What is the Joint Call for Action?
The coronavirus pandemic affects practically every country in the world. Past experiences have shown that even with the availability of effective tools at the world’s disposal, some are protected, while others are not. This inequity is unacceptable – all tools to address the pandemic must be available to all.
With this in mind, the World Health Organization (WHO) and an initial group of global health actors have launched a landmark, global collaboration for the accelerated development, production and equitable global access to new COVID-19 essential health technologies. The partner organisations include: the Bill and Melinda Gates Foundation (BMGF), the Coalition for Epidemic Preparedness Innovations (CEPI), the Global Alliance for Vaccines and Immunisations (GAVI), the Global Fund, UNITAID, the Wellcome Trust and the World Bank.
What is the Coronavirus Global Response?
To respond to the joint call for action from health actors, the EU is joining forces with France, Germany, the United Kingdom, Norway and Saudi Arabia to host a pledging event.
Researchers and innovators around the world are working very hard to find solutions to save lives and protect our health. But they need more funding. World-leading scientists and health experts say €7.5 billion ($8 billion) is now needed to develop solutions to test, treat and protect people, and to prevent the disease from spreading.
With the Coronavirus Global Response, the EU and its partners are taking the lead in the global effort to close this funding gap.
The initiative has two main aims:
- To rally support for global efforts and attract sizeable financial contributions from the public, private and philanthropic sectors, to bridge the funding gap estimated at €7.5 billion for the development and deployment of diagnostics, treatments and vaccines;
- To secure a high-level political commitment to ensuring equitable access to therapeutics and vaccines, leaving no-one behind.
How was the €7.5 billion fundraising target set?
The €7.5 billion ($8 billion) figure is based on an assessment, done in March 2020, by the Global Preparedness Monitoring Board (GPMB), an independent monitoring and accountability body to ensure preparedness for global health crises.
GPMB identified a shortfall of funding for major needs to fight this pandemic in key areas:
- $1.25bn for the World Health Organization (WHO) to support the most vulnerable countries;
- $3bn for research and development (R&D) of vaccines for COVID-19 ($2bn), plus seed funding for manufacturing and deployment ($1bn);
- $2.25bn for R&D on therapeutics for COVID-19, plus seed funding for manufacturing and deployment;
- $0.75bn for R&D on diagnostics for COVID-19, plus seed funding for manufacturing and deployment, and
- $0.75bn to stockpile essential Personal Protective Equipment (PPE) and vaccines.
GPMG has indicated that the full scale up of manufacturing and delivery will cost well above the current target, which is covers only the most urgently needed initial amounts.
Where are the main needs in the areas of vaccines, therapeutics and diagnostics?
In these three areas, underfinancing exists mainly on manufacturing, procurement and deployment rather than research and development, even if this is the most urgent area to cover. The current situation in the three selected areas is as follows:
Vaccines are difficult to develop and the outcome of research is uncertain. Currently, there are more than 70 vaccines in development, and at least 3 have entered into clinical trials. Once a vaccine is available, the challenge will be to produce it in the extremely high quantities needed and required, as well as to ensure that it is available and accessible for all countries, including low and medium-income countries.
Therapeutics: So far more than 40 developers of potential treatments for COVID19 have contacted the European Medicines Agency (EMA) and the Member States for scientific advice. Most of the treatments proposed are medicines currently authorised for other diseases. Clinical trials are currently ongoing to determine their efficacy for the treatment of COVID-19 patients. Once new therapies are identified, the challenge will be their production and manufacturing capacity and the need for large-scale procurement. Procurement at a global level will be costly and funding is therefore needed.
Diagnostics (Tests): At the moment, several types of tests, for different purposes, are in use. Some are used to detect the active disease and others to detect if the person passed on the disease. The latter still have be validated in terms of performance and produced on a large scale. The challenge is procurement and deployment, including equipment to analyse the results when applicable, as well as the link with effective and well-resourced testing strategies.
All new vaccines, diagnostics and treatments developed for COVID-19 will need to be made available globally for an affordable price, regardless of where they were developed or how they were funded. That is the reason why funds from this pledging initiative will go to organisations that are coordinating the global response to this crisis.
What is the GPMB?
Launched in 2018, the Global Preparedness Monitoring Board (GPMB) is an accountability and advisory body composed by 15 members to better respond to global health emergencies. It was created following the recommendations formulated by the UN Secretary General’s Global Health Crises Task Force in 2017.
The goals of the Board are to 1) assess the world’s ability to protect itself from health emergencies, 2) identify critical gaps to preparedness across multiple perspectives and 3) advocate for preparedness activities with national and international leaders and decision-makers and mobilise its influence with other leaders and policy makers at global, national and community levels.
The EU as such is not represented in the Board.
Who is in charge of the funds raised?
The European Union will coordinate the collection of the funds, which will be directed towards the needs identified by the GPMB in three strands: diagnostics, treatments and vaccines.
What is the breakdown of funds allocated to the three strands of work?
The 4 May will mark the beginning of the rolling out of the initiative aimed at developing three strands of work: diagnostics, treatments and vaccines. The breakdown of the funds will be further refined based on the initial indication of the needs identified by GPMB.
Pledges may be general or they may be earmarked for a specific strand.
Who will be developing the diagnostics, treatments and vaccines?
As of 20 April, the WHO had already identified 76 vaccine candidates supported by public, private and public-private consortia. There are many researchers and developers worldwide currently working on innovative solutions, including vaccines, treatments and diagnostics. The pressing needs and the special nature of research and development requires strong global collaboration.
Who will have ownership of the products produced with funding from the initiative?
Funding will benefit organisations that strive to ensure that the products will be available, accessible and affordable across the world, especially in the most vulnerable countries. Pledges will notably target CEPI and GAVI.
Funding pledged will also be accompanied by high-level commitments from donors in support of global access and fair deployment of new diagnostics, treatment and vaccines against COVID-19.
Who can donate?
All countries, international organisations or financial institutions may contribute, but also the private sector, or foundations.
Why can’t private individuals make a donation?
The EU is not legally able to ask for citizens’ donations. Nonetheless, we are calling on individuals to d show their support by interacting on-line, spreading awareness about the initiative and encouraging the private sector to pitch in. In addition, individuals may make contributions to partner funds, such as the WHO COVID-19 solidarity response fund: https://covid19responsefund.org.
Until when can donations be made?
Donations can be made as of 4 May 2020. On that day, the Commission will also announce the next milestones of a global campaign, which is to kick off an ongoing rolling replenishment.
What will you do if you exceed the fundraising target?
We aim is to reach €7.5 billion as we believe it is a realistic target for the current needs. More funding will be needed to sustain the actions in the coming months, which could benefit from donations beyond the targets.
What is the estimated timeline for delivery on the three strands?
Given the current crisis, there is no time to lose. Funds will be allocated as quickly as possible. While a number of solutions are already being investigated, R&D, manufacturing and deployment are all time-consuming, resource-intensive steps. This is why it is crucial to coordinate efforts at international level, to identify as quickly as possible the most promising approaches while accelerating their development.
What are the links with the funds already raised for the WHO?
The WHO is currently helping to coordinate the worldwide response to COVID-19, which it declared to be public health emergency of international concern (PHEIC) on January 30, and a global pandemic on March 11, 2020. The WHO Strategic Preparedness and Response Plan outlines the public health measures that the international community stands ready to provide to support all countries to prepare for and respond to COVID-19.
The funds raised by the Coronavirus Global Response would be complementary to the WHO’s work and their appeal. The first iteration of the WHO Strategic Preparedness and Response Plan (SPRP) called for a total resource requirement of $675 million, of which $61.5 million were for WHO’s urgent preparedness and response activities for the period of February to April 2020. An updated plan will be launched in April and will identify significantly larger resource needs for country response, research and development and WHO itself.
The EU’s partnership with the WHO to respond to the COVID-19 is not new and will be reinforced via our current initiative. For example, the EU is already working with the WHO to supply medical devices and personal equipment such as ventilators, laboratory kits, masks, goggles, gowns, and safety suits.
Which countries were invited to take part in the initiative?
All countries, international organisations and foundations who have shown interest in fighting the COVID-19 have been invited to participate.
Will the fruits of the initiative only benefit countries that participate?
No, the objective of this pledging event is to speed up innovations and ensure access for all, irrespective of the geographical origin of funds. Pandemics can only be effectively controlled when solutions are deployed globally. The initiative aims to rally significant financial contributions to develop diagnostics, treatments and vaccines and secure a high-level political commitment to ensure equitable access to diagnostics, treatments and vaccines to make sure no-one is left behind.
How does this pledging event compare to and complement other international initiatives?
This is an integral part of the multilateral response to the COVID-19 emergency and is aligned with the logic of on-going UN appeals. It stems directly from G20 Leaders’ commitment, and the G20 Action Plan to provide immediate resources to key entities in the global health response.
The conference will focus on the quest for solutions that currently do not exist, first through R&D, then deployment (access to new solutions), whereas the UN system is primarily tackling other needs such as humanitarian assistance, mitigation of the socio-economic impacts and preparedness of health systems for future outbreaks.
Millions in Yemen ‘a step away from starvation’
The crisis in Yemen, now in its seventh year of war, continues unabated, with thousands of people displaced and millions “a step away from starvation”, the UN Humanitarian Relief Coordinator said on Wednesday during a high-level side event on the margins of the 76th General Assembly.
“The country’s economy has reached new depths of collapse, and a third wave of the pandemic is threatening to crash the country’s already fragile health-care system”, Humanitarian Affairs chief Martin Griffiths told world leaders at the meeting: Yemen: Responding to the crises within the world’s largest humanitarian crisis.
Underscoring that the most vulnerable always “bear the highest cost” of the crisis, he said that females were more likely to be hungry, sick or exposed to gender-based violence and, with little access to essential services, millions of internally displaced people face “a daily struggle to survive”.
Cause for hope
In a positive development, the UN official credited the international community for stepping up support to the country’s humanitarian aid operation.
With over $2 billion received, the UN and its partners were able to “prevent famine and pull people back from the brink of despair”, delivering assistance to “every single one of the country’s 333 districts”.
‘Far from done’
Despite these important achievements, Mr. Griffiths acknowledged that the work there is “far from done”, as many sectors still face “alarming funding gaps” and humanitarians are working with less than one-fifth of the money needed to provide health care, sanitation, and shelter.
“Without additional funding, these and other forms of critical life-saving support – including food assistance – will have to be reduced in the coming weeks and months”, he warned.
The UN relief chief asked global leaders to continue generously supporting Yemen’s humanitarian operation; respect international humanitarian law and protect civilians; and address the root drivers of the crisis, including restrictions on imports, which elevate the prices of essential goods.
He urged them to do “everything in our collective power to stop this war”, saying, “at the end of the day, peace is what will provide Yemenis the most sustainable form of relief”.
The war has robbed too many of Yemen’s children of safety, education and opportunities.
“Each day, the violence and destruction wreak havoc on the lives of children and their families”, Henrietta Fore, Executive Director of the UN Children’s Fund (UNICEF), told the meeting.
She painted a grim picture of 1.7 million displaced youth, 11.3 million youngsters depending on humanitarian assistance to survive and 2.3 million under-five “acutely malnourished” – nearly 400,000 of whom are at “imminent risk of death”.
“Being a child in Yemen means you have probably either experienced or witnessed horrific violence that no child should ever face”, said the UNICEF chief.
“Quite simply, Yemen is one of the most difficult places in the world to be a child”.
Millions ‘marching towards starvation’
In his address, World Food Programme (WFP) chief David Beasley said that in a nation of 30 million people, food rations are needed by 12.9 million; while 3.3 million children and women need special nutrition, together with 1.6 million school children.
“We’re literally looking at 16 million people marching towards starvation”, he said.
With one thousand people a week dying from a lack of food and nutrition, the senior WFP official warned that if $800 million is not received in the next six months, the need to cut rations could lead to the death of 400,000 children under the age of five next year.
“We have a moral, obligation, to speak out and step up”, he stated, appealing to the world leaders to “put the pressure on all parties…to end this conflict”.
“These are our children; these are our brothers and sisters we need the donors to step up immediately otherwise children are going to die. Let’s not let them down. Let’s do what we need to do”, concluded Mr. Beasley.
South Sudan ‘determined to never go back to war’
South Sudan is “ready to turn a new page” towards greater peace, development and prosperity, Vice-President Rebecca Nyandeng de Mabior said in her speech in the UN General Assembly on Friday.
A decade after gaining independence from Sudan, the country remains “on a path of nation-building” and is working to implement a 2018 revitalized peace deal which led to the formation of a unity government last year.
“I want to assure our friends and partners that we are determined to never go back to war,” said Ms. De Mabior.
“We must replace the destruction of war with the productive use of our vast natural resources and national assets for the good of our people.”
The Vice-President recalled that when South Sudan became independent, the international community pledged to build capacity in nation-building, establishing a UN mission in the country, UNMISS, to support this process.
“However, after the outbreak of the war, that vision was abandoned, and priority was placed on protecting civilians and providing humanitarian assistance. As a result, support for capacity building of the State was terminated,” she said.
Ms. De Mabior stressed that supporting a State’s ability to govern responsibly and effectively is essential. It is also necessary to guard against what she called “the unintended consequences of dependency on humanitarian assistance.”
Given improvements in peace and security, she said it was now time to transition from emergency towards sustainable development.
“It is a painful and shameful situation for a country endowed with vast fertile land to be regarded as poor,” she added.
“We must ensure peace and security in the country and double our efforts to support our people who want to return, and are returning, to their areas of origin, for them to participate fully in nation-building and contribute to building food security in the country.”
Support youth and women
South Sudan is also “a youthful country”, and the Vice-President called for continued efforts to develop the skills of its youth and women “to provide an alternative to picking up the gun again and engaging in destructive behavior.”
Encouraging developments have included joint efforts by the national security forces and their UNMISS counterparts to promote rural peace and security, while the Government is set to unveil a national youth service programme.
“To fulfill the vision of our liberation struggle, we must use our oil revenues to fuel economic growth through investment in agriculture,” she said.
“We will invest in infrastructure to connect our rural communities to the markets. We need the public and private sectors, including foreign investors, to join hands in turning South Sudan’s potential wealth into a reality.”
Ms. De Mabior reported progress in implementing aspects of the Revitalized Peace Agreement, particularly in the creation of state and national bodies and public financial management reforms
However, “the glass remains half-empty” in implementing a permanent ceasefire and transitional security arrangements, she said, noting the urgency for a unified army.
“The security sector reform is the most challenging part of the Agreement as it contains elements at the center of the violent conflicts in the country,” she said, calling for continued dialogue.
“Building sustainable peace requires inclusivity, collective investment, determination, diligence, and patience.”
Meanwhile, relations with Sudan have also improved, though outstanding issues remain over the oil-rich Abyei border area.
Ms. De Mabior stressed her country is determined to learn from the past.
“We must make the Revitalized Peace Agreement succeed, and we can only do that with the support of our regional and international partners. Simply stated, South Sudan desires and is ready to turn a new page,” she said.
WHO backs Regeneron COVID-19 drug cocktail – with equal access, price cut
The Regeneron antibody drug cocktail – casirivimab and imdevimab – has been added to the World Health Organization’s (WHO) list of treatments for COVID-19 patients, the UN agency said on Friday, before underscoring the need for lower prices and equitable distribution.
“This is a major breakthrough in the care of COVID-19 patients”, said Dr. Janet Diaz, WHO head of clinical care. “This is our first recommendation for a therapeutic for those patients with mild, moderate disease,” she said, because it reduces “the need for hospitalisation if they are at high risk”.
Effective ‘reduction in mortality’
WHO’s conditional recommendations are for use of the drug combination on patients who are not severely ill, but at high risk of being admitted to hospital with COVID-19, or those with severe cases of the disease and no existing antibodies.
“Giving them this additional antibody seems to show an effect. And what effect is that? A reduction in mortality” Dr. Diaz told a briefing in Geneva.
The antibody therapy was granted emergency use authorization in the United States November last year after it was used to treat former President Donald Trump when he was admitted to hospital with the virus. The United Kingdom has also approved Regeneron, while it is under review in Europe.
The WHO recommendations were largely based on data from a British study of 9,000 patients in June which found that the therapy reduced deaths in hospitalised patients whose own immune systems had failed to produce a response.
“We are taking the information (from the UK study) and generalizing it to other persons,” said Dr. Diaz. “We saw there was a benefit we thought was meaningful.”
The treatment has been on the market for decades to treat many other diseases, including cancers. It is based on a class of drugs called monoclonal antibodies which mimic natural antibodies produced by the human body to fight off infections.
Equity, price cut call
Swiss drugmaker Roche, has been working in partnership with Regeneron, which holds the patent, to produce the antibody treatment.
Dr. Diaz urged Regeneron to lower the drug’s price and work on equitable distribution worldwide: “We know that the life-saving benefits and the benefits for patients with COVID-19 is significant and requires action.”
She added that WHO-hosted health agency UNITAID, has been negotiating directly with Roche for lower prices and equitable distribution across all parts of the world, “including low and middle-income countries”.
WHO has also been in discussions with the company for a donation and distribution of the drug through UN Children’s Fund UNICEF, following an allocation criteria set by the health agency. “We are working together with the company so we can address these very important issues so we can have equitable access” she said.
Call to manufacturers
In a statement, WHO said in parallel it had “launched a call to manufacturers who may wish to submit their products for pre-qualification, which would allow for a ramping-up of production and therefore greater availability of the treatment and expanded access.
ACT-A partners are also working with WHO on an equitable access framework for recommended COVID-19 therapeutics”. On that subject, Dr Diaz added that “there are bottlenecks and we are aware of those.
WHO has launched the pre-qualification expression of interest call so that the manufacturing companies can start to submit their dossiers to WHO”.
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