After two days of more hopeful signs that new cases of the novel coronavirus in China might be stabilizing, a sharp increase of 14,840 new COVID-19 infections was reported Thursday by the Province of Hubei, more than 10 times the previous day.

Meanwhile, Vietnamese authorities had reportedly imposed a mass quarantine on a number of villages in the Son Loi commune, about 40 kilometers from Hanoi, where six among the 16 cases confirmed so far in Viet Nam, have been reported. It was the first mass quarantine to be placed on an entire community outside of China where over 50 million people remain under partial or total lockdown in the city of Wuhan and around Hubei Province, where the novel coronavirus first first emerged in a wild animal market in December 2019.

CNA News report shows police patrol on perimeter of Viet Nam’s Son Loi commune. (CNA News)

The upsurge in China cases was in part due to an expansion of diagnostic criteria, said Hubei officials in a statement. Those who show clinical signs of COVID-19 were previously not included in the count, which only tallied lab-confirmed cases. However, officials amended the definition so that patients who show clear symptoms of the disease based on clinical exams and chest x-rays “can receive standardized treatment…as early as possible to further improve the success rate of treatment”[translated from Chinese].

A total of 59,907 cases had been reported in China on Thursday, according to the latest Chinese government data, posted just before midnight Beijing time. There was also a steep 48-hour increase in deaths, with total fatalities inside China now at 1,368. The second death outside of China was registered in Japan, in a woman in her 80s. Some 500 people in 24 other countries were also infected with the virus as of Thursday evening, central European time.

“This increase that you have seen in the past 24 hours is largely due to a change in how cases are being diagnosed and reported,” said WHO’s Emergencies Director, Mike Ryan at a press briefing Thursday, explaining the huge leap in case reports in Hubei Province, the epidemic epicentre.  “We need to be very careful in interpreting any extremes.” He noted that some of the increase is also attributable to clinical cases reported days or even weeks ago, but only included now after the reporting criteria was changed.

There were further spikes in the two biggest COVID-19 hot spots outside of China.  On the Princess Diamond Cruise ship, where more than 3600 passengers and crew remained quarantined in Japan’s Yokohama harbor, a total of 218 passengers tested positive for the virus, a leap of 44 cases since Wednesday. Singapore, the next largest cluster, was reporting 58 cases Thursday evening, 11 more than Wednesday.

Government-reported data for COVID-19 cases in China, on a popular health workers website, as of 16:51 Central European Time.

Experts are carefully watching trends in the Asian city-state, where original contacts for some of the Singaporeans falling ill cannot be traced. This has sparked fears that wider community-based spread of the virus may be occurring, making Singapore the next test ground for virus containment. Elsewhere, conferences and meetings were being delayed or cancelled, and school start dates suspended, as the fallout from the virus echoed across the Western Pacific region, Europe, and beyond.

The sharp uptick in reported cases on Thursday occured only hours after Dr Tedros Adhanom Ghebreyesus, World Health Organization director general warned that ¨the number of newly reported cases reported from China has stabilized over the past week, but that must be interpreted with extreme caution.”

“The outbreak could still go in any direction” he told reporters Wednesday after the conclusion of a two-day Global Research and Innovation Forum in Geneva, and just hours before Hubei province officials released the new daily numbers.

The forum sought to identify the best clinical care treatment for patients with the virus; explore why some people become seriously ill while others do not; as well as to forge ahead with a coordinated approach to research on potential treatments and vaccine candidates, said Dr Soumya Swaminathan, WHO chief scientist, describing outcomes of the meeting.

WHO Press Briefing on Coronavirus situation

First Large-Scale China Study Finds Case Fatality Rate Higher Than Previous Estimates

Meanwhile, the first large-scale study of some 4,021 Chinese patients with COVID-19 reported that the case fatality rate of confirmed people who fell ill in January was averaging about 3%, significantly higher than the 2% fatality rate that had been cited previously.

According to a pre-print version of the study by researchers from China Centers for Disease Control (China CDC), published on MedRXiv, patients 60 years or older had even higher fatality rates of 5.4%, as compared to 1.43% for that of younger patients.

Male patients also had a case fatality rate more than triple that of female patients – 4.45% as compared to 1.25%, the study found.

The study, which examined cases in 30 Chinese provinces including the virus epicentre of Wuhan, also provides the first detailed age distribution of confirmed cases of the virus, which had been known to researchers as 2019-nCoV, until WHO gave it a formal name on Tuesday.

Despite the higher fatality rates than previously assumed, the new COVID-19 virus is still less deadly than Severe Acute Respiratory Syndrome (SARS), which had a case fatality rate of 9.2%, during the 2002-03 epidemic, the study’s authors conclude. The COVID-19 virus transmissibility is similar to that of SARS – with a single infected person passing the virus to nearly 4 other people [3.77], on average.

Among those studied, people aged 30-65 years comprised the majority of reported cases, while 47.7% of patients were age 50 and over. The lowest incidence of reported cases was among people under 20 years of age.

Overall, more men than women were reported to be infected, the study found – although gender differences in incidence were only significant outside of Wuhan.

“The high incidence subpopulation outside Wuhan tended to be younger than in Wuhan,” the study’s authors also noted.

The study is the first published report covering a large group of Chinese patients.  But WHO scientists have noted that the true case-fatality rate remains difficult to assess in the early stages. The fatality rate could also prove to be lower if many people with asymptomatic or mild infections are missed by hospital-based surveillance systems.

Experts Closely Watching new COVID-19 hubs like Singapore

Outside of China, global health experts were closely watching trends in Singapore, which has the largest concentration of COVID-19 cases outside of China – with the exception of the Diamond Princess cruise ship.

Singaporeans clear out supermarket shelves on 8 February as coronavirus fears spike

The most worrisome aspect of Singapore’s outbreak is the emergence of cases in people whose original contact with the virus couldn’t be traced, experts have observed. If the outbreak expands from known chains of contacts into more “community-based” transmission, then it’s “game over” in terms of containment and preventing a worldwide pandemic, in the words of one BBC commentator.

In fact, some experts are already using the so-called “P” word. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told Health Policy Watch.  There is a “real possibility that it’s a pandemic – which means it could be a worldwide epidemic where most citizens are at risk of being infected,” he said in an interview.

But while WHO is closely watching the “behaviour of the virus outside of China,” Mike Ryan, WHO’s Emergencies head, has sought to mitigate fears about virus expansion abroad. He notes that the number of cases where contacts cannot be traced remains limited.

Ultimately, public health officials need to  pursue a two-track strategy of both containment and preparation for further expansion. “We must stop the virus while preparing countries for the arrival of the virus…. even if that sounds like a contradiction,” Ryan said, speaking in a press briefing on Wednesday.

Speaking on Thursday he said, “We can only find eight cases [abroad] that are not linked in some way to one of the identified transmission chains,” he observed. He said that researchers are rushing to develop a simple blood test for virus antibodies. But in the absence of such a test, it is difficult to determine how much broader “community” transmission might be occuring. “This may be only the tip of the iceberg, or the iceberg may not be as great,” he said.

Clinical Trials For Vaccine Candidates Could Begin In April

Following the conclusion of the WHO Research and Innovation Forum, WHO’s Chief Scientist Swaminathan told Health Policy Watch that clinical trials of the first COVID-19 vaccine candidate, could begin as early as April.

She said that tests of the first vaccine candidate, an mRNA vaccine, are being supported by the Oslo-based Coalition Epidemic Preparedness Initiative (CEPI) as part of a collaboration with the pharmaceutical company Moderna and the US National Institutes of Health. The vaccine candidate functions on principles similar to vaccines tested against other coronaviruses, such as SARS.

Swaminathan said that she was optimistic about China’s ability to quickly ramp up manufacturing capacity to produce any new vaccine shown to be effective. “There was a Chinese vaccine company present at the meeting, and they were very interested in collaborating on this, and they did raise the issue of exploring manufacturing capacity from an early stage,” she said.

In terms of therapies, trials have already started on the widely-used HIV drug combination, lopinavir-ritonavir as well as on an experimental drug called remdesivir, she noted, although it is “too early” to identify what might be the most promising treatments.

Ad for HIV/AIDS combination drug now being tested for effifacy against COVID-19

Tests of other antivirals, some Chinese traditional medicines, and the FDA approved treatment for seasonal flu, oseltamivir (Tamiflu) are also rapidly being scaled up, she said.

But there are a broad range of other potential treatments as well, she observed: “When we look at our clinical study registry there are about 87 – 89 trials [of antivirals] already under way, and about one-third of them are clinical trials.”

WHO Protests Cases of Stranded Maritime Passengers

Meanwhile, cases of COVID-19 continued to climb aboard the Princess Diamond, the cruise ship that has been under quarantine in while docked in Yokohama, Japan, since 7 February.

Of the 48 new cases of infection outside of China that were reported on Wednesday, 40 were on the ship, noted WHO’s Dr Tedros in his briefing to the press. That adds up to 174 passengers with confirmed cases of the coronavirus.

Dr Tedros protested the fact that in the wake of the Princess Diamond case, two other cruise ships have also been turned away from ports, despite having no suspect cases of the coronavirus.

He said that WHO would be issuing a communique with the International Maritime Organization, asking countries to respect the principle of “free pratique”, for ships’ movement, and proper care of passengers.

And he praised Cambodia’s government for finally agreeing to allow one of two other cruise ships, the Westerdam, to dock, after days of being stranded in international waters.

“Based on what we have been told, there are no suspected or confirmed cases of COVID-19 on board the Westerdam,” he said, noting that the ship is due to arrive in Cambodia Thursday morning.

“This is an example of the international solidarity we have consistently been calling for,” he said.

Inside China – Rising Concerns Over Health Worker Infections & Freedom Of Speech

Inside China, there were growing concerns about the rate of health worker infections, as the South China Morning Post reported that over 500 medical workers had been infected by COVID-19 in Wuhan by mid-January. Although the Chinese government has been releasing daily case counts, no separate tally of health worker cases has been made public.

That issue surfaced against the continuing current of protest over how the Chinese authorities’ repression of free speech might have delayed warnings about the virus and exacerbated its spread in the early days, highlighted by a new petition circulating on freedom of speech. The petition has been signed by hundreds of Chinese, including a number of notable Chinese academics, reported the South China Morning Press.

The petition followed the widely-mourned death on 6 February of Li Wenliang, one of eight doctors punished by Wuhan authorities in early January for “spreading rumors,” after he tried to warn fellow health workers about the new coronavirus on a social media chat.

WHO and its Director General Dr Tedros have also been criticized for white-washing the Chinese repression of initial reports of the novel coronavirus, which is believed to have first infected people working in, or visiting, a wild animal market in Wuhan in December 2019.

Asked about such criticism at Thursday’s press briefing, the WHO head was adamant that he was not pandering to Chinese political pressures in his repeated praise for the Chinese response.

“China doesn’t need, or want, to be praised. Let the truth speak for itself and the world can judge,” he told journalists, adding that thanks to China’s response measures,  “The rest of the world is still safer and in a better shape.

“If there is any failure, that should be challenged. We will assess and learn from it,” he said, adding, “We should not be stigmatizing or attacking a country, but stand in solidarity and fight against this common enemy, COVID-19, as humanity because we are one. This virus attacks every human being.”

Grace Ren contributed to this story.

 

This story was updated 13 February 2020, at 3:19AM & 19:00 CET .

 

Image Credits: CNA News, Dingxiangyuan, Yang et al.2020, Medrxiv, Cattan2011.

The novel coronavirus has been officially named by the World Health Organization as COVID-19, in the first day of a global consultation with about 400 researchers and public health experts charged with designing a coherent way forward to confront the expanding epidemic.

However, as the case count rose by Tuesday afternoon to 42,747 people with confirmed infections in China and 394 abroad, and the death count rose to 1018 people, according to the latest Beijing government data, there were still far more questions than answers about the new virus, which first emerged in December 2019 in a Wuhan, China food market selling wild animals.

“The main outcome we expect from this meeting is not immediate answers to every question that we have,” said World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, at a Tuesday press briefing following the first day of the Global Research & Innovation Forum convened by WHO in Geneva.  “The main outcome is [to be] an agreed roadmap on what questions we need to ask, and how we will go about answering those questions.”

A scientist doing coronavirus research at the US National Institute of Allergies and Infectious Diseases (NAID) Vaccine Research Center (VRC).

While WHO and other partners have all placed a great deal of emphasis on the transparent sharing of scientific knowledge about the virus to rapidly advance solutions to the epidemic, the two-day forum ongoing Tuesday and Wednesday in Geneva has been closed to the public, and participants were reportedly asked to avoid speaking to the media.

“We were instructed not to speak externally really but what I’ll say is that the atmosphere was quite good and the report will be quite action focused,” one participant from a leading global health research institution told Health Policy Watch.

Key questions that remain unanswered by WHO, its global partners and advisors cover some of the most characteristics of the virus as well as the outbreak dynamics, such as:

How contagious is the virus and what preventive measures can the public take? And how easily can asymptomatic carriers pass it to others? WHO’s Dr Tedros stressed in Tuesday’s press briefing that the virus can be passed by the respiration of tiny airborne droplets from an infected person – and that makes it far more contagious than diseases such as Ebola, which raged for a year in the Democratic Republic of Congo, but now appears to be finally on the wane. At the same time, besides hand washing and maintaining distance from people who are visibly ill, WHO and other public health authorities have so far been unable to issue clear guidance as to what else the general public can do to protect themselves from the virus. For example, WHO experts have said that there is mixed evidence about the extent to which simple surgical masks may or may not provide an added measure of protection – despite their increasingly widespread use not only in China, but also in other potential outbreak hotspots, as well as on some airline carriers.

How long is the virus incubation period? Most scientists have estimated 14 days, but there have been some estimates of up to 24 days. However, 24-days so far appears to be an outlier figure, noted WHO’s Sylvie Briand, in a briefing on Monday,

What is the actual death-rate?  In terms of a simple calculation of the numbers of the confirmed infections as compared with those who died, the fatality rate has hovered around 2.4%, which is higher than the death rate for seasonal flu, running at about .05% in the US this flu season, and for which vaccines also exist.  Better tracking of the COVID-19 virus, and inclusion in records of more asymptomatic cases, which seem to be common, might yield a lower fatality rate, some WHO experts have suggested. At the same time, the death rate could also prove to be higher, cautioned Gabriel Leung, infectious disease specialist and dean of medicine at the University of Hong Kong, writing in the New York Times.  He noted that in the early days of the SARS epidemic, experts believed that the case fatality rate was hovering between 2-3 percent. It later proved to be much more deadly – with the fatality rate for SARS in Hong Kong a “staggering 17 percent.”

Why are there variations in the death rate of those infected in China and abroad? Among the latter 394 cases, only one person has died. The disparity has been attributed by some scientists to the fact that most of the cases abroad were among travelers who were presumably younger and more fit, whereas the cases in China have involved the whole population.

What is the age and gender breakdown of those seriously ill?  While WHO has reported that about 15% of cases are serious enough to require hospitalization, and these tend to be older, no more detailed breakdown of cases has released. However, a study published last week in JAMA of 138 people hospitalized in Wuhan in January noted that their median age was 55 years of age.  This suggests that a significant proportion of those becoming seriously ill could be younger than had been assumed. Slightly more than half of the hospitalizations were men. And while most people recovered, they also required long periods of hospital care, averaging ten days or more, the study noted – something that could overwhelm a health care system with weaker hospital capacity.

What about children?  There have not, however, been many reported cases in children, said Nancy Messonnier, director of the US Centers for Disease Control’s Center for Immunization and Respiratory Diseases, speaking at a panel on the coronavirus Tuesday at the Aspen Institute.  That should be good news, although if the cases are mild or asymptomatic, then children could also “seed” cases to other more vulnerable family members in the household.

What is the animal source of the novel infection?  WHO’s Sylvie Briand said in Tuesday’s briefing that the original source for the new coronavirus had likely been a bat, which are common carriers of many different types of coronaviruses. However, an assessment by Chinese researchers last week in Nature, and also cited by Leung, points to the endangered species of pangolins, or other small mammals, as likely the point of contact with humans. Pangolins are commonly hunted and sold in Asian live animal markets for their meat, while their scales are used as an ingredient in traditional medicines.

Aerial shots of a large quarantine site being built in Hong Kong as coronavirus cases climb above 40.
WHO Boosting Diagnostics Capacity – But Many Countries Lack Respiratory Care Facilities   

As soon as a public health emergency was declared on 30 January, WHO swung into action to equip low-income countries, particularly in Africa, with diagnostics to identify the virus in suspected cases. The results have been impressive, in just two weeks, 13 African countries as well as Iran have been equipped with the laboratory tests, and technicians from a dozen African countries were trained in their use last week. Another 150,000 tests were about to be shipped to more than 80 labs worldwide, WHO has said. Personal protective gear for health workers, critical to infection control, is also being shipped from WHO emergency stocks to countries lacking strong supplies.

However, if cases clusters appear in Africa, or expand more widely in hotspots of South-East Asia and elsewhere – other serious capacity issues will emerge for health systems, including quarantine and containment facilities, which are expensive to mount and maintain. There is also a lack of hospital respiratory equipment to support those with pneumonia-like symptoms – one of the most common features of serious illness, one WHO official noted on Tuesday.

“Severe cases tended to be taken in charge by an intensive care unit where you have to provide the respiratory equipment, and this capacity is very limited in many African cities,” said Michel Yao, head of emergencies in WHO’s African Regional Office, in an interview with National Public Radio. That lack of supportive care could lead to a much higher death rate in poor and underserved regions.

At least a dozen R&D biopharmaceutical companies are working on vaccines, antivirals or other treatments to confront the fast-spreading coronavirus, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers, in an interview Monday with Health Policy Watch. The Chinese government has, meanwhile, authorized initial research or exploratory trials of some 30 existing anti-viral treatments developed to treat other serious viruses, including Ebola and HIV, as well as other coronaviruses such as SARS and MERS. Still, it may be some time before one or two of those being tested shows evidence of efficacy against this new virus.

And in the absence of effective medicines, providing good supportive care and preventing further infection spread, will be the main things that health care systems can do to combat the virus.

And that is why, for the moment, WHO’s Director General is placing his bets on “containment” strategies to slow the virus spread outside of China, what he is wont to call “a window of opportunity.”

“We are having a real problem in our hands, and we must take what is happening now seriously,” he said.  “I have a great concern that if this virus makes it to a weaker health system, it will create havoc. It will. For now, it doesn’t seem so, but this doesn’t mean that it will not happen. It depends on how we lead this response and how we respond to the outbreak,” he said.

Describing the virus as “Public Enemy Number 1,” the WHO Director General said: “The world talks about terrorism.  But to be honest, a virus is more powerful in creating economic, social and political upheaval than any terrorist attack.”

Grace Ren contributed to this story – Updated 12 February 2020

 

Image Credits: NIAID, Studio Incendo.

“We all have a vested interest to stop this epidemic,” says Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). As WHO on Tuesday convenes a Global Research & Innovation Forum to rapidly ramp up R&D, Cueni spoke with Health Policy Watch  about what he describes as  “the extraordinary willingness of everyone involved – regulators, pharma companies, public health institutes, and many others – to reach out and work collaboratively to respond to the 2019_nCoV.”

Thomas Cueni, director general of the IFPMA

Health Policy Watch: In terms of the R&D response to the coronavirus crisis, which has taken China and the world by storm, can you give a broad overview of what is going on the R&D front? 

Thomas Cueni: This is clearly a rapidly evolving situation, one where it is important to acknowledge how quickly things have moved in just a few weeks.  On 9 January 2020, the Chinese health authorities and the World Health Organization (WHO) announced the discovery of a novel coronavirus.  A virus that was confirmed as the agent responsible for the pneumonia cases and for which there are no known effective therapies.

Then in a matter of days, (11-12 January 2020), the Chinese authorities shared the full sequence of the so called 2019-nCoV genome, as detected in samples taken from the first patients.  Sharing the sequence of the virus is crucial for the development of specific diagnostic tests and the identification of potential treatment options.

Coronavirus spike protein structure: Enveloped viruses responsible for 30 percent of mild respiratory infections and atypical deadly pneumonia in humans worldwide. This illustration shows a viral membrane decorated with spike glycoproteins; highlighted in red is a potential neutralization site, a protein sequence that might be used as a target for vaccines. (Photo: NIH/David Veesler, University of Washington)

From that moment onward, the scientific community was able to start getting to grips with the new threat posed by the novel coronavirus.  As a first step, data- sharing channels are a must for researchers to mobilize.  Fortunately, the Global Initiative on Sharing All Influenza Data/GISAID Initiative, set up twelve years ago, was immediately pressed into action to share the information across their network.

From this point, it was possible for collaborative R&D platforms to begin to look at how they could respond.  CEPI (Coalition for Epidemic Preparedness Innovations), announced as early as 23 January 2020, that some companies were already lined up and ready to initiate vaccine development.  Since then, the European Innovative Medicines Initiative (IMI), a European Union public-private partnership with the pharma industry, has also begun looking into establishing collaborative initiative on 2019_nCoV therapeutics and diagnostics.

What characterizes the R&D approach for the novel coronavirus is that we are NOT starting from scratch.  The global collaborative research community has responded to health crises before.  SARS, MERS, and Ebola have, all in their own ways, forged pathways for collaboration to accelerate development of resources to tackle this new outbreak.  The 2016 WHO R&D Blueprint for Action to Prevent Epidemics, which put forward funding & coordination models for preparedness and response has clearly been important in helping pull together this week’s Forum to fast track R&D for the novel coronavirus.

HP-Watch: An important part of the R&D effort will be directed towards identifying/repurposing existing medical treatments –  Are there any promising existing treatments out there so far that have come on your radar – we were hearing about chloroquine and HIV drugs as one alternative last week?

Cueni: One of the main actions that the China government has already started to investigate is whether existing anti-viral drugs could be successfully repurposed to treat this novel type of coronavirus.

It has already authorized to test 30 compounds against 2019_nCoV. One of the key ones being Remdesivir, a new (experimental) antiviral drug by Gilead Sciences Inc. aimed at infectious diseases such Ebola and SARS. We understand that this treatment will be tested by a medical team from Beijing-based China-Japan Friendship Hospital for efficacy in treating the novel coronavirus.

This is just one of the experimental drugs that have not been approved for use to treat the novel coronavirus by drug regulators but that are in the frame to be repurposed.  Scientists in academia and companies are reviewing existing compounds and research. We have learnt about AbbVie’s Lopinavir – Repurposed HIV protease inhibitor (under the trade name Kaletra) as well.  Interferon and Oseltamivir which were used to treat some patients with MERS are also being tested.

Pharma industry associations such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) have issued a call to their members to identify suitable assets in their libraries that could be utilized in the fight against coronaviruses.  Relevant assets include diagnostics and biomarkers, approved therapies, or compounds in development that could be repurposed for use in treating patients with the coronavirus.  EFPIA members have also been asked to identify any ACE inhibitors (used to dilate vessels and lower blood pressure), protease inhibitors (antivirals widely used to inhibit HIV)  or immunotherapies that could be relevant in the context of CoV.

Artificial Intelligence is finding its place in the process, and is being used to mine through medical information to find drugs that might be helpful for tackling the novel coronavirus. Overall, there has been an extraordinary willingness of everyone involved – regulators, pharma companies, public health institutes, and many others – to reach out and work collaboratively to respond to the 2019_nCoV.

HP-Watch: As for vaccines, the new Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI) seems to be leading the search.  And it has signed a collaboration agreement with GSK as well as a number of other private sector partners.  However, Anthony Fauci, director of the US National Institutes of Health/National Institute of Allergy and Infectious Diseases, has pointed out that any vaccine would take at least a year to develop and approve, so the real solutions will have to be focused on “good public health measures” for now.  Any thoughts on this and the timeline?

Cueni: CEPI is clearly well positioned to demonstrate what the WHO rightly underscores as the importance of global collaboration among the public and private sector. The funding and research landscape for diseases of epidemic potential has evolved since the SARS and Ebola outbreaks.

Developing and approving repurposed or new diagnostics, vaccines and other treatments will all vary greatly. Clearly, the jury is out in terms of how long it will take; and lest we forget, an essential condition for better R&D preparedness and response is the availability of funding.

That notwithstanding, at least a dozen R&D biopharmaceutical companies are working on vaccines or antivirals and other treatments to help those infected with the fast-spreading contagion.

I’ve spoken to Thomas Breuer, chief medical officer of GlaxoSmithKline’s (GSK.L) vaccine unit, who said it was working with developers by providing a technology that could make their vaccines more potent.  He gives a timeframe of at least 12 to 18 months to develop an effective vaccine.

HP-Watch: With the efforts that are already going on, what more can this urgent  R&D meeting in Geneva called by WHO accomplish to advance critical public-private collaboration on R&D?   

Cueni: This week’s forum is timely, and the agenda will hopefully allow to scope out many of the R&D challenges and help identify the possible gaps.

The fact it was possible to quickly organize and assemble such a gathering of so many experts, including the R&D biopharmaceutical industry, is proof that there is today a clearly identified global health community that can be mobilised at short notice – I guess it is a positive legacy of past epidemics.

I think it would be wise to let the meeting take place before passing judgement on what further public-private collaboration is needed.  We have some good platforms in place such as CEPI and IMI who are as we understand going to contribute to the meeting this week.  Hopefully the resulting research roadmap and governance framework for the tackling of the novel coronavirus that will come out from the forum will recognize the ongoing contributions and role of the R&D biopharmaceutical industry.

HP-Watch: Regarding protective equipment, WHO raised an alarm last week about hoarding and price gouging for specialized masks and other PPE devices that health workers need desperately — and they stressed that this can happen at various points on the supply chain, from rubber plantation upward.  What measures can, or is, IFPMA taking to facilitate industry collaboration on this issue all along the supply chain?

Cueni: Panic, hording and speculation clearly have the potential to undermine the response to this public health epidemic. The R&D biopharmaceutical industry is going to great lengths to respond appropriately with the measured urgency that the situation demands. Many IFPMA member companies responded swiftly in the first week of the epidemic being announced to support the Chinese government with donations for diagnostics and protective equipment.

IFPMA and its members are monitoring the situation in China closely. R&D biopharmaceutical companies are working proactively to monitor their supply chains in order to prevent and mitigate potential shortages through close coordination with national regulatory authorities and other global stakeholders, including the World Health Organization.

Protective suits, surgical masks and respiratory masks
for health workers in China are loaded onto a truck at UNICEF’s global supply hub in Copenhagen on 28 January 2020.

HP Watch: In terms of the sharing of vital information about pathogens, to expedite research into therapies and vaccines, you recently noted that the Nagoya Protocol, which aims to ensure a country’s control over the genetic materials of indigenous plants and animals species, as part of biodiversity protection, needs to be urgently amended to exclude pathogens – otherwise this could greatly impede their sharing.  Can you please explain this complex issue.

Cueni: The Nagoya Protocol (NP) on Access and Benefit Sharing (ABS) is a legally-binding, supplementary international agreement to the Convention on Biological Diversity (CBD). Its objective is the fair and equitable sharing of benefits arising from using genetic resources for the conservation and sustainable use of biodiversity. To put it simply, the Nagoya Protocol has the laudable aim of giving each country sovereignty over its biological resources.

Today, more and more countries are moving towards enacting the Nagoya Protocol in national legislation, interpreting it in a way that requires sharing of the genetic resource and their information to be subject to negotiation between two parties.  The inclusion of pathogens (as a genetic resource) under the NP was not directly addressed in the final text, and the decision was made to leave it to each Party to “pay due regard” to potential public health risks when implementing legislation.

As I recently wrote in First Opinion in STAT, applying the Nagoya Protocol in the case of the novel coronavirus could have hindered or even prevented the global collaboration required to find new treatments or vaccines. Luckily, China has seemingly not followed Access and Benefit Sharing (ABS) requirements when it discovered the novel coronavirus 2019_nCoV.  In principle, a country with such a new virus could have embarked on discussions with each country, one by one, about how to share the sequence of this pathogen.

While we are today focusing on putting all our efforts on the novel coronavirus; there are other examples where difficulties can arise.  For example: in the case of seasonal influenza vaccines, the WHO acknowledged that there have been instances where sharing of seasonal influenza virus samples with WHO has been hindered, or halted altogether, on the grounds of conflicting or unclear local ABS legislation. This is concerning. If the WHO cannot fully see what strains of influenza viruses are circulating, the probability of them being able to make an incorrect recommendation with regards which strains to include in seasonal vaccines, increases quite substantially.

I firmly believe it is in the world’s best interests to promote trust and fairness for the sake of global public health by making the sharing of pathogens swift and predictable.  We must question the sense of retaining pathogens within the scope of the Nagoya Protocol and associated national legislation. It is in the interest of global public health and epidemic and pandemic preparedness for the international community to work towards an effective and internationally coherent approach to exempt pathogens from the protocol.

HP-Watch: As for the WHO’s Pandemic Influenza Preparedness (PIP) framework – which the WHO Executive Board (EB) also reviewed at its meeting last week – how does that framework fit into the current crisis?  Is it relevant, or not, in expediting needed R&D?

Cueni: The main objectives of the PIP Framework are to improve pandemic influenza preparedness and response, and strengthen the protection against the pandemic influenza by improving and strengthening the WHO global influenza surveillance and response system WHO GISRS, which includes a global network of national influenza centres, WHO collaborating centres and other research laboratories. The novel coronavirus brings the advantages of this network sharply into focus.

The PIP framework has as its objective to provide a fair, transparent, equitable, efficient, effective system for all.  In addition to ensuring that it operates on equal footing for all, it underscores the need for the sharing of H5N1 and other influenza viruses with human pandemic potential; as well as providing access to vaccines and sharing of other benefits.

The PIP Framework was adopted in 2011, but we have not yet seen its principles put into practice. It should also be noted that influenza is quite a unique situation, where potential manufacturers of a pandemic vaccine can leverage on developing and distributing seasonal vaccines annually, with global pandemic preparedness being underpinned by seasonal vaccine coverage; no other emerging virus can claim the same.

As the PIP Framework itself is not legally-binding for Member States, so far very few countries have made specific provisions for it in their national legislation. This means that, in the event of a pandemic, a country could refuse to immediately share their pandemic virus samples on the grounds of conflict with local ABS legislation.  This could lead to delays as bilateral contracts are negotiated,

This creates a situation of inequity where some countries include public health provisions in their local legislation, and are willing to share with the global community, but others do not on the basis that the Nagoya Protocol is an environmental piece of legislation.  The fear I have is that many legislators are not even aware in passing this legislation that public health could be impacted.

HP-Watch: Any other observations from the recent WHO EB debates on PIP, Ngoya and emergency preparedness ?

Cueni: I think that we cannot under-estimate the importance of having systems in place to make sure that the global health community can act fast to tackle threats to public health. The need for collaboration and alignment that are underpinned by effective networks and sharing platforms are key.

While the Executive Board had to deal with many tough questions, let us not lose sight of what is happening in Wuhan and beyond. My first thoughts are with all those affected by the outbreak of the novel coronavirus (nCov-2019).

The World Health Organization is clearly pulling out all the stops to handle this public health emergency.   The R&D biopharmaceutical industry is supporting the global community and the WHO; as an industry we are fully committed to joining global efforts to care of those affected, contain the outbreak and develop resources to tackle future outbreaks.

HP-Watch:  Other issues you would like to address at this critical moment – in terms of how to ensure what Tedros described as “solidarity, solidarity, solidarity” between public and private sectors.   

Cueni: Since the WHO declared the coronavirus a Public Health Emergency of International Concern on 30 January 2020, their continued leadership will be crucial in helping ensure an effective and appropriate response to this public health threat.

As a science-driven industry that aims to address some of the world’s biggest health care challenges, the R&D biopharmaceutical industry clearly has a role to play in developing new and improved medicines and vaccines to help respond to this epidemic.  The industry is fully supportive of efforts that will ensure the scientific community can respond quickly to the challenges this epidemic faces.

There are a number of factors today that give me hope that the situation can be managed.  Firstly, rapid access to the virus has speeded up the process of kick starting the search for solutions, secondly, there is global recognition, funding and structures in place to share the burden of R&D.  Last but not least, there are tried and tested sharing platforms in place for influenza that can be leveraged.

Epidemics are a time when we are all starkly reminded that putting up fences across the global health community does not work.  We all have a vested interest in trying to stop the epidemic from spreading, especially to countries with weaker health systems – this would be an absolute tragedy.  We all have a vested interest in finding treatments and preventative vaccines as soon as possible.

 

Image Credits: NIH/David Veesler, University of Washington, IFPMA , Prachatai.

“Containment” remains the main objective of the battle against the coronavirus, said WHO’s Director General Dr Tedros Adhanom Ghebreyesus on Monday, following a weekend where reports of new virus clusters in the United Kingdom and France raised fresh concerns about the virus capacity to spread rapidly beyond China’s borders.

The WHO Director General spoke to press after a weekend uptick of freshly reported cases of the mysterious new virus (2019-nCoV) in China as well as abroad.

In China, there were 42,359 confirmed cases and 1012 deaths as of Monday night – passing the watershed mark of the nearly 800 deaths recorded in the SARS epidemic of 2003-2003. Outside of China there are now 319 cases in 24 countries, with one death, WHO reported.

The new cases abroad included 5 adults and a child in France and 5 more people in the UK and Spain. All contracted the virus from the same so-called “superspreader,” a British man who had attended a sales conference in Singapore, also attended by an infected man from the virus epicentre in Wuhan, China. The British man had then hopped to a ski holiday in France, staying at a rented chalet that he shared with friends, before returning home to Britain.

WHO Director General at Monday press briefing

“In recent days we have seen some concerning instances of onward transmission from people with no travel history to China, like the cases reported in France yesterday and the UK today,” said Dr Tedros at the press briefing. “The detection of this small number of cases could be the spark that becomes a bigger fire. But for now, it’s only a spark. Our objective remains containment. We call on all countries to use the window of opportunity we have to prevent a bigger fire….We should work hard as one human race to fight this virus before it gets out of control.”

At least eight other cases of the coronavirus among Singaporeans, Koreans and Malaysians have been linked to the private Singapore conference event, according to Bloomberg News reports on those who fell ill. However WHO emergencies head, Mike Ryan, said that it was “too early to consider the Singapore conference cluster as a superspreader event.”

Despite new reports of conference cancellations in Singapore, which has the largest number of cases reported outside of China, Ryan said that WHO isn’t recommending that mass meetings be called off.

“Certainly it’s a concern when people come together and move apart,” Ryan said. “But you can’t shut down the world here. We cant say that we are going to cancel every event. Where is the limit to this?  We need to remain calm and measured, ask what are the risks and how can those risks be minimized?”

Global Research Forum Starts Tuesday – WHO Team In China

Meanwhile, a hastily-convened Global Research and Innovation Forum was due to kick off a meeting at WHO headquarters in Geneva on Tuesday, in a quest to find more answers on treatments for the mysterious virus.

The meeting, involving member states, the private sector, other UN agencies and global research institutions, will review existing knowledge about the nature of the virus, clinical symptoms and its transmission; infection prevention and control, particularly in health care settings; potential drug treatments; and prospects for the rapid development of vaccines.

The aim is to identify target product profiles for new treatments, and then ensure that there is both institutional support as well as financing to roll them out as soon as possible, said Dr Tedros at the press briefing.

“This is an amazing initiative to centralize our knowledge.. to identify the gaps, what are the specific research priorities and how do we accelerate action o n the most needed medical technologies and vaccines.  How are these priorities going to be turned into product profiles? How will those be financed? How are we going to ensure accessibility to the products? This is not just a scientific discourse.. we need to ensure the broader outcomes of that process so that the results are available to all.”

Dr Tedros said he hoped that the forum would serve as a “leapfrog moment, in terms of coherence and priority setting, setting that roadmap so we all travel together in coming months.

Simultaneously a small WHO advance team arrived Monday in Beijing to lay the groundwork for the arrival of a larger group of international researchers, to support the Chinese research and disease control effort.

Ryan said that the international team was planned to include about 10-15 experts, representing “the best of China and the world.” The team would be “fully-empowered” to explore the challenges posed by the virus and opportunities for bringing the epidemic more rapidly under control.  “We need to give them time to interact, to step back and let the scientists do the work and see what they come up with,” said Ryan.

Thirteen African Countries & Iran Equipped with Laboratory Tests for Coronavirus

Meanwhile, thirteen African countries, as well as Iran, have now been specially equipped by WHO with laboratory tests to identify the novel virus.  Those countries included Cameroon, Cote d’Ivoire, the Democratic Republic of Congo, Egypt, Ethiopia, Gabon, Ghana, Kenya, Morocco, Nigeria, Tunisia, Uganda and Zambia.

Another shipment of 150,000 tests is being assembled in Berlin this week, to be sent to more than 80 labs worldwide. These are among the 168 labs globally that have been identified as having the right technology to use the tests, WHO said. Last week the African Centers for Disease Control conducted a training in Senegal with lab technicians from 12 countries on use of the diagnostic tests. Another training will take place in South Africa next week.

“Without vital diagnostic capacity, countries are in the dark as to how far and wide the virus has spread – and who has coronavirus or another disease with similar symptoms,” said Dr. Tedros.

Latest WHO dashboard showing coronavirus epidemic distribution as of Sunday evening. Cases reported as of Monday morning bring the total up to 40,554 worldwide.

Image Credits: WHO .

Governments are falling behind in the battle against a “global epidemic” of noncommunicable diseases (NCDs), say two new reports by the World Health Organization and the NCD Alliance, launched on the first day of a Global NCD Alliance Forum in Sharjah, United Arab Emirates.

Many countries are stalled in implementing basic prevention policies, such as reducing tobacco and harmful alcohol consumption; promoting health eating and physical activity; and strengthening early NCD detection and treatment in primary health care systems, according to the WHO NCD Progress Monitor 2020 report, released Monday. Such policies are among the so-called WHO “Best Buys” for NCD prevention.

Only 19% of 194 countries surveyed have fully implemented tobacco taxes; just 20% are meeting targets for salt-reduction, and one-third of countries are providing basic NCD health services such as drug therapy and counseling.  And less than half of the 194 countries surveyed met at least two of the ten targets that would reflect progress against NCDs – a “grim sign” as the report calls it.

Speakers of the opening plenary at the Global NCD Alliance Forum

“Countries are still failing to meet basic indicators. If they continue on this path then millions of people will die needlessly from heart attacks, stroke, diabetes, cancers, and respiratory disease.” said Ren Minghui, assistant director-general for Universal Health Coverage, Communicable & Noncommunicable Diseases at WHO in a joint press release, issued with the NCD Alliance at the Global NCD Forum.

According to the WHO report, about a quarter of all countries also do not have a national NCD plan in place, and one-third of all countries lack time-bound national targets to drive and monitor progress in the overall Sustainable Development Goal of reducing deaths from NCDs by one-third by 2030.

Data from the second report, the NCD Alliance’s Bridging the Gap backs up this stark reality. The report, based on surveys of national and regional NCD alliances, found that only 20 percent of members believed that their country is on track to meet global NCD targets. Some 82% of members did not believe their country had sufficient accountability mechanisms to ensure NCD targets were being met.

“This report confirms what we’ve long suspected – that the United Nations targets aimed at reducing NCDs are not bearing fruit on the ground,” said CEO of the NCD Alliance Katie Dain. “Unless the gaps in the response are addressed, we’ll be faced in 2030 with a tsunami of disease-related impacts, both human and economic, that could have been avoided.“

NCDs account for over 70% of all deaths worldwide. An estimated 41 million people die from NCDs such as cardiovascular disease, cancer, stroke, diabetes and respiratory illnesses every year.

5 Major Gaps Impeding Progress

The Bridging the Gap report points to gaps in five major areas that are impeding progress – political leadership, investment, care, community engagement, and accountability.

The report found that political commitment to NCDs at the country level is low – only Brazil and Turkey have implemented all five of the tobacco demand reductions measures from the Framework Convention on Tobacco Control for example. Additionally, while domestic financing in NCD control is increasing in some places, international funding for NCDs remains a paltry 2% of total multilateral aid for health.

Only about a third of all countries provide drug therapy and counseling to prevent heart attacks and strokes, and just 40% of countries provide palliative care in primary healthcare or in the community.

““We know what works — primary health care, with its emphasis on promoting health and preventing disease, is the most inclusive, effective and efficient way to reduce premature mortality from NCDs and promote mental health and well-being,” said Minghui.

The report also finds that countries are lagging in engaging communities of people affected by NCDs, and creating independent, civil-society led accountability mechanisms for monitoring progress on reducing NCDs. These measures, the report says, are crucial to push forward action on political promises for NCD control.

“The evidence before us is indicating that we need to move well beyond the health sector to really make a dent in the epidemic. We need to address the root causes of NCDs, in the food we eat, the water we drink, the air we breathe and the conditions in which people live, work and play,” said Minghui.

Image Credits: NCD Alliance/Gilberto Lontro, NCD Alliance.

[STAT News]

As China struggles to contain an epidemic caused by a new coronavirus, science is racing to develop vaccines to blunt the outbreak’s impact. Central to the effort is CEPI — the Oslo, Norway-based Coalition for Epidemic Preparedness Innovations — a global partnership created to spearhead development of vaccines in just this type of emergency.

Two weeks after China announced on 7 January that a new coronavirus had ignited a fast-growing outbreak of pneumonia cases in the city of Wuhan, CEPI announced funding for three efforts to develop a vaccine to protect against the virus, currently known as 2019-nCoV. A week later, it added a fourth. Just days after that, it announced major vaccine manufacturer GSK would allow its proprietary adjuvants — compounds that boost the effectiveness of vaccines — to be used in the response.

But to date, most of the CEPI-funded efforts are focused on partners that don’t have the production facilities to make a commercial product in bulk. They include Inovio, a partnership between Moderna and the National Institute of Allergy and Infectious Diseases; CureVac; as well as the University of Queensland, in Australia. All use innovative approaches that offer the promise of unprecedented speed to the development of a vaccine candidate. But none of the companies has yet licensed a vaccine.

Read the full interview on STAT News.

Image Credits: CEPI/University of Queensland.

The world is facing a “severe disruption” in stocks of personal protective equipment vital for health workers to fight the novel coronavirus  raging through China’s Hubei Province and threatening other countries worldwide, said WHO Director-General Dr Tedros Adhanom Ghebreyesus at a Friday press briefing.

The Director-General spoke as cases of the new (2019-nCoV) virus continued to rise inside China to 31,211 confirmed infections on Friday. Abroad some 270 cases were confirmed. However, for the second day running, the 24-hour increase in new cases was slightly lower, Dr Tedros noted.

Nurse wearing a specialized mask, cap, gown and gloves measures the body temperature of a coronavirus patient in Hubei TCM Hospital. Such gear is vital to protect health workers from infection.

“Fewer new infections have been registered in the last two days, which is good news, but to be taken with caution,” Dr Tedros said. Overnight Tuesday, there were 3,925 new cases in China, as compared to 3,697 overnight Wednesday and 3,151 overnight Thursday to Friday morning.

However the number of new cases reported elsewhere in the world was still increasing every day, with a total of 54 new cases recorded overnight Thursday in 24 countries. That included cases on a cruise ship quarantined in Tokyo’s harbor, where some 61 people among over 3,000 passengers have now been confirmed to be infected with the virus.

In the face of worldwide public fears over infection, demand for specialized masks with N-95 or other high-quality filters and other personal protective gear usually worn by health care professionals is “100 times greater” than normal, said Dr Tedros, and that has depleted stockpiles, created a backlog of orders while sending prices through the roof.

(left-right) Mike Ryan, Dr Tedros, Maria Van Kerkhove

He said he had convened a teleconference with equipment manufacturers on Friday, to asking them to avoid hoarding materials and ensure a more targeted release of stocks to front-line workers in China and elsewhere that need the materials the most.

“When there is a shortage, there can be hoarding to sell at higher prices. There is a moral issue here. That is why we had a discussion with manufacturers,” said Dr Tedros. “It’s really important that we prioritize this for people who need it most, health workers and people caring for their families.”

Added Mike Ryan, WHO’s head of emergencies, “At every stage of the supply chain there is a possibility for disruption, for profiteering. We need the public and the private sector, the wholesalers and retailers” to come together, he added.

Studies Provide Initial Profile Of Seriously Ill Patients

Meanwhile, new a study that analysed the profile of 138 patients hospitalized in Wuhan for the virus between 1-28 January, found that the median age of those seriously ill was 56 years old – with the range between 22 and 92 years of age. Some 54% were men.

The most common symptoms at onset of illness were fever, fatigue, dry cough (82), muscle pain (34.8%), and breathing difficulties (31.2%), according to the study published in JAMA, the Journal of the American Medical Association. Less common symptoms were headache, dizziness, abdominal pain, diarrhea, nausea, and vomiting. A total of 14 patients (10.1%) initially presented with diarrhea and nausea 1 to 2 days prior to development of fever and other symptoms.

Of the patients admitted, 36 (26.1%) were admitted and transferred to an intensive care unit, (ICU) because of the development of organ dysfunction. The median durations from first symptoms to hospital admission, and acute respiratory distress syndrome was about 5 days. Of the 138 patients, 64 (46.4%) had 1 or more coexisting medical conditions, including hypertension, diabetes, cardiovascular disease, or cancer.  As of 3 February, 34% of those patients had been discharged, after an average stay of 10 days. Among those hospitalized, 4.3% had died.

Among the entire population of those infected, some 82% of have only mild cases, while some 15% are severely ill, and another 2% have died, said Maria Van Kerkhove, a WHO emergencies expert in Friday’s briefing.

New Research Suggests Pangolin, Scaly Mammal Used In Traditional Medicines, May Be Coronavirus Source

Meanwhile, a report published in Nature suggested that the Pangolin, a scaly mammal that is an endangered species in Africa and Asia, but still popular for its meat as well as uses in traditional Chinese medicine, may have been the source of the coronavirus that infected humans in Wuhan.

Two researchers at South China Agricultural University in Guangzhou, Shen Yongyi and Xiao Lihua, announced the preliminary finding in a press conference on Friday, based on a genetic analysis of coronaviruses that the mammals carry, which are 99% similar to that of the 2019-nCoV virus circulating in human populations.  The United Nations Environment Programme and World Wildlife Fund WWF have been waging campaigns to save the world’s only scaly mammal, often described as “the most trafficked” on the plant.  The eight pangolin species living in Africa as well as in Asia, are protected by international and national laws, but they are threatened with extinction by illegal wildlife poaching and trade.

Scientists have previously suggested that the coronavirus first originated in bats. But it is also likely that the virus was transmitted to humans by another animal on sale at a wild animal market in Wuhan, China, where the outbreak first occured. If the scientists are proved correct, it would be the second time that a coronavirus that causes severe acute respiratory disesase spread from a traditional Chinese food market to trigger a major global disease outbreak.  Severe Acute Respiratory Syndrome, or SARS, which caused the 2002-03 outbreak, originally spread from bats to civet cats to humans.

 

WHO Executive Board Acts On Emergency Preparedness – Travel Restrictions Skyrocket

Meanwhile, on Saturday, the final day of a week long meeting of WHO’s Executive Board, the governing body approved a draft World Health Assembly resolution on “Strengthening Preparedness for Health Emergencies; Implementation of International Health Regulations“. 

The United States dissassociated from one provision that referred to the need to deliver “sexual and reproductive health, and maternal, newborn and child health services” during health emergencies. 

The final text of the disputed paragrah recognizes “the need to involve women, youth, people with disabilities, and older people in planning and decision-making, and the need to ensure that during health emergencies, health systems ensure the delivery of and the universal access to health-care [services, including strong routine immunization, mental health and psycho–social support, trauma recovery, sexual and reproductive health, and maternal, newborn and child health].”

The resolution, which will go before the WHA for final approval, sets out a detailed list of measures that the UN, global community and member states should take to improve international coordination as well as national preparedness for emergencies.

The resolution also calls on member states to adhere more diligently to the WHO International Health Regulations, a binding convention that governs international and national health responses to emergencies such as the coronavirus epidemic.

Friday’s WHO outbreak situation report noted that 72 out of 194 member states have now implemented some form of travel restrictions as a result of the epidemic. That included 10 more countries that had applied restrictions in just the past 24 hours, the report stated,

Among the countries that had imposed restrictions, however, only 23 had filed official reports with WHO regarding the measures taken and their public health rationale, as they are required to do under the IHR.

Updated 8 February 2020

Image Credits: China News Service.

After a total of 12.5 hours of consultations in five informal meetings, a bloc of countries led by Thailand won WHO Executive Board approval for a landmark decision to develop a new ten year-action plan to reduce the harmful use of alcohol.

Representatives of Norway and the European Union joined as co-sponsors in a compromise decision, which nonetheless saw an earlier reference to the possible development of an international legal instrument removed.

Civil society actors who had lobbied hard for the new action plan, described it as a “historic moment” but lamented that the “overarching need” for more binding international measures to limit alcohol marketing and advertising, particularly to youths, had not been answered.

However, the compromise text asked WHO to prepare a technical report on the harmful use of alcohol related to cross-border advertising, including marketing targeted towards youth.

The compromise also greatly softened a reference to WHO’s own internal policies, which generally tolerate alcohol consumption in office cafeterias and official events, including at the Geneva Headquarters.  An earlier draft had asked WHO to exercise of “global leadership” by refraining from providing or selling alcohol on all WHO-campuses and at WHO-sponsored events. The amended text simply acknowledges that some WHO offices do not offer alcohol as a practice.

Thailand expressed that the text was amended “in the spirit of compromise to move this very important agenda forward.”

Still, the Thailand delegation urged WHO to take action outside of the Executive Board framework and consider an “alcohol-free” policy for the Organization in the coming months.

In a win for the bloc of sponsors, the revised text retained a reference to alcohol’s carcinogenic properties, which had been opposed initially by the United States.

“Cancer is one of the diseases linked causally to alcohol, “ said Germany, on behalf of the EU. The delegate also expressed concern about the “cross-border “digital marketing” of alcohol towards minors.

“We have to do better,” Germany concluded. The reduction of the harmful use of alcohol “cannot be addressed effectively without cross-border collaboration.”

Norway, the second co-sponsor added to the resolution last night, has also made harmful alcohol use reduction a key cornerstone of a new development aid policy that focuses on non-communicable disease prevention and control.

In a statement, the NCD Alliance lauded the action by member states, saying, “Today’s decision, adopted by consensus, will ensure alcohol harm will be given greater time and attention….We are particularly pleased to see the EU co-sponsor the decision and call on all EU member states to walk the talk by tackling alcohol as a carcinogen in the EU cancer plan announced earlier this week on World Cancer Day. The EU Cancer Plan which so far overlooks alcohol as a major risk factor for premature death, in the heaviest alcohol drinking region in the world.

“The proposed new Action Plan holds great potential to provide a stronger whole-of-government and inter-agency framework for accelerated action, accountability and impact. It is also an opportunity to address barriers to progress, such as by ensuring a robust monitoring and accountability framework and providing guidance on managing alcohol industry conflict of interest and interference.

“It is important that the Action Plan addresses industry interference as a barrier to alcohol policy progress, as it has been acutely apparent that throughout recent months and days, the alcohol industry were actively lobbying Member States in efforts to dilute existing evidence based recommendations policies which are known to reduce alcohol harm, as well as undermining efforts by Member States to secure a stronger global response to alcohol,” he addded.

“We are also very pleased to see that attention will be given to the impact of cross-border alcohol marketing, particularly its impact on youth and adolescents. Marketing of health harming products such as alcohol and unhealthy food and drinks is insidious and inadequately regulated. The evolving marketing and sponsorship landscape demands far greater scrutiny and regulation to protect the health and wellbeing of people across the life-course.”

Maik Duennbier, director of Strategy and Advocacy at Movendi International, an alcohol abuse NGO, told Health Policy Watch that the EB action follows a decade of inertia. “It has taken 10 years for a substantive discussion of the global alcohol burden and the necessary policy response at the WHO governing bodies. Thanks to today’s decision, this will change: the issue will be on the agenda more often and more regularly,”

“But what this week of debating the response to alcohol harm has shown is: while we are where we need to be yet…  the action plan needs to be filled with bold targets and actions to turn the tide on alcohol harm. The overarching need is still a global binding treaty on alcohol to effectively protect the human right to health.”

Updating the WHO alcohol strategy was a key element of this year’s EB decisions on combatting NCDs. The EB recommendations also prioritize global action on cervical cancer control and stronger prevention and early detection services at the primary health care level.  A menu of treatment options for mental health is also under development along with a package of interventions for reducing air pollution risks and disease.

EB Members Urge WHO To Accelerate Roll Out Of New Polio Vaccine, Ensure Supply

Meanwhile the Executive Board also approved a recommendation urging WHO to accelerate the roll-out of a novel oral polio vaccine that could help reduce incidence of vaccine-derived polio virus – which was the cause of several polio outbreaks in Africa in 2019, according to WHO.

The new polio type II vaccine is expected to be available by mid-2020, Michel Zaffran, head of WHO’s Polio Eradication efforts, told the governing board.

The draft decision adopted Friday by the Board requested WHO to: accelerate the assessment and roll-out of the novel oral polio vaccine type 2, including through the “WHO Emergency Use Listing” procedure; and to initiate a process for prioritizing the “equitable allocation of limited supplies” of the novel vaccine.

The EB also urged WHO member states to expedite the processes for authorizing the importation and use of polio vaccines, including the novel vaccine on the basis of its emergency use listing, as well as stepping up domestic funding for vaccination.

Gabon, speaking on behalf of African states, said the decision represents a “major undertaking for the African region.”

Zaffran acknowledged that 2019 was “a very difficult year” for polio eradication, with wild virus outbreaks in Afghanistan and Pakistan as well. He underlined the need for stronger outbreak strategies in countries as well as stronger domestic resource allocation.

US Blocks Request for Report on Digital Marketing of Breastmilk Substitutes

In other EB action on Friday, Bangladesh requested the WHO to “collect data and prepare a comprehensive report to address digital marketing and promotion of breastmilk substitutes,” in line with the WHO Code of Marketing for Breast-milk Substitutes. However, the United States expressed concerns about the “resources involved” in conducting the study, ultimately leading to the request being tabled for further discussion.

The Bangladesh request was proposed as an amendment under an EB agenda item on “maternal, infant, and young child nutrition.” WHO and UNICEF both currently recommend exclusive breastfeeding until 6 months of age, with sustained breastfeeding up to 2 years. The Code of Marketing for Breast-milk Substitutes serves as strict guidance for marketing infant formula – which WHO called a “major factor in undermining efforts to improve breastfeeding rates” in a 2018 report.

Several countries supported Bangladesh’s request, including Benin on behalf of the Who AFRO region, and several countries of the PAHO region such as Guatemala and Chile.

The US, home to some of the largest infant-formula companies in the world such as Abbott, said that nutrition initiatives should “include the private sector” and initially declined to comment on Bangladesh’s proposed amendment.

However, once the decision on the amendment was brought to the floor, the US expressed concerns regarding the “implications of the amendment,” including reporting requirements from WHO Member states and other “resources” that would need to be involved.

“We respectfully ask for more time… We would be happy to continue the discussion into May,” said the US delegate.

Ultimately, the Chair of the EB proposed a compromise to suspend a decision on Bangladesh’s  request until Saturday, asking the WHO Secretariat to “facilitate discussions” on the matter.

Wider WHO guidance around nutrition and health was requested by several states – including a request from Austria asking for further guidance on how to measure childhood obesity in kindergarten and a plea from Sudan on behalf of the Eastern Mediterranean region to consider “conflict-affected countries” facing food insecurity and undernutrition. The discussion set the stage for the December 2020 Nutrition for Growth Summit in Tokyo, which will precede the release of new WHO Nutrition guidelines for 2021, including a specific roadmap for closing gaps for specific country needs.

EB Debates IP Protection, Access to Medicines

The Executive Board also approved a GSPOA that aims to balance access to medicines with innovation needs – but not without debate around intellectual property protection. The decision, which will now go to the May World Health Assembly for final approval, asks countries and the WHO to proceed swiftly on the implementation of recommendations approved by the 2018 World Health Assembly (WHA) on next steps for the 2008 Global Strategy and Plan of Action on Public Health, Innovation and Intellectual property. The European Union joined as a co-sponsor of the decision

Brazil, leading the charge on the draft decision, explained that the document is meant to renew the political push given by World Health Assembly in 2018 and 2019 on greater frameworks for discussions about medicines prices and the R&D costs of developing them. Germany, which fought alongside the United Kingdom during the last WHA against a resolution on price transparency of medicines markets, spoke for the European Union, co-sponsor of the draft decision. The German delegate, while acknowledging that millions of people have no access to medicines, said the issue should be tackled in a holistic manner, reflecting the complexity of the problem and considering the entire life cycle of medicines.

Still, the final decision left out more explicit language asking Member States to support disclosure of R&D costs; more explicit identification of supply shortages; and national commitments to allocate at least 0.01% of national gross domestic product to research “relevant to the health needs of developing countries.”

Instead, after five rounds of discussions, the final resolution simply left the door open to member states to consider such issues in the framework of national policies on patents and intellectual property rights. Low-income countries are accorded some flexibilities allowing them to override patents on certain medicines so as to increase access to generics and biosimilars, under the World Trade Organization’s (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The EB text also requests the WHO Director-General to report back by 2021 on the results of an informal consultation on drug price transparency, medicines shortages, and investments in research, including R&D costs.

Members of the EB were clearly reluctant to suggest more explicit language that might somehow impinge on intellectual property rights that protect medicines patents, which industry leaders are an important driver to R&D for new health products. The United States said intellectual property is “the corner stone of medical innovation,” while Switzerland said the protection of IP rights should be discussed at the World Trade Organization and at the World Intellectual Property Organization (WIPO). WHO’s discussions, the Swiss delegate said, should be focused on price transparency and on efforts to stop shortages.

Even so, the decision was largely seen as a step forward by civil society actors on an oft-polarized issue.

Jamie Love, director of Knowledge Ecology International, told Health Policy Watch, “This decision strengthens the mandate for the WHO to work on transparency of medicine prices.” We hope the member states will also spend some time looking at the R&D Observatory, which has failed to have much of an impact so far, at the WHA.”

Mariângela Simão, WHO assistant director-general of Access to Medicines and Health Products said the WHO has made substantive progress in response to some member states’ reticence to address the issue. The sheer number of recommendations in the first 2008 Global Strategy and Plan of Action (108) was paralysing, she said, and when in 2018, the recommendations were pared down to just 33 it became much more manageable.

Simão added that WHO, along with the WTO and WIPO, were working on the latest update to a trilateral study on “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade.” The report is due to be launched just before the WHA in May.

Israeli Proposal on Removal of Special Item on Palestine Knocked Down

Also at the Executive Board, Israel submitted once again a request to change the status of a WHA agenda item on health conditions in the occupied Palestinian territories and Golan Heights, where the matter is discussed every year, separately from other health and humanitarian emergencies. But the request was denied by the EB in a 15-7 vote.

“We heard many times that WHO is engaged in international emergencies and assisting people around the world… yet none of these programmes is presented by the Secretariat in a standalone item, and none receive the attention they deserve in the limited time in the Assembly,” said Israel’s delegate, protesting the singling out of the Israeli-Palestine issue at every WHA.

The Secretariat’s report could still be presented “without opportunity for political attack against one Member State,” added the delegate. The Israel delegation also expressed disappointment over the withdrawal of a draft WHO report that had included details of Israeli health and humanitarian support to Syrians, which was supposedly suppressed by the Syrian government.

Syria quickly shot back, “once again, Israel is trying to misuse its membership in this technical forum to achieve political gains by returning to proposals that this board has rejected last year.”

Palestine, a permanent observer to the EB proceedings, joined in and added that they did not find “any justification” for Israel’s request to move the agenda item from WHA’s Committee B to Committee A, which effectively would give the matter less attention at the Assembly.

“Health for all is and remains our goal… as the DG has said, we have to show solidarity and cooperate,” said the Palestine delegate. “We shouldn’t be referring to purely political matters… in order to deal with a draft decision to deal with moving an item from Committee B to Committee A, especially when we know this is an issue we’ve been debating for years… at committee B.”

The Israel proposal was then brought to the table and shut down in a 15-7 vote against amending the agenda, with 10 abstentions by EB voting members.

Updated on 8 February 2020

Image Credits: Flickr/Steven Miller.

WHO member states were locked away in late-night negotiations over the shape of a proposed new WHO roadmap for reducing harmful alcohol consumption.

A group of member states, led by Bangladesh, Indonesia, Iran, Sri Lanka and Thailand, have been pressing the WHO Executive Board (EB) to support the rapid development of a tough new WHO approach to a health risk that claims 3 million lives a year – to replace the failed strategy of a decade ago.

The member states, supported by civil society groups combatting alcohol abuse and non-communicable diseases, want to see WHO embrace the development of binding “international instruments”, such as measures to reduce digital and cross-border marketing of alcohol products to adolescents.

A copy of the initial draft EB decision circulating among member states, and obtained by Health Policy Watch, also asks WHO to “exercise global leadership” by banning the sale and consumption of alcohol on WHO premises.

Finally, proponents want to highlight the fact that alcohol is a Group 1 carcinogen, according to  WHO’s own International Agency for Research on Cancer.

However, such measures have met with stiff opposition from a cluster of countries that have big alcohol industry lobbies, including Japan and the United States.

Civil society groups note that harmful alcohol consumption claims as may as 3 million lives a year, either directly through cancer, liver disease, heart attack and stroke, or indirectly, through alcohol-induced violence and traffic injuries.

And with a few striking exceptions, most notably Russia, the last decade has seen a worldwide increase in harmful alcohol consumption, particularly in low- and middle-income countries, said Nina Renshaw, of the NCD Alliance.

She spoke out on the alcohol issue at Wednesday’s EB debate, on behalf of the Union for International Cancer Control, Vital Strategies and the World Cancer Research Fund International.

Alcohol consumption and related deaths in different regions of the world

The group has called upon member states to: establish a new ten-year Global Action Plan on Alcohol, with a view to gaining World Health Assembly endorsement of the new plan no later than 2022.

The group also called upon member states to create an expert working group to come up with a roadmap for “delivering dramatic reductions in alcohol harm by 2030, including consideration of internationally binding instruments.”

Interviewed by Health Policy Watch, Renshaw said that member states’ Geneva missions had been subject to “harassment” by alcohol industry representatives over the past few months leading up to the EB discussion, which was to evaluate the old strategy and explore a way forward.

“Recognising the intense pressure applied by the alcohol industry to governments and Missions, we call on WHO to case bi-lateral dialogues with alcohol industry actors and call on Member States to publish public records of any engagement,” Renshaw stated in her formal message to the EB on behalf of the other NGO groups.

While the civil society groups are optimistic that a compromise formula can be reached on a draft EB decision before the EB governing board meeting ends on Saturday – it remains to be seen if the decision will lay the foundation for a strategy that can really reverse current trends in alcohol-related deaths and disease.

Image Credits: WHO, WHO .

As the number of novel coronavirus infections rose again on Thursday – to 28,060 confirmed cases in China and 225 abroad – a US Centers for Disease Control official raised the possible spectre that the epidemic could become a global “pandemic” – if countries fail to take assertive action now.

“While unclear how the situation will evolve, we are preparing as if it were the next pandemic – while hoping that it is not,” said Barbara Marston, head of the International Coronavirus Task Force, speaking at a US State Department teleconference for foreign press about the epidemic currently raging in Hubei Province, China.

Her remarks followed a statement Wednesday by US Senator Chuck Grassley, who said that while “not yet a pandemic, there are signs that it could develop into a worldwide threat.” Grassley spoke after receiving a classified briefing by the Department of Health and Human Services.

US Calls For WHO Technical Guidance On Travel Restrictions – WHO To Convene Global Research Forum 

In Geneva, the US meanwhile called upon the World Health Organization to provide more advice to countries about protective measures countries could take to protect themselves from new cases of virus arriving with travelers from China.

WHO Executive Board discussion on coronavirus outbreak, led by Deputy Director General Zsuzsanna Jakab and Emergencies Head Mike Ryan

Speaking at WHO’s Executive Board meeting Thursday, the US representative asked WHO to “provide technical advice to member states as to how they can implement appropriate travel restrictions consistent with the International Health Regulations (IHR) to minimize the spread, and complement the travel restrictions that China has put in place.”

WHO has generally opposed travel restrictions by countries outside of China – saying that the disease first needs to be attacked at its source in Wuhan and Hubei province, where tens of millions of people remain under lockdown.

Even so, some 22 countries have put in place measures ranging from cancellation of flights and visas to the temporary quarantine or barring of entry to people arriving from China.

In an afternoon press briefing WHO’s Emergencies Head Mike Ryan responded saying that, “Under the IHR, where countries have exceeded or appear to have exceeded those recommendations, we are bound to ask the country for the rationale,” he said, speaking in an afternoon press briefing. “The IHR does not deny or prevent a country from taking measures, but requires to justify the risk assessment. This is a very important balance.

(Left-right) Mike Ryan, Tedros Adhanom Ghebreyesus, Maria Van Kerkhove

“All risk assessment is local, so local dynamics and local capacity are important. Sometimes you have a limited toolkit and you have to use it in a certain way.  Sometimes you have to make decisions based on communities’ perceptions of fear.

But he added that travel measures such as quarantine, are generally too expensive and complex for low-income countries to undertake, and investments would better be spent in preparing clinicians and laboratories to handle the virus.

As compared to travel restrictions, he said WHO’s outreach has been focused on preparing health systems in low income countries to detect and diagnose the disease, if and when cases arrive, as well as to take appropriate infection control measures.

“High-impact quarantine measures are some of the most expensive measures to implement. Low-income countries have choices to make, and the real point of entry to a country [for a new infection] is a poorly equipped emergency room or  doctors’ clinic.

“We do support screening [at point of entry], but to have disease arriving to untrained health workers and unprepared in a clinical setting thats the worst thing. And we are focusing on weaker countries with weaker health systems to support the key parts of their health system… the last thing we need is the front-line health workers becoming victims.

“Where countries have more resources they can put in place more expensive measures.  You can argue about the value.. we want to extract the most from every dollar invested.”

Against the more dire predictions of a possible pandemic, Ryan also voiced one cautious note of optimism.

He noted that the overnight increase in new cases in China between Wednesday and Thursday of 3,697 confirmed infections had been slightly less than the whopping 3925 new cases recorded between Tuesday and Wednesday.

“Today is the first day that overall new confirmed cases dropped,” said Ryan, noting that the large 24-hour increase nonetheless remained a cause for significant concern.  The epidemic has so far claimed 564 lives in China, while there has been only 1 death abroad, officials also note, an indication that infection spread to other countries is so far being contained.

WHO To Sponsor Research Forum On Coronavirus Next Week

Meanwhile, WHO Director General Dr Tedros Adhanom Ghebreyesus said that the Organization would convene a global research and innovation forum next week, 11-12 February, to respond to the novel coronavirus (2019-nCoV).

He noted that currently there are no effective treatment tools or vaccines for the virus – and with tens of thousands of people ill, those are desperately needed.

“We don’t know the source of the outbreak. We don’t know what its natural reservoir is, and we don’t properly understand its transmissibility or severity. We have no vaccine to prevent infections and no therapeutics to treat them,” said Dr Tedros, at the Thursday press briefing.

“We are shadow boxing, we need to bring this virus out into the light so we can attack it properly.  So on February 11 and 12, we are convening a global research forum.  This will be a meeting of scientists from all over the world, including China, both in person and virtually. The aim of the meeting is to fast track development of effective diagnostic tests, vaccines and medicines.”

“A lot of donors want to help, but we need to direct them to support agreed priorities, rather than going off in different directions,” he added.  “I have said we need to be led be facts not fear, and science not rumours. That’s exactly what we’re doing. We are letting science lead.”
WHO Director General also said that he had convened a teleconference on Thursday with more than 200 United Nations Country representatives to brief them on the risks posed by the new virus, following a briefing Wednesday with senior UN leadership. “We are also mobilizing the full power of the UN system,” he said.

Human Rights Watch Protests Wuhan Lockdown

Meanwhile, Kenneth Roth, Executive Director of Human Right Watch, an advocacy group, took China to task over its handling of the coronavirus epidemic- on both public health and rights grounds, and noted apart from its welcomed prompt public genetic sequencing of the virus, China’s reaction has been a cover-up.

The criticism came just as one of the first doctors to sound the alarm about the new disease, 35-year old ophthalmologist Li Wenliang, tragically passed away from a battle with the novel coronavirus on Thursday night. Li was detained by police and asked to sign a statement swearing he would “not spread rumors” after he tried to warn members in a group chat about cases of a potential “SARS-like” illness in December. Li is survived by his pregnant wife and young child, according to tributes to the doctor circulating on Weibo, China’s Twitter equivalent.

“It may be good for political self-preservation but its a disaster for trying to contain the epidemic,” Roth told reporters at a news conference in Geneva Thursday.

Kenneth Roth, Executive Director, Human Rights Watch, during press conference with UN correspondents in Geneva, 6 February 2020.

Asked about China’s handling of the information surrounding the outbreak, especially on social media, the veteran HRW chief said, “There has been an enormous amount of information put out on social media but there’s also an active government effort to suppress it. The government does seem determined to limit the flow of information about the coronavirus outbreak. Particularly, criticism of its response to that.”

Roth, a harsh critic of China’s rights record, argued, “When push comes to shove, do you allow open information, open debate, and indeed criticism of governmental conduct in the face of something threatening the Chinese public, or do you try to cover it up to preserve the power of Beijing. It’s always official power that is the priority.”

Turning to China’s massive quarantine efforts- to try and contain the spread of the virus- Roth declared: “There are major questions about this, besides the nature of the quarantine. A quarantine of this sort, and magnitude, has never been attempted. Only an autocratic government, like China, could try that. Quarantines of this sort, normally do not work.”

He critically observed the quarantines that public health officials advocate, are much more targeted.”They’re aimed at people who have been identified as having the virus, and they’re put in a place where they can receive treatment, as well as food and housing, and then that is a way of avoiding infecting others.”

Roth said the idea of a quarantine of Hubei province – a region of 60 million – has never before happened and pondered ” it’s utterly unclear whether it’s going to be effective. People need to be housed, they need to get treatment, and there are huge gaps in the Chinese government’s response to individual needs.”

“So, this is not a rights-oriented approach to public health. This is treating public health with a sledgehammer, and public health officials will tell you this is not an effective way to proceed…” he added.

Concerning the large number of countries that have notified the WHO of the restrictive measures they’ve taken – which appear to go against the grain of WHO’s recommendations – and some countries, such as the U.S., holding classified briefings on the outbreak, Roth said, “There’s no place for secrecy in fighting an epidemic.”

” I think it’s broadly understood that you need total and complete transparency to effectively fight an epidemic. You need to know where it’s breaking out, you need to know in real-time where medical energies have to be focused. And so, this is not a time for secrecy, it’s not a time to suppress criticism of governments’ reaction. It’s a time for total transparency, even if it’s embarrassing. ”

Executive Board Raises Concerns About WHO Emergencies Contingency Fund & Staffing

In a morning discussion on Emergency Preparedness at WHO’s Executive Board, Japan asked whether WHO’s emergency contingency fund had assurance of sustainable funding, while Germany, speaking on behalf of the European Union, underlined the need for WHO to support countries in measures to guarantee the safety and security of health workers and health facilities – to create “resilient health systems able to withhold the shock of health emergencies.”

Singapore stressed the need to examine more deeply the increased global health risks faced due to increased urbanization, more and more densely populated cities, where viruses can be easily transmitted in crowded spaces, both public and private.

China, meanwhile, called on the global community to react in a “rational manner” to the crises and “refrain from panic.”  But it also asked WHO why some 30% of posts in the Organization’s Health Emergencies Department were vacant, as of November 2019.

Ryan, in response to the query, said that vacancies were largely due to budget shortages.

 

Image Credits: HPW/Catherine Saez, Fletcher/HPW, John Zarocostas.