The six dogs being trained in the UK to detect COVID-19

Dogs could be trained to discern COVID-19 in humans, reported researchers from The London School of Hygiene and Tropical Medicine (LSHTM), Medical Detection Dogs and Durham University in a podcast last Wednesday. The study has received £500,000 from the UK government and hopes to be able to train dogs for rapid virus detection in airports and other ports of entry. 

The work builds on previous malaria research, which successfully trained dogs to detect malaria in people based on its characteristic odour.

Over 10 years ago, anecdotal evidence suggested that dogs could detect cancer in urine samples, leading to formal studies that confirmed the theory. Ever since, dogs have been used to detect a wide range of conditions – including bladder cancer, but also rapid changes in blood sugar levels in advanced diabetics.

Dogs are an ideal candidate to detect subtle smells because their sense of smell is highly developed. They have over 350 million olfactory receptors, allowing them to sniff out a teaspoon of sugar in the volume of water held in two Olympic-sized swimming pools, said researchers at the podcast. Another advantage of using dogs is that they are used to working alongside humans and are ‘highly trainable’- their use is already widespread in security programs and agriculture, among other uses.

Dogs could also screen up to 250 people an hour, said researchers. But if dogs were used in the future to detect COVID-19, they would not replace swab tests or antibody tests; rather, they would augment the testing capacity in specific locations. The team is looking to scale up the venture and apply it to other countries, if it proves to be successful. 

The study on malaria detection — which used foot odours from socks worn by Gambian children, that dogs could detect at a high accuracy — provides a template for the COVID-19 study and could help “prevent a second wave by identifying people from high-risk countries at ports of entry”. 

In the case of COVID-19, dogs will be given samples from face masks or the feet of people with COVID-19, as well as placebos, and researchers will evaluate whether the dogs can recognise COVID-19 odours, which they will communicate to researchers through physical gestures. The samples collected will also be analysed in laboratories to identify whether there are volatile biomarkers associated with COVID-19 infection. 

If there are odours associated with COVID-19, dogs could take about eight weeks to train, before practicing in more realistic scenarios.

Currently, six dogs (cocker spaniels, retrievers and mixes) are being trained to identify the odours of COVID-19. These dogs are experienced bio-detection dogs as well as assistance dogs that monitor the health of people with life-threatening diseases. 

 

Image Credits: MDD/BexArts/Nigel Harper.

Antimicrobials are becoming less effective at treating infections

As the COVID-19 pandemic spawns increased antibiotic use all over the world, more drug-resistant microbes are bound to bite us back , said Dr. Tedros at a WHO press conference on Monday. The repercussions on disease treatment and deaths will be severe, given that the world is running out of effective ways to treat antimicrobial resistance (AMR).

“COVID-19 has led to an increased use of antibiotics, which ultimately will lead to higher bacterial resistance rates that will impact the burden of disease and deaths during the pandemic and beyond,” Dr Tedros said.  He was referring to the fact that patients seriously ill with the SARS-COV-2 virus are often receiving antibiotics to prevent secondary bacterial lung and other infections.

“As we gather more evidence, it’s clear that the world is losing its ability to use critically important antimicrobial medicines, all over the world…In some countries, there is an overuse of antibiotics and antimicrobial agents in both humans and animals,” Dr Tedros said.

That is the picture painted by the latest data updates of WHO’s Global Antimicrobial Resistance (AMR) and Use Surveillance System (GLASS).  The trends reflect ‘”disturbing” rates of increases in antimicrobial resistance, WHO says. On the positive side, participation in the surveillance has grown exponentially since the system was created in 2018.

Microbe Resistance to Some Common Drugs – Running as High as 93%

Among the worrisome indicators, the rate of resistance to ciprofloxacin, an antibiotic commonly used to treat urinary tract infections, varied from 8.4% to 92.9% in 33 reporting countries, the WHO data found.

The WHO data comes a year after the major UN interagency report “No Time to Wait” predicted that mortality from drug resistant infections could increase more than ten-fold, causing up to 10 million deaths a year by 2050, in business-as-usual scenarios.

And as antimicrobial resistance increases, the R&D pipeline to bring effective antimicrobials to the market is drying up.

“There has been very little market incentive to develop new antibiotics and antimicrobial agents, which has led to multiple market failures of very promising tools in the past few years,” Dr Tedros also said.  

Antibiotics are ubiquitous in modern medicine – They are used in most surgical procedures like joint replacement, but also in patients with conditions like cancer, cystic fibrosis or diabetes. When antimicrobials like antibiotics are used excessively, microorganisms can mutate to become drug-resistant.

R&D for antibiotics has declined for over three decades
Record Number Of Countries Are Participating In WHO’s Surveillance System For AMR

Despite the looming threat of antimicrobial resistance, a record number of countries are now monitoring and reporting antibiotic resistance through WHO’s GLASS system – marking a major step forward in the global fight against drug resistance. 

“This step is extremely important so we can look into the magnitude of the problem within different countries. And we hope that more will engage,” said WHO’s Assistant Director-General for Antimicrobial Resistance Hanan Balkhy, at Monday’s press conference.

Since 2018, GLASS has grown ‘exponentially’, she said, with over 64,000 surveillance sites, across 66 countries, as compared to only 729 sites across 22 countries when the system was founded. That led to some two million patient reports in 2020. 

AMR Is A Global Health Priority That Disproportionately Affects Low And Middle Income Countries 
Distribution of antimicrobial resistance around the world

Many low and middle-income countries already have high AMR rates – And AMR was projected to grow faster in these contexts than in high-income countries, according to a 2018 report by the Organisation for Economic Co-operation and Development (OECD).

In Brazil, Indonesia and the Russian Federation, for example, about half of infections are caused by drug resistant microorganisms – and resistance in these countries is predicted to rise 4–7 times faster than in other OECD countries.

With increasing globalization, tackling AMR is a “global health priority” because microorganisms know no borders, said Assistant Professor at Warwick University Marco Haenssgen, at a webinar on Tuesday hosted by the London School of Tropical Hygiene and Medicine.

In the late 1950’s and early 1960’s, South East Asia was one of the first regions to report about the development of drug-resistant strains of malaria (plasmodium) parasites. Since then, drug-resistant malaria has even spread to high-income countries like the UK, said Haessgen. 

Rationalizing Antibiotics Use in Humans and Animals Requires ‘Multi-Sectoral’ and ‘Customized’ Solutions
WHO Assistant Director-General Hanan Balkhy

Resolving AMR is ‘very complex’, said Balkhy, as it is ‘extremely difficult to identify’. Another issue is that the drivers of resistance are “very different” in each country.

In some contexts, AMR may be caused by over-prescription of antibiotics in human patients. In OECD countries, about half of antibiotics were inappropriately prescribed by general practitioners, which either prescribed the wrong antibiotic, or prescribed unecessarily. reported a 2018 OECD study. The same OECD study projected that AMR could cost up to $3.5 billion per year. 

In other settings and countries, AMR may be largely due to excessive use of antibiotics in agriculture. Antibiotic consumption in livestock was projected to increase by almost 70% in the most populated countries of the world by 2030, according to a 2014 study published in the Proceedings of the National Academy of Sciences. And livestock consumption of antimicrobials will be 99% higher in Brazil, Russia, India, China, and South Africa (BRICS) compared to other countries, the study estimated. 

Whether antimicrobials are used in livestock or humans, they are not a panacea for ‘good hygiene’, said Balkhy. “It is important that we do not replace good hygiene in either context by the excessive use of antimicrobials.”

WHO’s Interim Guidance on mitigating antimicrobial resistance during COVID-19

Given the complexity of the problem, the WHO has “taken a big step” to address AMR in a “customized, multi-sectoral fashion” by working directly with countries and regularly updating technical advice.

In the WHO’s latest interim guidance for clinical management of COVID-19 from late last month, it has outlined how antibiotic therapy can be used to treat patients in a way that mitigates antimicrobial resistance.

But to accelerate the development of viable candidates, new R&D models and public-private partnerships will be needed to incentivize “sustainable innovation” of newer, and more effective antimicrobials, said Dr. Tedros.

“We must bolster global cooperation and partnerships including between the public and private sectors to provide financial and non-financial incentives for the development of new and innovative antimicrobials”, added Balkhy.

Image Credits: WHO / Sergey Volkov, OECD, WHO, FAO and OIE, PNAS, WHO.

Dr Tedros speaking at a WHO COVID-19 press briefing.

China stalled for ‘at least’ two weeks in providing the World Health Organization with detailed data on COVID-19 cases, frustrating WHO’s top echelons –  even as they tried to put on a positive public face, according to an investigative report by the Associated Press of exchanges that occured in January.

China also withheld the genome sequence of the COVID-19 virus for over a week, releasing it only on  11 January – though three separate government labs in China had already sequenced the SARS-CoV-2 virus as of 3 January, states the AP report. . 

As the World Health Organization publicly praised Beijing for ‘immediately’ sharing the genetic sequence of the SARS-CoV-2 virus in January, internal WHO meetings record the “considerable frustration” of  WHO officials with the “significant delays” in China’s timely release of the gene sequence and other critical information,  according to the AP report, which it said was based on dozens of confidential interviews as well as written and audio recordings of internal WHO conversations in early January. 

“We have informally and formally been requesting more epidemiological information,” WHO’s top China official, Gauden Galea, was quoted as saying in one critical meeting. “But when asked for specifics, we could get nothing.

“We’re currently at the stage where yes, they’re giving [the necessary information] to us 15 minutes before it appears on CCTV,” Galea added, referring to the state-owned China Central Television.

Mike Ryan, Executive Director of WHO Health Emergencies Programme

In the second week of January, WHO’s chief of emergencies, Dr. Michael Ryan, reportedly told other WHO colleagues it was time to “shift gears” and apply more pressure on China, saying that he feared China’s lack of transparency would lead to a repeat of circumstances similar to those that fueled the spread of Severe Acute Respiratory Syndrome 2002, which began in China but led to the deaths of nearly 800 people worldwide.

“This is exactly the same scenario, endlessly trying to get updates from China about what was going on,” he is quoted as saying. With reference to SARS, he added:  “WHO barely got out of that one with its neck intact given the issues that arose around transparency in southern China.”

In fact, the WHO management of SARS under former director general Gro Harlem Brundtland, who publicly called out Beijing for its lack of transparency, and then issued an unprecedented  advisory against travel to the country, has been heralded, even by US President Donald Trump, as exemplary.

Wedged between Two Superpowers

The AP report comes as WHO has faced a hail of criticism from the United States, culminating in Friday’s decision by Trump to withdraw the United States membership in the UN agency and terminate its funding.

The AP report provides a fresh narrative of the China-WHO dealings, one which ultimately left the global health organization trapped in a bitter United States-China rivalry – even though its own collaboration with China was laced with internal frustrations, which officials were loathe to express publicly at the risk of information flow further drying up.

Already on 6 January, the WHO had privately complained about being kept in the dark as China gave it insufficient information despite the legal provisions of the International Health Regulations: “We’re going on very minimal information,” said WHO’s technical lead for COVID-19, Maria van Kerkhove, at another internal meeting, cited by AP. “It’s clearly not enough for you to do proper planning.”

China’s Xi Jinping in 18 May address before the World Health Assembly

Given the WHO’s position, public praise  of China was probably the only strategy at its disposal to secure access to crucial epidemiological data, public health experts familiar with the organization noted.    

If the WHO pushed too hard on Beijing, WHO officials might even have been expelled from the country, Adam Kamradt-Scott, global health professor at the University of Sydney told AP. In mid-March, China kicked out American journalists from the New York Times, The Wall Street Journal and The Washington Post – most of whom aggressively reported on the evolving COVID-19 epidemic in its earliest days as the Chinese government tried to play down its severity.

WHO – Lack of Enforcement Power

In Friday’s announcement over the severing of ties, Trump charged that WHO had given into Chinese pressures to coverup its mistakes in the coronavirus response, “China has total control over the World Health Organization.”

But the fundamental weakness by the AP report uncovered is not any active collusion, but rather WHO’s lack of enforcement power in health emergencies. This means that WHO must rely entirely on voluntary cooperation from countries. It does not have the power to compel nations to do what it says, nor to independently investigate outbreaks in countries. 

Even so, WHO Director General Dr Tedros Adhanom Ghebreyesus’ efforts to coax China into cooperation while avoiding any public criticism of Beijing for its handling of the pandemic has come at a high price.

“It’s definitely damaged WHO’s credibility,” said Kamradt-Scott told AP. “Did he go too far? I think the evidence on that is clear….it has led to so many questions about the relationship between China and WHO. It is perhaps a cautionary tale.”

AP notes that WHO officials named in its story declined to answer questions posed about the internal meetings, without direct access to audio or written transcripts of the recorded meetings, “which the AP was unable to supply to protect its sources.”

For more details on the unfolding of COVID-19 in its early stages and the politics of China;s response that cost many lives, see AP’s full report here.

Image Credits: WHO/Pierre Virot, WHO.

Police handcuff and arrest protestors in Brooklyn, New York. Even in peaceful protests, social distancing crumbles.

“I can’t breathe” could have been a slogan for those suffering the worst effects of COVID-19. But now it has become the battle cry of Americans angered over the police killing by strangulation of a Minneapolis man, George Floyd, last week. 

While this is the latest in a years-long series of violent events involving African American men and women who were abruptly shot, choked or otherwise killed by police for either minor offenses or no offense at all, it has heightened significance in the wake of the widespread economic and social disparities created by Covid-19 pandemic.   

What the New York Times called the “parallel plagues” of COVID-19 and police brutality have both taken an outsize toll on American’s minorities—sparking outrage and grief across a nation already polarized by racial, ethnic and economic divisions that have been heightened by Covid-19. 

And indeed, civil violence is also a public health threat, both recognized by the World Health Organization as well as tracked by countless experts.

“The same broad-sweeping structural racism that enables police brutality against black Americans is also responsible for higher mortality among black Americans with Covid-19,” Maimuna Majumder, a Harvard epidemiologist also working on the Covid-19 response, told Vox.

African-American Deaths from COVID-19: 2-3 Times More than Expected
Protesters with hands up, symbolic of the Black Lives Matter movement, at a peaceful Minneapolis protest over the death of George Floyd

For Americans, Minneapolis has long had a reputation as a progressive and tolerant city and state, graced with higher than average incomes and educational levels and a strong social welfare net, compared to many other parts of the US. However, the protests that began in Minneapolis quickly spread over the weekend to some 140 other urban centers, which face even sharper racial and economic divides. The circle of violence quickly choked Washington DC, Los Angeles, Atlanta, and New York City – where poor and working class minority communities often live in close proximity to the national power centers of government, business and culture.

The brutal scenes of police pushback against the protestors captured on Twitter and Instagram, fueled a feedback loop of yet more outrage and waves of demonstrations. 

https://twitter.com/i/status/1267306908983218176

“Last night was an ugly night in the state and the country,” remarked New York Governor Andrew Cuomo in a press conference on Sunday.

A national analysis of data from the COVID Racial Tracker, finds that African-American deaths from COVID-19 are nearly two times greater than would be expected based on their share of the population, National Public Radio reported. In four states, the rate is three or more times greater.  In some 42 states plus Washington D.C., Hispanics/Latinos also make up a greater share of confirmed cases than their share of the population. White deaths from COVID-19 are lower than their share of the population in 37 states and the District of Columbia, the analysis also found.  

Other studies have found that low socio-economic status is closely associated with crowded living conditions and a higher rate of other chronic health conditions, all of which raise the risks of serious illness from COVID-19.

African-Americans make up 35 percent of coronavirus cases in Minneapolis, though they are less than 20 percent of the city’s population.” “By one estimate, black people accounted for at least 29 percent of known Covid-19 cases in Minnesota, despite making up about 6 percent of the state’s population, reported VOX.”

Critics have also compared the very hard line taken by US President Donald Trump against the current wave of protests to his much softer line vis a vis the gun-bearing demonstrators that marched around business centers and state capitals, such as Lansing Michigan, only a few weeks ago, demanding that COVID-19 lockdown measures be ended.

Tweet compares President Trump’s reaction to protests against lockdown in early May and police brutality last week.

The United States is not the only COVID-19 epicentre now facing major social upheaval. In Sao Paolo, Brazilians were met by a hail of police rubber bullet fire when they came out into the streets to protest President Jair Bolsonaro’s laissez faire handling of the crisis over the weekend.

Meanwhile, in Brazilia, Bolsonaro joined protestors in Brasilia demanding the total reopening of the country, as well as the shutdown of Congress and the Supreme Court – which is set to hear an investigation over the president’s allegedly illegal interference with Federal Police. The protests rocked major cities as the country marked 500,000 COVID-19 infections, with the fourth highest number of deaths worldwide – outpaced only by the US, the United Kingdom and Italy.  

In a parallel development, the US sent two million doses of hydroxychloroquine to Brazil, reported the White House on Sunday. The anti-malarial drug will be used to treat Brazilians infected with COVID-19, the White House said. This was despite the fact that a growing body of evidence indicates that hydroxychloroquine can increase mortality and lead to heart complications in people with Covid-19.

United States Continues Business Reopenings

While some US cities were put under tough curfews due to the wave of unrest and violence, the reopening of businesses following the COVID-19 lockdown has continued apace. 

In New York, Governor Cuomo announced Sunday that dentists could reopen their offices statewide on Monday. He said that overall cases in the state continued their sharp decline – although there were still 1,110 new infections reported overnight Saturday-Sunday.  New York State has seen a total of some 370,000 virus cases, and more people have died in New York State alone than in any other country, except for Italy and the United Kingdom. 

On the far end of the continent, however, Alaska saw an uptick in cases in the past few days, reporting some 30 new cases  on Sunday, the largest increase seen since April 1-2 when cases peaked at 187. Alaska was one of the first states to open restaurants and rollback business restrictions in mid-April. On May 22, Alaskan Governor Mike said “it will all be open just like it was prior to the virus,” at a press conference.

On Sunday, some 600 Americans died from COVID-19 – in a week that saw mortality nearly double, and then decline again. 

WHO Warns Against Infection Spread From Mass Gatherings  

Protests seen in the US may also increase risks of refueling the US centres of the outbreak, politicians and some public experts have also worried.

Los Angelos Mayor Eric Garcetti warned that the protests could become “super-spreader events” – although other public health experts said that the outdoor settings may mitigate infection spread.

“The outdoor air dilutes the virus and reduces the infectious dose that might be out there, and if there are breezes blowing, that further dilutes the virus in the air,” Dr. William Schaffner, an infectious disease expert at Vanderbilt University, told the New York Times. “There was literally a lot of running around, which means they’re exhaling more profoundly, but also passing each other very quickly.”

However Howard Markel, a medical historian, countred that “Public gatherings are public gatherings — it doesn’t matter what you’re protesting or cheering,” he told The Times. Screaming and shouting slogans during a protest also can accelerate the virus spread, Markel said, while tear gas and pepper spray used to disperse crowds, also cause people to tear up and cough, and further increasing respiratory secretions and the possibility of transmission. Police barricades, arrests and efforts to move in and around crowds also results in more contact in tight spaces.

And while some of the US protestors have been donning masks and attempting to keep a distance, many precautions are thrown to the wind during the kinds of spontaneous protests now being seen in the United States, he added.

The risks of virus spread in uncontrolled mass gatherings were echoed by WHO Director General Dr Tedros Adhanom Ghebreyesus and senior WHO scientists at in a press briefing on Monday.

“Mass gatherings have the potential to act as super spreading events,” Dr Tedros said, even though he made no mention of the wave of US protests.  He announced that WHO was releasing updated guidance to help organizations determine how and when mass gatherings can safely resume.

“The close contact between people can pose a risk,”said WHO’s Technical Lead for COVID-19 Maria van Kerkhove, adding that such events need “rigorous planning” to ensure that physical distancing is not forgotten.

“And we need to ensure that in locations that are considering these…mass gathering events, that you have a system in place to prevent and detect and respond to any such cases.” she added. 

After a tough, public rebuke of protestors that rioted in the city’s streets over the weekend, saying that they had dishonored the memory of the slain George Floyd, Atlanta’s mayor, Keisha Lance Bottoms, had a simple piece of advice. She told them to: “go get a COVID test this week.”

 

Image Credits: G. Ginsberg/HPW, Jenny Salita.

Aerosol transmission of COVID-19 is looking to be more significant, and it is ‘essential’ to introduce widespread mask use to reduce COVID-19 transmission by that route – aerosol chemists and infectious disease researchers wrote in a commentary published in Science. 

The authors refer to a growing body of evidence on aerosols and masks that runs counter to the WHO’s advice – which has not recognized aerosols as a key driver of COVID-19 transmission and has warned against widespread mask use.

The WHO has maintained that contact with people or contaminated surfaces is the main route of transmission, rather than aerosols.

However, a ‘large proportion’ of COVID-19 spread appears to occur through ‘airborne transmission of aerosols’, especially in asymptomatic individuals when they breathe and speak, suggest researchers from the University of California and National Sun Yat-sen University in China and Taiwan. Two of the authors of the commentary, Kimberly A.Prather and Chia C. Wwang, study aerosolization of chemicals – and the third author, Robert T. Schooley, is affiliated with the infectious disease department at the University of California.

In a Wuhan commentary, up to 80% of COVID-19 transmission was asymptomatic, though the US CDC’s estimate is about 35%.

The article also mentions that countries which successfully curbed COVID-19 outbreaks and avoided full-blown lockdowns – Taiwan, China, Singapore, Republic of Korea – largely implemented masks, while hard-hit regions that did less well, like New York, did not use masks.

Aerosol transmission must be recognized as one of the ‘major’ routes of transmission of the virus, urged the commentary:

‘Aerosol transmission of viruses must be acknowledged as a key factor leading to spread of infectious respiratory diseases…Evidence suggests that SARS-CoV-2 is silently spreading in aerosols exhaled by highly contagious individuals with no symptoms.”

When individuals with COVID-19 sneeze or cough, droplets containing the virus are released into the air. These droplets can evaporate into thousands of aerosols that float in the air for almost half a day, potentially infecting other individuals. 

Airborne transmission has been reported in other respiratory viruses like measles, SARS and chickenpox – And recent evidence demonstrates that 1 minute of loud speaking can generate over a thousand infectious virus-containing aerosols. 

Given that people with COVID-19 are highly contagious several days before symptoms occur, these ‘silent shedders’ of the virus may be ‘critical drivers’ of COVID-19 transmission, especially in poorly-ventilated areas like health care settings, airplanes or restaurants, reported the commentary.

Masks provide a ‘critical barrier’ to reduce COVID-19 transmission in exhaled breath, especially in people that are asymptomatic and those with mild symptoms, stated researchers. Masks should we worn even when people are 6 ft apart, especially in crowded areas, they said.

Dr Tedros at a regular press briefing

The commentary comes in contradiction to WHO’s guidance from late March. The WHO has largely refrained from widespread mask use, mainly because of the shortage in supplies that are already-limited in critical populations –  healthcare workers, older people and other vulnerable populations with underlying conditions. 

While the WHO has acknowledged that aerosols can form under certain surgical procedures – like intubation for patients that need a ventilator to breathe –  the Organization has not recognized it as a key route of transmission, citing ‘respiratory droplets’ and ‘contact’ as the ‘main modes of transmission.’

The WHO’s recommendations ‘are based on studies of respiratory droplets carried out in the 1930s,’ when technologies necessary to detect aerosols ‘did not exist’, said researchers.

Homemade masks could be used to protect the general population against COVID-19, while also avoiding mask shortages:

“The aerosol filtering efficiency [of]… homemade masks was recently found to be similar to that of the medical masks that were tested. Thus, the option of universal masking is no longer held back by shortages.”

The commentary could also shed light into why some individuals have severe COVID-19 while others do not. Given that aerosols are below 1 micron in size – as compared to respiratory droplets which range between 0.1-1000 microns – aerosols could reach deeper parts of the lungs, where immune responses are ‘temporarily bypassed.’

Influenza virus is more severe when it is spread in smaller aerosols compared to respiratory droplets, suggested one commentary. 

Image Credits: Flickr/Nicolò Lazzati, V.Altounian / Science.

Donald Trump speaks at a May 29th press briefing

US President Donald Trump announced on Friday he was terminating the US’ relationship with the World Health Organization.

Trump’s declaration came hours after WHO’s celebratory launch of a new ‘Solidarity Call to Action ,’ urging countries to make patents and data for COVID-19 treatments and vaccines freely available as ‘global public goods.’ Some 37 countries have supported the call.

“Because they have failed to make the greatly needed and requested reforms, we will be today terminating our relationship with the WHO and redirecting those funds to other worldwide and deserving urgent global public health needs,” said Trump in a Friday press briefing.

The decision also followed WHO’s release of a “Healthy COVID-19 Recovery Manifesto” on Tuesday, which called on governments to stop subsidizing fossil fuel production, a move that directly counters the US administration’s industry-friendly approach.

Trump’s announcement came at the end of a lengthy tirade against China’s trade and economic policies, geopolitical ambitions, and it’s management of the COVID-19 virus, which ended with the claim that “China has total control over the World Health Organization.”

Trump then went on to say, “We have detailed the reforms they needed to make but they [WHO] have refused to act.” WHO has refuted these claims by laying out the timeline of investigations. Trump also announced he was ending the US’ special trade relationship with Hong Kong over China’s handling of the pandemic.

The President’s move was criticized by European Union leaders and condemned by many health experts in the US and abroad, who say that withdrawal is counterproductive to US objectives.

The European Union said on Saturday that it would continue to back the World Health Organization after President Trump announced on Friday that he was pulling the United States’ support, and the bloc urged him to reconsider his decision.

“The W.H.O. needs to continue being able to lead the international response to pandemics, current and future,” said Ursula von der Leyen, president of the European Commission (EC) along with EC vice president, Josep Borrell, in a joint statement. “Actions that weaken international results must be avoided,” they added. “We urge the U.S. to reconsider its announced decision.”

Jens Spahn, health minister of Germany, said on Twitter that the U.S. decision was “disappointing” – adding reform of shortcomings was a better path forward.

“We’re less likely to get answers on anything, or viral samples for research, if we’re not a WHO Member. He’s planning on ‘redirecting funding’-where? For what? Polio? AIDS? Malaria? TB?” tweeted Chelsea Clinton, daughter of former US president Bill Clinton, and a professor in Health Policy at Columbia University Mailman School of Public Health.

Some have questioned if it’s even legally possible for the US President to withdraw from international treaties affirming the country’s membership in the WHO, others noting that US law requires the country to pay any outstanding dues to the agency before withdrawing.

Tweet by Alexandra Phelan, Health Policy Expert in Infectious Diseases at Georgetown University
 WHO launches “Solidarity Call-to-Action” To Drum Up Support for COVID-19 Technology Access Pool 

The Trump announcement from Washington DC came on the tail end of the celebratory launch of the World Health Organization’s COVID-19 Technology Access Pool (C-TAP), an initiative to make vaccines, tests, treatments and other health technologies needed to fight COVID-19 accessible around the world, that received immediate support from some 37 countries. 

“Global solidarity and collaboration are essential to overcoming COVID-19,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Based on strong science and open collaboration, this information-sharing platform will help provide equitable access to life-saving technologies around the world.” 

The COVID-19 Technology Access Pool was first proposed in March by President Carlos Alvarado of Costa Rica. Alvarado joined WHO Director-General Dr Tedros Adhanom Ghebreyesus, Prime Minister of Barbados Mia Amor Mottley, as well as Aksel Jacobsen, State Secretary Norway’s Ministry of Foreign Affairs, at Friday’s official launch of the initiative.

“Vaccines, tests, diagnostics, treatments and other key tools in the coronavirus response must be made universally available as global public goods,” said Alvarado. “The COVID-19 Technology Access Pool will ensure the latest and best science benefits all of humanity.”

Carlos Alverado Quesada speaks at the COVID-19 Technology Access Pool launch

Heads of States and Ministers of Health from Indonesia, Ecuador, Palau, Barbadoes, the Maldives, and others, also sent video messages. The Netherlands, Chile, Brazil, Belgium, South Africa, Indonesia and Mexico were among other major countries affirming their support. 

But the United States, which has poured billions into COVID-19 vaccine research, was silent about the new WHO initiative. Also absent were the United Kingdom, Switzerland, and other key European Union countries that house many of the world’s pharmaceutical gian, such as France, Germany, and Italy. Leaders of the latter three countries, however, have recently called for any COVID-19 vaccine to be treated as “a global public good.”

China and India have likewise yet to pledge their support. Leaders in the pharma industry, which hold the reins on much of the research and development information key to developing tools for COVID-19, have also been dismissive. 

C-TAP Isn’t Just an IP Pool, but a Knowledge Sharing Initiative

In the “Solidarity Call to Action” WHO and co-sponsoring countries also asked donors, researchers, industry, and civil society to also join and support the initiative.

“The call is far broader than in scope than patents, calling for sharing essentially everything that is necessary for additional companies to also produce those products that are found to be effective against COVID-19,” said a spokesperson from Unitaid, founder of the Medicines’ Patent Pool and one of WHO’s major partners in the initiative.

“In this way, it will be easier to meet the global demand, which is expected to be huge and beyond the manufacturing/supply capacity of any single company,” the spokesperson told Health Policy Watch.

An exciting point is the fact that it promotes an ‘open-science’ approach where information and data can be shared before any successful treatments or vaccines have been found, said Gregg Alton, former chief patent officer at Gilead Sciences.

“I think this is an opportunity to see if this pooling of knowledge, sharing of intellectual property, breaking down these barriers can expedite development and allow these [faster] breakthroughs to come through,” he added.

“The most important ingredient is other knowledge. And when speed is as important as it is in this pandemic, you want that knowledge to be shared very quickly,” said Joseph Stiglitz, an economics expert and Nobel Prize winner at Columbia University.

There are five key elements to C-TAP:

  1. Public disclosure of gene sequences and data; 
  2. Transparency around the publication of all clinical trial results; 
  3. Governments and other funders are encouraged to include clauses in funding agreements with pharmaceutical companies and other innovators about equitable distribution, affordability and the publication of trial data; 
  4. Licensing any potential treatment, diagnostic, vaccine or other health technology to the Medicines Patent Pool – a United Nations-backed public health body that works to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries.
  5. Promotion of open innovation models and technology transfer that increase local manufacturing and supply capacity, including through joining the ‘Open COVID’ Pledge and the Technology Access Partnership (TAP).

C-TAP will serve as a sister initiative to the Access to COVID-19 Tools (ACT) Accelerator, announced by the European Commission and the WHO in late April, which has raised over  €7.4 billion for drug and vaccine development and distribution. 

Political Leaders Proclaim Support
Barbados Prime Minister Mia Amor Mottley speaks at the launch of the COVID-19 Technology Access Pool

Other countries supporting the technology pool at Friday’s launch included: Argentina, Bangladesh, Belgium, Belize, Bhutan, Ecuador, Egypt, Honduras, Lebanon, the Maldives, Mongolia, Mozambique, Oman, Pakistan, Palau, Panama, Peru, Portugal, Dominican Republic, St. Vincent and the Grenadines, Sri Lanka, Sudan, Timor Leste, Uruguay and Zimbabwe.

Small island states are especially vulnerable to getting left behind in the race to procure any effective COVID-19 drugs, diagnostics, or vaccines, said Barbados Prime Minister Mia Amor Mottley, explaining.

“Access to new data and health products to treat and prevent COVID-19 must not create winners and losers, and small states, who are often the casualties of market conditions, cannot be dispensable in the wake of this disease,” said Mottley. “We cannot command large types of orders, in order to be able to guarantee access, because of our lack of size.”

“We therefore encourage all flexibilities in the licensing of these products to quickly scale up global production. And we ask for full cooperation with this technology access partnership, so that the global community can exit this crisis together on fair and equitable terms,” Mottley concluded.

Likewise, Norwegian State Secretary Aksel Jakobsen affirmed that “global challenges need global solutions.”

“I’m convinced that the only way to succeed, is to collaborate and share knowledge and technologies to have the necessary
tools, as soon as possible,” said Jacobsen.

Aksel Jakobsen speaking at the COVID-19 Technology Access Pool launch
Industry Pushes Back Against C-TAP – Intellectual Property Major Sticky Point
Emma Walmsle, CEO of GSK, speaking at a May 28 press briefing

Despite support from some major countries in both north and south, the response from the pharmaceutical industry has been dismissive. A major industry critique is the use of language promoting global licensing, e.g. waivers of intellectual property rights, in the Call to Action to support C-TAP. 

“While we share a number of the objectives of access and cooperation of the “Solidarity Call to Action,” we disagree with some of its premises, as they imply that intellectual property (IP) rights that are not waived or licensed globally are potential barriers to R&D, public-private collaborations or access to COVID-19 products,” said the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in a statement released Thursday. “This does not correspond to our experience, and may be counterproductive.”

“There’s not enormous evidence that IP is a barrier to access,” said GlaxoSmithKline CEO Emma Walmsley, in an IFPMA webinar the day before. Pharma company Pfizer CEO Albert Bourla even called the removal of intellectual properties “dangerous” and “nonsense,” in comments at the same webinar. However, Walmsley and other pharma execs in the same call said that any vaccines they develop would be sold on a not-for-profit basis while the pandemic continues.  

But C-TAP collaborators and one former pharma executive, now leading the UN-hosted Unitaid, expressed hope that the industry tone would change.

“Intellectual property rights are not the problem here, it is the way in which they are used. We expect the pharmaceutical industry to turn IP issues into solutions,” Unitaid acting Executive Director Philippe Duneton told Health Policy Watch.

 “In terms of fair and equal access, I do think it would be fantastic to see the industry come forward and commit to working with the Medicines Patent Pool or other mechanisms to make the intellectual property that comes out…. available to generic manufacturers and to make [vaccines, drugs, and other technologies] available on equitable terms globally,” said Alton, who is the former chief patient officer at Gilead Sciences.

“I’m a big supporter of intellectual property and the role that the industry’s played in bringing medicine forward. I do think to make this happen, we have to expect and respect that companies will have different concerns that they’re going to need addressed, whether it’s around tuning to different [country income levels]… or protection around their commercial interest or indications for use,” Alton added.

Story updated on 31 May, 2020

Story updated on 5 June, 2020 to correct Albert Bourla’s title. 

Image Credits: Salvatore di Nolfi/EPA, Twitter: @alexandraphelan, Twitter: @WHO.

Smoking increases vulnerability to COVID-19

In light of millions of smokers attempting to quit the vice during the COVID-19 pandemic, the industry has employed ‘very mean’, ‘very subtle’ and ‘very targeted’ tactics to hook young populations to “deadly’ tobacco products, according to WHO experts. 

“The tobacco industry understands what they’re doing, they’re targeting these children and adolescents. And that’s deliberate. It’s not a mistake [and] what they do is deadly,” WHO’s Director of the Health Promotion Department Ruediger Krech, said at a webinar on Thursday’s  “World No Tobacco Day” which drew attention to preventing the 8 million premature deaths from tobacco every year.

Krech presented the WHO’s new toolkit to empower young people to make their own decision on tobacco products.

Now, more than ever, there’s a “huge potential” for the tobacco industry to “hook our children to tobacco products” – mainly through advertising, promotion and sponsorship of tobacco products – which has a “direct impact on tobacco consumption,” said Adriana Blanco Marquizo, Head of the WHO’s Framework Convention on Tobacco Control (FCTC) Convention Secretariat, and another panelist at Thursday’s webinar.

Adriana Blanco Marquizo, Head of the WHO’s FCTC Convention Secretariat

“Every day or every week,” new tobacco products and e-cigarette devices are rolled-out by the tobacco industry – with “more and more flavors and more tactics”, said Krech, as he warned that 9 out of 10 of smokers start consuming tobacco products before they are 18 years old.

And as “hundreds of thousands” of smokers from ‘many countries’ have committed to quit smoking since the COVID-19 crisis began, the tobacco industry is scrambling to find new ways of marketing their products, reported Vinayak Prasad, Coordinator of WHO’s No Tobacco Unit. These countries include Mexico, India, China, Timor Leste, Philippines, Kazakhstan, Tajikistan and Kyrgyzstan.

Since the raging pandemic started, the WHO has noticed new tactics – ranging from tobacco manufacturers emblazoning their trademark on “free masks”, to suing countries like South Africa as they halt tobacco sales in the midst of lockdowns. 

As Tobacco Market Grows, ‘We May Lose Ground In Tobacco Control’ As Industry Is Eager To Hook Adolescents

WHO’s Director of the Health Promotion Department Ruediger Krech

We may lose ground in tobacco control as the industry is looking to hook a younger generation to its products, warned Krech – With a ‘huge increase’ in the number of adolescents that are smoking in past years.

And the market for tobacco products is increasing, apart from a handful of countries: the US, UK, France, and China, said Vinay. 

In Switzerland, young people are 11-times more likely to use e-cigarettes than adults – almost 17% of young people use e-cigarettes compared to 1.5% of adults, said Krech. Globally, around 9% of adolescents aged 13-15 use e-cigarettes, according to global data from 39 countries.

Currently, some 44 million children and adolescents are smokers, though 100 million smokers began before the age of 15, said Krech. And over 14 million young people aged 13-15 have already started to use tobacco.

However, these numbers “don’t even begin to scratch the surface of young tobacco users”, mainly because there is no solid data on children below the age of 13, said Krech. 

And smoking is “obviously not starting at the age of 13,” according to Prasad. In some cases, it starts earlier. 

Every hour, the tobacco industry spends a million dollars on advertising, and $ 9 billion every year, said Prasad on Thursday. 

Heated tobacco products account for about half a percent of the world’s market, 80% of which is in the developing world – with over 400 million smokeless tobacco users In the South East Asian context, said Prasad.

As COVID-19 Rages On, Tobacco Industry Shift Tactics In Efforts To Maintain Sales

Vinayak Prasad, Coordinator of WHO’s No Tobacco Unit

The tobacco industry has a long history of using all sorts of tactics that oppose “all forms of evidence-based measures” to reduce tobacco use, said Prasad – ranging from direct to indirect forms of advertisements, sponsorships or promotions, some of them “very subtle.” 

“They start with slim [cigarettes], they start with mild [cigarettes], they start with filters [although] the evidence base [does not show] that it’s safer or less safe…their aim is to create confusion amongst [tobacco] regulators,” said Prasad.

And as the industry scrambles to maintain profits during the raging pandemic, health experts have seen some of their tactics change.

In South Africa and Bangladesh, the tobacco industry is lobbying lockdowns to lift the existing sale ban on tobacco products. The industry is using ‘all kinds of arguments’ to support their claims – They have even argued that smokers that are unable to get their products are ‘victims’, said Prasad.

In South Africa, the industry is fighting a case in Supreme Court to lift the sale ban on tobacco products since the country imposed a 21-day lockdown in late March. In Bangladesh, a similar challenge is being fought as “the current law has not made it essential to sell tobacco products,” he added. 

The tobacco industry also uses other strategies to entice adolescents to consume their products – a tasty selection of flavors like bubblegum, as well as bringing cigarette representatives into schools to present their products.

On-screen smoking is another common but highly effective tactic to promote smoking in younger populations, warns the WHO.

In a British study of over 5000 adolescents 15-year-olds who saw more films with smoking imagery were almost three quarters more likely to have tried smoking than those who had seen movies where people smoked less. In the USA, almost 40% of all new young smokers begin as a consequence of seeing smoking on TV, reported another study. 

Pulling out smoking from youth-rated films is “one of the most powerful ways to protect children from the harms of smoking,” said programme manager of WHO’s Tobacco Free Initiative Armando Peruga, in a WHO bulletin from 2016.

WHO’s Toolkit To Empower Youth ‘To Say No’ To Tobacco Products

In light of the tobacco industry’s tactics to promote smoking in teenagers, the WHO has launched a novel, interactive toolkit for youth between 13-17 years of age.

The aim of the toolkit is to provide children with the tools “to say no” to the tobacco and nicotine industry:

“Adolescents and young people can be empowered to protect themselves when they understand the intention of [the tobacco] industry…that really wants them hooked and addicted in order to keep the profits, even if it goes against public health,” said Marquizo.

The toolkit offers different activities for teachers in classrooms, but also for parents at home, either in-person or virtually – ranging from a tobacco mythbuster quiz, a ‘how to sell death’ workshop to expose tobacco industry tactics, or even roleplay for teenagers to practice refusing tobacco products when offered by their peers or others.

The campaign is ‘very much’ based on social media because the tobacco industry’s tactics often hook teenagers through social media, said Krech.

The WHO is also working with media partners like TikTok, Pinterest and YouTube to promote their #TobaccoExposed challenge.

WHO’s Mythbuster Toolkit For World No Tobacco Day 2020

Claims That Tobacco Is Helpful Against COVID-19 Are Unfounded, Warns WHO 

Youth Representative for Students Working Against Tobacco Nicholas Martinez

“ We [adolescents] are the new lab rats to big tobacco…We don’t know what they’re putting in their cigarettes that might affect us 10-20 years from now…before, tobacco was promoted as a good thing, a healthy thing.” said Youth Representative for Students Working Against Tobacco Nicholas Martinez, who also spoke at Thursday’s webinar. 

“But now, we know the real consequences of it,” he added.

Last month, two linked Parisian studies put forth claims that nicotine in tobacco products could protect against COVID-19 infection, leading to panic buying in Iran -And also a decree by the French government to limit the sale of nicotine products.

However, these studies were ‘not peer-reviewed’ and had ‘huge methodological weaknesses,’ said Krech.

“There is currently insufficient information to confirm any link between tobacco or nicotine in the prevention or treatment of COVID-19. WHO urges researchers, scientists and the media to be cautious about amplifying unproven claims that tobacco or nicotine could reduce the risk of COVID-19,” said a WHO statement from mid-May.

The WHO’s review of the latest evidence ”shows exactly the opposite’ result to the Parisian studies, warned Krech, as he referred to this week’s review of 27 observational studies and 8 meta-analyses published by the WHO.

Not only is tobacco product consumption likely to increase COVID-19 infection, tobacco products may also increase COVID-19 disease severity, warns the WHO – for several reasons.

It has long been acknowledged that smoking impairs lung function and the body’s ability to fight off diseases. It also increases the severity of respiratory diseases – including COVID-19 – according to a review last month by public health experts convened by WHO.

And while the effect of smoking on COVID-19 infection has not been confirmed in peer-reviewed studies, smokers “may be more vulnerable” to COVID-19 infection as the act of smoking increases the likelihood that a virus will transmit from hand to mouth,” warns the WHO – especially because smokers may share products between each other:

“Smoking waterpipes, also known as shisha or hookah, often involves the sharing of mouth pieces and hoses, which could facilitate the transmission of the COVID-19 virus in communal and social settings,” said the WHO in a Q&A on tobacco and COVID-19 on Wednesday.

There is another link between smoking and COVID-19 illness – Non Communicable Diseases (NCDs) like cardiovascular disease, cancer, respiratory disease and diabetes.

Smoking is the ‘single most preventable cause of NCDs’, and people with NCDs are much more likely to die of severe COVID-19 illness. In Latin America, 80% of deaths are due to NCD’s – And worldwide, 75% of deaths are due to NCDs. 

While there are currently no peer-reviewed studies that directly estimate the risk of hospitalization with COVID-19 among smokers, it is likely that smoking worsens COVID-19 outcomes, reports the WHO.

Image Credits: WHO, Smoke Free Movies Initiatives, WHO, NCD Alliance.

As the COVID-19 pandemic continues to ravage the world, hope has been pinned on the development and roll-out of an effective vaccine. But in a global crisis where demand for the vaccine will be everywhere, how can fair and equitable distribution be ensured?

Panelists from the World Health Organization; the Coalition for Epidemic Preparedness Innovations (CEPI); Medicines Law and Policy, the Shuttleworth Foundation, and a former Brazilian diplomat tackled this question in the second webinar in the ‘Global Pandemics in an Unequal World’ series, cosponsored by the New School and Health Policy Watch.

“How do we turn the commitment to a universal vaccine from rhetoric to an implementation plan?” posed Sakiko Fukuda Parr, moderator of the discussion and director of the Julien Studley Graduate Programs in International Affairs at the New School.

“What we have now is not only a health crisis, but a crisis that shakes your world order. We can’t separate what is going to happen in health from what happens in the global geopolitical situation,” said Celso Amorim, former Brazilian Minister for External Relations.

In the midst of redefining the world order, a new paradigm for ensuring access must emerge in order to roll-out any successful COVID-19 vaccines in an equitable fashion, said other panelists.

“The supply of any successful and safe and efficient vaccine will be limited for several years…[because] the global demand will be everywhere at the same time,” said Elen Høeg, policy manager at the Coalition for Epidemic Preparedness and Innovation (CEPI), which is supporting the development of at least three different vaccine candidates.

Fair allocation of any vaccine should then be based on public health need, rather than countries’ ability to pay, said Mariângela Simão, assistant director-general for Access to Medicines & Vaccines at the World Health Organization.

“We are bound to establish new [allocation] criteria that are unprecedented in the world, based on ethical and moral values. And then we need to make these products accessible and affordable,” she added.

To do that requires the buy-in of major Heads of States, says Amorim, who proposed a United Nations General Assembly Session to put pandemic preparedness and response on the agenda for all Member States.

“Like it or not, people are represented internationally by governments and I think we have to have a very broad discussion in the United Nations in a political body,” he said.

But another looming issue is the problem of scale – manufacturing capacity will have to ramp up significantly to meet the global demand, even with equitable access conditions in place.

One solution is to tie access requirements into funding agreements for vaccine development, said Achal Prabhala, Shuttleworth Foundation fellow. 

“The EU, the US and the UK could attach some access conditions to the billions of dollars being given to vaccine developers,” Prabhala explained. But he also lamented that this is “the solution that will probably not be implemented.”

Other solutions may be on the horizon.

The panelists spoke just a day before the official launch of the World Health Organization’s COVID-19 Technology pool, which aims to pool all data, technology, and other research necessary to speed development and scale manufacturing of any COVID-19 treatments, diagnostics, and vaccines.

“What this whole initiative will do, is create a place where donors can put conditions on spending so that research and development funding comes with conditions regarding sharing technologies that are needed to scale up production worldwide,” said Ellen t’Hoen, director of Medicines, Law & Policy. “I hope that this crisis will lead to increased multilateralism and collaboration, and then we can move away from the kind of vaccine nationalism that we now see around the world.”

(top, left-right) Sakiko Fukuda-Parr, Achal Prabhala, Celso Amorim (bottom, left-right) Elen Høeg, Mariângela Simão, Ellen t’Hoen)
Here are some key remarks from the featured speakers:
Sakiko Fukuda-Parr, director, Julien J. Studley Graduate Programs in International Affairs, The New School

We need a global public good vaccine for COVID-19 that is effective and safe, but also mass produced, priced affordably and distributed widely and equitably. And that would reach all people, especially vulnerable populations and developing countries. There’s an overwhelming support for this idea as an objective, and it’s been endorsed by political and religious and intellectual leaders around the world such as presidents and prime ministers of France, Germany, Canada, China, China, South Africa and others. And there’s also a broad consensus that this is not only an ethical imperative, but an urgent public health priority and that there is a need for international cooperation and multi stakeholder partnership. 

But there is much greater difficulty in achieving agreement on how to get there. How do we go from the business as usual market model upon pharma research and development, financed by charging high prices under 20 year patents and other intellectual property exclusivity with limited distribution focusing on high income countries first, and from that to a people’s vaccine that is patent free mass produced accessible in the global south?

Who will have early priority access to the vaccines or other necessary technologies, who will bear the financial burden, who will benefit from the investments and who will receive the treatments? How can the values of solidarity and multilateralism prevail over nationalism? How can 21st century capitalism address market failures by creating innovative social institutions to protect public health priorities that do not align with just a maximum profit, private profit and revenues? How do we turn the commitment to a universal vaccine from rhetoric to an implementation plan? And in particular, how will low-income people and countries in the Global South have access to vaccines and other treatments so that we can actually end the pandemic?

 Mariângela Simão, assistant director-general for Access to Medicines & Vaccines, World Health Organization

First we live in a globalized world, so anything that happens in one country affects others. Secondly, it’s also shown that the countries are not prepared, no matter how many resolutions were approved in the World Health Assembly. On the other hand, this has been a very democratic virus… It raised an enormous, collaborative effort to try to sort it out, because no one is safe as long as someone else is vulnerable to this virus. 

We cannot let low and middle income countries end up with an unfair allocation of the leftovers. The market cannot work the same way it worked in the past pandemics and it cannot work the same way. We think we should be all applying at least to five principles; transparency, because we have right now we have a situation where you have companies trying to sell products that we don’t have yet to countries in, we have some countries trying to buy products that are not there yet. We are talking about a new normal, where income should not play a role anymore.

We also need flexible regulatory in procurement approaches, we need collaboration among the different stakeholders to produce a safe and effective product in the shortest time possible. But we also need these products to be allocated to address public health needs, with ethical rules informing the allocation. So it’s really super important that we have agreed criteria to allocate products that will enable equitable access. We’ll need to take into account the vulnerability. 

For example, the Bahamas, a high income country. Suddenly last year, they were devastated by a hurricane. And now they get COVID, so their ability to pay is very limited. So income doesn’t play the same role anymore. So we are bound to establish new criteria that are unprecedented in the world, based on ethical and moral values. And then we need to make these products accessible and affordable.

Achal Prabhala, Shuttleworth Fellow in advancing innovation and access to medicines

The thing that strikes me the most over the last 20 years is that access to treatments and vaccines is no longer an afterthought.The model that we followed right through something like one year ago was develop the drug first, get a treatment, and then let’s figure out how to give people access to it. That’s not the model here. But having said that, there are two big threats that confront us. And the first is intellectual property, private monopolies that are owned by corporations. And to provide one quick example of how IP remains a threat, I think one can do no better than to look to Gilead’s license for remdesivir, which is the first US FDA approved emergency use treatment for COVID-19.

They released an access agreement that allows a few production facilities in India to sell generic versions of the drug in 127 countries. But about half the world is left out – every middle income country, so every country in Latin America including Brazil, which is particularly severely hit by the coronavirus. Many of the former Soviet Union countries are completely left out. 

The second trait, however, is nationalism. And I think the perfect example of how nationalism is playing out is when the CEO of Sanofi, which is registered in France, suggested that the US would have first dibs on its vaccine. And of course, this raised a fly in France. Since the French President intervened, and then the chairman of Sanofi had to backtrack those comments. When it comes to vaccines, there are very, very few production facilities around the world that can even make a generic vaccine.

There are solutions that countries are advocating for themselves. Brazil, Chile, Germany, Canada, Ecuador, have begun taking actions to suspend monopolies around Coronavirus related treatments, vaccines and diagnostics, should that be necessary. There are multilateral solutions that have been discussed like the WHO COVID-19 Technology pool. And then finally, we have the solution that probably will not be implemented, which is having the EU, the US and the UK attach some access conditions to the billions of dollars being given to vaccine developers. 

Elen Høeg, Policy Manager, Coalition for Epidemic Preparedness and Innovation (CEPI)

The challenge of ensuring access in a pandemic is fundamentally different from an epidemic in that the global demand will be everywhere at the same time. Hence, the supply of any successful and safe and efficient vaccine will be limited for several years. 

So, as pointed out, then there’s this balance between the national interests and  global solidarity, because I do think we all recognize this is a global challenge that requires a global solution. There will be both development challenges and access challenges. One thing that has become evident is the need to step up and very urgently get in place large scale manufacturing across many geographies to cover the global demand. 

So we must put in place mechanisms for a global procurement and ordering system, both to give predictability for manufacturing and security of investments as well as addressing the regulatory measures. A fair allocation mechanism, which will be led by the WHO, will be established. We see great will from partners to commit to having doses secured for a global pool of vaccines to serve a fair global allocation model. 

Celso Amorim, Minister of External Relations of Brazil (1993-94; 2003-2010), and Minister of Defense of Brazil (2011-2014)

What we have now is the biggest crisis that’s not only a health crisis, but a crisis that shakes your world order. We can’t separate what is going to happen in health from what happens in the global geopolitical situation. I think there are changes that are going to help. I hope it doesn’t lead to conflict at some point; I hope it can lead to new kinds of cooperation in the world which are multipolar in which developing countries can help. 

I think this is basically a political question. Even the Doha Provision only was able to pass because rich countries also saw they needed it. Of course, technical expertise has to come from the WHO. But we really need the involvement of the United States. That’s why we have been proposing the idea of a special session of the General Assembly where all countries would participate. Like it or not, people are represented internationally by governments and I think we have to have a very broad discussion in the United Nations in a political body. You need a big, international conference, Heads of State in order to push for better replies to world problems. The WHO  simply is not enough. We have to have big political support – the General Assembly of the United Nations is the only place where you can have really a big impulse.

Ellen t’Hoen, director, Medicines, Law & Policy

If a vaccine becomes available, the demand will be immediate, it will be global, and it will be enormous. And we need to plan for this. Now, if there’s one thing that we’ve learned from the HIV crisis, it’s the danger of having no plan. The drugs were developed, but it took about a decade before they became available in low and middle income countries. One lesson-learned from that is that you need to sort out the ownership issue. And this is not only about patterns with HIV, there were barriers to the low cost, generic production of drugs on a large scale, and that was largely solved through the Doha Declaration and the establishment of the Medicines Patent Pool (MPP), where patents for antiretrovirals (ARVS) could be pooled [and licensed to generics manufacturers]. All the patent licenses for all WHO-recommended antiretrovirals are available through the MPP. 

In mid-March, Costa Rica, proposed to the WTO to establish a COVID-19 technology pool that brings together all the necessary intellectual property – data, cell lines, know-how, technology – in order for that to be freely shared to advance science and future large scale production of vaccines ,therapeutics and diagnostics. The pooling of such knowledge was endorsed by the World Health Assembly and tomorrow, there will be an announcement with the president of Costa Rica, WHO, and a number of other member states to launch this initiative. What this whole initiative will do, is create a place where the donors funding the research and development of vaccines, drugs, and diagnostics, can put conditions on that spending regarding sharing technologies that are needed to scale up production worldwide.

I hope that this crisis will lead to increased multilateralism and collaboration, and then we can move away from the kind of vaccine nationalism that we now see around the world. The people first in line for a vaccine should be the health care workers of the world, but you need to have agreements for making that happen. 

Upcoming Webinars in ‘Global Pandemics in an Unequal World’

The Tuesday event was the second in a series of four webinars, co-sponsored by The New School and Health Policy Watch, with the Centre for Development and Environment at the University of Oslo joining as a partner. Join us in June and July for the next two webinars, covering these themes:

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

22 July – COVID-19 inequalities and the environment

 

This story was updated 2 June 2020 to amend a quote by Ellen t’Hoen.

(Top, left-right) Pascal Soriot, CEO AstraZeneca; Emma Walmsley, CEO GSK (Bottom, left-right) Albert Bourla, CEO Pfizer; Paul Stoffels, CSO Johnson&Johnson

The UK-based Pharma firm AstraZeneca and US-based Pfizer announced they are planning to start Phase III trials as early as July for an experimental COVID-19 vaccine in the United States and the United Kingdom. The massive trials would enroll over 30,000 people, and AstraZeneca’s hope is to have an effective vaccine by the end of the year. 

Pfizer is aiming for an even more ambitious timeline to have a vaccine ready for approval by the US Food and Drug Administration and European Medical Agency by October, announced Albert Bourla, chairman and CEO of Pfizer. 

“If things goes well, and the stars are aligned, we will have conclusive or enough evidence of safety and efficacy so that we can feel comfortable and the FDA will feel comfortable, and EMA will feel comfortable to have a vaccine around the end of October,” said Bourla, speaking at a briefing by pharma industry leaders, hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). GlaxoSmithKline (GSK) and Johnson&Johnson were also present at the briefing.

Pfizer’s Phase I clinical trials will conclude in June, Bourla added.

AstraZeneca meanwhile is conducting studies in Kenya, in South Africa, in Brazil, with the hope that trials in many other countries will start “anytime soon.”

“The hope is that we will have a [Covid-19] vaccine, hopefully several, by the end of this year,” said Pascal Soriot, CEO of AstraZeneca. 

Not for Profit Approach – But Vaccine Will Likely Be Rolled Out First In Countries With Stronger Infrastructure

Johnson & Johnson, GSK and AstraZeneca executives said that they were taking a “not-for-profit” approach to vaccine development and sale, at least for now.   

“We do it not-for-profit for the pandemic period, as we want to [ensure] equitable access over the world…and especially to get vaccines to make sure we get a stop to the pandemic,” said Stoffels of Johnson & Johnson. 

“We can actually provide this vaccine in a fairly equitable manner to everybody around the world. And finally, just like everybody else, we do it at no profit,” said Soriot.

Said GSK’s CEO Emma Walmsley: “We’re on record saying we don’t expect to profit during this period because we want to invest in short term profit in pandemic preparedness and in donations.”

While Pfizer’s CEO Albert Bourla did not commit to a ‘not-for-profit’ approach explictly, he acknowledged that vaccine pricing will have to approached differently in times of the pandemic:

“Typically the industry is pricing their product based on the value that they bring. And this is impossible to happen right now. In times of pandemic, you can’t have pricing policies that respect [demand and the rules of an open market]…I don’t know what will be the price reduction because I’ve never thought about it.”

Bourla also stressed that the lack of infrastructure would still be a barrier to global rollout of a new COVID-19 vaccine. 

Albert Bourla speaking at a May 28 press briefing

“Technologies [we are developing] right now require -80 °C,” said Bourla. “The technology is not very convenient for Africa because they will likely lack basic infrastructure…[the vaccine] will come to the Western world first but [in the] second wave, we are working on making sure that we can develop and manufacture products that are not requiring [refrigeration in Africa]”.

“Not all vaccine candidates can go all over the world,” agreed Stoffels, saying this will depend on its features. 

Even so, Bourla said that Pfizer was “absolutely engaged”’ in joining coalitions like the European Union-led ACT Accelerator to ensure equitable access for COVID-19 health technologies. 

Patent Pool Gets Cold Shoulder 

Thomas Cueni speaking at a May 28 press briefing

The pharma leaders spoke just a day before the World Health Organization was to launch a new COVID-19 patent pool, which is supposed to group intellectual property of any coronavirus-related technologies – to ensure accessibility in low and middle income countries. 

IFPMA head Thomas Cueni said he would not be joining Friday’s ceremony, which followed the announcement two weeks ago Costa Rica, Chile and the WHO.

“I don’t quite see what the new initiative adds [in comparison to existing mechanisms] I’m too busy [to participate],” Cueni said.

Cueni and other industry leaders have said that infrastructure shortcomings, manufacturing challenges and supply chains are likely to be bigger access obstacles than patents in the current race to achieve universal access to a pandemic vaccine.

Distribution Bottlenecks Likely

One of the main issues with mass-producing a vaccine is not necessarily the amount of vaccine itself, but getting enough vials, said Soriot. 

“The challenge is not so much to make the vaccine itself, it is to fill the vial. And there’s not enough vials in the world,” he said.

In light of limited vial supplies and the fact that some 15 billion vaccine doses might be needed, said Cueni, pharmaceuticals like AstraZeneca and Johnson & Johnson are trying to squeeze a handful of vaccine doses within each vial to distribute more of the vaccine with less vials:

“Like everybody else, we are looking into five or ten doses per vial,” said Soriot.

And as vial makers scramble to produce more vials, they face an unprecedented challenge as they have never had to produce such quantities – Planning needs to happen ‘now’ to tackle the vaccine distribution issue: “If we go to 15 billion vaccines, that has never been done in history from a filling capacity as well as vials… planning [is not] for next month…we need to start planning now,” he said

Who Gets Priority? 

Reports of some countries signing pre-purchase agreements for COVID-19 vaccines have surfaced in the past few weeks, sparking concerns that some countries will jump the line in the queue for an effective vaccine. 

Last week, the French-based company Sanofi sparked outrage in Europe when they announced that they would first sell the vaccine in the United States – which had invested heavily in R&D at the company’s US locations as well as making pre-purchase agreements. After protests by French government officials, Sanofi’s CEO retracted the statements. 

But so far, the Pfizer CEO said the company had not signed any pre-purchase contracts for their vaccine, currently concluding Phase I clinical studies that will likely yield results by June 2020.  

“We haven’t signed contracts and also I think it is known that Pfizer is not taking any money from any government, the US government or any other government to advance our vaccines. We don’t do that,” said Bourla.

France rolled back recommendations on the use of hydroxychloroquine, a malaria drug, for severe COVID-19 patients, just two days after the World Health Organization suspended its large multinational hydroxychloroquine trial.

Meanwhile, the United Kingdom has authorized the use of remdesivir for severe cases of COVID-19. The drug showed modest potential to shorten the length of infection in a large, US study. 

France had previously recommended hydroxycholoroquine to be used at providers’ discretion for treating patients with severe COVID-19. However, the French Ministry of Solidarity and Health on Wednesday issued a revised recommendation stating, “whether in town or in hospital, this molecule should not be prescribed for COVID-19 patients.”  

The Ministry statement is informed by the High Council for Public Health (HCSP), which earlier in the week also reversed its stance on the drug, no longer recommending it for discretionary use for severe COVID-19 patients.

“The working group concluded in a collegial manner that there was no sufficiently robust clinical study demonstrating the efficacy of hydroxychloroquine in COVID-19 regardless of the severity of the infection,” stated the HCSP in a notice posted Tuesday. 

The moves by the WHO and France were prompted by a massive study published in The Lancet that found a much higher risk of cardiac arrhythmias and mortality among nearly 15,000 COVID-19 patients who were given hydroxychloroquine, chloroquine, or either drug plus a macrolide antibiotic, compared to 81,000 who did not receive any combination of the drugs.

However, the jury is still out on use of hydroxychloroquine as a preventative medicine. India recently expanded its recommendations for prophylactic use of hydroxychloroquine based on early results from a small observational study. 

Both President Trump of the United States and  Salvadoran president Nayib Bukele have touted the use of a drug as a prophylactic. In a parallel development, Brazil’s Jair Bolsonaro has also unveiled plans to expand the prescription of chloroquine, a predecessor of the drug, while acknowledging that there is no scientific evidence of its efficacy, however, the situation continues to be monitored in Brazil and globally. 

UK Issues Emergency Use Guidelines for Remdesivir

Hope is turning more towards remdesivir, an antiviral originally developed by Gilead Sciences for treating Ebola, which has shown modest positive effects on speeding recovery. 

“This shows fantastic progress. As we navigate this unprecedented period, we must be on the front foot of the latest medical advancements, while always ensuring patient safety remains a top priority,” said Minister for Innovation Lord Bethell of the UK’s recent remdesivir approval. 

However, the drug is still being studied in ongoing clinical trials, and some experts warn against pinning all hopes on remdesivir.

“Whilst this is clearly the most ethically sound approach, it also means that we ought not to expect the drug to immediately act as a magic bullet. We can instead hope for improved recovery rates and a reduction in patient mortality, which we hope will benefit as many patients as possible,”  Stephen Griffin, a professor from the University of Leeds Medical School told BBC.

Thus, countries like the UK, which just released a package of guidance for emergency use of remdesivir, are approaching the rollout of the drug carefully, limiting it to use only to patients with severe disease. 

Merck Joins The COVID-19 Vaccine Race

Merck, one of the largest pharmaceutical companies in the world, has announced deals to develop and manufacture two different COVID-19 vaccines as well as an experimental antiviral compound which is already in early clinical trials. 

The company will be collaborating with IAVI to develop a vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO®, which was the first rVSV vaccine approved for use in humans. Initial funding support for the initiative comes from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within an agency of the United States Department of Health and Human Services.

Merck also announced on Tuesday it would be acquiring the small biotech company Themis, which is working with the Institut Pasteur on a COVID-19 vaccine candidate delivered using the same technology used to carry the measles vaccine. The Themis vaccine candidate is still in preclinical trials, and will aim to begin clinical trials by late 2020.

According to the World Health Organization’s latest table of COVID-19 vaccines, 124 candidates are at various stages of development with eight different technologies, or platforms. 

Merck has also backed the development of the compound EIDD-2801, which is designed to inhibit viruses with RNA-based genetic material, including SARS-CoV-2. In this regard, the company is collaborating with Ridgeback Biotherapeutics, which has started a safety trial of the compound in healthy patients in the UK. 

Image Credits: Jamie.