Tuberculosis is a disease of poverty, and economic distress with 1.4 million deaths annually1 and the growing challenge of drug resistance is adding to the global health crisis
WHO guidelines support the expansion of tuberculosis diagnostics in resource-limited countries, enabling patients to receive timely diagnosis leading to proper treatment, which benefits their recovery and slows the transmission of disease
Roche’s Global Access Program aids clinicians in improving disease and patient management through increased access to innovative diagnostic solutions, allowing more patients to get test results promptly
Basel, 09 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas® MTB and cobas® MTB-RIF/INH tests for use on the cobas® 6800/8800 Systems are included as part of the updated World Health Organization (WHO) policy guidelines on nucleic acid amplification tests (NAATs) to detect tuberculosis (TB) and drug-resistant TB. The new guidance expands the number of rapid molecular tests available to national TB programmes in high-burden countries, enabling multi-partner diagnostic approaches that can benefit patients and communities.
The WHO estimates that about 1.7 billion people are living with tuberculosis globally, with an estimated 10 million new active tuberculosis cases and 1.4 million deaths annually. Approximately 29% of new infections were undiagnosed and untreated, potentially contributing to further transmission. When drug-resistant TB (RR/MDR-TB) is present, the challenge is greater, with only 44% properly diagnosed.1 Although TB can be cured once it is diagnosed, people affected are often faced by vulnerability, marginalization, stigma and discrimination.
To increase early detection, diagnosis, and treatment of TB among vulnerable populations, the updated WHO guidelines aim to help countries identify populations at highest risk of infection and the locations most affected. This includes 30 low- and middle-income countries (LMICs), which bear the majority of the TB burden.1 These countries rely on the WHO to evaluate test performance and provide centralised testing guidance and diagnostic guidelines prior to the use of any TB test. The new policy guidance enables LMICs to use donor funds for implementation and purchase of TB tests, increasing diagnostic options for people living with TB and drug-resistant TB.
“Roche’s diagnostic solutions detect both TB and drug-resistant TB, enabling patients to be diagnosed earlier and treated with the appropriate regimen to stop the spread of the disease,” said Thomas Schinecker, CEO Roche Diagnostics. “Roche plays a significant role in the fight against TB through our Global Access Program, which focuses on sustainable solutions that can help diagnose infections and save lives.”
WHO guidelines are an important step toward ending the global TB epidemic by increasing patient access to high-quality diagnostics. The organisation’s multi-faceted End TB Strategy aims in part for a 90 percent overall reduction in TB incidence and a 95 percent reduction in TB deaths by 2035. High-volume, multi-disease testing systems and innovative diagnostic tests can accelerate eradication efforts and further improve health outcomes for people living with TB.
In 2014, Roche announced the Global Access Program for increased access to HIV diagnostics. Roche partnered with national governments, local healthcare facilities, communities and international agencies, including UNAIDS, Clinton Health Access Initiative (CHAI), Unitaid, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), Global Fund and Center for Disease Control and Prevention (CDC) to establish programmes that would go beyond providing diagnostic tests.
Since its inception, the program has expanded substantially in menu and geographic footprint to provide increased access to diagnostics at affordable pricing for qualifying organisations in eligible countries with the highest disease burden. The Global Access Program includes diagnostic solutions for HIV, Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV) and human papillomavirus (HPV) to help towards implementation of elimination programmes in efforts to eradicate disease and in line with the 2030 elimination goals.
The cobas MTB and cobas MTB-RIF/INH molecular tests provide clinicians flexibility to detect a combination of tuberculosis and drug-resistant tuberculosis infections from a single patient sample. When a patient presents with symptoms of tuberculosis, the highly sensitive cobas MTB test is performed. If positive, the patient should be evaluated for drug resistance using cobas MTB-RIF/INH test. Roche’s mycobacteria tests are for use on the cobas 6800/8800 Systems.
Hemlibra is approved for routine prophylaxis of bleeding episodes in people with haemophilia A with and without factor VIII inhibitors in over 100 countries worldwide for those with inhibitors and over 80 countries for those without inhibitors, in adults and children, ages newborn and older. Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once-weekly, every two weeks or every four weeks (after an initial once-weekly dose for the first four weeks). Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech. It is marketed in the United States by Genentech as Hemlibra (emicizumab-kxwh), with kxwh as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the US Food and Drug Administration.
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The cobas 6800/8800 Systems are part of the Molecular Work Area—a fully integrated laboratory workflow strategy that empowers labs to further elevate their levels of efficiency, flexibility and scalability. With proven performance, absolute automation, and unmatched flexibility delivering unparalleled throughput 24/7, cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever. Learn more: www.molecularworkarea.com.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
Geneva/Johannesburg/Paris, 21 June 2021: The World Health Organization (WHO) and its COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the Africa Centres for Disease Control and Prevention (CDC) to establish its first COVID mRNA vaccine technology transfer hub.
The move follows WHO’s global call for Expression of Interest (EOI) on 16 April 2021 to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. Over the coming weeks, the partners will negotiate details with the Government of South Africa and public and private partners inside the country and from around the world.
South African President Cyril Ramaphosa said: “The COVID-19 pandemic has revealed the full extent of the vaccine gap between developed and developing economies, and how that gap can severely undermine global health security. This landmark initiative is a major advance in the international effort to build vaccine development and manufacturing capacity that will put Africa on a path to self determination. South Africa welcomes the opportunity to host a vaccine technology transfer hub and to build on the capacity and expertise that already exists on the continent to contribute to this effort.”
“This is great news, particularly for Africa, which has the least access to vaccines,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “COVID-19 has highlighted the importance of local production to address health emergencies, strengthen regional health security and expand sustainable access to health products.”
The announcement follows the recent visit to South Africa by the President of France, Mr Emmanuel Macron, who said his country was committed to supporting efforts in Africa to scale up local manufacturing capacity of COVID-19 vaccines and other medical solutions.
“Today is a great day for Africa. It is also a great day for all those who work towards a more equitable access to health products. I am proud for Biovac and our South African partners to have been selected by WHO, as France has been supporting them for years,” said President Macron. “This initiative is the first of a long list to come, that we will keep supporting, with our partners, united in the belief that acting for global public goods is the fight of the century and that it cannot wait.”
Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed. Interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.
The technology transfer hub will benefit from the Medicines Patent Pool’s (MPP’s) vast experience of intellectual property (IP) management and issuing of IP licenses. MPP is also assisting WHO to negotiate with technical partners and supporting in the governance of the hubs.
Biovac is a bio-pharmaceutical company that is the result of a partnership formed with the South African government in 2003 to establish local vaccine manufacturing capability for the provision of vaccines for national health management and security.
Afrigen Biologics and Vaccines is a biotechnology company focuses on product development, bulk adjuvant manufacturing and supply and distribution of key biologicals to address unmet healthcare needs.
The organizations complement one another, and can each take on different roles within the proposed collaboration: Biovac will act as developer, Afrigen as manufacturer and a consortium of universities as academic supporters providing mRNA know-how, and Africa CDC for technical and regional support.
The South African consortium benefits from having existing operating facilities that have spare capacity and because it has experience in technology transfers. It is also a global hub that can start training technology recipients immediately.
WHO’s April call for expressions of interest has so far generated 28 offers to either provide technology for mRNA vaccines or to host a technology hub or both. There have been 25 expressions of interest from low- and middle-income country respondents who could receive the technology to produce mRNA vaccines.
Over the coming weeks, WHO will continue the rolling evaluation of other proposals and identify additional hubs, as needed, to contribute to health security and equity in all regions.
Through the COVAX partnership, WHO will continue its assessment of potential mRNA technology donors and will launch subsequent calls for other technologies, such as viral vectors and proteins, in coming months.
WHO is also hosting the Local production forum this week, to identify strategies to expand pharmaceutical manufacturing capacity in low- and middle-income countries for COVID-19 and other priority diseases.
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
WHO today validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use, giving countries, funders, procuring agencies and communities the assurance that it meets international standards for safety, efficacy and manufacturing. The vaccine is produced by the Beijing-based pharmaceutical company Sinovac.
“The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products. “We urge manufacturers to participate in the COVAX Facility, share their knowhow and data and contribute to bringing the pandemic under control.”
WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply and international procurement. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions.
In the case of the Sinovac-CoronaVac vaccine, the WHO assessment included on-site inspections of the production facility.
The Sinovac-CoronaVac product is an inactivated vaccine. Its easy storage requirements make it very manageable and particularly suitable for low-resource settings.
WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. On the basis of available evidence, WHO recommends the vaccine for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks. Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalization in 100% of the studied population.
Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. Nevertheless, WHO is not recommending an upper age limit for the vaccine because data collected during subsequent use in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons. There is no reason to believe that the vaccine has a different safety profile in older and younger populations. WHO recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to verify the expected impact and contribute to making the recommendation more robust for all countries.
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan with a focus on low- and middle-income country needs. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.
As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.
WHO has already listed the Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Astra Zeneca EU, Janssen, Moderna and Sinopharm vaccines for emergency use.
SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and immunization technology, research and development, to delivery of immunization and its linkages with other health interventions. SAGE is concerned not just with childhood vaccines and immunization, but all vaccine-preventable diseases.
SAGE assesses evidence on safety, efficacy, effectiveness, impact and programmatic suitability, considering both individual and public health impact. SAGE Interim recommendations for EUL products provide guidance for national vaccination policy makers. These recommendations are updated as additional evidence becomes available and as there are changes to the epidemiology of disease and the availability of additional vaccines and other disease control interventions.
SAGE has issued recommendations on Pfizer (8 January 2021), Moderna (25 January 2021), AstraZeneca (21 April 2021), Janssen COVID (17 March 2021) and Sinopharm (7 May 2021) vaccines, as well as issued a framework for access and population prioritization roadmap. The SAGE interim recommendations on Sinovac-CoronaVac will be available online at 17:00 CEST today.
SAGE and EUL recommendations are complementary but independent processes. The EUL process is centred on determining if a manufactured product is quality-assured, safe and effective. SAGE is policy oriented, assessing safety, efficacy, public health impact, and programmatic feasibility. Policy recommendations for a vaccine are generally made only for those products that have been listed or authorized for use.
In the context of COVID-19 and due the pressing need for vaccines, the Secretariat of SAGE and the EUL team have been working in parallel to allow WHO EUL and policy recommendations, based on the available evidence, to be issued in a synchronized manner.
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
New resolutions on the health and care workforce and strategic directions for nursing and midwifery
Decisions on patient safety; health, environment and climate change; chemicals management; coordination of work on noncommunicable diseases
Global Action Plan for Healthy Lives and Wellbeing for All
Prevention of sexual exploitation, abuse and harassment
The COVID-19 pandemic has underscored the critical role of all health and care workers at the forefront of the pandemic, who have faced multiple risks related to their health, well-being and safety.
The resolution on Protecting, safeguarding and investing in the health and care workforce calls for action to guarantee that investments in our workforce ensure they are: skilled, trained, equipped, supported and enabled. It stresses the need for decent pay, recognition, a safe working environment, and protection of their rights.
The resolution highlights the need to:
enable all health and care workers to access COVID-19 vaccines, Personal Protective Equipment, decent work conditions, and equitable labour protection that is free from all forms of discrimination
accelerate multisectoral collaboration and sustained investments in health workforce education, skills and jobs
drive the implementation, measurement and reporting on the WHO Global Strategy on Human Resources for Health and the WHO Global Code of Practice on International Recruitment of Health Personnel
prepare a global health and care worker compact.
It mandates the Director-General to update and strengthen implementation of WHO’s action plan on health employment and inclusive economic growth, working with Member States and relevant partners.
The Global Strategic Directions for Nursing and Midwifery 2021–2025 and its accompanying resolution provide policy recommendations on education, jobs, leadership, and service delivery that will help countries ensure that their nurses and midwives have maximum impact on population health outcomes. These policies are derived from the evidence published in the State of the World’s Nursing Report (2020) and the State of the World’s Midwifery Report (2021).
2021 is the International Year of the Health and Care Workers. At the heart of this Year is the recognition that in order to manage the pandemic, maintain health services, improve health workforce readiness, education and learning, and roll out COVID-19 vaccination equitably, the world must protect and invest in health and care workers.
Delegates agreed on concrete action to eliminate avoidable harm in health care by adopting the first ever “Global Patient Safety Action Plan 2021–2030”. Every year, millions of patients suffer injuries or die due to unsafe health care globally, with 134 million adverse events occurring annually in low- and middle-income countries alone, contributing to 2.6 million deaths. Even in high-income countries, about 1 in 10 patients is harmed while receiving hospital care. It is estimated that almost half of these events can be prevented.
In 2019 a WHA resolution on global action on patient safety recognized patient safety as a key global health priority, requesting WHO to consult with countries and stakeholders to formulate a global patient safety action plan.
Today’s decision provides strategic and practical direction to countries to formulate policies and implement interventions at all levels and settings aimed at improving patient safety. The action plan outlines priority actions to be taken by governments, civil society, international organizations, intergovernmental organizations, WHO and, most importantly, by health care facilities across the world. WHO will work in cooperation with Member States in the development of their respective implementation plans, according to their national context.
Important steps have already been taken to implement the 2019 WHO global strategy on health, environment and climate change: the transformation needed to improve lives and well-being sustainably through healthy environments.
These include the manifesto for a green and healthy recovery from COVID-19, a plan of action on biodiversity and health; advocacy for water, sanitation and hygiene in health-care facilities; launch of the Hand Hygiene for All Global Initiative; health messages for the upcoming COP-26 (UN Climate Change Conference of Parties); the global campaign to prevent lead poisoning; various regional action plans and fora to support country action on health and environment. WHO has provided support to a number of countries on health and environment related projects.
Delegates at the WHA have now decided to report on progress on the strategy in 2, 4, and 8 years’ time.
Delegates also decided to report again in 2 years’ time on progress towards the implementation of the WHO Chemicals Road Map, highlighting the critical role of health in sound chemicals management, and need to mainstream chemicals management into all health programmes. They also requested the Secretariat to update the road map to prepare recommendations regarding the Strategic Approach and the sound management of chemicals and waste beyond 2020.
The Global Coordination Mechanism (GCM) for Noncommunicable Diseases will be extended until 2030. The GCM was established in 2014.
A number of measures have been recommended to improve its effectiveness. These include development of a workplan for the delivery of the 5 functions for which the GCM has responsibility. The plan will include a clear vision, a robust results framework, performance and outcome indicators and clarity on how the mechanism will carry out its functions in a way that is integrated with WHO’s ongoing work on NCDs. The plan will be submitted to the World Health Assembly in 2022, after consideration by the Executive Board.
Practical tools for sharing knowledge and disseminating information about innovative activities from a variety of stakeholders working at country level will be developed. So will a global stock-take of action from various stakeholders at country level, together with guidance to Member States on engagement with non-State actors, including on the prevention and management of potential risks. Advice will be provided to civil society on how to develop national multi-stakeholder responses to NCDs and hold governments to account; and the capacity of people living with NCDs to participate in the co-creation of whole-of-society responses to NCDs will be strengthened.
Delegates highlighted that the COVID-19 pandemic has reversed a decade of progress on SDG targets and underscored the need to redouble efforts by accelerating implementation of SDG3 GAP, WHO’s 13th general programme of work, and the Primary Health Care special programme.
There was wide support for the SDG3 GAP and WHO's convening role. Delegates noted the GAP’s key role in strengthening primary health care and advancing progress towards the targets set out in the Global Strategy on Women's, Children's and Adolescents' health. They also emphasized its focus on country-level impact and its critical role in supporting equitable and resilient recovery.
At the Strategic briefing Preventing sexual exploitation and abuse: from policy to practice in health emergencies, the Secretariat outlined what WHO is doing across all levels of the organization to prevent sexual exploitation and abuse (PSEA) and harassment.
WHO is committed to taking a comprehensive, holistic and survivor-centred approach to PSEA and sexual harassment, and is taking actions in the areas of policy, capacity-development and operations. PSEA focal points in Ukraine, Guinea and Bangladesh informed Member States of their work in crisis settings for communities and staff, including regular and mandatory PSEA training for WHO staff, implementation of hotlines to safely report complaints, designation of trusted community focal points, and continued liaison with partner agencies in prevention efforts.
The Director-General addressed the 5th meeting of Committee B on Agenda item 30.2 – the report of the Internal Auditor on preventing sexual exploitation, abuse and harassment (A74/36). The Director-General assured Delegates that they will receive regular monthly updates on the investigations of the Independent Commission on allegations of sexual misconduct during the response to the 10th Ebola outbreak in the Democratic Republic of the Congo.
The Secretariat will also provide quarterly briefings to Member States, as required by the Executive Board, and have dedicated agenda items on this topic for future WHO governance meetings. In addition, WHO will:
establish a WHO task team, led by a senior female staff member, to accelerate the implementation of organization-wide WHO policies and procedures, adopting a holistic approach to prevention and management of sexual exploitation and abuse and sexual harassment. The task team will also oversee the implementation of the Independent Commission recommendations;
establish an informal consultative group of external experts who can advise on ‘best in class’ approaches, recognizing that Member States and other entities have valuable experience and expertise that WHO can draw upon.
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
In the past week, the number of new COVID-19 cases and deaths continues to decrease, with over 3.5 million new cases and 78 000 new deaths reported globally. Although the number of global cases and deaths continued to decrease for a fifth and fourth consecutive week respectively, case and death incidences remain at high levels and significant increases have been reported in many countries in all regions.
In this edition, special focus updates are provided on:
SARS-CoV-2 Variants of Interest (VOIs) and Variants of Concern (VOCs), including the introduction of new labels for public communications, updates on VOI and VOC classifications and the global geographical distribution of VOCs Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1) and Delta (B.1.617.2). Lessons learned during the early phases of rolling out COVID-19 vaccines, with a particular focus on low-and-middle income countries (LMICs).
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
Countries that are advanced in their vaccination programmes are seeing cases of COVID-19 decline, hospitalisations decrease and early signs of some kind of normality resume.
However, the global picture is far more concerning.
At no point in this pandemic have we seen such an acute need to look to the future challenges and not rest on the patchy achievements made so far.
We are seeing the traumatic effects of the terrible surge of COVID-19 in South Asia – a surge which has also severely impacted global vaccine supplies.
We are also witnessing why access to vaccines before a surge occurs is so important. For that reason, we must focus on ensuring countries who have not benefitted from these life-saving tools do so now, and with urgency.
As the global mechanism for equitable access to COVID-19 vaccines, COVAX has proven it works. Designed and implemented in the midst of an unprecedented global public health crisis, it has delivered over 70 million doses to 126 countries and economies around the world since February – from remote islands to conflict settings – managing the largest and most complex rollout of vaccines in history. Over 35 countries received their first COVID-19 vaccine doses thanks to COVAX.
However, the terrible surge of the virus in India has had a severe impact on COVAX’s supply in the second quarter of this year, to the point where, by the end of June we will face a shortfall of 190 million doses.
Even though COVAX will have larger volumes available later in the year through the deals it has already secured with several manufacturers, if we do not address the current, urgent shortfall the consequences could be catastrophic.
But we can meet this challenge with concerted action and global leadership.
Millions of dollars and doses were committed to COVAX on 21 May, bringing the total of doses pledged so far to more than 150 million. At the World Health Assembly, governments have been united in recognising the political and financial urgency of supporting COVAX with doses and dollars. It is now imperative to build on this momentum to secure full funding for COVAX and more vaccines – right now – for lower income countries at the Advance Market Commitment Summit on 2 June.
If the world’s leaders rally together, the original COVAX objectives – delivery of 2 billion doses of vaccines worldwide in 2021, and 1.8 billion doses to 92 lower income economies by early 2022 are still well within reach.
But it will require governments and the private sector to urgently unlock new sources of doses, with deliveries starting in June, and funding so we can deliver. COVAX has the infrastructure in place to facilitate and coordinate this complex global effort.
To enable COVAX to deliver on the promise of global equitable access, we call for the following immediate actions:
· Fund the Gavi COVAX Advance Market Commitment (AMC). The AMC mechanism is how COVAX provides doses to lower income economies. Thanks to the generosity of its donors, the AMC has already secured 1.3 billion doses for delivery in 2021. This is enough to protect the most at-risk population groups: health workers, the elderly and those with underlying health conditions. We need an additional $2 billion to lift coverage in AMC countries up to nearly 30%, and we need it by June 2 to lock in supplies now so that doses can be delivered through 2021, and into early 2022.
· Share doses, now. The pandemic has just taken a frightening new turn, as a deadly surge of cases rages across South Asia and other hotspots. Countries with the largest supplies should redirect doses to COVAX now, to have maximum impact.
We are starting to see countries stepping forward with doses, with the United States and Europe collectively pledging to share 180 million doses. But we still need more, we need them to go through COVAX, and we need them to start moving in early June. At least one billion doses could be shared by wealthy countries in 2021.
COVAX’s need for doses is greatest right now. Countries with higher coverage rates, which are due to receive doses soon should swap their places in supply queues with COVAX so that doses can be equitably distributed as quickly as possible.
· Free up supply chains by removing trade barriers, export control measures, and other transit issues that block, restrict or slowdown the supply and distribution of COVID-19 vaccines, raw materials, components and supplies.
Now more than ever, at the peak of the pandemic, we need ambitious, global solutions. When it comes to worldwide vaccine distribution, COVAX is the only initiative capable of rising to the challenge of this moment.
It’s understandable that some countries want to press ahead and vaccinate all of their populations. By donating vaccines to COVAX alongside domestic vaccination programmes, the most at-risk populations can be protected globally, which is instrumental to ending the acute phase of the pandemic, curbing the rise and threat of variants, and accelerating a return to normality.
COVAX is hugely appreciative to France, Germany, Italy, New Zealand, Spain, Sweden and the UAE for their initial commitments to donate doses through COVAX. We also welcome announcements by the USA, Norway, Croatia, Romania, Australia and Portugal to donate doses to countries in need and we put COVAX forward as the proven mechanism for global, rapid and equitable distribution to facilitate this.
Since COVAX was established in mid-2020, it has had the support and resources of 192 of the world’s economies. This tremendous vote of confidence has enabled us to demonstrate our ability to deliver an unprecedented global rollout. It’s time to finish the job.
Dr Richard Hatchett Chief Executive Officer, Coalition for Epidemic Preparedness Innovations (CEPI)
Dr Seth Berkley Chief Executive Officer, Gavi, the Vaccine Alliance (Gavi)
Dr Tedros Adhanom Ghebreyesus Director-General, World Health Organization (WHO)
Ms Henrietta Fore Executive Director, UNICEF
The goal of sharing at least 1 billion excess doses by the end of 2021 is based on a Bill & Melinda Gates Foundation analysis of current projections of excess doses globally. Even under conservative estimates, the analysis finds that after sharing 1 billion doses, wealthy countries would have sufficient doses to vaccinate 80% of their populations 12 years and older in 2021.
COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-convened by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (Gavi) and the World Health Organization (WHO) – working in partnership with UNICEF as key implementing partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.
CEPI is leading on the COVAX vaccine research and development portfolio, investing in R&D across a variety of promising candidates, with the goal to support development of three safe and effective vaccines which can be made available to countries participating in the COVAX Facility. As part of this work, CEPI has secured first right of refusal to potentially over one billion doses for the COVAX Facility to a number of candidates, and made strategic investments in vaccine manufacturing, which includes reserving capacity to manufacture doses of COVAX vaccines at a network of facilities, and securing glass vials to hold 2 billion doses of vaccine. CEPI is also investing in the ‘next generation’ of vaccine candidates, which will give the world additional options to control COVID-19 in the future.
Gavi is leading on procurement and delivery at scale for COVAX: coordinating the design, implementation and administration of the COVAX Facility and the Gavi COVAX AMC and working with its Alliance partners UNICEF and WHO, along with governments, on country readiness and delivery. As part of this role, Gavi hosts the Office of the COVAX Facility to coordinate the operation and governance of the mechanism as a whole, manages relationships with Facility participants, and negotiates advance purchase agreements with manufacturers of promising vaccine candidates to secure doses on behalf of the 190 economies participating in the COVAX Facility. It also coordinates design, operation and fundraising for the COVAX AMC that supports 92 lower-income economies, including a no-fault compensation mechanism that will be administered by WHO. As part of this work, Gavi supports governments and partners on ensuring country readiness, providing funding and oversight of UNICEF procurement of vaccines as well as partners’ and governments work on readiness and delivery. This includes support for cold chain equipment, technical assistance, syringes, vehicles, and other aspects of the vastly complex logistical operation for delivery.
WHO has multiple roles within COVAX: It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. Its Strategic Advisory Group of Experts (SAGE) on Immunization develops evidence-based immunization policy recommendations. Its Emergency Use Listing (EUL) / prequalification programmes ensure harmonized review and authorization across member states. It provides global coordination and member state support on vaccine safety monitoring. It developed the target product profiles for COVID-19 vaccines and provides R&D technical coordination. WHO leads, together with UNICEF, the Country Readiness and Delivery workstream, which provides support to countries as they prepare to receive and administer vaccines. Along with Gavi and numerous other partners working at the global, regional, and country-level, the CRD workstream provides tools, guidance, monitoring, and on the ground technical assistance for the planning and roll-out of the vaccines. Along with COVAX partners, WHO has developed a no-fault compensation scheme as part of the time-limited indemnification and liability commitments
UNICEF is leveraging its experience as the largest single vaccine buyer in the world and working with manufacturers and partners on the procurement of COVID-19 vaccine doses, as well as freight, logistics and storage. UNICEF already procures more than 2 billion doses of vaccines annually for routine immunisation and outbreak response on behalf of nearly 100 countries. In collaboration with the PAHO Revolving Fund, UNICEF is leading efforts to procure and supply doses of COVID-19 vaccines for COVAX. In addition, UNICEF, Gavi and WHO are working with governments around the clock to ensure that countries are ready to receive the vaccines, with appropriate cold chain equipment in place and health workers trained to dispense them. UNICEF is also playing a lead role in efforts to foster trust in vaccines, delivering vaccine confidence communications and tracking and addressing misinformation around the world.
The Access to COVID-19 Tools ACT-Accelerator, is a new, ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.
The ACT-Accelerator is not a decision-making body or a new organisation, but works to speed up collaborative efforts among existing organisations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organisations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.
The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
Brazzaville, 27 May 2021 – Africa needs at least 20 million doses of the Oxford-AstraZeneca vaccine in the next six weeks to get second doses to all who received a first dose within the 8—12-week interval between doses recommended by the World Health Organization (WHO).
A single dose of the Oxford-AstraZeneca vaccine gives around 70% protection for at least 12 weeks. Data on the protection from one dose after 12 weeks is limited, however COVID-19 antibodies have been found in the body up to 6 months after one dose. The full course provided with a 12-week interval gives 81% protection for an extended period.
In addition to this urgent need, another 200 million doses of any WHO Emergency Use Listed COVID-19 vaccine are needed so that the continent can vaccinate 10% of its population by September 2021. This follows a call made by WHO Director General Dr Tedros Adhanom Ghebreyesus at the World Health Assembly, WHO’s governing body earlier this week for all Member States to support a massive vaccination push.
To date, 28 million COVID-19 doses, of different vaccines, have been administered in Africa, which represents less than two doses administered per 100 people in Africa. Globally, 1.5 billion COVID-19 vaccine doses have been administered.
“As supplies dry up, dose-sharing is an urgent, critical and short-term solution to ensuring that Africans at the greatest risk of COVID-19 get the much-needed protection,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “Africa needs vaccines now. Any pause in our vaccination campaigns will lead to lost lives and lost hope.”
“It’s too soon to tell if Africa is on the cusp of a third wave. However, we know that cases are rising, and the clock is ticking so we urgently appeal to countries that have vaccinated their high-risk groups to speed up the dose-sharing to fully protect the most vulnerable people.”
France is the first country to share COVID-19 vaccines from its domestic supply, donating over 31 000 doses to Mauritania, with another 74 400 set for imminent delivery. France has pledged to share half a million more doses with six African countries in the next few weeks. The European Union and its Member States have pledged over 100 million doses for low-income countries by the end of 2021. The United States of America has pledged to share 80 million doses with lower-income countries, and other high-income countries have expressed interest in sharing vaccines. Expediting these pledges is crucial and the COVAX Facility is a proven tool for swift delivery.
African countries that are unable to use all their vaccines are sharing them across the continent. While this prevents vaccine wastage, redistributing doses is costly and countries must roll out all available doses as soon as possible. WHO is working closely with countries to improve vaccine rollout by optimizing delivery strategies and increasing uptake.
In the longer term, Africa must boost its manufacturing capacity for vaccines. Yet there is no quick-fix and putting the policies, processes and partnerships in place may take years. Intellectual Property waivers are a crucial first step but must come alongside the sharing of expertise and critical technologies.
More than 100 WHO Member States, including 54 African countries are co-sponsoring a draft resolution led by Ethiopia which is being presented at this week’s World Health Assembly. The resolution aims to strengthen local production, promote technology transfers and innovation, and consider the agreement on Trade-Related Aspects of Intellectual Property Rights and intellectual property rights through the lens of boosting local production.
WHO is helping African Member States to lay the groundwork to build up vaccine manufacturing capacity. Around 40 African countries joined a recent WHO training to build manufacturing capacities and WHO is working with the African Union to support the African Pharmaceutical Manufacturing Plan for Africa, supporting feasibility studies and potential technology transfers on request, sharing expertise and helping forge crucial partnerships.
Dr Moeti spoke during a virtual press conference today facilitated by APO Group. She was joined by Honorable Semano Henry Sekatle, Minister of Health, Lesotho, and Her Excellency Stéphanie Seydoux, Ambassador for Global Health, Ministry for Europe and Foreign Affairs, France. Also on hand to answer questions were Dr Richard Mihigo, Coordinator, Immunization and Vaccines Development Programme, WHO Regional Office for Africa, and Dr Nsenga Ngoy, Emergency Response Programme Manager, WHO Regional Office for Africa.
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
By Dr Michael Ryan, Executive Director, WHO Health Emergencies Programme
Below are some highlights from the presentation:
Relaxing measures prematurely has contributed to the surge we have seen through 2020 and the first quarter to 2021. Maintaining strong public health and social measures in every community and thoughtfully adjusting them based on local epidemiology and capacities is absolutely critical for epidemic and pandemic control of COVID-19 for the weeks and months ahead. Ultimately, it is in communities, at the frontline, where epidemic and pandemic prevention and control begins and ends. Communities, health workers, facilities facing COVID-19 must be informed, engaged, trained, equipped, protected and supported.
Operationally, WHO works with a huge range of partners but is always ready to be the first mover, and the provider of last resort.
On critical supplies, I would like to recognize our partners in the UN supply chain taskforce. We collectively delivered an overwhelming $1.2 billion worth of supplies to 184 countries in 2020, representing over 50% of the stated demands of low and middle-income countries during that period. I am deeply proud of the partners who work so hard to make sure we could fix the broken supply chain.
At present, a funding shortfall of more than 70% when only received funds are considered has left the Organization in real and imminent danger of being unable to sustain core functions for urgent priorities. The challenges faced by WHO in responding rapidly to acute events are exacerbated by the fact that over 90% of funds received so far are specified or earmarked. We must move forward to improve preparedness, preventing emerging risks, increase readiness, be ready to detect and respond, be able to scale and contain small outbreaks quickly, and be in a position to bring pandemics under control earlier, not only to protect health and life but to protect our economies and our ways of life.
Link to COVID-19 Pandemic Response presentation, video and speaking notes:
https://who.canto.global/b/MCBH7
By Dr Bruce Aylward, Senior Advisor to the Director-General and Head of the ACT-Accelerator Coordination Hub
Below are some highlights from the presentation:
The ACT Accelerator has helped to fundamentally improve our ability to tackle COVID-19 globally. 12 months ago, we only had non pharmaceutical interventions along with PCR testing.
Today, vaccines can prevent COVID-19 everywhere, tests can rapidly and accurately detect COVID-19 anywhere, and guide our response, and treatments can save lives through the simple combination of oxygen and steroids. All due to the new knowledge we've been able to generate over the past year.
COVAX works, the machine works, the facility works. The challenge is getting the vaccines into the facility through the cooperation and support of countries and companies, to be able to address what we are seeing now, an increasing inequity in distribution.
83% of the 1.6 billion distributed Vaccine doses have been used in high and upper middle income countries, which are about 50% of the global population. The difference to low income countries is more than 75 fold.
High income countries are currently testing at about 125 times more tests per day than low income countries, in large part because low income countries have not been able to procure at the same rate nor roll them out at the same rate, with the same volumes.
If you can't see the virus, you can't manage your outbreak, and you cannot understand the gravity of the situation, until it's too late, and you're then faced with catastrophic consequences.
We have an oxygen need of about 3.3 million cylinders per day for low and low middle income countries, and we are currently only at a fraction of that.
There are 3 parts to solving the challenge of equitable access and this is the focus of the ACT Accelerator over the coming 12 months:
First close the financing gap.
The second crucial thing is to address the growing equity gap and share vaccine doses through COVAX. Even with financing alone, we cannot access doses because they are contracted elsewhere. We need at least a quarter of a billion vaccine doses over the next four months and to double that to get two doses into the population & protect the most vulnerable, save the lives of the older people who may be affected by this and reduce exposure of course of health care workers.
We need these doses to start immediately in May and June, if we get behind and receive doses only in September & October, we will not be able to catch up & we will lose many lives that we shouldn't be losing.
Thirdly, we must fully integrate and finance the SPRP. This is going to be crucial as we move from development of products to delivery.
Exiting the pandemic requires multiple lines of defense: the vaccines, diagnostics, treatments and PPE. There is no one piece, you cannot simply vaccinate your way out of the crisis we've got to have all pieces.
We are in a fundamentally different place than we were 12 months ago, there is no reason with the coordination and financing we lay out here, we should not be able to fundamentally change the dynamic direction of this pandemic in the coming months.
Link to ACT-Accelerator presentation and video:
https://who.canto.global/b/SOGCT
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
Globally, over the past week, the number of new cases and deaths reported continued to decrease, with over 4.1 million new cases and 84 000 new deaths reported. The European Region reported the largest decline in new cases and deaths this week, followed by the South-East Asia Region. The Region of the Americas, Eastern Mediterranean, African, and Western Pacific Regions reported similar numbers of cases to the previous week.
In this edition, a special focus update is provided on SARS-CoV-2 Variants of Interest (VOIs) and Variants of Concern (VOCs) B.1.1.7, B.1.351, P.1, and B.1.617. This includes updates on emerging evidence surrounding the phenotypic characteristics of VOCs (transmissibility, disease severity, risk of reinfection, and impacts on diagnostics and vaccine performance), as well as updates on the geographic distribution of VOCs.
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The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
Your Excellency Jean-Yves Le Drian, Minister for Europe and Foreign Affairs of France,
Your Excellency Niels Annen, Minister of State at the Federal Foreign Office of Germany,
Professor Wanda Markotter and Professor Thomas Mettenleiter,
Mr Qu Dongyu, Ms Inger Andersen, Dr Monique Eloit,
Good morning, good afternoon and good evening,
First of all, I would like to thank the governments of France and Germany for their leadership and support in establishing the One Health High-Level Expert Panel.
Its creation fulfils a commitment made at the Paris Peace Forum last November.
I also want to give a special thanks to the co-chairs, Professor Markotter and Professor Mettenleiter, and the other panelists for lending us their time and expertise.
The COVID-19 pandemic is a powerful demonstration that human health does not exist in a vacuum, and nor can our efforts to protect and promote it.
The close links between human, animal and environmental health demand close collaboration, communication and coordination between the relevant sectors.
One Health is not a new concept, but the High-Level Expert Panel is a much-needed initiative to take it to the next level.
The High-Level Expert Panel will advise us on how to bridge the gaps between sectors, connecting veterinary and human medicine and environmental issues, and to address the challenge of implementation at both the global and country level.
The work of the panel will help us advocate for bold policy measures and investments to reduce the risk of future pandemics and to change harmful practices that threaten us now and in future generations.
The four organizations that will participate in the Joint Secretariat bring world-class expertise in their respective areas. We believe that by working together more closely in this way, we will be much more than the sum of our parts.
One of the many lessons of the pandemic is that we can only confront shared threats with shared solutions.
Thank you once again to France and Germany for your support, and to my colleagues at FAO, OIE and UNEP.
Now let’s get to work.
I thank you.
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.