokine storm, thus helping to reduce lung inflammation and improve lung function in severe cases of COVID-19 patients. Roche’s biotherapeutic Actemra, commonly known as tocilizumab, is an anti-IL-6 receptor antibody that has been used clinically to treat rheumatoid arthritis and other autoimmune diseases. Since its approval a decade ago, it has become the go-to drug against inflammatory conditions, including cytokine storms in cancer patients receiving cell therapies, and it has also been approved for the treatment of a variety of clinical conditions that include CRS.

A small cohort study in China has suggested that tocilizumab effectively improved clinical symptoms and repressed the deterioration of severe COVID-19 patients.

According to reports, a 3-month clinical trial with tocilizumab has been registered in China, that has recruited 188 coronavirus patients, and will take place from February 10 to May 10, 2020. Malaysia will begin a 6-month clinical trial involving about 300 COVID-19 patients starting in mid-April. Furthermore, Roche has also confirmed that it will expedite the trials of the drug to determine its effectiveness in COVID-19 patients.

Another biologics drug, Kevzara (Sarilumab) jointly developed by Regeneron and Sanofi, also inhibits the IL-6 pathway and clinical trials have been initiated for the treatment of patients with COVID-19. This U.S.-based trial will begin at medical centres in New York, one of the epicenters of the U.S. COVID-19 outbreak. The multi-centre, double-blind, Phase 2/3 trial has an adaptive design with two parts and is anticipated to enrol up to 400 patients.

Even though these biologic medicines hold promising avenues for the treatment of severe diseases, offering new hope for patients, the real question is how many people will really be able to access this class of drugs. With an estimated cost of infusions per patient per year between US$ 20,000 and US$ 30,000 for rheumatoid arthritis (RA) treatment, the U.S. was the drug’s biggest market, and Americans spent about US$ 620 million on tocilizumab prescriptions. This high price of tocilizumab already excludes it as a viable option for RA treatment in many low and middle-income countries. Introducing non-originator versions is the best way to reduce the price and enhance the supply. Unfortunately, this is not possible due to the high regulatory barriers to introduce the non-originator versions of biotherapeutics (biosimilars), which are in fact established by the WHO.

IL-6 inhibitors like Tocilizumab can dampen cytokine storm in patients with severe COVID-19.

WHO Guidelines On Biosimilar Approvals – Requiring New Phase 3 Comparative Trials

According to WHO’s own guidelines on biosimilar drug development, which date to 2009, regulatory approval for biosimilars requires developers to launch comparative Phase 3 Comparative Clinical Trials (CCTs) – a costly and time-consuming requirement that does not exist for generic versions of small molecules.

Nearly 50% of the development cost of a biosimilar is to purchase the originator version for the comparative clinical trials. This regulatory barrier virtually eliminates the competition even in the absence of patent protection. WHO is the main influential agency that has created these entry barriers; its own SBP guidelines make Phase 3 clinical trials a rule of thumb for biosimilar approval. Against these guidelines, the discretionary powers of national and regional regulatory authorities to approve biosimilars without Phase 3 trials remains very limited.

For instance, one of the conditions set down by the WHO guidelines for waiving Phase 3 trials of biosimilars is that the drug under review possess at least one identical pharmacodynamic (PD) marker, which is a marker linked to efficacy (e.g. an accepted surrogate marker for efficacy). In many cases, PD markers for efficacy do not exist, and hence biosimilar manufacturers are forced to carry out CCTs. Thus, WHO’s SBP Guidelines from 2009 have even delegitimised the diverse regulatory pathways that previously existed in many countries for approval of biosimilars.

Looking at the progress of scientific knowledge, technical advancements, accumulation of experience in the field and fast-expanding national regulatory needs and capacities, voices have been repeatedly raised, including those from the scientific field, to increase access and affordability of biosimilar products across the globe.

Life-saving biologics need to be affordable to the burgeoning population of people who can be successfully treated with these drugs. Last year a group of scientists wrote to WHO demanding a review of its SBP Guidelines, and elimination of Phase III Comparative Clinical Trials. The letter noted that advancement in analytical techniques enables the biosimilar developer to capture the molecule structure of the originator drug very accurately, and the structural similarity of the biosimilar is thus reflected in its therapeutic efficacy.

Requirements for CCTs should be replaced by requirements for detailed structural characterisation as part of the WHO guidelines, the scientists stated. The demonstration of similarity in quality is sufficient to assure the safety and efficacy of most products.

Emphasis on further testing should focus on quality-assurance, e.g. drug impurity profiles and potency. Further, the safety concerns should be addressed through in vitro studies. According to the scientists, carrying out Phase 3 trials in around 300 to 500 clinical subjects does not reveal any difference between similar products.

As Francois-Xavier Frapaise, one scientist in the field, stated in his paper: “Clinical trials are not powered to detect meaningful differences in the safety profiles of biosimilars, and when numerical imbalances in adverse events are observed during clinical development of a biosimilar, the interpretation of limited differences is very difficult; only large cohort studies may detect differences, if there are any, in safety parameters.”

Even so, WHO has consistently opposed changes to its SBP Guidelines.

Already in 2014, a World Health Assembly Resolution asked then-WHO Director-General Margaret Chan “to convene the WHO Expert Committee on Biological Standardization to update the 2009 Guidelines”.

But the Expert Committee in its subsequent meeting, refrained from any revisions, rejecting the decision of its highest decision-making body without citing any reason.

Once again, in October 2019, WHO’s Expert Committee on Biological Standardisation (ECBS) declined a request to revise the SBP Guidelines without citing any reason.

The Chair summary simply states: “Chair of the Committee communicated the conclusions of the Committee to the WHO Assistant Director-General MVP (Access to Medicines, Vaccines and Pharmaceuticals) who said that WHO will evaluate current scientific evidence to support the updating of the 2009 Guidelines”.

The summary failed to provide any scientific rationale for its decision. And since then, there has been absolute silence from WHO regarding the promised science review.

This stonewalling also generates doubts about whether such a review, whenever it is finally carried out, will be undertaken in a transparent manner and free of conflict of interest.

WHO’s reluctance to update its SBP Guidelines has effectually created a wall blocking access to generic versions of many important and expensive biologics medicines such as tocilizumab, and has inadvertently nudged COVID-19 patients to face the deadly cytokine storms without such drug treatments.

Will the organisation with a mandate to safeguard public health show greater accountability and transparency about biologics in this moment of a global pandemic?

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Chetali Rao is a lawyer specializing in patent, access to medicines and health issues.

 

 

K M Gopakumar works as Legal Advisor for the Third World Network (TWN).

 

 

Both authors are based in New Delhi.

Image Credits: Scientific Animations, University of Science and Technology of China, Chetali Rao, K.M Gopalkumar.

Emma Walmsley discusses GSK’s new collaboration with Sanofi to develop a adjuvanted COVID-19 vaccine.

Two of the largest vaccines companies in the world, GlaxoSmithKline (GSK) and Sanofi, are teaming up to hasten vaccine development for COVID-19.

“By combining our science and our technologies, we believe we can help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19”, said Emma Walmsley, chief executive officer of GSK, in a joint Sanofi-GSK press release on Tuesday.

“One of the important things in this collaboration is our combined scale. Both companies have significant manufacturing capacity,” Walmsley added in a separate video message.

“We still have a lot of work to do since this is still at an early stage of development. We believe that if successful, we’ll be able to make hundreds of millions of doses annually by the end of next year,” she said.

The collaboration was applauded by industry representatives as well. 

“Today’s announcement is an illustration of the biopharmaceutical industry’s strong sense of responsibility to act together and live up to its COVID-19 commitments, which include working in a concerted manner to increase industry’s manufacturing capabilities and willingly share available capacity to ramp up production once a successful vaccine or treatment is developed”, said Thomas Cueni , Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) told Health Policy Watch.

The recent alliance aims to combine Sanofi’s protein-based vaccine with GSK’s adjuvant technology. Adjuvants are commonly added to protein-based vaccines to boost the immune response to the vaccine, allowing the vaccine to be more effective at lower doses. This makes the vaccine easier to mass produce. 

The companies have entered into a Material Transfer Agreement to enable them to start working together immediately. Definitive terms of the collaboration are expected to be finalised over the next few weeks.

If the new vaccine candidate is successful in Phase 1 Clinical Trials planned for late 2020, it will be available in the first 6 months of 2021, says the joint Sanofi-GSK press release.

The companies have established a Joint Collaboration Task Force for the project, co-chaired by David Loew, Global Head of Vaccines, Sanofi and Roger Connor, President Vaccines, GSK. The Biomedical Advanced Research and Development Authority (BARDA), an arm of the US Department of Health and Human Services (HHS), has already committed to funding part of the Sanofi vaccine’s development.

Image Credits: Heather Hazzan, GSK.

[Unitaid]

Geneva, Switzerland (14 April 2020) – Unitaid marked the first World Chagas Disease Day with the release of a comprehensive report on how to better confront the potentially deadly parasitic infection that strikes hardest among Latin America’s poor and marginalized.

It was on this date in 1909 that a Brazilian doctor, Carlos Chagas, diagnosed the first case of what was to be called Chagas disease.

Unitaid is also developing an initiative to help eliminate mother-to-child transmission of Chagas disease as part of its mandate to improve maternal, newborn and child health.

“Unitaid was created to speed equitable access to innovative health solutions, and we are thrilled to join global efforts against this insidious disease,” Unitaid Executive Director a.i. Philippe Duneton said. “Access to simpler and more affordable test and treat tools will help end the suffering Chagas causes, and cut costs for families and health systems.”

Unitaid’s work aligns with global health plans that call for eliminating Chagas disease as a public health problem by 2030.  Currently, only an estimated 7 percent of people with Chagas disease get diagnosed, and only 1 percent receive effective treatment.

Unitaid’s just-released report, Technology and Market Landscape for Chagas Disease, maps out the diagnostics and treatments that are in use now and identifies innovations that could improve upon them. The report also examines market barriers that could be removed to make way for better tests and treatments.

Unitaid’s upcoming investment to tackle mother-to-child transmission seeks to address some of these challenges, notably the lack of diagnostic tools and medicines in primary health care clinics. At least two million women of child-bearing potential are chronically infected with ‘Trypanosoma cruzi’, but active screening and optimal treatment can prevent transmission to their babies. In addition, early detection of infection in infants can greatly reduce the number of hospitalizations and deaths related to Chagas disease.

Transmitted by the blood-sucking triatomine bug, Chagas disease (American trypanosomiasis), slowly brings on cardiac, neurological and digestive problems. Up to 7 million people are thought to be infected with it, 75 million people are considered to be at risk of infection and about 10,000 die from it annually. In Brazil, Chagas disease causes more deaths than any other parasitic disease, including malaria.

In the last decades, the disease has moved from the countryside to urban settings, and is now found outside the borders of the 21 Latin American countries where it is endemic. Cases now appear in places such as the United States, Europe, Canada, Japan and Australia.

For more information: Gloria Vinyoles | 41 79 121 18 65 | vinyolesg@unitaid.who.int

Image Credits: Unitaid.

Dr Tedros at WHO’s regular press briefing on COVID-19

WHO Director General Dr. Tedros Adhanom Ghebreyesus said on Monday that the relationship between WHO and the United States is “very good” and that, despite the recent maelstrom of criticism by President Donald Trump over WHO’s handling of the COVID-19 crisis, he hoped that funding from the USA will continue. 

“I hope the funding to WHO will continue. And the relationship we have is very good. And we hope that this will continue,” said Dr Tedros at a press briefing.

The WHO Director-General was responding after a rash of remarks late last week by Trump, other key White House figures and allies over the agency’s handling of the crisis, which Trump and some of his political allies have described as “China-centric.”  There have been suggestions, including from Trump, that the US might consider suspending its contributions to the organization, and Congressional Republicans have demanded more documentation about key exchanges between WHO and China over issues that arose in the early days of the outbreak, such as whether the virus could be transmitted, person-to-person. 

The USA is the biggest contributor of funding to the WHO and has provided US$ 400 million to the Organization in 2019, which was ten times more than China. 

Meanwhile, however, WHO received a big boost from another major donor country, the United Kingdom. The announcement of a contribution of £ 200 million came just after Prime Minister Boris Johnson was discharged from a hospital where he was treated in an intensive care unit for several days, crediting the British National Health Service (NHS) for “saving my life”. Dr. Tedros welcomed this “generous support” and urged other member countries to follow the UK’s initiative.

Countries Need To Be Wary of Lockdown “Exit Strategies” Even In Places Where Outbreak Has Stabilized 

Countries planning to lift their lockdowns must do so carefully and gradually, urged Mike Ryan, Executive Director of the WHO’s Health Emergencies Programme, at the press briefing. He underlined this as a key principle even as outbreaks have stabilized in a “pretty consistent way” for a number of European countries.

“Lockdowns can be lifted in certain strategic areas, maybe where there’s lower incidence. But it does have to happen slowly, it does have to happen in a very controlled manner. And it is important that the community understands this,” said Ryan. 

As countries begin to open up again, they must maintain aggressive surveillance, testing and community engagement to keep the outbreak at bay. “We need to have a much more stable exit strategy that allows us to move carefully and persistently away from lockdown. And the only way to do that is to have fully empowered communities and a fully activated public health architecture and to the strengthen health system”, said Mike Ryan.

It is also “really important” that the lifting of these measures doesn’t happen “all at once all over Europe”, added Maria Van Kerkhove, Technical Lead for the WHO’s Health Emergencies Programme, as this may trigger another outbreak wave.

Huge Unknowns About Coronavirus Contagion Period & Immunity Gained After Illness  

3D print of a spike protein of the SARS-CoV-2 virus

Scientists still don’t have a full picture of the immune response to COVID-19, and that is one of the other issues confounding policymakers as they try to make decisions about exit strategies.

People infected with COVID-19 produce antibodies, but it is unclear whether these antibodies confer immunity, and for how long, Ryan pointed out adding, “The data is quite limited.”

“Some individuals had a strong antibody response. Whether that antibody response actually means immunity is a separate question”, said  Kerkhove referring to a new study from Fudan University in Shanghai that has not been peer-reviewed yet. The study, which compared antibody responses of almost 200 patients, showed that some people infected with COVID-19 may not develop any antibodies at all.

Yet another big knowledge gap centers around the time during which people carrying the virus may transmit it to others, Kerkhove said.

Although most people infected with COVID-19 develop symptoms within five days, scientists do not know whether patients are contagious for several days or weeks. Polymerase Chain Reaction (PCR) tests, the lab-based gold standard for diagnostics, suggest that contagion could last several weeks. However, just because people with the mild disease test positive for several weeks does not necessarily mean that they are still contagious, said Kerkhove.

“We don’t have the full picture,” she said, “What we need is much more data from countries to actually be able to say, how long is someone contagious.” 

In light of limited testing capacity and unknowns about the length of time a person can be contagious, individuals in home isolation should stay at home until their symptoms resolve, and even continue isolating themselves for another two weeks after that as well, recommended Kerkhove.

“What we recommend right now is that those individuals are in home isolation, if they can’t be isolated in a medical facility, until their symptoms resolved, plus an additional 14 days”.

More data is also urgently needed to understand if the immune response is different between patients with mild and severe COVID-19, especially in those with severe infection that have recovered, added Kerkhove. Such studies will help researchers determine what type of immune response helps a patient clear SARS-CoV-2 safely and effectively from their body.

Many of the deaths associated with COVID-19 may also be due to an overreraction of the immune system, rather than the the virus itself, suggests a study published late last month. As part of the immune reaction, so-called “cytokine storms” can lead to an excess amount of immune cells piling up in the airways and blocking them off, leading to death.

WHO Softens Position on Masks 

Wearing masks to protect from COVID-19 in Nigeria (Photot: @CRSPHCDA1)

As mask use in the general population has gained momentum in various countries, including not only Asia, but the USA, eastern Europe and Israel, the WHO officials at the briefing expressed a more positive line on the practice, saying that they could support public use of masks as part of a comprehensive strategy. Previously, WHO’s Emergencies team had said mask use in the general population was unnecessary, except among people who are symptomatically ill, or caring for other sick household members.  

“The WHO will support countries who wish to implement a more broad based strategy of mask use “as long as it’s part of a comprehensive strategy”, said Ryan.

“[The comprehensive strategy] includes physical distancing. It includes hand hygiene. It includes respiratory etiquette. It includes staying home if you’re unwell. It includes cases being isolated confirmed cases being isolated. It includes contacts being in quarantine, and it includes following the directives of the national government”, added Kerkhove.

WHO has also stressed that masks, when worn or used improperly, can still lead to transmission of the virus.  This is supported by a recent study that found large quantities of SARS-CoV-2 can accumulate on masks. The study, which was published last Friday, recommends adequate desinfection of masks before discarding them.

“There are issues around wearing those face coverings and disinfecting those face coverings and disposing of those face coverings or masks”, said Ryan. 

But for those who know that they are ill, masks are not an alternative to self-isolation, emphasized Ryan. “We don’t want people to think that putting a mask on is the same as staying home and reporting the fact that you’re sick to authorities”, he said.

The WHO’s policy on broad-based mask use has been tweaked amid growing recognition that social isolation is unrealistic in some settings and communities, especially those in developing countries with high population densities, said Kerkhove at the press briefing. In addition, in places where transmission of the virus is high, many people who are in fact ill and contagious may be unaware of their status, experts have said. 

Total cases of COVID-19 as of 10:20PM CET 8 April 2020, with active case distribution globally. Numbers change rapidly.

Image Credits: NIAID, Cross River State Primary Health Care, Nigeria .

Photo: D Sharon Pruitt

Although there have been suggestions that warmer weather might lead to the waning of the COVID-19 pandemic in the Northern Hemisphere, a new study published by the United States National Academy of Sciences has dashed some cold water on that hypothesis, saying that available data on diease spread has so far failed to show strong seasonality.

The preliminary analysis by the National Academies’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats said that the number of well-controlled studies showing reduced survival of the coronavirus in elevated temperatures and humidity is small, and urged caution not to over-interpret results. While some data, particularly from laboratory studies, provide evidence supporting seasonality, the researchers note that these are not necessarily representative of the natural environment and that multiple countries currently in their summer season are experiencing significant volume of transmission,

Even if warmer temperatures are less favorable for COVID-19, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” the experts wrote.  Some countries in warm climate are also experiencing rapid virus spread, the experts added, so that “a decrease in cases with increases in humidity and temperature elsewhere should not be assumed.”

The report also notes that neither of the other coronaviruses that have recently leaped from animals to humans, Severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), nor the flu strains of previous pandemics, have shown a seasonal pattern.

The study evaluated available observational epidemiological data as well as laboratory experimental data, including studies both in China and other countries. Further study is required to better characterize the virus’ transmission patterns, reported the Univeristy of Minnesota Center for Infectious Disease Research and Policy. 

COVID-19 Cases in Spain Rise Once More

After a week of decreasing daily COVID-19 incidence, Spain once more reported elevated numbers on 3 consecutive days. Today, Spain reported 5,756 new cases, bringing the national total to 152,446 cases, including 15,238 deaths (683 new), reported the Johns Hopkins Center for Health Security. Italy reported more new cases than the previous day (3,836 compared to 3,039), but the daily incidence remains below 4,000 for the third consecutive day after exceeding that number for nearly 3 weeks. Italy is reporting a total of 139,442 confirmed cases, and 17,669 deaths.

Meanwhile, while US President Donald Trump expressed hopes that the US could “reopen again soon” experts were more reserved in light of the continued increase in US cases, with some 30,000 more infections reported in the US over the past 24 hours, 10,000 more than on the day before.

In South-East Asia, cases also continued to rise in India, in partvcular, which has reported more than 500 new cases a day, over the past 10 days, for a 300% increase, There are now 6,412 cases in the country, according to the official India Ministry of Health and Family Welfare data.

Meanwhile, WHO Director General Dr. Tedros Adhanom Ghebreyesus brushed off recent criticism of WHO’s response to the COVID-19 crisis, which US President Donald Trump on Tuesday tweeted was “very China centric.”  At a later White House briefing Trump repeated his charge that WHO had been too soft on China’s early management of the emergency, and suggested that US funding to the organization would be re-examined. Trump also criticized WHO’s strong opposition throughout January and February to the imposition of travel restrictions to stop the spread of the virus, saying that the Organization should have recommended restrictions much earlier, which the US later adopted on unilaterally followed by countries around the world.

At a WHO press briefing on Wednesday, the WHO Director General urged political leaders not to play politics with the coronavirus emergency, adding: “why do I care about being attacked when people are dying.”

    Cumulative and active cases. Numbers change rapidly.

-Updated 4 April, 2020

Image Credits: D Sharon Pruitt.

An N95 respirator, used during the COVID-19 pandemic to protect healthcare workers against infection

Dutch Deputy Prime Minister Hugo de Jonge on Wednesday offered to support the World Health Organization to develop a pool of intellectual property rights for COVID-19 technologies, just days after WHO Director-General Dr Tedros Adhanom Ghebreyesus announced WHO’s public support for the initiative.

“In principle, I am sympathetic to this initiative,” Minister de Jonge wrote in an update on the Netherlands’ COVID-19 response on Tuesday. “The development of this initiative in relation to the availability and affordability of vaccines must take place in the coming period.”

This makes the Netherlands the latest country to back a call by Costa Rica to establish a freely accessible pool of rights for tools to fight the pandemic. Rights holders would voluntarily contribute IP rights on any data, treatments, diagnostics, vaccines, or COVID-19 technologies to the pool, which would then be made available to a number of manufacturers to quickly scale up production and access to such tools.

These rights “must be made available to everyone for free, or for a reasonable license fee,” said de Jonge.

Dr Tedros first publicly announced WHO’s commitment to the Costa Rica proposal on Monday, adding that WHO was currently working with Costa Rica to “finalize the details.”

The Board of UN-backed Medicines Patent Pool, which manages a “pool” of patent rights for essential medicines, announced its support for the COVID-19 IP pool last week, temporarily expanding its mandate outside of medicines and treatments.

Kentucky Governor Requests 3M Release N95 Patent

Kentucky Governor Andy Beshear called on the United States-based company 3M to release its patents for N95 respirators – a type of protective mask in desperately short supply during the COVID-19 pandemic.

“The procurement is incredibly difficult, as is the manufacture because it’s under patent,” Beshear said in a press conference on 1 April. He added that it was the company’s “patriotic duty” to license the N95 patents “to the nation” during the pandemic so that “everybody else can manufacture it.”

While 3M is not the only producer of N95s, it is the largest domestic producer. The company holds 441 patents in the US that mention ‘N95’ or ‘respirator,’ according to a list from James Love, director of Knowledge Ecology International, a patent watchdog group. The newest respirator-related patent granted to 3M was approved just yesterday, on 7 April 2020.

The respirators are used by healthcare workers in order to protect against the virus, and offer much better protection than surgical masks. However, due to the extreme shortage of respirators around the world, most hospitals in the US are running low or completely out of the protective masks. Many have resorted to rationing the N95s to one per physician every two to three days, or collecting and sanitizing them after use. Under normal circumstances, N95s are discarded after each use.

Beshear’s comments come just on the wake of US President Donald Trump’s invocation of the ‘Defense Production Act,’ a Korean War era law that allows the federal government to redirect domestic industries’ capacities towards wartime production.

See The Courier Journal for more on this story.

Image Credits: OSHA's Respiratory Protection Standard 29 CFR 1910.134.

Community health worker distributes Mectizan (ivermectin) to eliminate river blindness

While much of the public fanfare around new COVID-19 drugs has centered around the lupus drug, hydroxychloroquine, and a failed Ebola remedy, remdesivir, other researchers are keen to explore the potential of other time-worn remedies – although here, too, experts are urging extreme caution.   

Ivermectin, the antiparasitic drug that turned the tide in the West African fight against river blindness (onchocerciasis) some 30 years ago has been found to slow the growth in the laboratory of SARS-CoV-2, the virus behind COVID-19. Meanwhile, a widely circulated preprint study claiming that countries with mandatory Bacillus Calmette-Guérin (BCG) vaccination against tuberculosis may experience lower rates of COVID-19 cases and deaths has led to the initiation of at least two clinical trials on the prophylactic use of BCG in Australia and the Netherlands, with more countries planning on follow suit.

Still, the concentrations of ivermectin that were demonstrated as effective against SARS-CoV-2 in the laboratory cell culture experiments are “far beyond” dosage levels approved by the FDA to safely treat river blindness in humans, warned the Mectizan Donation Program, in an Expert Committee Statement, issued on Tuesday. High doses of ivermectin have shown “serious toxicity” in animal studies, they added.

In the laboratory trial, the single dose of ivermectin [Mectizan®] slashed the growth of SARS-CoV-2 by 5000-times within 48 hours, reported the study published in Antiviral Research last Friday. 

Clinical trials would be needed to determine if there is a dose of ivermectin that is both safe for humans and effective against the SARS-CoV-2, and even expedited human safety trials can take time, a WHO scientist told Health Policy Watch. 

“There is a long path from showing something works at certain concentrations in [cell culture studies] on the virus to showing that the required concentrations can be achieved in the target tissues in humans and are expected to be safe for humans,”  said the scientist.

Then, the drug would also have to be studied further in randomized controlled studies in COVID-19 patients, and must be proven to demonstrate “clinical benefit,” added the scientist. 

Millions of doses of the FDA-approved medication are donated every year to oncho-endemic countries through the Mectizan Donation Programme created by Merck Sharpe & Dohme (MSD), which developed the drug in collaboration with the TDR, the WHO-hosted Special Programme for Research and Training in Tropical Diseases, in the late 1970s. Ivermectin is typically administered once a year in communities of West Africa where onchocerciasis is endemic, to prevent the development of the disease, which can lead to blindness when it goes untreated. 

BCG Clinical Trials Beginning in Australia and Netherlands  – But Researchers Warn Against Complacency in Countries Where Vaccine is Widely Used 

Similarly, researchers have questioned the validity of the BCG vaccine study, urging for more robust studies on the effectiveness of the vaccine.

The initial pre-print study by researchers at the New York Institute of Technology found that in 28 middle- and high-income countries, which did not require BCG vaccination, there were also higher numbers of COVID-19 cases per capita and higher death rates than in countries that enforced universal BCG vaccination. BCG is a vaccine typically given to infants, which protects against tuberculosis in young children, although protection wanes by age 12. The vaccine has been demonstrated to induce a more general immune response, which may offer protection against other respiratory diseases. The study was published on the preprint server MedRxiv in mid-March, which means that it has not yet been peer-reviewed.

“Accepting these findings at face value has the potential for complacency in response to the pandemic, particularly in low- and middle-income countries [where BCG vaccination is highly prevalent]” warned infectious disease researchers Emily Maclean, Lena Faust, Sophie Huddart, and Anita Svadzian of McGill’s International TB Centre in Canada, in a searing critique published in Nature Microbiology Community. 

“The pre-print’s study design, timing of analysis and data collection, lack of adjustment for important confounders, and uncertain biological plausibility mean that we cannot view the paper’s findings as causal,”  Maclean told Health Policy Watch. 

Rather, she said, this type of ecological study, which only observes broad population level data, should be “hypothesis generating”. Under normal circumstances, such a study would spark more epidemiological studies and early phase clinical trials to test the vaccines’ safety and efficacy.

“However, given that we’re in extraordinary times, I think following up on promising vaccine leads is a good choice,” said Maclean, particularly because scientists already know the long-established vaccine is “safe for use” to humans.

“Ethically- and properly-conducted randomized control trials will allow us to see if BCG has a causal effect regarding COVID-19 morbidity and mortality,” she added. 

That’s exactly the step that some countries are taking. Phase III clinical trials to test the BCG vaccine in healthcare workers have begun in the Netherlands and in Australia, and researchers in the United States are also exploring ways to begin trials. The Inserm Research Director at the Institut Pasteur in Lille France, Camille Locht, is preparing for the implementation of a double-blind clinical trial in collaboration with Spain. 

Still, the vaccine is not a “panacea” warned Nigel Curtis, coordinator of the clinical trial in Australia, to the the New York Times. Both the Australian and the Dutch trials will aim to only assess whether the vaccine would reduce the duration of illness, thus allowing sick healthcare workers to recover more rapidly and return to work.

Japanese BCG vaccination kit

WHO Africa Region Hits 10,000 Cases

The WHO Africa region, which encompasses most of Sub-Saharan and Southern Africa, hit a sober new mark on Tuesday when the region surpassed 10,000 cases.

“COVID-19 has the potential not only to cause thousands of deaths, but to also unleash economic and social devastation. Its spread beyond major cities means the opening of a new front in our fight against this virus,” said WHO Regional Director for Africa Matshidiso Moeti in a press release.

Moeti urged for a “decentralized response” tailored to the local context across the continent. “Communities need to be empowered, and provincial and district levels of government need to ensure they have the resources and expertise to respond to outbreaks locally,” she added.

Of particular concern are countries with fragile health systems experiencing complex emergencies – some countries in Africa do not have the hospital bed capacity, enough ventilators, and trained personnel to take care of a surge of patients.

“Africa still has an opportunity to reduce and slow down disease transmission.  All countries must rapidly accelerate and scale up a comprehensive response to the pandemic, including an appropriate combination of proven public health and physical distancing measures,” said Ahmed Al-Mandhari, WHO’s Regional Director for the Eastern Mediterranean, which includes North African countries such as Egypt, Morocco, and Tunisia.

South Africa, with 1,749 cases and 13 deaths, has the highest number of cases, but the death rate so far is highest in Algeria with 205 deaths and 1,572 cases.

Total cases of COVID-19 as of 7:30PM CET 8 April 2020, with active case distribution globally. Numbers change rapidly.

Image Credits: Mectizan Donation Programme, Y Tambe, Johns Hopkins CSSE.

Nurses are on the frontline of the COVID-19 response in Thailand, where public sector nurses have been fighting for pay raises.

The world needs 6 million more nurses in the next 15 years in order to reach the Sustainable Development Goals, according to the first-ever State of the World’s Nursing report released by the World Health Organization, Nursing Now, and the International Council of Nurses.

The report, released Tuesday on World Health Day, explores challenges and successes faced by the world’s largest cadre of health workers, whose essential roles have been highlighted even more dramatically during the COVID-19 pandemic. 

“Nurses are the backbone of any health system. Today, many nurses find themselves on the frontline in the battle against COVID-19,” said WHO Director General Dr Tedros Adhanom Ghebreyesus, in a press release. ‘This report is a stark reminder of the unique role they play, and a wakeup call to ensure they get the support they need to keep the world healthy.’

“[The report] shows very clearly that we do not have enough nurses to meet the challenge of the SDG of Health for All by 2030 and that we will need to raise the number of qualified nurses by at least 6 million by 2030 to achieve that aim,” said Mary Watkins, co-chair of Nursing Now.

There are just under 28 million certified nurses working around the world today. However, the distribution of nurses is highly unequal – approximately 80% of nurses serve only 50% of the world’s population. The greatest shortages of nurses are in Africa, South East Asia and the WHO Eastern Mediterranean region as well as some parts of Latin America. 

But governments all over must increase investment in nursing education, protections and pay for nurses – even high-income countries. “Individually, professionally, morally of course we all value nurses – but not economically,” said Howard Catton, chief executive officer of the International Council of Nurses. Shortages of nurses in poorer countries are exacerbated by “an over-reliance in high-income countries on migration” to supply nursing staff.

“Wealthier countries are not producing enough nurses and are hiring them from ‘less fortunate’ countries at higher wages than can be achieved in their home countries,” added Watkins. 

The largest shortages of nurses are seen in some parts of Latin America, Africa, and Southeast Asia.

Globally, nurses make up nearly 60% of the health workforce, but only 25% of the education budget is spent on them. Nurses’ pay is highly affected by austerity measures – just as one example, nurses in Zimbabwe are only paid US $60 per month despite rampant inflation raising the cost of living.

In light of the global shortage of personal protective equipment during the COVID-19 emergency, governments must also work on improving nurses’ working conditions, according to the report.

“There is a real need to see that employment terms are attractive for nurses, not only in terms of remuneration but also safety, both in terms of violence and sufficient personal protection equipment,” said Watkins. 

Additionally, nursing is a “female-dominated profession” with “a history of discrimination and inequality, pay and gender biases,” added Catton. The report noted that over 90% of the world’s nurses are women, but most leadership roles in nursing are held by men. 

“Our nurses are the bedrock of preparedness and strong health systems,” he added. “We need a change in thinking and mindsets about the value of nursing.”

The State of the World’s Nursing report recommended ten key steps to increase investment in nursing:

  • increase funding to educate and employ more nurses;
  • modernize professional nursing regulation by harmonizing education and practice standards and using systems that can recognize and process nurses’ credentials globally;
  • strengthen capacity to collect, analyze and act on data about the health workforce;
  • monitor nurse mobility and migration and manage it responsibly and ethically;
  • educate and train nurses in the scientific, technological and sociological skills they need to drive progress in primary health care; 
  • establish leadership positions including a government chief nurse and support leadership development among young nurses;
  • ensure that nurses in primary health care teams work to their full potential, for example in preventing and managing noncommunicable diseases;
  • improve working conditions including through safe staffing levels, fair salaries, and respecting rights to occupational health and safety; 
  • implement gender-sensitive nursing workforce policies; and
  • strengthen the role of nurses in care teams by bringing different sectors (health, education, immigration, finance and labour) together with nursing stakeholders for policy dialogue and workforce planning. 

In light of the COVID-19 pandemic, which has revealed weaknesses in health systems around the world, implementation of the report’s recommendations is  “not optional or ‘nice-to-do’”, it is a “must”, Catton urged.  

Gauri Saxena contributed to this story

Image Credits: Public Services International/Madelline Romero, State of the World's Nursing Report 2020 Executive Summary.

Maps show (top) county level 17-year long-term average of PM2.5 concentrations (2000-2016) in the US in ug/m3 and (bottom) county level number of COVID-19 deaths per one million population in the US up to and including April 4, 2020.

People with COVID-19 are dying at significantly higher rates in communities in the United States with higher air pollution levels, according to a new Harvard University study  – the first such study to systematically examine links between air pollution and higher COVID-19 mortality. 

For every 1 microgram/ cubic meter (µg/m3) increase in average annual levels of fine PM2.5 particle pollution, COVID-19 death rates as of 4 April, 2020 were 15% higher, according to the pre-print study of death rates across some 3,080 counties of the United States, where 98% of the US population resides, by a group of researchers from the Harvard Chan School of Public Health, published Tuesday.

The strong association between higher average levels of air pollution over the past 20 years, and higher mortality rates in the ongoing COVID-19 emergency was observed even at comparatively low average annual air pollution exposure levels, of just 2-12 µg/m3 of PM 2.5.

In comparison, WHO guideline limits for PM2.5 concentrations are 10 µg/m3 annual average, although the Agency has long observed that health effects from air pollution are also observed at much lower levels.  PM 2.5 levels in some major European cities often exceed the WHO guidelines by as much as 5-10  µg/m3 or more, while air pollution levels in many low and middle-income cities may be 5-10 times above the WHO guideline levels.

The association between slighty higher levels of air pollution and much higher rates of COVID-19 mortality held firm, even after data was adjusted for a range of other variables that can also influence COVID-19 mortality such as population age and poverty rates; smoking and obesity prevalence; as well as health services availability and rates of COVID-19 testing.

“A small increase in long-term exposure to PM2.5 leads to a large increase in COVID-19 death rate, with the magnitude of increase 20 times that observed for PM2.5 and all cause mortality. The study results underscore the importance of continuing to enforce existing air pollution regulations to protect human health both during and after the COVID-19 crisis,” said the researchers, members of the Department of Biostatistics

Moreover, the association seemed to be cumulative – at least at the comparatively lower levels of air pollution common in the United States. So while higher average annual PM2.5 concentrations of 1 µg/m3 was associated with a 15% greater mortality rate, PM2.5 levels just 2 µg/m3 higher, would be associated with a 30% higher rate of COVID-19 mortality, and so on.

“We hypothesize that because long-term exposure to PM2.5 adversely affects the respiratory and cardiovascular system, it can also exacerbate the severity of the COVID-19 infection symptoms and may increase the risk of death in COVID-19 patients,” the authors concluded. “The association between PM2.5 and health including pregnancy outcomes, respiratory diseases, cardiovascular diseases, neurocognitive disease in the United States and worldwide is well established.”

Some 248 Lives Could Have Been Saved In Manhattan Alone

At the New York City epicenter of the pandemic, the researchers found that some 248 lives could have potentially been saved, so far,in the borough of Manhattan, alone, if average air pollution levels over the past 20 years had been just 1 µg/m3 lower.

Similar associations have been found for death rates in Italy, according to a another new review published by European researchers in the Environmental Pollution journal.  The study by researchers from the University of Siena and Aarhus University noted that COVID-19 mortality rates were highest in Italy’s most polluted regions, Lombardy and Emilia Romagna, at 12% compared to 4.5% in the rest of the country. However that review did not examine death rates as systematically as the Harvard study, or did it analyse against other confounders, including age, other health risk factors, and access to health services. 

Other studies of “before” and “after” pandemic satellite images have also noted that one big bonus of the COVID-19 crisis has been the cleaner skies observed over many parts of the world, from highly polluted parts of northern Italy to India and China. However, environmental health experts worry that those gains will be only temporary unless policy makers recognize more widely the huge health penalty imposed by chronic air pollution exposures -which WHO estimates kill some 7 million people every year.

On March 30, the European Public Health Association (EPHA) warned that years of exposure to air pollution may have left patients with pre-existing heart or lung conditions, rendering them more vulnerable to COVID-19. 

The statement was accompanied by satellite images showing nitrogen dioxide (NO2) air pollution levels over the Americas, Europe and Asia in March 2020 as compared to March 2019, to illustrate the blue skies impacts of COVID-19.  But the “The damage is already done. Years of breathing in dirty air from traffic fumes and other sources will have weakened the health of all those who are now embroiled in a life or death fight against COVID-19,” warned Sascha Marschang, acting secretary general of the EPHA in a statement. 

Images combine NO2 emission readings from 5-25 March in 2019 versus the same period in 2020, based on ESA Sentinel-5 satellite data, following recommended image processing guidelines. Image credits: ESA / EPHA / James Poetzscher

Air pollution exposures lead to  chronic inflammation of the lungs, even in young and healthy subjects, and exposures over time increase the risk of acute respiratory distress syndrome – a severe manifestation of COVID-19 that leads to death, according to the authors of the European paper. Air pollution is also a factor in cardiovascular disease and stroke, as fine particles enter the blood stream as well, causing inflammation, hypertension, and increasing risks of blood clots. 

The link between COVID-19 mortality and the range of air-pollution related chronic diseases has already been well-established. Significantly higher proportions of people with acute and chronic respiratory disease, lung cancer, heart disease, and stroke, are hospitalized and eventually die from COVID-19.   But the Harvard study establishes an even more direct link.  

“The results of [our] study underscore the importance of continuing to enforce existing air pollution regulations during the COVID-19 crisis,” Harvard researchers Xiao Wu, Rachel Nethery, Benjamin Sabath, Danielle Braun, and Francesca Dominici wrote. “We anticipate a failure to do so can potentially increase the COVID-19 death toll and hospitalizations.” 

The Harvard paper was published just days after the US Administration of Donald Trump relaxed emissions requirements on new vehicles for the coming years, and just ten days after the US Environmental Protection Agency (EPA) relaxed reporting requirements for not only for air pollution emissions from factories and power plants, but also for emissions of effluents and hazardous waste materials, citing the COVID-19 emergency. The new policy sparked fears that polluters were now given a “free for all” to increase emissions, although the US EPA has since pushed back on that claim.

In one bright spot, the lower levels of nitrogen dioxide (NO2) and particulate matter (PM) from road traffic may bring “some relief” to patients currently stricken with coronavirus, according to the EPHA.

Iran & Other Countries Consider Gradual Relaxation of Lockdown 

In other developments, Iran, which has been the Eastern Mediterranean Region’s COVID-19 epicentre, may relax its nationwide business shutdown by Saturday, allowing for the resumption of  “low-risk” activities, said President Hassan Rouhani in a televised meeting. The country has been reporting about 100 fewer new cases per day over the past week. Still, 2100 new cases were reported today, and Iran remains the hardest hit country in the region, with a cumulative total of 62,589 total cases and 3,872 total deaths as of Tuesday night.

Iranian health worker disinfects bus.

In Europe, The Czech Republic announced that it would also relax lockdown measures from next Tuesday, reopening some shops and industries, and allowing limited travel abroad. The country of 10.65 million people currently has recorded 4944 cases and 87 deaths, less than a fifth of Switzerland, which has only 8.5 million people. 

Wuhan city in Hubei, China, the original epicentre of the COVID-19 pandemic, also announced that it would finally lift lockdown measures on Wednesday after more than two months in whch residents have been besieged by the virus, according to a notice posted by provincial authorities. Economic recovery is the next challenge, said Hu Chaowen, director of Hubei Province’s Poverty Alleviation Office at a press conference. He calling 2020 “the year of a decisive battle against poverty,” alluding to the economic hardships experienced by poor and day wage laborers.

In other pandemic hotspots, however,  lockdown measures were still being tightened as cases continued increasing. 

Authorities in Switzerland called on the public to maintain social distancing, saying it is too early to tell if the slowdown in new infections meant that the apex had been reach. Total COVID-19 deaths rose from 590 to 641 over the past 24 hours in a country that has 22 242 confirmed cases, for one of the the highest incidence rates of COVID-19 in Europe (259 cases/100 000 people). 

Despite initial signs that new case counts in key countries such as the United Kingdom, Italy, France and Spain, were stabilizing, others were still seeing sharp daily increases. Turkey reported some 3,148 new cases on Tuesday, for a total of 30,217. And The Republic of Belarus, which until now had very few cases at all, reported 794 total cases on Tuesday, as compared to 562 the day before.  

In an urgent attempt to stave off a wider outbreak in Belarus, a special WHO Delegation will arrive today by invitation from the President of Belarus Aleksandr Lukashenko. The Delegation will “assess the real situation, adequacy and efficiency of measures taken to prevent the spread of coronavirus the country, as well as to analyze clinical protocols and approaches to medical care”, says the National State TV and Radio Company of the Republic of Belarus. 

In the US, New York State doubled the maximum fine for violations of the state’s social distancing protocol and extended the closure of nonessential businesses and schools until the end of the month, according to a Tuesday press release from the Governor’s office. Some 1000 beds aboard the US Navy’s hospital ship the Comfort were made available to treat COVID-19 patients, following requests from New York officials to expand the ship’s mission. 

New York City experienced the “largest single day increase” in death toll of 731 deaths, said Governor Andrew Cuomo in a press briefing Tuesday. On a more positive note, however, the Governor added that the three-day average of daily hospitalization rate is reducing, and that the number of daily intensive care admissions is also “way down.”

Total cases of COVID-19 as of 6:04 PM CET, with active case distribution globally. Numbers change rapidly.
WHO Maintains Position that Public Mask Use Unnecessary- Despite Increasing Evidence of Airborne Virus Transmission

In updated guidance, issued Tuesday, WHO continued to maintain that evidence of virus transmission as very fine “aerosol” particles was insufficient to justify universal use of masks by the public. However, that position is being challenged by a number of leading experts who say such airborne transmission is a possibility, and that masking helps protect healthy individuals from others who may unknowingly be COVID-19 carriers. 

While WHO has contended that the virus can only be transmitted effectively by droplets released through coughing or sneezing, Tang and other experts believe that it may also be transmitted by even tinier aerosol particles, released through the simple acts of breathing or speaking.

And since many people anyway don’t know if they are infected, universal masking would ensure that infected individuals don’t transmit transmission of the virus to other, healthy people, who are in their close proximity.

“The assumption should be that airborne transmission is possible unless experimental evidence rules it out, not the other way around”, said virologist Julian Tang at the University of Leicester, writing for Nature. “If everyone can mask, it is double, two-way protection,” Tang added. 

Improving ventilation indoors or banning indoor meetings could be other measures helpful to preventing aerosol transmission, said scientist Lidia Morawska from the Queensland University of Technology in Australia in the Nature article.

WHO has also expressed concerns that public adoption of masks would create even greater shortages of protective equipment for health care workers, who are already desperately short. However, some health authorities, including the US Centres for Disease Control and Israel’s Ministry of Health, are also recommending that people fabricate their own cloth masks, which can be washed and reused. 

If the most vulnerable populations are guaranteed masks, the wider public could adopt masks as well, suggests Ben Cowling, an epidemiologist at the University of Hong Kong.

WHO’s Scientific brief acknowledges that airborne transmission of the virus “may be possible,” but it is limited to certain specialized medical procedures. That position is anchored in a WHO analysis of 75,465 COVID-19 cases from China from mid-February, which found that airborne transmission was “not reported.” 

“There is currently no evidence that wearing a mask (whether medical or other types) by healthy persons in the wider community setting, including universal community masking, can prevent them from infection with respiratory viruses, including COVID-19,” the WHO guidance states.

“The wide use of masks by healthy people in the community setting is not supported by current evidence and carries uncertainties and critical risks”. Medical masks should be reserved for healthcare workers. Only persons with symptoms or health personnel working under “aerosol-generating procedures” should use a mask, advises the WHO.

Commuters wear masks to protect against transmission of COVID-19 on a train in Singapore

-Svĕt Lustig Vijay and Gauri Saxena also contributed to this story

 

Image Credits: Wu et al. "Exposure to air pollution and COVID-19 mortality in the United States," Harvard University, Mina Noei, Jade Lee .