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 .

Volunteer assembles 3D- printed face shields in NYC. The face shields are donated to and sanitized before use at local hospitals facing protective equipment shortages.

WHO deferred any broad recommendation to the public on the use of face masks, even as more countries were recommending some kind of a face cover or protective mask to reduce COVID-19 transmission.

World Health Organization Director General Dr Tedros Adhanom Ghebreyesus stressed that health workers need to remain the key priority for the use of medical masks.

Dr Tedros spoke at a press briefing on Monday, where Lady Gaga also made a special appearance to announce plans for a mass virtual concert, “One World – Together At Home” on Saturday April 18th, involving dozens of celebrity stars such as Sir Elton John and Paul McCartney.

The event, in collaboration with Hugh Evans of Global Citizen,  aims to raise money for the WHO’s COVID-19 Solidarity Response Fund, particularly for test kits and protective gear to shield health workers in low- and middle-income countries from infection.

In other key comments, WHO’s head of Emergencies Mike Ryan said there is growing evidence of a strong correlation between the “dose” of viral infection to which an individual is exposed and the severity of disease that they develop, but those questions need to be explored further by researchers.

“We need to look at who is getting sick and is the type of exposure they are getting different?” said Ryan at the press briefing. “It’s not just looking at who is infected, but whether there are specific exposures that cause more severe infection. We need to have the serological-epidemiological studies to find out what the infectious dose is, and the dose of exposure, and severity of infection.

If someone is exposed to a high dose from another individual directly, or a surface that’s heavily contaminated, is that significant in terms of driving infection? We have seen that in many many other diseases in the past including cholera, Ebola and others.”

Cloth Masks & Face Covers ? WHO Refrains From Comment 

Dr Tedros said that WHO would be issuing updated guidance on masks, which so far only recommends them for health workers; people who know they are sick; or people caring for the sick.

“Use of general masks in the general population could exacerbate the supply for those who need it most. These shortages are putting health workers in real danger in some countries”, he said.

However, he noted that in some crowded, low-income settings, where other social distancing and sanitation measures are difficult to maintain, then public mask use might be more justified, adding, “What is clear is that there is limited research in this area. We encourage countries that are considering the use of masks for the general population to study their effectiveness so we can all learn. Most importantly, masks should only ever be used as part of a comprehensive package of interventions.”

The WHO Director-General offered no direct comment on the recommendations issued last week by the US Centres for Disease Control calling on the general public to wear cloth masks or other non-medical face covers. Israel also has called on the public to wear simple surgical masks, cloth masks, or cloth face covers when outside of the home, while Hungary and  Austria made wearing of masks mandatory in supermarkets.  

Public health authorities in those countries say the universal wearing of masks seems to have been a factor that helped reduce high rates of disease transmission in countries like China, the Republic of Korea, and Singapore. 

As growing evidence seems to support the fact that people who are either pre-symptomatic or asymptomatic may be unknowingly transmitting the virus, the Center for Disease Control (CDC) last week recommended wearing cloth face coverings in public settings, especially in places where adhering to social distancing guidelines are challenging, such as grocery stores and pharmacies. 

As part of the new CDC move, the US Surgeon General issued guidance on You Tube, explaining to the public how to make their own protective masks.

https://www.youtube.com/watch?time_continue=1&v=tPx1yqvJgf4&feature=emb_title

The CDC recommendation exempts young children under age of 2, people with trouble breathing, or people who are unconscious, incapacitated or otherwise unable to remove a face covering without assistance. And while it is hoped that the pervasive use of face coverings would slow the spread of the virus by carriers who are unaware that they are infected, masks will only be effective when supplemented by frequent hand cleaning with alcohol-based hand sanitizer or soap and water, CDC stressed. 

As shortages in medical supplies continue, experts stressed that medical masks, particularly high-performance N-95 masks should be mainly reserved for the healthcare workers who are on the frontlines of the pandemic.

In that vein, New York City authorities have been sending SMS messages to city residents that read: “New Yorkers: Wear a face mask when you go outside and near others. It can be a scarf, a bandana or one you make at home” However, the messages added the caveat: “The city urges you to save medical masks for our healthcare workers and first responders who truly need them.” 

Yet the new US recommendations were not without dissonance, reflecting the hesitations that some members of the public also might have over mask use, beginning with the President himself. “With the masks, it is going to be a voluntary thing. I am choosing not to do it,.” Donald Trump remarked in a press briefing after the White House issued its own recommendation echoing that of the CDC. 

Lockdowns Proving Effective for COVID-19 Control- But Exit Strategies Key to Economies

As regards lockdowns, the main disease control tool being used, Ryan said “lockdowns in many situations are proving effective in dampening outbreak, but those lockdowns are causing economic hardships. [We need ] a more sustainable way.”

He stressed, however, that any effort to lift lockdowns will require a “stepwise approach” by governments, with careful consideration of those restrictions that can safely be lifted without recharging the infection cycle. 

Among the parameters that are important to consider are hospital capacity;  the “doubling rate” – that is the number of days over which the cumulative number of COVID-19 cases are doubling; as well as the proportion of COVID-19 test sample that are testing positive.

“You need to look at doubling rate and positivity rate,” said Ryan, citing as one example of the latter, Korea, where 2-6% of samples are testing positive and restrictions on economic activity and public movements are relatively relaxed, as compared to New York City, where 37% of testing samples are turning out to be positive. 

“A carefully calibrated stepwise approach is the safe path out of lockdown.”

And once lockdowns are lifted, other tactics will become all the more important, he stressed. Those include: “active case finding, testing, isolation of cases, quarantine and strong community education around physical distancing.” 

WHO Welcomes Costa Rica Overture on Patents Pool for COVID-19 Therapies
Carlos Alvarado Quesada, President of Costa Rica

In his remarks on Monday, Dr Tedros also said that he “supported” the proposal by the President of Costa Rica, Carlos Alvarado, to create a global pool of rights to COVID-19 therapies, and would be working to finalize its details.

The WHO Director General had responded positively to the overture last week in a Tweet, but this was the first time that he made a more formal comment on the developing initiatives around an international patent pool by Costa Rica, which was also backed last week by the UN-supported Medicines Patent Pool.

“I want to thank the Medicines Patent Pool and UNITAID for the initiative they announced last Friday to include medicines and diagnostics for COVID-19 in their licensing pool,” he said.

In a parallel move, the International Federation of Pharmaceutical Manufacturers (IFPMA) and Associations on Monday released a statement responding favorably to the Medicines Patent Pool’s move.

“While we are not aware of any instance to date where intellectual property management has been an impediment in the global response to this pandemic, proposals for voluntary pooling of intellectual property assets, including the decision of the Medicines Patent Pool (MPP) to temporarily expand its mandate to include health technologies related to COVID-19, adds to the arsenal of options available to companies when establishing access to any potential COVID-19 product,” said Thomas Cueni, director-general of IFPMA.

Cueni added that the biopharma industry “recognized there was no ‘one-size fits all’ approach” to supporting research and development, and access efforts. Thus, the industry was “open to explore innovative approaches and partnerships to facilitate further R&D to develop new medicines and vaccines for patients suffering from COVID-19 and to expand access.”

Dr Tedros also thanked the President of Costa Rica, Carlos Alvarado, and Health Minister Daniel Salas for submitting the proposal to create a pool of rights to diagnostics, treatments and vaccines, with free access or licensing on “reasonable and affordable terms.”

“Muchas gracias, Mr President. I support this proposal, and we are working with Costa Rica to finalize the details,” added the WHO Director-General.

“More than 70 countries have joined WHO’s Solidarity Trial to accelerate the search for an effective treatment. And about 20 institutions and companies are racing to develop a vaccine. WHO is committed to ensuring that as medicines and vaccines are developed, they are shared equitably with all countries and people,” he added.

India bans Hydroxychloroquine Exports – Following Despite US Efforts to Access Supplies  

Despite the calls for global solidarity, individual countries continued moves to restrict exports of certain supplies and medicines viewed as potentially critical. Over the weekend, India banned all export of the drug hydroxychloroquine, a drug currently approved for the treatment of immune disorders such as lupus, but also viewed as a potential remedy for COVID-19.

The Indian limitation on exports followed a new, and unprecedented recommendation by a National Task Force for COVID-19, led by the Indian Medical Research Council, on the use of hydroxychloroquine as a prophylactic for asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19, as well as for asymptomatic houseold contacts of laboratory confirmed COVID-19 cases. 

Over the weekend, the Indian Ministry of Health and Family Welfare issued a more formal guidance permitting the off-label use of hydroxychloroquine with the antibiotic azithromycin in COVID-19 for patients in intensive care or with severe respiratory disease

“The export of hydroxychloroquine and formulations made from hydroxychloroquine shall remain prohibited, without any exception,” stated the order by India’s Directorate General of Foreign Trade in the wake of the national policy directives.  

The Indian export ban was imposed despite US President Trump’s call this weekend with Indian PM Narendra Modi during which Trump urged the release of “the amounts that we ordered”.

Although hydroxychloroquine’s safety and efficacy for treating COVID-19 have not been demonstrated, various countries, including India and the US, have incorporated the antimalarial drug into their national containment plans.

The pharmaceutical industry is not waiting for the final evidence either. It has already made commitments to ramp up production of the drug. Pharmaceutical giants like Novartis, Bayer, Teva and Mylan NV, amongst others, have all pledged to contribute some 220 million tablets, by mid-May, more than half of which will be donated by the Swiss-based pharma firm Novartis.

New York may be Reaching Plateau – Africa doing “Well” So Far In Response

In terms of pandemic trends worldwide, it appeared that New York may be near the apex of its infection wave, or already plateauing, New York Governor Andrew Cuomo said on  Sunday. New York City’s daily number of deaths dropped for the first time in weeks from 630 on Saturday to 594 on Sunday, and the number of new hospitalizations was halved overnight.

“The number of deaths over the past few days has been dropping for the first time. What is the significance of that? It’s too early to tell”, Cuomo said in yesterday’s speech.

“Three or four days” may be needed to see whether the death rate is actually decreasing. Some 4,150 people have died among the 122,031 confirmed cases in the USA’s epicentre, the Governor said. 

However, cases are rising fast elsewhere in the US – and President Trump is facing mounting pressure from healthcare groups to put a national shelter-in-place order. So far, stay at home orders have been up to state governors’ discretion. Yesterday, Texas officials installed COVID-19 Checkpoints at the border with Louisiana. Vehicles are screened at all roadways crossing into Texas including interstates .Commercial motor vehicle traffic will not be obstructed, says Louisiana’s State Police. Louisiana’s case count shot up, almost doubling over the past weekend.

Africa has been doing “well in the outbreak response so far,” said Mike Ryan, WHO Executive Director of the Health Emergencies Programme, at today’s press conference. Even so, the number of cases in the African region have doubled over the past last week, with a total of some 9 200 cases as of Monday. 

There were even more worrisome trends in some countries; the number of infected people in Guinea, Niger and Cameroon doubled over the past 2-3 days, a faster pace of growth than most other countries today. South Sudan also reported cases of COVID-19 for the first time, according to the latest WHO Situation Report.

Still, some African countries still only have imported cases, leaving a window to contain further disease expansion, said Maria Van Kerkhove, WHO’s Technical Lead for the COVID-19 outbreak, at Monday’s press briefing.

Responding to a journalist’s suggestion in a TV interview last week that Africa could be the ideal test ground for a possible COVID-19 vaccine, Dr Tedros said, “Africa can’t and won’t be a testing ground for any vaccine.”

He described the remarks as a “hangover from a colonial mentality.”

“It was a disgrace, appalling, to hear during the 21st Century, to hear from scientists, that kind of remark. We condemn this in the strongest terms possible, and we assure you that this will not happen,” he added.

The offensive remarks were made during a discussion on French TV channel LCI, as Camille Locht, head of research at Inserm Health Research group, talked about a possible vaccine trial in Europe and Australia.

Jean-Paul Mira, head of intensive care at Cochin hospital in Paris, then said: “If I can be provocative, shouldn’t we be doing this study in Africa, where there are no masks, no treatments, no resuscitation?

“A bit like it is done elsewhere for some studies on AIDS. In prostitutes, we try things because we know that they are highly exposed and that they do not protect themselves.”

Mr Locht nodded in agreement at this suggestion, and said: “You are right. We are in the process of thinking about a study in parallel in Africa.”

Cochin later apologized for the remark.

There is still a window of time in Africa, as some countries only have imported cases, rather than local transmission.
Spain & Italy Stabilizing – UK Public Warned to Prepare for Worst

In the United Kingdom, the public was warned to prepare for the worst as cases were still rapidly increasing, and Prime Minister Boris Johnson was moved to the intensive care unit  Monday night, following ten days of COVID-19 self-quarantine and a deterioration in his health status. Concurrently,  Queen Elizabeth II addressed the nation in a rare, and well-received speech on Sunday.

Spain’s cases and deaths continue to fall for the fourth day in a row, as the Spanish government continued to bolster its efforts on testing, including with the rollout of new rapid tests.

“Throughout the day, the first part of a million rapid tests will be received by the Autonomous Communities,” said Spanish Health Minister Salvador Illa. In an effort to counter the economic effects of the Covid-19, the Spanish government also announced plans to guarantee a universal basic income to all citizens.  

Italy’s infections rates also seemed to be finally declining, after the numbers first began to plateau over the past week. With the flattening of Italy’s curve following a month of lockdown, the Italian authorities were debating if and how to let some members of the workforce return to work, focusing first on people who could be tested and found to have antibodies against COVID-19.

Lately, Belarus has witnessed the most rapid growth of coronavirus in Europe, with cases having doubled in only three days. There is no need to stop normal daily life, said the Belarusian President Alexander Lukashenko president in an interview with The Times, who even recommended a glass of vodka for lunch to citizens. The Eastern European country has not imposed a lockdown and has not closed its borders. Belarus currently has some 560 cases.

Today, Japan announced a national state of emergency after the country experienced the  highest daily jump in cases on Sunday, with numbers soaring to 1000 cases. Many of Tokyo’s cases are untraceable, said Governor Yuriko Koike said in a livecast YouTube video on yesterday, according to a report from Reuters. 

Total cases of COVID-19 as of 6:55 PM CET, with active case distribution globally. Numbers change rapidly.

Image Credits: HP-Watch/G Ren, Africa CDC.

The European Medicines Agency on Friday issued new guidance supporting the use of Gilead Sciences’ antiviral remdesivir as a COVID-19 treatment under compassionate use programmes.

The new EMA guidelines on remdesivir recommend its compassionate use  in adult COVID-19 patients experiencing severe disease requiring invasive mechanical ventilation.

Such compassionate use programmes are set up by individual country governments to allow patients suffering from life-threatening diseases access to experimental treatments that have not yet received full marketing approval. However, the EMA  issued specific guidance for remdesivir after Estonia, Greece, the Netherlands, and Romania requested an opinion from the agency’s Committee for Medicinal Products for Human Use (CHMP) on compassionate use protocols.

While large, randomized clinical trials remain the “gold standard” for assessing the safety and efficacy of investigational treatments, the EMA acknowledged the need for a ” harmonised approach to compassionate use in the EU to allow access to remdesivir for patients who are not eligible for inclusion in clinical trials,” said Harald Enzmann, chair of the CHMP in a press release.

The CHMP further encouraged Gilead to make remdesivir available in a “fair and transparent” way to all EMA Member States that wished to take part in clinical trials or use the drug under compassionate use.

The EMA move came as controversy continued to swirl around Gilead’s rights to remdesivir in light of growing demand for the investigational treatment. Medicines access advocates have argued that exclusive patent rights on COVID-19 technologies could result in shortages of essential new treatments or vaccines in an accelerating global crisis.

The company just opened an “expanded access” program after temporarily suspending its own “compassionate use” program due to an overwhelming flood of requests from COVID-19 patients unable to enroll in clinical trials.

Under the expanded access program, hospitals and physicians can apply for emergency use of remdesivir for multiple severely ill patients at the same time. Gilead’s own “compassionate use” program will continue, but enroll only pregnant women and children, Gilead CEO Daniel O’Day wrote in a statement.

Medicines Patent Pool Expands Mandate to Support Establishment Of IP “Pool” for COVID-19 Technologies

Meanwhile, the respected Medicines Patent Pool (MPP) threw its support behind a global initiative to create a World Health Organization-led “pool” of intellectual property rights for COVID-19 technologies, saying that it could help facilitate efforts to make key COVID-19 technologies more widely available to countries as they come to market. 

The UN-backed Medicines Patent Pool (MPP) works as an intermediary between pharma companies and global health agencies such as WHO and UNAIDS, to increase access to treatments for HIV/AIDs, hepatitis C, and tuberculosis. MPP negotiates with patent holders for voluntarily licenses of their products to MPP, which then “pools” the intellectual property rights so that generic manufacturers can enter the market. 

While primarily focused on medicines access, the MPP Governance Board temporarily expanded its mandate on Friday to include all potential COVID-19 health technologies, which could potentially include diagnostics and vaccines. With support from Unitaid, MPP’s founding organization, this allows the organisation to contribute IP and licensing expertise on any relevant COVID-19 products to the World Health Organization.

Unitaid’s Board issued an open letter last week supporting Costa’s Rica’s call for the WHO to create a pool of patents for COVID-19 related technologies.

“In these difficult times, the MPP Board recognises the important role that MPP can play to increase access to life-saving products for those who need them most. And importantly, with time of the essence, to ensure that we make use of the expertise and mechanisms that already exist,” said Marie-Paule Kieny, chair of the MPP Board, in a press release.

“The Medicines Patent Pool, set up and funded by Unitaid a decade ago, has a proven track record and is immediately available to the WHO to begin this urgent work,” said Marisol Touraine, chair of the Unitaid Executive Board, reiterating Unitaid’s support for a global “pool” of intellectual property rights.

The organisation aims to follow the lead of WHO, which is currently exploring with other stakeholders the implications of a global “pool” of intellectual property rights, a spokesperson for MPP told Health Policy Watch.

140 Organizations, Researchers, & Educators Call On WIPO To Ensure Intellectual Property Frameworks Support COVID-19 Response

In a parallel move, some 140 organizations, researchers, educators, and students called on the World Intellectual Property Organization to provide clear guidance to governments on using intellectual property laws to support the COVID-19 response.

The COVID-19 pandemic has shone a bright light on how important intellectual property limitations and exceptions can be to development and human flourishing,” the organizations stated in an open letter to WIPO Director General Francis Gurry. For example, data sharing has facilitated cross-border collaboration on COVID-19 research. Schools, universities, libraries, museums, and other research institutions are transferring materials online in the wake of widespread closures. However, remote access to such materials is only available where copyright laws permit. 

WIPO, as the leading agency on global intellectual property, should step in and issue guidance to governments in response to any thorny “intellectual property issues that the coronavirus is raising,” the organizations say.  

The letter suggests WHO take four steps:

  1. Encourage WIPO member states to take advantage of intellectual property flexibilities to increase access to protected works for online learning and research;
  2. Request right holders to remove licensing restrictions that inhibit remote learning, research, and access to culture to both help address the global pandemic and minimise disruption caused by it;
  3. Support the call by Costa Rica for the World Health Organization to pool intellectual property rights for all COVID-19 related technologies and promote use of the Medicines Patent Pool;
  4. Support countries’ rights to enact and use exceptions to trade secret and IP rights to facilitate access to data and technologies needed to increase equitable access to COVID-19 technologies.

Image Credits: Medicines Patent Pool.

As the global count of COVID-19 cases hit the sobering 1 million mark Thursday midnight, countries should not have to face the choice of protecting lives or protecting livelihoods, World Health Organization Director-General Dr Tedros Adhanom Ghebreyesus and International Monetary Fund Managing Director Kristalina Georgieva said at a Friday press briefing.

More than half of the new cases reported worldwide were still in WHO’s Europe Region, but an explosion of cases in low- and middle-income countries points to a looming health and economic crises in some of the world’s weakest health systems.

“We know that this is much more than a health crisis. We are all aware of the profound social and economic consequences of the pandemic,” said Dr Tedros. “The restrictions many countries have put in place to protect health are taking a heavy toll on the income of individuals and families, the economies of communities and nations”.

Countries around the globe have enacted widespread lockdowns in an effort to slow the spread of the virus, forcing businesses and employers to close or scale back operations. Millions of workers, particularly day wage workers, have lost their jobs overnight.

“This is a crisis like no other, never in the history of the IMF we have witnessed the world economy coming to a standstill,” said Georgieva. “We are now in recession, it is way worse than the global financial crisis.” 

Of particular concern are “emerging markets” in developing countries, said IMF’s Georgieva, which are hardest hit and have less resources to protect themselves from both the virus and the global recession. Since the beginning of the pandemic, nearly US $90 billion in capital has left such emerging economies.

“Many countries are facing this dilemma of do they provide support to people to survive, or fight the virus,”  said Georgieva. “We want to fight this false dilemma.”

“The issue of debt in developing countries must be addressed urgently,” she added. The IMF is providing debt relief for its poorest countries through a catastrophic containment relief trust support. Along with the World Bank, the IMF is also calling on bilateral creditors to place a moratorium on official debt payments to provide space for countries to address immediate priorities.

Georgieva’s message on debt echoed the moratorium on debt for developing countries put forward by the United Nations Conference on Trade and Development (UNCTD) in Monday’s $2.5 trillion coronavirus crisis package for developing countries.

So far, more than 90 countries have applied for emergency financing from the IMF. Rwanda’s request was granted today – and two other African countries requests will likely be approved today, said Georgieva. The IMF aims to double the normal amount of emergency financing offered to countries.

On where the funds should be directed in the short term response, Dr Tedros said that governments should be strengthening the foundations of the health system, paying their healthcare workers and removing financial barriers to care, and setting up social welfare support for the most vulnerable.

The WHO also voiced their concern today about lifting restrictions too quickly, and the importance of developing effective transition strategies as outbreaks in countries begin to dampen. “If countries rush to lift restrictions quickly, the coronavirus could resurge, and the economic impact could be more severe and prolonged”, said Dr. Tedros.

“We don’t want to have cycles of lockdown and release. This is not what anybody needs right now. The way to avoid that is a transition strategy to get ahead of the virus . Like this, we can protect our economies”, said Mike Ryan, Executive Director of the WHO’s Health Emergencies Programme.

COVID-19 Surge Past 1,000,000 Cases Worldwide

COVID-19 infections hit the one million mark on Thursday evening, according to latest reports by Worldometer, an independent digital team tracking case counts by official national and global sources.

COVID-19 hits the one million mark today.

More than half of the new cases worldwide over the past 24 hours were still being recorded in WHO’s European region. New cases in Europe totaled 38 809, with Spain, Germany, France, Italy and the UK accounting for almost three quarters of new cases.

As France approached the tipping point in demand for intensive care units, a National Ethics Consultation Committee had established “ethical support units” to “help doctors make difficult choices about which patients with “COVID-19 to treat in intensive care”. A summary of the new guidance was also published in English by the British Medical Journal

In the Americas, meanwhile, there were 28 161 new cases over the 24-hour period between 1 April -2 April, largely in the United States. As the USA’s numbers continue to increase to almost 245,573 confirmed cases, the Governor of Florida finally bent to national directives and issued stay-at-home orders for state residents yesterday. Overall, almost 90% (290 million people) of the USA’s population scattered across 37 states have received orders to remain at home. 

Indian Authorities Call For Provision of Food, Medical Facilities & Clean Drinking Water to Internal Migrants

Trends in India as of 13:04 CET. Confirmed cases increase exponentially. Logarithmic curve shown.

As India witnessed a massive internal migration of laborers from cities to their rural homes in response to a nation-wide lockdown, India’s Chief Secretary of State, Preeti Sudan, issued an order on behalf of the Ministry of Health and Family Welfare, calling on State Governments to provide adequate medical facilities, food, clean drinking water and sanitation for people on the move. 

The “anxiety and fear of the migrants should be understood by the police and other authorities and they should deal with the migrants in a humane manner,” stated the order, based on directives issued by India’s Supreme Court.  She called on “all concerned to appreciate the trepidation of the poor men, women and children and treat them with kindness.”  

The migration was occurring as South East Asia experienced a 7-fold increase in new cases in just 24 hours (31 March1 April). Just three of South-East Asia’s 11 countries, including India (2640), Indonesia (1986) and Thailand (1978) account for about 96% of the cases reported in the region so far. 

Prime Minister Narendra Modi had earlier announced $US 24 billion package to support India’s vulnerable populations during the COVID-19 crisis; the PM-CARES Fund is supposed to include free food rations for 800 million disadvantaged people, cash transfers for 204 million poor women, and free cooking gas for 80 million households. 

The fund is being financed by various contributions from other government branches, such as the military and the railways authority, as well as by contributions from government employees and celebrities. 

Africa’s cases have also increased exponentially in the past week, according to a weekly bulletin the WHO African Regional Office. In comparison to two weeks ago, new cases have almost doubled in the past week (185%), with three more countries reporting COVID-19 (Botswana, Burundi, and Sierra Leone). Currently, most member states in the WHO Africa region (42/45) have confirmed cases of COVID-19. The African region has exceeded 7000 cases today, says Africa’s Centre for Disease Control.

Total cases of COVID-19 exceed 1 million as of 7:01:32 PM CET, with active case distribution globally. Numbers change rapidly.

New Guidance Issued For Preventing COVID-19 In Refugee And Migrant Camps 

A new strategy called “shielding”, that aims to limit transmission of COVID-19 in migrant and refugee camps, has been proposed by the London School of Tropical Hygiene and Medicine’s Health in Humanitarian Crises Centre

The strategy recommends that people at high-risk from COVID-19 be identified and separated from other camp members in so-called ‘green-zones’ for an extended period of time, so as to reduce their risks of serious illness and possible death. The zones, ideally, would be located as close as possible to primary health care and other essential services, to minimize their need for movement. 

The guidance notes that the kinds of ‘stay-at-home’ orders and self-isolation tactics that have been widely adopted in developed countries are unworkable in migrant camps and camp-like settings. And at the same time, overcrowding, poor access to safe water, sanitation and limited access to health services could also lead to very high rates of infection among camp residents.

In the guidance, high-risk individuals are defined as those over the age of 60, as well as individuals that have low immunity due to genetic conditions or chronic diseases (e.g. HIV) or non-communicable diseases (NCDs) such as high blood pressure, lung diseases or cancers. 

“Green Zones” can be established at the household level, as well as at the neighborhood level, or as part of a broader community approach.

“Green Zones” can in fact be established at the household level, for older or weaker family members, as well as at the neighborhood level, or as part of a broader community approach – depending on the characteristics of the migrant camp or settlement, the document suggests.  

The guidance document suggests that “social care committees” can coordinate the shielding response and facilitate acceptance of and adherence to the shielding measures.

Grace Ren, Tsering Llamo, and Zixuan Yang contributed to this story

Image Credits: London School of Hygiene and Tropical Medicine , COVID-19 India , London School of Hygiene and Tropical Medicine.

Iceberg melting in Iceland

The critical UN Climate Conference of Parties (COP26) that was scheduled to take place in Glasgow, in November, has been postponed until 2021 as a result of the COVID-19 emergency.

“The COP26 UN climate change conference set to take place in Glasgow in November has been postponed due to COVID-19,” stated an official message by the UN Framework Convention on Climate Change to UN member states and observers.

“This decision has been taken by the COP Bureau of the UNFCCC, with the UK and its Italian partners.  Dates for a rescheduled conference in 2021, hosted in Glasgow by the UK in partnership with Italy, will be set out in due course following further discussion with parties. In light of the ongoing, worldwide effects of COVID-19, holding an ambitious, inclusive COP26 in November 2020 is no longer possible. Rescheduling will ensure all parties can focus on the issues to be discussed at this vital conference and allow more time for the necessary preparations to take place. We will continue to work with all involved to increase climate ambition, build resilience and lower emissions.”

Patricia Espinosa,  UNFCC Executive Secretary said that the decision had been reached after receiving “a detailed assessment from the representative of the United Kingdom of Great Britain and Northern Ireland, the host of COP 26.

Patricia Espinoza, Executive Secretary of UN Climate Change.

“COVID-19 is the most urgent threat facing humanity today, but we cannot forget that climate change is the biggest threat facing humanity over the long term”. Espinoza added. However, she named no future date for the meeting, saying only: “The Government of the United Kingdom will initiate consultations with Parties and stakeholders to identify a suitable new date for the Conference which will be presented to the Bureau for its endorsement,” said the official message to UN member states and observer organizations.

The COP26 meeting has been viewed as particularly critical both in light of the speed at which climate change is occuring, and the huge gap in mitigation commitments to slow its current pace. As the five year mark since the 2015 Paris Climate Agreement, countries were due to submit new, more ambitious long-term goals to reduce emissions at COP26. 

Despite the delay, the head of the European Green Deal initiative of the European Commission, pledged to continue efforts towards dramatic reductions in carbon emissions by 2030. “We will not slow down our work domestically or internationally to prepare for an ambitious COP26, when it takes place”, said Frans Timmermans, executive vice-president for the European Green Deal in a statement.

The European Commission’s plans are “on track” to present by September 2020 a detailed plan to cut greenhouse gas emissions by 50-55% compared to 1990 levels, in line with EU’s 2030 ambitions, he added. 

“At home, we have put in place the key EU laws to meet our existing 2030 climate and energy targets. In the long-term, we have committed to climate neutrality by 2050 and proposed a climate law that will make this objective legally binding. The legislative work on this proposal has started, even in these challenging circumstances.

“An impact assessed plan to raise the EU’s 2030 ambitions and cut greenhouse gas emissions by 50-55% compared to 1990 levels is on track, and the Commission will stick to that. The same goes for the work necessary to submit an enhanced Nationally Determined Contribution to the UNFCCC in line with our commitment under the Paris Agreement,” he said.

Countries are “not off the hook and will be held accountable” to display greater climate ambition when the COP26 finally does convene, said Tassnem Essop, Executive Director of Climate Action Network International, a worldwide network of some 1300 NGOs in over 120 countries. “The postponement of the COP does not mean a postponement in climate ambition”, he said.  

Experts Debate Long-Term Impacts of Pandemic on Political Will For Climate Action 

Rooftop assembly of solar panels in New York City has given way to makeshift construction of COVID-19 hospital tents.

Some observers of the COVID-19 emergency, including billionaire philanthropist Bill Gates, have recently asserted that the crisis can be a catalyst for more coherent action on other global challenges because it is facilitating innovation, and more direct, daily collaboration amongst scientists and between scientists and policymakers.

“Until we get out of this crisis, COVID will dominate, and so some of the climate stuff, although it will still go on, it won’t get that same focus,” Gates said in a recent Ted Talk, but he added that, “As we get past this, yes, that idea of innovation and science and the world working together, that is totally common between these two problems. And so I don’t think this has to be a huge setback for climate.” 

Observed Espinosa in her statement on the COP-26 postponement. “This is an opportunity for nations to green their recovery packages, an opportunity to include the most vulnerable in those plans, and an opportunity to shape the 21st century economy in ways that are clean, green, health, just, safe and more resilient. In the meantime, we continue to urge nations to significantly boost climate ambition in line with the Paris Agreement.” 

Leading scientists and environmentalist have also pointed out that the illegal hunting and consumption of endangered wild animal species, such as the pangolin, were in fact drivers that contributed to the leap of the coronavirus from bats to other animals in China’s wild animal markets, and then to humans.

Logically then, ecosystem stability should be considered more seriously by policymakers in the wake of COVID-19. “Nature is sending us a message,” Inger Andersen, head of the United Nations Environment Programme said in a recent interview, noting that some  75% of new infectious diseases originate from animals.  Longstanding environmental campaigns to halt illegal wildlife trade and the destruction of habitats are all the more improtant now, so as to prevent future outbreaks like Covid-19. 

Still, the pandemic is also a bitter reminder of the barriers to coherent global action, as well as the fact that the public as well as most politicians tend to avoid dealing with long-term and unseen environmental health threats – at least until the moment when people are literally, dropping dead in hospital corridors.

Writing in Foreign Policy,  one senior official to former US President Barack Obama said that the extreme measures governments are taking on COVIVD-19 may have given hope to “climate activists that similarly ambitious policies might be possible to address global warming, which many consider a similar existential threat.

“Yet that would be the wrong lesson to draw, as the very same barriers preventing an effective COVID-19 response continue to keep climate change action out of reach,” “said Jason Bordoff, a former U.S. National Security Council senior director in the Obama White House.

“Cities across the world are shutting down businesses and events, at great cost. Yet the effectiveness of any one government’s action is limited if there are weak links in the global effort to curb the pandemic—such as from states with conflict or poor governance—even if the world is in agreement that eradicating a pandemic is in every country’s best interest,” he said.

“Climate change is even harder to solve because it results from the sum of all greenhouse gas emissions and thus requires aggregate effort, a problem particularly vulnerable to free-riding,” added Bordoff, now a professor and founding director of the Center on Global Energy Policy at Columbia University’s School of International and Public Affairs.

“The pandemic is a reminder of just how wicked a problem climate change is because it requires collective action, public understanding and buy-in, and decarbonizing the energy mix while supporting economic growth and energy use around the world,” said Bordoff.

Cleaner Skies Now – Dirtier Ones Later

Of course, COVID-19 may deliver some short-term climate benefits by “curbing energy use, or even longer-term benefits if economic stimulus is linked to climate goals — or if people get used to telecommuting and thus use less oil in the future,” Bordoff acknowleged.  “Yet any climate benefits from the COVID-19 crisis are likely to be fleeting and negligible.”

Historically, building political will around environmental goals is usually more difficult during periods of economic downturn, he added.  “Historically, there is an inverse relationship in the United States and Europe between public concern about the environment and worries about economic conditions. Similarly, concern about economic growth has often caused China to ratchet back its environmental ambitions.  Just last week, China was reportedly considering relaxing emissions standards to help struggling automakers,” he noted.

A similar pattern is also emerging, in the United States.

On Monday, the US Environmental Protection Agency announced that it would relax vehicle fuel economy standards for vehicles for model year 2021, as well as for model years 2022-2026, which had been approved under the Obama administration. The rules, which would lead to the release of 900 million more tons of CO2  every year, are being opposed by the State of Califorinia, but the Trump administration is also trying to strip states of the authority to enact stricter vehicle emissions rules.

And last Thursday, the US Environmental Protection said that it would suspend enforcement of a wide range of environmental regulations regarding, air, water, wastewater and even hazardous waste emissions – until the COVID-19 crisis is over, noting that companies violating emissions rules might be excused from their violations if they were somehow associated to COVID-19.

“During this extraordinary time, EPA believes that it is more important for facilities to ensure that their pollution control equipment remains up and running and the facilities are operating safely, than to carry out routine sampling and reporting” said EPA Administrator Andrew Wheeler in a statement.

“The Trump administration is cynically abusing this crisis to achieve its pre-COVID-19 goal of gutting US environmental regulations. The decision to indefinitely suspend the protections afforded by environmental laws will kill or compromise the health of large numbers of people”, warned Richard Pearshouse, Amnesty International’s head of Crisis and Environment, in a statement

-Tsering Llhamo and Zixuan Yang contributed to this story. 

 

Image Credits: Andrew Bowden, Patricia Espinosa C., Renovus Solar.