Bagh Bazaar, Kolkata, post cyclone Amphan

Even as Eastern Africa and the Horn of Africa are facing unprecedented flooding and locust swarms, a cyclone that has hit Southeast Asia, is presenting new challenges there in the battle against the COVID-19 pandemic.

Torrential rain, fierce winds of up to 180 km per hour, and a 16-foot tall storm surge cut off road links, snapped power lines, destroyed crops and displaced hundreds of thousands in Bangladesh and India’s West Bengal region after the storm made landfall  last Wednesday. 

In India, Kolkata was particularly hard hit by the cyclone.  And while vulnerable Rohingya refugee camps in Bangladesh escaped its worst effects, several United Nations agencies and NGOs warned that Amphan could thwart existing efforts to contain the current COVID-19 pandemic. In Kolkata, many residents had to be forcibly displaced from their homes to shelters, due to their fears of becoming infected, authorities said.  At least 5 cases of COVID-19 have already been confirmed in Cox’s Bazaar, the largest refugee camp in Bangladesh.

Amphan Could Exacerbate Efforts to Contain COVID-19 pandemic in Region

Early evacuation of 2.5 million people in Bangladesh and half a million people in India helped mitigate the worst effects of the cyclone, but some civilians refused to evacuate from their homes for  fear of becoming infected by COVID-19 in crowded shelters, authorities said.

In the West Bengal city of Kolkata, “we have literally had to force people out of their homes, make them wear masks and put them in government buildings,” a senior police official told Reuters. 

There are now “hundreds of thousands” of Indians sheltered in relief camps across West Bengal, Indian government officials said – fueling fears that the shelters may spawn a breeding ground for COVID-19.

In Bangladesh, some two million people in total had been evacuated to over 12,000 cyclone shelters, and supplied with masks and sanitizers to combat the spread of the coronavirus, according to the UN. In the temporary shelters as well as the crowded refugee camp of Cox’s Bazaar, home to around a million Rohingya refugees from Myanmar, conditions are ripe for virus transmission, officials warned.

“With 40,000 people crammed per square kilometre [in Cox’s Bazar] maintaining social distance is impossible. People share water and toilet facilities making it extremely challenging to maintain the strict hygiene needed,” said Oxfam’s Bangladesh Country Director Dipankar Datta. “If a serious outbreak is to be avoided more prevention and containment measures – adapted to the needs of women and men – must be rapidly put in place.”

“Communities are already vulnerable to the devastating health crisis and we know that if people are forced to seek communal shelter, they will be unable to maintain physical distancing and run the risk of contracting or transmitting the disease,” warned the International Organization for Migration’s (IOM) Deputy Chief of Mission Manuel Pereira.

Relief Efforts Swing Into Action 

Indian Prime Minister Narendra Modi announced a US $132 million emergency relief package for West Bengal after he was flown through the cyclone affected areas on Friday. A day later, he deployed 5 columns of the Indian army to help restore infrastructure.

German NGO Welthungerlife released 100,000 Euro on Monday to fund Cyclone Amphan relief efforts. In Bangladesh local NGOs, such as the Bangladesh Women’s Development BRAC released BDT 30 million for the response, following a pre-release of US$138,000 in funds from the International Federation of the Red Cross .

Children displaced by cyclone Amphan get a meal from relief workers in Kolkata, India

Despite its precarious coastal location, Cox’s Bazaar fortunately escaped the worst wrath of the storm.  UN agencies and NGOs had issued early warnings about the potentially devastating effects should the storm hit the refugee camp frontally. 

As it turned out, just over 7,000 Rohingyas refugees in the settlement were directly affected, and 555 had been moved to temporary shelters or were staying with relatives while their homes were repaired, UNHCR’s Charlie Yaxley told UN News. Some 118 shelters were destroyed and 1,423 had been damaged, while relief organizations were positioning to respond.

Across Bangladesh, however, over 370,000 houses have been damaged as of Friday, according to the UN Office of Humanitarian Affairs.

In neighboring India, the cyclone left a “trail of destruction”, said one relief officer. Reports were that the cyclone so far had claimed  80 lives in eastern India’s West Bengal and some 20 lives in neighboring Bangladesh, mostly from people trapped in collapsed homes or electrocuted by falling wires. Some 176,000 hectares of crops, 200 bridges, 150 km of dams and 1,100 km of road in coastal districts had been damaged.

Relief workers battling cyclone aftermath under Covid-19 shadow in Kolkata, India

UNESCO World Heritage Mangrove Forest Suffers Major Blow In Trail of Destruction

The Sundarban mangrove forest straddling India and Bangladesh has also suffered a devastating blow – The UNESCO World Heritage Site is the largest contiguous mangrove forest in the world, and is  home to some 4 million Indians. The total damage of the cyclone could amount to 1 trillion rupees ($13 billion), said Indian state officials to Reuters.

The Sundarban’s embankments may have been breached, with many houses already damaged, Anamitra Anurag Danda, a senior fellow at the Observer Research Foundation think-tank, told Reuters.

Road connectivity is a priority right now, said Kolkata’s deputy mayor Atin Ghosh to Reuters. And although municipal teams, civil defence and police personnel are working “overtime”, “there is an acute shortage of manpower due to coronavirus related restrictions,” he said.

And water contamination from heavy rains and flooding could lead to a spike in illnesses, warned the UN Office for the Coordination of Humanitarian Affairs (UNOCHCHA).

Massive damage is also expected to standing crops and plantations.  The cyclone destroyed farmland in Bangladesh’s low-lying coastal areas, damage that will likely endanger livelihoods, the non-profit ActionAid said.

“Communities need urgent support as they are without basic necessities such as food, clean water and materials to rebuild their homes,” Farah Kabir, the country director of ActionAid Bangladesh said.

Eastern India and Bangladesh are frequently battered by cyclones between April and December, although climate change is making them more frequent and severe, experts say.  On the other side of the hemisphere, Caribbean regions like the Bahamas are less than a week away from the beginning of their hurricane season, said Caribbean Community and Common Market Chair Mia Mottley last week at the World Health Assembly.

 

Image Credits: Ramakrishna Math & Ramakrishna Mission, Ramakrishna Math & Ramakrishna Mission, Ramakrishna Math & Ramakrishna Mission.

Workers manufacture PPE in a Kenyan factory (Photo: MOH, Kenya)

Low and middle-income countries urgently need affordable personal protective equipment, diagnostics, treatments and vaccines to ward off even bigger waves of COVID-19 infection and mortality – and global production capacity is failing to ensure timely supply even of those products now on the market.

Now, more than ever, producers in poor countries need to be integrated into the health products ecosystem – at national, regional and global level – something that is good for public health, local economic development – and global public health security.

In the wake of the far-reaching commitments already made by the global community at the World Health Assembly, to stimulate R&D and voluntarily pool new intellectual property (IP), James Zhan, senior director of Investment and Enterprise, and Christoph Spennemann, head of the IP Unit at the United Nations Conference on Trade and Development (UNCTAD), are calling upon the UN system, governments, industry and international investors to create a bold new partnership.

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Remarkable efforts are underway to ensure effective research and development (R&D) of COVID-19-related diagnostics, treatments and vaccines, inter alia at last week’s World Health Assembly, and in the context of a recently announced WHO voluntary technology pool. But the international COVID-19 response is largely lacking a comprehensive strategy on how to ensure the missing link between R&D and distribution, i.e. large-scale manufacturing.

Already this has been plainly evident in the shortages of face masks, gloves and gowns for health workers in Africa – items that are generally simple to manufacture and yet often had to be shipped from thousands of miles away. 40% of the global market in personal protective equipment (PPE) is supplied by manufacturers in only three countries outside of Africa, and 35% of globally available medical products are sold in only three countries outside of Africa, according to UNCTAD. At least 47 countries have implemented one or more measures affecting exports of products or sub-products used in the public health response to COVID-19.

Once a treatment or vaccine for COVID-19 is available, massive demand is likely to outstrip supply even more rapidly and visibly – with huge consequences for health equity. Earlier hopes that, due to climatic conditions, countries in the global South might be less affected, are vanishing quickly. The pandemic is now hitting LMICs, with Latin America being considered a new epicenter of the pandemic, according to a WHO statement of 22 May.

Boosting local productive capacity therefore becomes a necessity to ensure public health security in LMICs (SDG 3). As the virus knows no borders, productive capacity in LMICs in return contributes to global health security.

In a longer-term perspective, local productive capacity nurtures expertise and creates quality jobs in LMICs, thus contributing to structural transformation and economic growth (SDGs 8 and 9), as well as pandemic preparedness.

Need to Act Urgently – So No Country Is Left Behind
Pharma R&Ds; an increasingly high tech affair. (Photo: Adobe Stock)

We need to act urgently. For vaccines, for instance, The Economist notes  that worldwide vaccine production – which is currently at over 5 billion doses a year – will not be sufficient to meet the massive new demand. Repurposing existing facilities is not a solution: this is not always feasible and would also reduce the capacity to make regular vaccines to address life-threatening diseases like measles and polio.

Diversifying the sources of pharmaceutical production could be of particular value for the supply of active pharmaceutical ingredients (APIs). Producers in LMICs, but also the global pharmaceutical industry are too dependent on suppliers in a very limited number of countries, and more diversified API production could increase overall health security.

We need to avoid a scenario where poor countries are left behind. This necessitates new industrial alliances, parallel manufacturing by multiple companies in multiple locations, and creative approaches to IP to ensure rapid availability of new technologies for high volume production. To boost productive capacity in LMICs, it is critical to engage in global partnerships among governments, local producers, development partners, and international investors and technology holders.

Not every LMIC is ready for this. But some have succeeded in establishing a local pharmaceutical or vaccines industry that can comply with international quality standards. Other countries are actively supporting the development of their domestic pharmaceutical industry to ensure public health security.

Many more countries should be able to engage in the production of personal protective gear that is equally vital in the COVID-19 battle.

Drug manufacturing facility in Ethiopia (photo: UNCTAD)
Five Challenges

However, local investors and producers alone cannot fulfill the daunting task of changing production patterns on their own. They are typically faced with five key bottlenecks.

  • Lack of capital, technology and skills. The key objective of any pharmaceutical production is to meet requirements related to drug safety, quality and efficacy, as well as WHO-based Good Manufacturing Practice (GMP). This requires technological capacity and know-how that is missing in most low income and some middle-income countries. Upgrading these capacities requires upfront capital. Commercial banks are often hesitant to provide loans to pharmaceutical projects considered highly risky.
  • Low quality and standards. In many LMICs, drug regulatory authorities lack the capacity to check and enforce companies’ adherence to quality standards and GMP. This is a major barrier to potential investment by GMP-compliant firms, which are concerned about unfair competitive advantage from non-GMP-compliant firms that can produce at lower cost.
  • Weak enabling policy frameworks. Cooperation with foreign investors and technology holders is essential to ensure the transfer of relevant technology and know-how. Unfavourable rules on investment, IP and drug regulation may discourage foreign investment or upset the balance between protection and technology dissemination. Tariffs and taxes imposed on ingredients needed for local production make local manufacturing less attractive.
  • Small markets and unstable demand. Many LMICs have relatively small population and weak purchasing power. Economies of scale are an important factor in attracting investment. But countries often fail to agree on harmonizing medicines procurement, thus missing an important opportunity to combine purchasing power and stabilize demand.
  • Poor infrastructure. The “last mile” to the patient is often difficult to stride, especially in low income countries with poor infrastructure. Many low-income countries are struggling with infrastructure challenges, including electricity cuts and cold chain interruptions.
Mass production of PPE in Kenya (Photo; MOH, Kenya)
Ten Actions

To address these bottlenecks, we suggest ten major actions to create a national enterprise ecosystem:

Investment in skills development to ensure GMP-compliant production

GMP-related skills can be promoted by attracting know-how transfer from foreign investors, by hiring foreign consultants and by exploiting existing technologies. Uganda has used multi-year government purchase commitments to ensure training of local pharmacists by an Indian investor for a Kampala-based plant. Firms in Bangladesh have relied on hiring foreign experts to transfer know-how. In the COVID-19 context, LMIC investment promotion agencies could put together a “grey corps” of retired engineers from advanced countries willing to offer their assistance. And national patent offices should promote scientific understanding of COVID-19-relevant technologies in patents that are no longer valid, or which have been abandoned by their holders, such as AbbVie’s patent on the antiretroviral combination drug Kaletra (currently in clinical trials for a potential COVID-19 treatment).

Sterile manufacturing laboratory for pharmaceutics and biotechnology. (Photo: Adobe Stock)
Sharing COVID-19-related technologies to enable affordable mass production

New COVID-19 technologies should be shared with LMIC-based producers, accompanied by know-how transfer programs to ensure the rapid uptake of quality high volume production. Various initiatives can contribute, e.g. the recently announced WHO voluntary technology pool and the UN-supported Medicines Patent Pool, the Coalition of Epidemic Preparedness Innovations (CEPI), and philanthropy programs of the R&D-based pharmaceutical industry. The results of any publicly funded COVID-19-related R&D should be available and affordable to all, as a global public good, and existing IP rights should be waived for the territory of LMICs or be licensed at reasonable fees. LMIC governments need to establish stronger linkages between domestic producers, foreign investors and domestic research institutions, inter alia through voluntary IP licensing, and they need to be aware of the tools available to promote public health under the WTO TRIPS Agreement.

Target impact investors to access necessary capital

Impact investment by the end of 2018 had reached a global value of USD 502 billion. Time is here to ensure that this enormous financial resource is made available to help the world’s poor access essential COVID-19 treatments and vaccines as soon as they are available, inter alia through local production. For instance,  Swedish asset investors recently contributed USD 319 million to a social bond issued by the International Finance Corporation to help LMIC-based producers involved in the production of medical equipment and pharmaceuticals. Intergovernmental organizations, such as UNCTAD and its World Investment Forum, can play a key role in reaching out to impact investors to facilitate investments in social bonds.

Build partnerships to initiate “lighthouse” projects on low-hanging fruit

Successful short-term projects on simple technologies, especially in the production of test kits, personal protective equipment and ventilators, can set good examples to attract subsequent investment in more ambitious projects such as the production of treatments, diagnostics and, to the extent possible, vaccines. Investment promotion agencies should reach out to development banks, impact investors and social entrepreneurs to forge partnerships to fund initial “lighthouse” COVID-19 projects.

Improve investment incentives to increase local firms’ sustainability

Various measures can be considered, such as financial or fiscal incentives to produce COVID-19-related products. A very important investment incentive is medicines procurement, which in an infant industry context can be designed to include a price preference for local producers. Ethiopia, for example, allows a preferential margin of up to 25% on bids from local producers. To provide some predictability, preferential procurement should aim at a time span of five to ten years and include foreign investors that assist in local production. Advance purchase commitments as in the referred Ugandan case could be useful to kick-start manufacturing new products, such as COVID-19-oriented vaccines, where the market is unpredictable and companies need guaranteed purchases.

Use streamlined regulation to facilitate investment

To stimulate investment in COVID-19 medical products and ensure fast delivery to the needy, swift marketing approval is essential. Drug regulators should explore ways of fast tracking COVID-19-related applications, with support from WHO. In addition, current scenarios in many LMICs, where a producer needs to pursue multiple registration procedures with a multitude of different national agencies, paying multiple different registration fees, should be avoided in the future. Electronic procedures should be enabled for easy and swift registration of business activities, with support from UNCTAD’s e-regulations program.

Young scientist in modern biological lab (Photo; Adobe Stock)
Invest in infrastructure

Investment incentives financed by national governments and development partners should prioritize the building of essential infrastructure for local production projects, such as ensured electricity supply. Innovative approaches such as the use of drones in Rwanda to fly needed medicines to patients in remote areas illustrate the importance of investing in digital connectivity.

Emphasize the regional approach to reduce costs

Regional cooperation will make the measures suggested above more sustainable. Regional economic areas such as the EAC, SADC and COMESA, and in particular the newly created African Continental Free Trade Area (AfCFTA) have the potential advantages of establishing regional value chains to enable small economies in the region to collectively build the productive capability. Different countries have different comparative advantages, and together they can participate in a value chain that generates the medical supplies and medicines that they need to fight major pandemics. The regional groupings should aim at abolishing tariffs and non-tariff barriers, while promoting transparency of non-tariff measures. In a similar vein, regional coordination of IP rights and their enforcement will promote legal certainty and predictability for traders, including those dealing with pharmaceutical products. Regional approaches to procurement enable the pooling of purchasing powers, and regional drug regulation substantially eases producers’ expenses and efforts for filing and processing multiple applications for the same pharmaceutical product.

Seek funding from official development assistance

Important amounts of official development assistance will be made available for the new Access to COVID-19 Tools (ACT) Accelerator Global Response Framework. Donors when operationalizing this initiative should consider the contribution that LMIC-based producers can make to global public health security. The statements made by global leaders at the 4 May pledging conference indicated will for a new approach: UN Secretary-General Guterres and French President Macron referred to the need to have COVID-19-related R&D results as global public goods,  and German Chancellor Merkel emphasized the need to discover new paths toward the production of vaccines. Boosting productive capacity in LMICs is indeed a case in point.

Pharmaceutical production line. 3D rendered illustration. (Photo: Adobe Stock)
Ensure sustainability of efforts despite an unpredictable market

This is a key concern in areas such as COVID-19, where investors cannot know for how long the pandemic will pose an actual threat to societies. It has been observed that many countries have failed to ensure pandemic preparedness, as past pandemics (Ebola, SARS) ceased rather quickly and made any further investment undesirable. An international coalition of governments, development banks, impact investors and like-minded stakeholders is needed to address this market failure and to define future roles in protecting humankind from the next pandemic.

Building and expanding local productive capacity cuts across multiple policy sectors and requires concerted actions by all stakeholders in order to effectively address the five key bottlenecks. Together, we can create a global enabling framework and national ecosystems to enable local manufacturing to contribute to both the local and global public health endeavor, and ultimately to achieving SDGs 3, 8 and 9.

The Way Forward

We envisage a two-pronged strategy to pursue our ten actions.

  1. Our proposal addresses a gap in the international COVID-19 response by boosting productive capacity in LMICs. UNCTAD will closely coordinate and cooperate with existing initiatives, especially the WHO voluntary technology pool and the ACT Accelerator Global Response Framework, with a view to adding value and creating synergies.
  2. UNCTAD will intensify collaboration with our five partner agencies, i.e. WHO, The Global Fund, UNICEF, UNIDO, and UNAIDS to implement the May 2019 Interagency Statement on Promoting Local Production of Medicines and Other Health Technologies. Other partners will also be welcome to join us at our World Investment Forum later this year to mobilize key global players to commit to longer term productive capacity building. Drawing the lessons from the COVID-19 crisis, we intend to increase LMICs’ resilience in pandemic preparedness beyond the pandemic.

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James Zhan is senior director of Investment and Enterprise at UNCTAD. He is also editor-in-chief of the UN World Investment Report, and the Transnational Corporations Journal. He chairs the Governing Board of the UN Sustainable Stock Exchanges Initiative (with all major stock exchanges worldwide as members). He initiated the establishment of the World Investment Forum. He is chief strategist for the World Association of Investment Promotion Agencies. He has held advisory positions with academic institutions, including Cambridge University, Columbia University, Cornell University, Oxford University and the University of Geneva. He has published extensively, and appears frequently in international media outlets and parliament hearings on key and emerging trade and investment issues.

Christoph Spennemann is in charge of the Intellectual Property (IP) Unit at the United Nations Conference on Trade and Development (UNCTAD). He oversees a program on IP and investment with emphasis on issues related to health, technology transfer, and the digital economy. Christoph holds a master degree in international economic law and European law of the Universities of Lausanne and Geneva and practised law in Berlin. Christoph has published and co-authored various articles in the areas of patent law, geographical indications and trademark law, particularly in the context of bilateral and regional free trade agreements and development cooperation policy.

The views expressed in this article are the authors’ personal opinions and do not necessarily reflect the position of the UNCTAD secretariat.

Image Credits: APO/MOH Kenya , (Photo: Adobe Stock), UNCTAD , Adobe Stock , UNCTAD.

Scientist conducting coronavirus vaccine research at NIAID’s Vaccine Research Centre, Moderna’s original collaborator on the SARS-CoV-2 vaccine.

A COVID-19 vaccine candidate made by Chinese researchers successfully induced the development of neutralizing and binding antibodies against SARS-CoV-2, the virus that causes COVID-19, according to early results from a non-randomized phase I clinical trial published Friday in The Lancet. 

The trial results follow on to results announced by Moderna earlier this week, which found that their vaccine candidate was able to induce neutralizing antibodies in 8 healthy volunteers. In vaccine trials, the development of neutralizing antibodies is the most sought-after immune response because these antibodies bind to viral particles in a way that immediately blocks infection.

The non-randomized Chinese study, which was published in The Lancet, reported preliminary safety and efficacy results for a vaccine in 108 healthy middle-aged adults at low, medium, and high doses; with 36 participants enrolled in each dosage level. At low dose and middle-doses, about a half of the individuals produced neutralizing antibodies after 28 days. At high doses, some three-quarters (27/36) of volunteers produced neutralizing antibodies. Regardless of vaccine dosage, over 90% of participants showed a four-fold increase in binding antibodies. 

“These results represent an important milestone,” said Wei Chen from the Beijing Institute of Biotechnology, who was responsible for the study. “The trial demonstrates that a single dose of the new adenovirus type 5 vectored vaccine produces virus-specific antibodies and T cells in 14 days, making it a potential candidate for further investigation.”

The Ad5-nCoV vaccine also stimulated a rapid T cell response in 83.3% of individuals that received a low dose – and in the medium and high- dose groups,  97% (35/36) of individuals exhibited rapid T cell responses. Certain types of T cells develop responses when exposed to specific antigens, or parts of disease-causing pathogens, and “remember” to attack the same pathogen once exposed to it again. Vaccines, which contain un-infective pieces of viruses or weakened viruses, help activate this immune memory by inducting a T-cell mediated response.

The most common adverse reactions to the vaccine persisted for less than 48 hours, which is usually considered acceptable for a vaccine. Side effects ranged from mild pain at the injection site reported in over half (54%, 58/108) of vaccine recipients, as well as fever (46%, 50/108), fatigue (44%, 47/108), headache (39%, 42/108), and muscle pain (17%, 18/108). 

Many Limitations to Chinese Vaccine Study & Concerns with the Adenovirus 5 Vector

Still, “the challenges in the development of a COVD-19 vaccine are unprecedented, and the ability to trigger these immune responses does not necessarily indicate that the vaccine will protect humans from COVID-19,” warned Chen.

Further, randomized trials are needed to tell whether the immune response the vaccine candidate elicits effectively protects against SARS-CoV-2 infection, he added.

And health experts have brought up concerns around the vector used to carry the vaccine, a weakened common cold-causing virus, adenovirus type 5 or Ad5.

“There has been a shadow with the Ad5 as a vaccine vector over the last decade, not seen with other Ad vectors for vaccines. Have these concerns been allayed?” tweeted Jeremy Farrar, director of the research foundation Wellcome Trust, in response to the study.

Farrar referred to a previous case where an HIV-vaccine candidate using the Ad5 vector was found to put study participants who received the vaccine at a higher risk of HIV infection – and further exploration of that vaccine candidate was promptly discontinued. It’s been posited that the T-cells activated by the Ad5-vector HIV vaccine candidate made the cells more vulnerable to infection by HIV-1, which attacks immune cells.

Of the concerns, the study authors write, “although the association between HIV-1 acquisition risk and Ad5 vectored vaccine is controversial and its mechanism is unclear, the potential risks should be taken into account in studies with this viral vector delivery platform.

“We plan to monitor the participants in our upcoming phase 2 and phase 3 studies to assess the indication for any such acquisition.” At least two other vaccine candidates using the Ad5 vector are listed in the World Health Organization’s draft registry of SARS-CoV-2 vaccine candidates, the study authors say.

However, another concern is that half of the participants in the COVID-19 vaccine trial also already had immunity to the Ad5 virus, and these participants showed weaker immune responses to the COVID-19 vaccine. 

“Our study found that pre-existing Ad5 immunity could slow down the rapid immune responses to SARS-CoV-2 and also lower the peaking level of the responses,” said Feng-Cai Zhu from Jiangsu Provincial Center for Disease Control and Prevention in China, part of the group that led the study. “Moreover, high pre-existing Ad5 immunity may also have a negative impact on the persistence of the vaccine-elicited immune responses.”

The authors note that the other limitations of the trial are its small sample size, relatively short duration, and most importantly, lack of a randomised control group – which may have biased their results.

To address these limitations, a randomised, double-blinded, placebo-controlled phase 2 trial in 500 healthy adults has been initiated in Wuhan to determine whether the results can be replicated, and if there are any adverse events up to 6 months after vaccination. For the first time, this will include participants over 60 years old, an important target population for the vaccine.

Moderna Vaccine Induces Immune Response In Limited Number Of Healthy Volunteers

In a parallel development, eight people injected with Moderna’s experimental COVID-19 vaccine, mRNA-1273, developed neutralizing antibodies against the virus, announced the US-based pharmaceutical firm on Monday.

Neutralizing antibodies were detected in 4 participants that were given a low vaccine dose of 25 micrograms, and in 4 others that received a higher dose of 100 micrograms, 43 days after receiving the vaccine. At these doses, the vaccine was generally safe and well tolerated, said Moderna in a statement.

Neutralizing antibody titers for the remaining study participants were not yet available. The data were from a Phase I clinical trial conducted in collaboration with the US National Institute for Allergies and Infectious Diseases (NIAID). 

“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 micrograms,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna.

“When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials,” added Zaks.

Based on these early results, Phase 2 trials for the Moderna vaccine were amended to include a 50 ug dosage and a 100ug dosage in order to finalize a dosage for Phase 3 studies. A 50ug dosage arm was added to the Phase 1  – NIAID study.

Phase 3 clinical trials could be initiated as soon as July 2020, an unprecedented speedy timeline for vaccine development.

However, similar to the Chinese vaccine study, the initial results don’t necessarily show that the vaccine induces an immune response strong enough to protect against COVID-19, nor do they show how long protection might last.

The concentration of neutralizing antibodies in the 8 participants was similar to the concentration found to be protective against COVID-19 in mouse models, although the results from animal models do not necessarily always correlate directly with humans. The 8 participants with neutralizing antibodies were sampled only two weeks after receiving the second dose of vaccine, and must be followed further in order to determine whether and for how long the neutralizing antibodies could protect against SARS-CoV-2 infection. 

Some 45 participants also developed ‘binding antibodies’, which can bind to a virus but do not make it less infectious.

Though Moderna’s vaccine study was led by the US National Institute of Allergy and Infectious Diseases (NIAID), the NIAID did not publish a press release, and declined to comment on Moderna’s announcement. If successful, this would be the first vaccine candidate that Moderna, a company that is experimenting with new, mRNA vectors for carrying vaccines, will bring to market. 

In recent months, health experts and government leaders are more and more pinning their hopes to quash the pandemic for good on a successful COVID-19 vaccine, as serological studies are beginning to show that a large proportion of countries’ populations will remain susceptible to the virus after the first wave.

Not everyone that gets infected with COVID-19 develops antibodies, suggest recent European serological surveys. In Switzerland, one of the hardest-hit countries in Europe, only 1 in every 10 people had antibodies against COVID-19 – and older people had about half as many antibodies as young and middle-aged individuals. 

Surveys in Spain and France also paint a solemn picture of immunity, as only about 4-5% of the population has detectable antibody levels. Though the number of people with antibodies is growing rapidly as infections increase, herd immunity is far away.

The creation of an effective vaccine is seen as the long-term solution to controlling the COVID-19 pandemic. Currently, there are more than 100 candidate COVID-19 vaccines in development worldwide.

Image Credits: NIAID.

This story was updated 4 June to reflect the paper’s retraction.

Colorized scanning electron micrograph of a dying cell (blue) heavily infected with SARS-COV-2 (yellow), the virus that causes COVID-19

New research published in The Lancet on Friday found that hydroxychloroquine and chloroquine has ‘no benefit’ for coronavirus patients, and could even increase the risk of heart arrhythmias and mortality. 

The study was retracted by three of its authors on June 4, due to the authors own concerns about the “veracity of primary data sources.”

“This is the first large scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with COVID-19,” said lead author of the study and Executive Director of the Brigham and Women’s Hospital Center in Boston Mandeep R. Mehra. “Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death.”

In the worst-case scenario, some 8% of patients in The Lancet study who were given hydroxychloroquine combined with azithromycin developed a heart arrhythmia (502/6,221), compared with 0.3% patients in the control group (226/81144).

Hydroxychloroquine and chloroquine use predicts in-hospital mortality

Treatment with hydroxychloroquine, chloroquine, or either drug in combination with azithromycin was also associated with higher odds of death, even after accounting for age, race, body mass index, and preexisting conditions.

While not a randomized control study, The Lancet article is the largest study to date on the hyped drugs, analyzing data from nearly 15,000 COVID-19 patients who received hydroxychloroquine, chloroquine, or a combination of either drug with a macrolide antibiotic such as azithromycin, and 81,000 COVID-19 patients who did not receive any of those treatments. The data came from 671 hospitals across 6 continents.

In light of mounting evidence that hydroxychloroquine provides little benefit to coronavirus patients, health experts are again repeating calls to take caution in rolling out emergency approval for unproven treatments, even as countries all over the map cautiously begin to authorize the use of hydroxychloroquine for COVID-19. India even issued a revised advisory on Friday expanding the use of hydroxychloroquine as a prophylactic treatment in healthcare workers and contacts of lab-confirmed coronavirus patients.

Experts from the World Health Organization have also been cautioning against widespread, unmonitored use of the drug. 

“We do point to the fact that… the current clinical evidence does not support the widespread use of hydroxychloroquine for the treatment of COVID-19, not until the trials are completed and we have clear results,” said WHO’s Executive Director of Emergencies Programme Mike Ryan, at WHO’s press conference on Friday, referring to evidence from clinical and systematic reviews carried out by the WHO Pan American Health Organization (PAHO).

Hydroxychloroquine, and hydroxychloroquine plus azithromycin are two of the drug regimens being tested for COVID-19 patients in WHO’s giant, multicountry Solidarity Trial.

The Lancet results support previous findings from a widely disseminated Brazilian study that found an increased risk of heart arrhythmias in COVID-19 patients receiving high doses of the drug. The study was discontinued shortly after, as subjecting patients to increased risk of death in the trial was deemed unethical by study coordinators.

The Lancet study however, does not explore another use for hydroxychloroquine – taking the drug to prevent onset of COVID-19.

India Revises Hydroxychloroquine Recommendations To Promote Prophylactic Use
Indian Ministry of Health recommends prophylactic use of hydroxychloroquine in revised advisory

On Friday, India’s National Task force (NTF) for COVID-19 issued a revised advisory on prophylactic use of hydroxychloroquine – expanding the recommendation to include all asymptomatic healthcare workers in COVID-19 positive and non-COVID-19 settings, all asymptomatic frontline workers in the COVID-19 response including contact tracers, and all asymptomatic household contacts of laboratory confirmed cases. 

The previous advisory, issued on 23 March, restricted the recommendation to healthcare workers who worked directly with confirmed and suspected COVID-19 patients, and asymptomatic household contacts of laboratory confirmed cases. 

The revised recommendation was based on a small prospective observational study of 334 healthcare workers. According to the advisory, the incidence of COVID-19 infection in the 248 healthcare workers who took HCQ prophylaxis in New Delhi was lower than the incidence of infection in those who did not take it after following up with the study subjects for a median of 6 weeks, however the exact reduction was not listed.

Still, the revised advisory recommends that the drug has to be given under ‘strict medical supervision with informed consent’ and ‘only on the prescription of a registered medical practitioner’ – noting a number of preexisting conditions that make taking the drug risky. 

The advisory also notes that only under ‘rare’ circumstances does hydroxychloroquine lead to the dangerous cardiovascular side effects. Among 1323 healthcare workers who took HCQ prophylaxis, serious side effects were reported in 7. Among those 7, three healthcare workers had a serious cardiac side effect – prolongation of QT interval on ECG.

“Rarely the drug causes cardiovascular side effects such as cardiomyopathy and rhythm (heart rate) disorders. In that situation the drug needs to be discontinued,” said the advisory. 

China, Spain, Brazil, and the United States have also issued recommendations for use of hydroxychloroquine in limited populations, largely restricting them to use in clinical trial settings in light of the new reports of serious cardiac side effects.

But the authors of The Lancet study still warn that the overall likelihood that these drugs improve clinical outcomes in COVID-19 patients is quite low, and underline that the medicines should not be recommended by countries for widespread treatment of COVID-19.

 “Several countries have advocated use of chloroquine and hydroxychloroquine, either alone or in combination, as potential treatments for COVID-19. Justification for repurposing these medicines in this way is based on a small number of anecdotal experiences that suggest they may have beneficial effects for people infected with the SARS-CoV-2 virus,”  said Director of the Heart Center at University Hospital Zurich Frank Ruschitzka, who also co-authored The Lancet study.

Image Credits: NIAID, The Lancet, India Ministry of Health.

New technical guidance for national governments was released to support the enhanced measurement of two key indicators for the COVID-19 response; the number of cases and the number of deaths, as reported on national and global dashboards. The package was launched by global health NGO Vital Strategies.

Limited COVID-19 testing capacity in low- and middle-income countries makes it especially challenging to use confirmed cases as a measure of epidemic impact and burden.

“In the absence of adequate global testing capacity, measuring cases and deaths specifically due to COVID-19 is not straightforward,” said Dr. Philip Setel, vice president of the Civil Registration and Vital Statistics Program at Vital Strategies in a press release. “Rapid surveillance of total mortality can provide critical data to national leaders and health authorities as they work to temper and control the pandemic within their borders.”

 The new guidance, Revealing the Toll of COVID-19: A Technical Package for Rapid Mortality Surveillance, offers a step-by-step manual on ‘rapid mortality surveillance,’ which relies on the key concept of estimating excess deaths due to COVID-19. The technique allows countries to rapidly determine the extent of the epidemic and accordingly plan outbreak responses.

By comparing year-on-year all-cause mortality data from national civil registration and vital statistics (CRVS) systems, countries can see how many more deaths occurred in 2020 compared to previous years, and get a snapshot of how many excess deaths may have been caused by COVID-19, according to the new guidance. The data can then be visualized separately by age group, sex, and location to further identify trends in deaths.

Brazil, Colombia and Peru already began using existing civil registration and vital statistics systems for rapid mortality surveillance through the Bloomberg Philanthropies Data for Health Initiative. Analysis of vital registration data helped identify a sharp increase in total mortality in April 2020 compared to the same time in 2019 in Manaus, Brazil, illustrating the enormous impact the pandemic has had on the city’s death rate.

“All countries need timely and reliable data to inform health planning. This need becomes particularly acute at times like now when they face a swiftly evolving pandemic,” said Dr. Samira Asma, Assistant Director General for Data, Analytics, and Delivery for Impact at the World Health Organization

Rapid mortality surveillance generates daily or weekly counts of total mortality by age, sex, date of death, place of death and place of usual residence, helping to provide a fuller picture of the scale and direction of the pandemic, including estimates of deaths due to COVID-19 that may have been missed by the traditional testing and surveillance system. Data is collected through facility- and community-based surveillance, which helps capture deaths that are also occurring in homes.

The technique also estimates indirect mortality caused by disruptions to health services, and the interaction of the virus with pre-existing conditions such as noncommunicable diseases.

“Governments need timely, reliable data to inform decisions that will ultimately save lives, now more than ever,” said Dr. Kelly Henning, head of Bloomberg Philanthropies’ public health programs. “This new technical package will empower leaders around the world with a faster, more accurate understanding of potential COVID-19 deaths, and allow them to take action to slow the spread of this pandemic.”

The technical package was developed with experts from Vital Strategies and partner organizations that helped shape the package, ensuring clarity, rigor and ease of use: Africa Centers for Disease Control and Prevention, Bloomberg Philanthropies Data for Health Initiative, CDC Foundation, Pan American Health Organization, UN Economic Commission for Africa, UN Economic and Social Commission for Asia and the Pacific, US Centers for Disease Control and Prevention, and the World Health Organization.

Image Credits: Twitter: @WHOKenya.

Western Uganda was hit by a wave of flash floods in May after days of heavy rain caused major rivers to burst their banks.

East Africa and the Horn of Africa are facing a series of unprecedented overlapping disasters – widespread displacement and food insecurity caused by a record season of flooding and locusts, along with the COVID-19 pandemic, according to a new report released Thursday by the International Federation of the Red Cross (IFRC).

Meanwhile, the United Nations High Commissioner for Refugees (UNHCR) and the World Health Organization (WHO) signed a new collaboration agreement on Thursday, with the aim to support efforts to protect the 71 million forcibly displaced people around the world from COVID-19.

Widespread flooding in Ethiopia, Kenya, Somalia, South Sudan, Tanzania, Rwanda and Uganda during this year’s record wet season has displaced around 500,000 people and killed nearly 300. The flooding has also set back key interventions against the worst locust crisis the area has faced in decades, and created conditions ripe for COVID-19 transmission. 

Food insecurity, already exacerbated by the locust crisis and economic devastation due to the coronavirus, will likely be amplified. Nearly 18 million people across the region are already facing an acute food crisis. 

“The ongoing flooding crisis is exacerbating other threats caused by COVID-19 and the invasion of locusts,” said IFRC Africa Director Simon Missiri in a press release. “Travel and movement restrictions meant to slow down the spread of COVID-19 are hampering efforts to combat swarms of locusts that are ravaging crops. Flooding is also a ‘threat amplifier’ with regards to the spread of COVID-19 as it makes it hard to implement preventive measures.” 

Many of the displaced people are being housed in crowded temporary shelters or internal displacement camps, where physical distancing to prevent the spread of COVID-19 is nearly impossible. 

As of Wednesday, two cases have already been confirmed in Dadaab camp in Kenya, the third largest refugee camp in the world, according to UNHCR and the Kenya Ministry of Health. As of Thursday night, there are 4,458 cases and 120 deaths across Ethiopia, Kenya, Somalia, South Sudan, Tanzania, Rwanda and Uganda, although the true numbers may be much higher due to limited testing capacities, according to IFRC.

Woman receives IFRC assistance after widespread flooding the Horn of Africa and East Africa
Increase In Food Insecurity Due To The Triple Threat

Additionally, the record wet season has hampered efforts to control the second wave of a deadly locust infestation, already estimated to be 20 times larger than the first invasion that began in late 2019. Nearly 18 million people in the region were already experiencing an “acute food and livelihood crisis” due to the locust invasion, according to the IFRC report, which classifies regions facing food insecurity using the Integrated Food Security Phase Classification (IPC) scale.

The increased rainfall in fact promotes locust breeding and growth of wild vegetation that acts as locust food, according to Euloge Ishimwe, spokesperson for IFRC Africa.

“The heavy rains rainfall recently experienced have caused a slowdown in locust control operations due to poor visibility during aerial spraying, and affected the movement of the spraying teams. This could have allowed continued locust destruction of crop and vegetation , further undermining the food security and livelihoods in the affected areas,”  said Ishimwe in an interview with Health Policy Watch. 

Why the Locust Problem Particularly Acute This Year?
(Photo: UN News)

Locusts typically breed and die in arid desert regions of the Sahara and the Arabian Peninsula. But unusually heavy regional rains over the past two years have greatly expanded the fertility of those remote breeding grounds – prompting locust swarms’ expansion and migration towards Yemen and Somalia. Those, in turn, are conflict zones where control activities are all the more difficult to carry out.

From there, the swarms have migrated even further across Ethiopia, South Sudan, Kenya, Uganda and Tanzania, where heavy rains gave them yet more sites to multiply.

“This crisis is both natural and man-made,” Baldwyn Torto, a scientist specializing in locusts at the International Centre of Insect Physiology and Ecology in Nairobi, Kenya, told the Christian Science Monitor. “There is a natural cycle of cyclones in this region, but there’s also so much insecurity in some parts of the region that the surveillance systems for locusts and other pests have broken down.”

Climate change is also contributing to the wet weather in normally arid areas, upon which locusts thrive, said Richard Munang, United Nations Environment Programme expert, in an interview with Reliefweb.int.  According to the World Metereological Organization, the last five years, hotter than any other since the industrial revolution, led to particularly web weather in Africa, which favours multiplication of locusts. Rains around the Horn of Africa from October to December 2019 were up to 400 per cent above normal rainfall amount. This abnormal rains were caused by the Indian Ocean dipole, a phenomenon accentuated by climate change.

Food insecurity – 100% Crop Loss in Worst Case Scenarios
Locusts swarming near a farm (Photo: UN News)

While the rains promote the growth of vegetation as locust food, African farmers displaced by flooding have also lost access to vital farmland, and are unable to harvest or replant crops during the most important planting season of the year, added Ishimwe.

“Harsh weather conditions are having a multiplier effect on an already difficult situation and this could potentially lead to worrying levels of food insecurity in the region,” said Missiri.

Loss of crops due to flooding and locusts, along with increased food prices due to supply chain disruptions caused by COVID-19, form a deadly combination that will exacerbate food insecurity in the East Africa and Horn of Africa region, said Ishimwe.

In a worst case scenario, there could be a nearly 100% loss of crops that the locusts feed upon, which include leaves and tender tissues of most food-producting plants, the IFRC report warns.

The IFRC has launched an emergency appeal for 1.8 million Swiss francs to help prevent 75,000 people from falling into deeper crises. Currently, the organisation has released over 7 million Swiss francs to local Red Cross and Red Crescent National Societies in East and Horn of Africa in order to provide food and non-food support to displaced populations. 

In Kenya, the Red Cross is conducting drone and satellite image assessments in 16 counties to observe the extent of damage caused by the overlapping disasters. Red Cross teams are also airlifting household items to families that have been marooned by floods, and UNHCR has doubled the amount of food rations distributed in Dadaab camp in an effort to cut down on crowding at distribution centers.

Filippo Grandi (left) and Dr Tedros (right) at the signing of a new agreement between WHO and UNHCR

WHO and UNHCR Sign Agreement To Protect Refugees Against COVID-19

WHO Director-General Dr Tedros Adhanom Ghebreyesus and UNHCR High Commissioner Filippo Grandi signed an agreement Thursday to collaborate on protecting refugees in the COVID-19 pandemic. The agreement renews a partnership that WHO and UNHCR have sustained since 1997.

The UNHCR also joined the UN COVID-19 Solidarity Fund on Thursday, allowing it to access US$10 million to finance the COVID-19 response in five countries hosting the largest populations of refugees; Jordan, Kenya, Lebanon, South Sudan and Uganda. The emergency funding will go towards financing community mobilization, procurement of hygiene and medical equipment, and the construction of isolation units for COVID-19 patients.

“UNHCR’s long-term partnership with WHO is critical to curb the coronavirus pandemic and other emergencies – day in, day out, it is improving and saving lives of millions of people forced to flee their homes,” said Filippo Grandi in a press release.

Dr Tedros added that the signing of the agreement represents the “principle of solidarity and goal of serving vulnerable peoples” carried by both agencies.

“We stand side by side in our commitment to protect the health of all people who have been forced to leave their homes and to ensure that they can obtain health services when and where they need them. The ongoing pandemic only highlights the vital importance of working together so we can achieve more,”  said Dr Tedros.

Elaine Ruth Fletcher contributed to this story

Image Credits: IFRC, UN News , UN News, Twitter: @WHO.

Dr Tedros Adhanom Ghebreyesus at this week’s 73rd World Health Asssembly

Over the past 24 hours, the world has seen the largest-ever increase in new COVID-19 infections, with most of the 106,000 cases cases occurring in just four countries, warned WHO Director General Dr Tedros Adhanom Ghebreyesus on Wednesday. 

“In the last 24 hours, there have been 106,000 cases reported to WHO – the most in a single day since the outbreak began. Almost two-thirds of these cases were reported in just four countries,” said Dr Tedros at a press briefing.  He spoke just a day after the World Health Assembly (WHA) meeting of 194 member states resoundingly endorsed a plan for a more unified global response against the virus threatening health and economies. 

The ‘unprecedented solidarity’ seen from member states at the WHA will be needed more than ever, he warned, as countries continue to combat the pandemic that is approaching 5 million cases worldwide. 

Numbers change rapidly

While the WHO Director General did not cite the countries by name, Tuesday’s WHO situation report had the US as the global leader in ever-rising COVID-19 cases, posting a whopping 45,251 new cases overnight. The US was followed by the Russian Federation (9263), Brazil (7938), and Saudi Arabia (5102).

On Monday, US President Donald Trump charged WHO with failing to control the pandemic, and said he would permanently cut funding to the organization within 30 days “if the World Health Organization does not commit to major, “substantive improvements.” The US has also demanded an independent investigation of WHO.

WHO Demonstrated “Leadership” on COVID-19 – Says Independent Oversight Committee

Regarding the US demands for independent review, Dr Tedros pointed to a just-published report on WHO’s January-April Health Emergency response by an Independent Oversight Advisory Committee (IOAC), led by a former UK Department of Health Director General, Felicity Harvey.

The committee concluded that the “WHO has demonstrated leadership and has made important progress in its COVID-19 response” considering the “novel nature of this virus and persistent unknown factors.”

But the committee, including six other public health officials or senior policy advisors from Canada, India, Japan, Lebanon, India, South Africa and The United States, warned against the “rising politicization of pandemic response” saying:  “WHO cannot succeed without unified global political support during the next phases of the pandemic.

“No single Member State can hope to defeat this virus solely with the tools that exist within their own borders,” the oversight report continues. ” Yet there has been a palpable lack of global solidarity and common purpose. That is a recipe for extending and worsening the global outbreak, leaving all countries less secure. The rising politicization of pandemic response is a material impediment to defeating the virus, while it aggravates other health, social and economic impacts.”

The IOAC report also condemned what members described as “credible threats targeted against the Director-General and staff members, which have followed criticism of the Organization in the media”. Dr Tedros had previously acknowledged that he has received death threats – although the report was the first formal reference to the issue.  

With regards to the United States call to review WHO’s performance, the IOAC warned, that “conducting such a review during the heat of the response, even in a limited manner, could disrupt WHO’s ability to respond effectively”. The Committee suggested, however, that it “may be useful, at an appropriate time, to independently assess the Organization’s performance during this response and identify lessons for the future”.

Such a review, in fact, was also mandated by a European Union-led resolution on COVID-19 response, approved by the WHA only yesterday,

The carefully-crafted resolution leaves some wiggle room in the pace at which WHO advances with further review. It calls for WHO to “initiate, at the earliest appropriate moment, and in consultation with Member States, a stepwise process of impartial, independent and comprehensive evaluation, including using existing mechanisms, as appropriate, to review experience gained and lessons learned from the WHO-coordinated international health response to COVID-19.”

However, with the threat of a complete cessation of US funding hanging over the future, the Director General had already indicated he would immediately act to advance further evaluation.

US Funding “Mostly Goes to Emergencies”

Tedros, who otherwise enjoyed resounding support at the Assembly, appeared unphased by the US threats, as such, which critics widely attributed as an attempt by Trump to shift criticism of his own administration’s performance in the pandemic response. 

However the WHO Director General expressed concerns about WHO’s future budget stability, wryly noting that funding for the Organization’s – charged with safeguarding the world – is comparable to that of an “average sized hospital”.  Only a precarious 20% of the budget is predictable “assessed” contributions by member states – while the rest is comprised of “voluntary contributions” by countries and donors, which are often earmarked for specific activities. 

US funding for 2020-2021 has already declined sharply, as a result of cuts in allocations by Washington, and now comprises only about 11% of the Organization’s planned budget of about US$ 4.9 billion.  

But US funding still accounts for about the single “greatest proportion of funding” earmarked for the WHO’s Emergencies Program, which is spearheading the COVID-19 response, said Executive Director of WHO’s Health Emergencies Programme Mike Ryan. 

In the new 2020-21 budget cycle, US contributions were expected to total some $553 million, including assessed contributions of 237 million and the remainder in earmarked funding for specific programmes. 

That’s almost 40% less than the $US 906 million that it had committed for 2018-2019 – of which about US$ 41 million still hasn’t been paid.

Quality And Stability Of Funding Also Needs Tweaking

However, ‘it’s not about having more money,” he added. “The amount of money is not the problem. The quality of it is also poor. We need to improve the quality of funding.”

WHO funding has witnessed a ‘complete reversal’ in the past 40 decades, said Dr. Tedros, as about 80% of WHO’s funding came from ‘assessed contributions’, or so-called ‘flexible funding’. Since then, flexible funding has dropped, accounting for 20% of the WHO’s budget. In other words, 80% of WHO’s funding relies on voluntary contributions, an unstable source of money.

We need to work on improving the WHO’s funding base to ensure continued flow of life-saving funds for frontline health services in some of the most difficult places in the world, said Ryan. To ensure that funds are still flowing, we will “obviously” have to work with other partners, he said. 

The WHO is ‘looking into resolving these financing challenges’, said Dr. Tedros –  especially in light of US President Trump’s blunt ultimatum to permanently suspend US funding, which accounts for almost a 6.5% of WHO’s budget for 2020-2021.

WHA Resolution Sets Out Clear Roadmap To Tackle COVID-19 Response

Dr. Tedros praised the WHA-approved resolution as a clear roadmap for confronting the pandemic:

“The resolution sets out a clear roadmap of the critical activities and actions that must be taken to sustain and accelerate the response at the national and international levels,” he said. “If implemented, this would ensure a more coherent, coordinated and fairer response that saves both lives and livelihoods.”

Critical Take-Homes In WHA Resolution 

Dr Tedros cited four critical take-homes from the resolution:

  • Fair distribution as a a global priority for all essential health technologies required to tackle COVID-19 pandemic 
  • Relevant international treaties should be harnessed where needed, including the provisions of the Trade-Related Aspects of Intellectual Property (TRIPS) agreement – Which can be used to temporarily override intellectual property rights to gain access to health technologies at an affordable price
  • COVID-19 vaccines as global public goods for health 
  • Collaboration is encouraged to promote both private sector and government funded research and development. This includes, but is not limited to, the patent pool initially proposed by Costa Rica, which aims to lift access barriers to COVID-19 health technologies.

Image Credits: WHO.

Seventy-Second World Health Assembly, Geneva, Switzerland, 20–28 May 2019

Although a proposal to include Taiwan as a World Health Assembly (WHA) observer was delayed until the WHA 73 session resumes again later this year, that didn’t prevent WHO member states from locking horns over the issue in statements on the second day of this week’s virtual WHA session. 

The charge was led by a handful of states, small and large, from the USA to the Caribbean islands of St Kitts and Nevis, Haiti and Belize; the Marshall Islands and Tuvalu in the Pacific; and Eswatini in Africa.

The People’s Republic of China countered with their own arguments:

“There are a few countries determined to plead for the [inclusion of Taiwan], seriously violating the relevant UN resolutions…This video conference decided not to examine the issue of Taiwan to guarantee the smooth running of the meeting. However, just now, the US delegate is still [politicizing this]. That is not acceptable.”

But only a few states, including Syria and Pakistan, openly endorsed China’s stance on Taiwan, reaffirming that ‘there is only one true representative of China,’ in the words of Pakistan.

Most of the world’s other conflicts and regional fault lines were also plainly evident at the Assembly; including member state protests over the plight of migrant populations and refugees in conflict zones such as Yemen and the Sahel, as well as the health status of people in  territories such as Russian Federation-occupied Ukraine and the Israeli-occupied Palestinian West Bank and Gaza. 

Iran, Syria and Cuba also protested unilateral sanctions imposed by the USA.

“The US must be held accountable for continuing to intensify sanctions against Iran, which are undermining our ability [to fight] against the virus,” said a statement by Iran. 

Replying to the political punches from Syria, Cuba and Iran, the US rebutted that its sanctions had not blocked COVID-19 related assistance, and it was even facilitating humanitarian and medical assistance. 

Election of 10 New Members To the WHO Executive Board

In a final item of business, the WHA elected ten new members to the WHA Executive Board, the 34 member governing body that provides oversight to the organization throughout the years. 

Those included representatives from Botswana, Colombia, Ghana, Guinea Bissau, India, Madagascar, Republic of Korea, the United Kingdom of Great Britain and Northern Ireland, and the Russian Federation.

Ukrainian delegate at the World Health Assembly on Tuesday

While Ukraine did not block the Russian Federation’s membership, it dissociated itself from the decision – denouncing Russia for violating international law and hampering health services delivery in occupied regions of the Ukraine affected by COVID-19. 

In a fiery rebuttal, the Russian Federation condemned Ukraine’s statement, calling it an attempt to scapegoat its own failure to handle the outbreak:

“Ukrainian authorities appear to be trying to push the responsibility” for its own failures “onto somebody else’s shoulders,” said the statement by Russia, where COVID-19 cases have exploded, leaving it as the second most infected country in the world, with almost 300,000 total cases that have been reported, and over 9,000 new cases over just the past 24 hours.

See more on WHA resolution.

Total cases of COVID-19 as of 8:32 PM CET 19 May 2020, with active case distribution globally. Numbers change rapidly.

Image Credits: WHO / Antoine Tardy, Johns Hopkins CSSE.

Dr Tedros Adhanom Ghebreyesus at close of WHA

With overwhelming support, the World Health Assembly (WHA) on Tuesday approved a resolution to combat the COVID-19 pandemic, which represents the strongest commitment yet from the global community to international cooperation in fighting the pandemic as well as ensuring access to COVID-19 treatments and future vaccines.

The final text also called for an independent evaluation of WHO’s performance during the pandemic.

The demand for the investigation of WHO has been included in a strident letter by US President Donald Trump to Director General Dr. Tedros Adhanom Ghebreyesus that issued a blunt ultimatum to WHO to undertake ‘substantive reforms’ – or permanently lose US funding. 

The letter, published earlier Tuesday by Trump on his personal Twitter account, was sharply critical not only of the organization, but of Tedros himself.

Trump compared the current Director General’s response to COVID-19 to that of former WHO Director General Gro Harlem Brundtland, who “did not hesistate to criticize China for endangering global health” in the 2003 SARS epidemic, and had even issued a WHO travel advisory, recommending against travel to and from the disease epicentre.   

Even so, Dr Tedros seemed to be bolstered by the otherwise resounding endorsement he and the WHO had received from global leaders and member states over the past two days.  Dressed casually, and posing for photos by the WHO flag, he responded with characteristic aplomb to the hailstorm of criticism by the US president, saying:  

“We welcome any initiative to strengthen global health security and to strengthen the WHO…I have been impressed and inspired [by the widespread adoption of the resolution as well as the call for an] independent and comprehensive evaluation of the international response”. He also noted pointedly that the evaluation is “not limited to the WHO” – but will also include responses by member states.  

In the closing moments of the abridged WHA73 session, to be resumed later in the year, world leaders including Ursula von der Leyen, President of the European Commission, Spain’s Pedro Sanchez and Colombia’s president Iván Duque Márquez, affirmed the need for multilateral cooperation, and its importance in the global health landscape, at closure of the two-day virtual WHA.

“I call on the World Health Organization and all the member states to face this COVID-19 with a better sense of international cooperation in order to protect those who most need it,” said Márquez, speaking at the close of the two-day virtual Assembly:

“International cooperation is our most immediate challenge…it should be a no-brainer”, added von der Leyen.  “Now is the time to act. We need to fight and defeat coronavirus in all continents….we need multilateral approaches,” she said.  She pointed to the EU-led Access to COVID-19 Tools Accelerator as one important start in the right direction. Earlier this month, the initiative raised some 7.5 billion Euros to speed development and improve equitable access to COVID-19 health technologies.

Her call for international cooperation was also echoed by Spanish President Sanchez: “The only response to COVID-19 is a multilateral one. This epidemic has highlighted our vulnerability. This should be a moment for re renewing our strong commitment to the WHO.”

At the same time, there is a need to  “modernize the WHO” to ensure that it can “live up to the new challenges”, stressed von der Leyen.

Other countries, including The Republic of Korea, Germany, France and The Netherlands, had already suggested yesterday that WHO member states also need to give the International Health Regulations, the binding convention governing health emergency responses, more teeth.

Heads of state at the WHA on Monday (top-down, left-right): France’s Emmanuel Macron, Germany’s Angela Merkel, Switzerland’s Simonetta Sommaruga, Republic of Korea’s Moon Jae-in

USA Questions Voluntary COVID-19 Patent Pool – Civil Society Argues ‘Voluntary’ Release of IP Is Not Enough

Even though EU-led resolution on COVID-19 responds to US demands for an impartial investigation of WHO’s performance as well as a scientific inquiry into the source of the virus, the US disassociated from key sections of the resolution. 

US objections centered on clauses that endorsed countries’ rights to override patent laws as well as preserving health services, including for sexual and reproductive health, which the US said could be interpreted as supporting abortion. In a written statement, the US argued that the resolutions clauses endorsing countries’ use of legal World Trade Organization “TRIPS flexibilities” to override patents when there are urgent health needs was “unbalanced” and could disincentivize innovation and R&D, saying:

“The United States recognizes the importance of access to affordable, safe, high-quality, and effective health products and the critical role that intellectual property plays in incentivizing the development of new and improved health products. However, as currently drafted, paragraphs 4, 8.2 and 9.8 send the wrong message to innovators who will
be essential to the solutions the whole world needs.”

While those objections had been expected, the US statement also questioned one of the resolution’s core provisions – an initiative to create a voluntary COVID-19 patent pool initiative to share rights to health technologies.  The initiative, which has been widely endorsed by leaders of developed and developing countries – was launched by WHO along with Costa Rica and Chile only last week. 

“The United States interprets this reference as limited to voluntary mechanisms existing before the COVID-19 pandemic, not new or proposed “patent pooling” mechanisms created in response to the pandemic. It is critical that any such voluntary mechanisms as applied to COVID-19 related technologies be narrowly tailored in scope and duration to the medical needs of the current crisis,” said the statement. 

In the end, even the pharma industry seemed to be more enthusiastic about the resolution outcome. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), gave the measure an unqualified endorsement. 

“We must also ensure equitable global access to safe, quality, effective, and affordable COVID-19 diagnostics, therapeutics and vaccines – making sure no-one is left behind, said Thomas Cueni, IFPMA Director General in a news release on Tuesday.

 *Biopharmaceutical companies have publicly committed to, and are actively working with, governments, insurers, foundations and international organizations to make future COVID-19 products available and affordable to those that need them,” said the statement. 

“COVID-19 is cruelly driving home a tough lesson: facing any global health challenge, in particular of such unprecedented scale, requires solidarity and inclusive cooperation. I think there has been a recognition among the broader health community that the industry has reached out, is teaming up and is responding at amazing speed. But at the same time, efforts to ensure essential medicines, vaccines and diagnostics for patients with other life-threatening diseases, must continue.”

Civil society actors, with WHO observer status, also lined up overwhelmingly to support the resolution – while warning that tougher measures would still be needed to put teeth in the high-minded declarations about equitable access to medicines. Some leading global health organizations also said that new COVID-19 innovations shouldn’t be restricted by patents at all. 

“[Member States must] guarantee that health tools are free of intellectual property restrictions…No new legal rights should be sought, and technology owners should either not enforce their existing IP or share it via non-exclusive licensing globally,” said a joint statement from Drugs for Neglected Diseases initiativeI (DNDi) and Médecins Sans Frontières.

To ensure that health technologies are affordable, the public needs more transparency from the pharmaceutical sector, added Knowledge Ecology International in their statement – urging the WHO’s R&D Observatory to setup a global database to keep track of clinical trial costs, public sector subsidies and prices for COVID-19 health technologies:  

“The WHO R&D Observatory needs to have a database of all R&D related to the coronavirus, including information on the costs of trials, the funders and the public sector subsidies [as well as] prices for all relevant COVID 19 drugs, vaccines and diagnostic tests.” 

The South Centre’s, Carlos Correa went even further, saying it is time to rethink the R&D process so that it is “solely” focused on access rather than being driven by commercial interest. 

Image Credits: WHO / Seventy-third World Health Assembly, European Parliament, Ministry of the Presidency. Government of Spain, Korea.net / Korean Culture and Information Service (Jeon Han).

Colorized electron microscope image of SARS-CoV-2 (yellow), the virus that causes COVID-19
Thomas Cueni

Now, more than ever, the pharma industry has been thrust into the limelight – as the world races to find new drugs and a hoped-for vaccine to beat COVID-19 and ensure universal access to critical treatment. Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), talks about the old-new tensions between profit and public needs and how a fiercely competitive industry is testing new models of cooperation.

Health Policy Watch: There is finally an agreed text on the EU-led resolution on COVID-19 Response, that was passed unanimously at the World Health Assembly on Tuesday.  What is your take on the result?

Thomas Cueni: Resolutions quite often have symbolic meaning. When I look at the outcome, it has the right focus, tasking the global community to work together to contain and one day to defeat COVID 19.   It does address the issues of health systems resilience; it does look at lessons to be learned and it calls for collaboration with WHO.

In the development of the call to action, which has become the ACT Accelerator, there are three pillars: vaccines, therapeutics and diagnostics. But there is also a focus on health systems. We’ve been working on the ACT A for three weeks now, and we are making progress in working together towards a common goal to tackle COVID 19.

There are, however, three references to countries’ rights to override patents with the use of WTO  TRIPS flexibilities in the text – something civil society saw as a modest victory.

What we got was a united, rapid, unprecedented industry response to COVID 19, in terms making decisions collectively, repurposing existing medicines, joining together for development of vaccines. When you look at who holds the keys to these, I think there is a recognition that it is indispensable to partner with the private sector and more specifically the biopharmaceutical industry. There has been a recognition among the broader health community that the industry has responded at amazing speed.  It is scaling up manufacturing, in some cases joining up, and committing to huge collaboration efforts in vaccine development. This is not our normal business model. Companies are putting aside normal rivalry and fierce competition, and working on the basis of high risk for high reward. Here companies are acting very differently, with a deep sense of responsibility. As a founding partner of the ACT Accelerator, pharma joins with it a strong belief in the need for solidarity, equity, and a clear notion that what comes out of our labs needs to be affordable.

[The reference to TRIPS] is symbolic and to some extent concerning. It is thanks to a flourishing, thriving innovation ecosystem based on IP that we have so many treatments and vaccines already being tested. Pharma companies moved really extremely fast opening, for example, their libraries to NIH and IMI [Innovative Medicines Initiative].IP has not been a hindrance to finding solutions, it has been an enabler. Without the IP system, we would not be where we are in just three months.  The pharma industry is teaming up with regulatory agencies around the world. It is sharing data. It did not need to be forced to move into discussions about how we can ramp up. Gilead has already contracted with the Medicines Patent Pool – [for voluntary licensing of remdesivir].  The scale, the size of [pharma’s engagement] is unprecedented. All of this is done voluntarily.

So, I was somewhat concerned that there are institutions or people that try to hijack COVID-19 to pursue the traditional attack on IP.  It’s not necessary right now – because companies are doing the right thing.  Undermining IP will be extremely dangerous, because when we have future pandemics and we will have future pandemics, it sends the signal that your IP won’t count for anything.  Honestly, that would be a dangerous signal because companies are doing the right thing. If somebody is already doing the right thing and is met by threats of coercion that would not be the best way to get them to engage.

HPW: Can you talk a little more about the Gilead collaboration with MPP on remdesivir for voluntary licensing of the treatment and these other industry collaborations?  

TC: Gilead is working with MPP, but they also have bilateral contracts. There are multiple ways of doing voluntary licenses.  Decisions in terms of testing, further ramping up [production], giving away huge doses, all of that, to the best of my knowledge was done by Gilead.

It is also important that companies maintain oversight over who they choose to collaborate. They have a responsibility to pick partners based on quality checks and assurances, because quality does matter.

One initiative that underscores our common goal of solidarity and equity, and I think has not been given adequate attention, is the ACT Accelerator initiative launched on April 24 by Dr Tedros. So many leaders among them: the European Commission President Ursula von der Leyen, French President Macron, German Chancellor Merkel, South African President Cyril Ramaphosa, and others spoke of this as they supported the WHO Conference Call for action that day.

In a matter of weeks, this [ACT Accelerator] has been implemented. We are making great progress in the work of these various accelerators. CEPI and GAVI are in the lead of an effort searching for a vaccine from end to end.  And everyone agrees that WHO should play a major role when it comes to allocation. We know that at the beginning [when a vaccine or hopefully vaccines are available], demand will far outstrip supply. In the industrialized world there are only handful of companies with the skill sets to scale up the manufacturing of vaccines, which are going to be needed in the hundreds of millions and probably billions [of doses]. In the case of vaccines, it is not just a question of IP, it is also a question of know-how and that you acquire over time. We will need global guidance on who should get the vaccine first: health care workers and vulnerable populations. This is why we support the vaccine accelerator.

Similar for a therapeutics accelerator. People are keen to get more guidance in terms of clinical practice. We should not focus on a few countries. We need a global focus on what is the best clinical practice in terms of treating COVID-19 patients.

HPW: Overall, there has been less talk about collaboration in the therapeutics accelerator ? Can you recap.

TC: There are three pillars under the ACT umbrella:vaccines diagnostics, therapeutics.

It is really good to see that there are tremendous dynamics coming out of ACT, based on the understanding that there will be a light touch coordination mechanism. And there will be leading roles for the likes of CEPI, GAVI, The Global Fund and FIND.

The Vaccine Accelerator is by far the most developed in terms of global approach. In therapeutics, you have a lot of progress happening at national level.  In the therapeutics, testing the different treatments is a key preoccupation. For therapeutics you already have leading regulatory agencies involved, and market mechanisms, whereas for vaccines, you need end-to-end collaboration. At the same time [whether for COVID-19 treatments or vaccines] you are confronted with the same problem: you want to know once they work that they also need to be made available to low- and middle-income countries.

HPW: Is IFPMA completely opposed to the use of TRIPS Flexibilities – or are there times this is justified?   

TC: Most countries have national emergency frameworks. In times of war, in times of crisis, countries can sequester production facilities through public interest compulsory license. I see it as a last resort. It would be very dangerous if this was seen as something that should be done systematically. It would send the wrong signal. If the industry engages in voluntary licenses in collaboration, emphasizes the importance of equity, then I believe that a general call for compulsory licensing would frighten them, and it would not be conducive to what needs to be done. Industry is already sharing the data, they are going to member states, WHO, asking for advice in allocation.  For example, UNICEF [which is also involved in the ACT Accelerator] in quite a number of cases has a huge experience in medicines and vaccines deployment and delivery. It is easier to get results if everyone has a common purpose than if you approach it in antagonistic manner.

HPW: What about transparency ?  There have been calls for more transparency around the prices of new COVID-19 drugs and particularly R&D costs for drugs such as remdesivir, which received very large public sector investments?  

TC: We are likely to see that there will be differential pricing. If you want to make sure that everyone who needs has access, there will have to be tiered prices

As for the transparency of R&D costs for new COVID-19 drugs and vaccines. I would expect that the affordability issue is handled through public private partnerships. It does include the know-how of who puts in how much.

Image Credits: NIAID.