The World Health Organization, with the support of the Strategic Advisory Group of Experts (SAGE) on Immunization and its COVID-19 Vaccines Working Group, continues to review the emerging evidence on the need for and timing of a booster dose for the currently available COVID-19 vaccines which have received Emergency Use Listing (EUL). This statement reflects the current understanding of vaccine performance and supply as presented to SAGE on 7 December 2021. It summarizes and contextualizes current evidence on booster vaccination. In recent weeks the SARS-CoV2 Omicron variant has emerged. Data are currently insufficient to assess the impact of this new variant of concern on vaccine effectiveness, in particular against severe disease. The statements and conclusions in this document will therefore be updated as data become available.
The following definitions and terminology are used by WHO throughout its policy recommendations on COVID-19 vaccination. This note focuses only on booster doses.
Booster doses are administered to a vaccinated population that has completed a primary vaccination series (currently one or two doses of EUL COVID-19 vaccine depending on the product) when, with time, the immunity and clinical protection has fallen below a rate deemed sufficient in that population. The objective of a booster dose is to restore vaccine effectiveness from that deemed no longer sufficient.
Additional doses of a vaccine may be needed as part of an extended primary series for target populations where the immune response rate following the standard primary series is deemed insufficient. The objective of an additional dose in the primary series is to enhance the immune response to establish a sufficient level of effectiveness against disease. In particular, immunocompromised individuals often fail to mount a protective immune response after a standard primary series, but also older adults may respond poorly to a standard primary series with some vaccines
The Director-General of WHO has called for a moratorium on booster vaccination for healthy adults until the end of 2021 to counter the persisting and profound inequity in global vaccine access (2). While many countries are far from reaching the 40% coverage target by the end of 2021, other countries have vaccinated well beyond this threshold, already reaching children and implementing extensive booster vaccination programmes. At the time of release of this statement, globally about 20% of COVID-19 vaccine doses, daily, are used for booster or additional dose vaccination.
Vaccine booster dose policy decisions should be based on evidence of individual and public health benefit and obligations to secure global equity in vaccine access as a means to minimize health impacts and transmission, and thereby reduce the risk of variants and prolongation of the pandemic. While vaccine supply is growing, it is not evenly distributed. Lower income countries have had far less access, and face unpredictable and irregular supply. Within countries, equity considerations support improving coverage of the primary vaccination series in high risk populations as the top priority use of vaccine doses
The WHO roadmap on the prioritization of vaccine use in situations of limited supply (hereafter: the Roadmap), (3) as well as the Strategy to Achieve Global COVID-19 Vaccination by mid-2022 (4), define a hierarchy of public health goals in accordance with progressively increasing control of the COVID-19 pandemic. Among those, the primary global goal for the acute phase of the pandemic is to reduce deaths and severe disease due to COVID-19 and to protect the health system. The level of population vaccination coverage needed to achieve this goal may differ between countries.
Subsequent public health goals include the reduction of COVID-19 disease burden and of viral transmission, to restore social and economic life, as described in WHO’s Strategy to Achieve Global COVID-19 Vaccination by mid-2022. These goals and vaccine use cases should be pursued only when priority risk groups have full access to vaccines in order to achieve the primary objective of substantial reduction in severe disease and mortality.
The vast majority of current infections and COVID-19 cases are observed in unvaccinated people. If breakthroughs occur in vaccinated persons, in most cases events are less severe than those in unvaccinated persons. However, emerging data consistently show a decline in vaccine effectiveness against SARS-CoV2 infection and COVID-19 with time since vaccination, and more significant decline in older adults. This evidence is mostly based on observational studies that may be subject to confounding factors (5).
Based on a recent systematic review and meta-regression analysis (6), across the four WHO EUL COVID-19 vaccines with the most data (i.e., BNT162b2, mRNA 1273, Ad26.COV2.S and ChAdOx1-S [recombinant] vaccine), vaccine effectiveness against severe COVID-19 decreased by about 8% (95% confidence interval (CI): 4-15%) over a period of 6 months in all age groups. In adults above 50 years, vaccine effectiveness against severe disease decreased by about 10% (95% CI: 6 – 15%) over the same period. Vaccine effectiveness against symptomatic disease decreased by 32% (95% CI: 11 – 69%) for those above 50 years of age.
For some inactivated vaccines (CoronaVac and COVID-19 vaccine BIBP), WHO has already issued the recommendation for the administration of an additional dose to those aged 60 years or older as part of the primary series to make initial immunity more robust (7, 8).
The degree of waning of immunity differs between vaccine products and target populations. Circulating viruses - in particular variants of concern; the extent of prior infection within a community at the time of primary vaccination; the primary vaccination schedule used (i.e. dose interval) and intensity of exposure are all likely to play a role in the findings on waning of protection but cannot be systematically assessed from current studies.
In several jurisdictions, booster vaccination has been authorized by regulatory authorities and added to the product labels of BNT162b2, mRNA 1273 and Ad26.COV2.S. In addition, for ChAdOx1-S [recombinant] and CoronaVac, COVID-19 vaccine BIBP, BBV152 and NVX-CoV2373 vaccines, clinical trial data of booster doses are available. All studies to date show a strong anamnestic immunological response achieving or improving upon the peak antibody levels following the primary immunization series, but with insufficient data and too little follow-up to assess the kinetics and duration of the response. Both homologous and heterologous booster regimens are immunologically effective(9).
Because no correlate of protection has yet been defined, it is not possible to predict with high confidence vaccine performance of these heterologous schedules based on the immune response. Vaccine effectiveness data for a booster dose are being published from an increasing number of countries, but remain limited in follow-up time. All studies demonstrate an improvement in protection against infection; milder disease; as well as severe disease and death (10-14) .
Safety and reactogenicity studies are based on small-scale clinical trials and post-licensure data with limited follow-up. Overall, they show a similar safety profile to that observed after the second dose in the primary series. Regulatory authorities and advisory bodies have thus assessed a favourable benefit risk ratio of booster vaccination at an individual level.
Factors to be considered when developing a booster vaccination policy
At least 126 countries worldwide have already issued recommendations on booster or additional vaccination and more than 120 have started programmatic implementation. The majority of these countries are classified as high-income, or upper middle-income. No low-income country has yet introduced a booster vaccination programme. The most commonly prioritized target populations for booster doses are older adults, health workers and immunocompromised individuals (in immunocompromised individuals the booster dose is considered as an additional primary series vaccination dose by WHO). The degree of primary vaccination coverage in the eligible adult population varies. In several of these countries which are administering booster doses the coverage rates for complete primary vaccination are below 30%.
In view of the continued supply uncertainties in global vaccine access and equity, individual country vaccine booster dose policy decisions need to balance the public health benefits to their population with support for global equity in vaccine access necessary to address the virus evolution and pandemic impact.
Of concern are broad-based booster programmes, including the booster vaccination of population sub-groups at lower risk of severe disease. Global supply is increasing significantly and is projected to be sufficient for vaccination of the entire adult population globally, and boosters of high risk populations (as defined in the roadmap, in particular older adults and immunocompromised persons), by the first quarter of 2022. However, projections show that only later in 2022 supply will be sufficient for extensive use of boosters in all adults, and beyond, should they be broadly needed.
Even as supply has continued to ramp up, hurdles in access and distribution have led to the prevailing inequities that can only be resolved by high coverage and supply and through countries’ commitment to global vaccine goals and targets, and to assisting other countries in need.
In accordance with the Roadmap and WHO’s Strategy to Achieve Global COVID-19 Vaccination by mid-2022, the first priority of a vaccination programme is to reduce mortality and severe disease and to protect health systems. The most important measure to achieve this goal is to maximize coverage among those most likely to become seriously ill and those most likely to become infected especially those who are critical for health system functioning. In order to do this, primary series coverage and selective booster options must be weighed and prioritized carefully. This priority also contributes to socioeconomic recovery, as the severity of COVID-19 and its potential to overwhelm health systems constitute a primary rationale for public health and social measures that restrict social and economic activity. To use vaccines first for those at lower risk of severe disease before achieving high primary series coverage and sustained protection through selective booster doses for those most likely to become seriously ill will reduce the impact that could be secured with the ongoing limited vaccine supply, and runs counter to the National Equity and Equal Respect principles of the Values Framework (15).
These use case principles are also supported by mathematical modeling on the optimization of public health impact of a limited vaccine supply. This modeling shows that greater reductions in mortality may be achieved by administering booster doses to high-risk populations than using those same doses for primary immunization of lower risk populations. As supply increases and vaccination is expanded to lower priority age groups, trade-offs may need to be considered as to prioritizing booster vaccination to high-risk populations over expanding primary immunization coverage to younger populations. WHO is currently not recommending the general vaccination of children and adolescents as the burden of severe disease in these age groups is low and high coverage has not yet been achieved in all countries among those groups who are at highest risk of severe disease
The decision to recommend and implement a booster dose is complex and requires, beyond clinical and epidemiological data, a consideration of national strategic and programmatic priorities, and importantly an assessment of the prioritization of globally limited vaccine supply. In this context, priority should be given to the prevention of severe disease and sustaining health systems. Evidence is accumulating to inform global recommendations, which may be refined as additional data become available. Additional data needs can be grouped into the following categories:
1. Assessing the need for booster doses:
Refined data on epidemiology and burden of disease:
Epidemiology of breakthrough cases, by disease severity, age, co-morbidity and risk groups, exposure, type of vaccine and time since vaccination, and in the context of variants of concern
Refined vaccine-specific data:
Efficacy, effectiveness, duration of protection of vaccination in the context of circulating variants of concern.
Supplementary evidence from immunological studies assessing binding and neutralizing antibodies over time, as well as biomarkers of cellular and durable humoral immunity.
2. Assessing the performance of booster doses:
Data on duration of protection of homologous and heterologous boosters. Safety and reactogenicity of booster vaccination, including heterologous boosting from larger-scale studies.
Impact of booster vaccination on transmission.
3. Additional considerations include:
Optimal timing of booster doses, possibility for dose-sparing for booster doses (e.g. fractional doses), booster needs in previously infected individuals, programmatic feasibility and sustainability, community perception and demand as well as equity considerations.
Refined modeling studies to guide strategies to optimize the impact of vaccination.
The focus of COVID-19 immunization efforts must remain on decreasing death and severe disease, and the protection of the health care system. Public health and social measures continue to be an essential component of the COVID-19 prevention strategy, especially in light of the Omicron variant. In the context of ongoing global vaccine supply constraints and inequities, broad-based administration of booster doses risks exacerbating vaccine access by driving up demand in countries with substantial vaccine coverage and diverting supply while priority populations in some countries, or in subnational settings, have not yet received a primary vaccination series.
Introducing booster doses should be firmly evidence-driven and targeted to the population groups at highest risk of serious disease and those necessary to protect the health system. To date, the evidence indicates a minimal to modest reduction of vaccine protection against severe disease over the 6 months after the primary series. Waning of effectiveness against all clinical disease and infection is more pronounced. Duration of protection against the Omicron variant may be altered and is under active investigation. Evidence on waning vaccine effectiveness, in particular a decline in protection against severe disease in high-risk populations, calls for the development of vaccination strategies optimized for prevention of severe disease, including the targeted use of booster vaccination.
More data will be needed to understand the potential impact of booster vaccination on the duration of protection against severe disease, but also against mild disease, infection, and transmission, particularly in the context of emerging variants. Over time, as vaccination programmes effectively protect populations from severe disease and death, the protection against milder disease and the reduction of transmission become important additional considerations.
SAGE has deliberated on the evidence for booster doses and the optimization of vaccination programmes during its Extraordinary SAGE meeting on 7 December 2021, which is reflected in this interim statement. SAGE will further discuss policies to optimize the use of vaccines including the consideration of booster vaccination at its forthcoming meeting on 19 January 2022.
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.
1)- COVID-19 infection prevention and control living guideline: mask use in community settings, 22 December 2021 -
https://www.who.int/publications/i/item/WHO-2019-nCoV-IPC_masks-2021.1
This first edition of the Infection Prevention and Control COVID-19 Living Guideline – Mask use in community settings provides the most up to date technical guidance on mask use in community settings in the context of COVID-19.
2)- WHO recommendations on mask use by health workers, in light of the Omicron variant of concern: WHO interim guidelines, 22 December 2021 -
https://www.who.int/publications/i/item/WHO-2019-nCoV-IPC_Masks-Health_Workers-Omicron_variant-2021.1
This document provides updated interim recommendations on the use of masks by health workers providing care to patients with suspected or confirmed COVID-19, in light of the rapid spread of the Omicron variant of concern of SARS-CoV-2.
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.
Past epidemics showed us the importance of resilient health systems. The COVID-19 pandemic brought into sharp focus the importance of resilient societies. The 10th Global Conference on Health Promotion on 13-15 December 2021 marked the start of a global movement on the concept of well-being in societies. A focus on well-being encourages different sectors to work together to address global challenges and help people take control over their health and lives.
Over 4,500 participants of the Global Conference, who met virtually and in Geneva, Switzerland, agreed on a Geneva Charter for Well-being. The Charter builds on the Ottawa Charter for Health Promotion and the legacy of nine global conferences on health promotion. It highlights the need for global commitments to achieve equitable health and social outcomes now and for future generations, without destroying the health of our planet. This charter will drive policy-makers and world leaders to adopt this approach and commit to concrete action.
“Health does not begin in a hospital or clinic. It begins in our homes and communities, with the food we eat and the water we drink, the air we breathe, in our schools and our workplaces,” said Dr Tedros Adhanom Ghebreyesus, WHO Director General. “We have to fundamentally change the way that leaders in politics, the private sector, and international institutions think about and value health, and to promote growth that is based on health and well-being for people and the planet, for countries in all income levels.”
The Charter outlines the necessary elements of a ‘well-being society’ and what needs to be done in order to better prevent and respond to the multiple health and ecological crises we face globally. It identifies key action areas and offers instruments for implementation.
The document encourages five key actions:
Design an equitable economy that serves human development within planetary boundaries;
Create public policy for the common good;
Achieve universal health coverage;
Address the digital transformation to counteract harm and disempowerment and to strengthen the benefits; and
Value and preserve the planet.
“It is time to look at how the economy can support the societal goal of well-being, as an investment that is the foundation of productive, resilient and inclusive economies,” said Dr Rüdiger Krech, WHO Director for Health Promotion. “We cannot – we must not – go back to the same exploitative patterns of production and consumption, the same disregard for the planet that sustains all life, the same cycle of panic and neglect, and the same divisive politics that fueled this pandemic.”
To change the global development landscape, both the well-being of people and the planet must become central to defining humanity’s progress. This Charter calls upon non-governmental and civic organizations, academia, business, governments, international organizations and all concerned to work in society-wide partnerships for decisive implementation of strategies for health and well-being. These will drive the transformation towards well-being societies in all countries, centering around the most marginalized populations.
Moving forward, countries must prioritize health as part of a larger ecosystem that encompasses environmental, social, economic, and political factors. Universal health coverage, based on strong primary health care, must be at the core of all our efforts, as the cornerstone of social, economic and political stability. And the narrative around health should be reframed, not as a cost, but as an investment in our common future.
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.
Urgent action is needed globally and locally to achieve safe and sustainably managed water, sanitation and hygiene for all in order to prevent devastating impacts on the health of millions of people.
Findings from WHO and UN-Water’s Global Analysis and Assessment of Sanitation and Drinking-Water (GLAAS) report show that acceleration is needed in many countries to achieve the UN Sustainable Development Goal (SDG) 6 – water and sanitation for all by 2030.
While 45% of countries are on track to achieve their nationally-defined drinking-water coverage targets, only 25% of countries are on track to achieve their national sanitation targets. Less than a third of countries reported to have sufficient human resources required to carry out key drinking-water, sanitation and hygiene (WASH) functions.
The GLAAS 2022 report, which details the latest status of WASH systems in more than 120 countries, is the largest data collection from the greatest number of countries to date.
While there has been an increase in WASH budgets in some countries, a large number--over 75% of countries reported insufficient funding to implement their WASH plans and strategies.
“We are facing an urgent crisis: poor access to safe drinking water, sanitation and hygiene claim millions of lives each year, while the increasing frequency and intensity of climate-related extreme weather events continue to hamper the delivery of safe WASH services,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “We call on governments and development partners to strengthen WASH systems and dramatically increase investment to extend access to safely managed drinking water and sanitation services to all by 2030, beginning with the most vulnerable.”
The GLAAS data show, however, that most WASH policies and plans do not address risks of climate change to WASH services, nor the climate resilience of WASH technologies and management systems. Just over two thirds of countries have measures in WASH policies to reach populations disproportionately affected by climate change. However, only about one third monitor progress or allocate explicit funding to these populations.
“The world is seriously off-track to achieve SDG 6 on water and sanitation for all, by 2030. This leaves billions of people dangerously exposed to infectious diseases, especially in the aftermath of disasters, including climate change-related events,” said Gilbert F. Houngbo, Chair of UN-Water, and Director General of the International Labour Organization. “The new data from GLAAS will inform the voluntary commitments the international community will make at the UN 2023 Water Conference in March, helping us target the most vulnerable communities and solve the global water and sanitation crisis.”
Dire consequences of climate change and extreme weather events bring more attention to the issues, underlining an urgent need for a whole-of-society approach and global cooperation to act together. The GLAAS 2022 report shows that countries making progress demonstrated high level of political commitment and investments in improving safe WASH systems.
With the GLAAS 2022 report, WHO and UN-Water call on all governments and stakeholders to scale up support for WASH service delivery, through strengthened governance, financing, monitoring, regulation, and capacity development.
The report sets the scene for action ahead of a historic water and sanitation meeting planned in 2023. For the first time in 50 years, the global community—through the United Nations—will review progress and make firm commitments to renew action on water and sanitation with global leaders. The UN 2023 Water Conference – formally known as the 2023 Conference for the Midterm Comprehensive Review of Implementation of the UN Decade for Action on Water and Sanitation (2018-2028) – will take place at UN Headquarters in New York, 22-24 March 2023.
Dedicated to the well-being of all people and guided by science, the World Health Organization leads and champions global efforts to give everyone, everywhere an equal chance at a safe and healthy life. Our mission is to promote health, keep the world safe and serve the vulnerable.
UN-Water coordinates the United Nations’ work on water and sanitation. UN-Water is a ‘coordination mechanism’. It is comprised of United Nations entities (Members) and international organizations (Partners) working on water and sanitation issues. UN-Water’s role is to ensure that Members and Partners’ deliver as one’ in response to water-related challenges.
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.
12 December 2022 I Geneva and Doha -- On Universal Health Coverage Day (UHC Day), the World Health Organization (WHO) teams up with international football icons to urge action by governments and people across the world to achieve health for all. UHC ensures that everyone, everywhere can access the support they need to be and stay healthy without being driven into financial hardship.
To mark UHC Day, WHO is launching two new tools: one to help governments design and deliver the right service coverage packages for their populations; and a second to provide people with reliable information to support the everyday decisions they make to protect their health and well-being.
“The World Cup is the greatest prize in football, and the greatest prize in life is good health and well-being,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Health is not a luxury for the rich, but a fundamental human right, and the foundation of peaceful, prosperous and sustainable economies and societies. The tools we are launching today will help governments and individuals to realise that right.”
UHC Day 2022 comes at a critical time when countries across the world are rebuilding from the impacts of the COVID-19 pandemic while facing many other crises such as economic and energy constraints, climate change and conflict.
UHC Day kicks off the countdown to the high-level meeting on UHC which will be held at the United Nations General Assembly in 2023. Heads of State and Government, at the first high-level meeting on UHC in 2019, affirmed that health is a precondition for and an outcome and indicator of the social, economic and environmental dimensions of sustainable development. They strongly recommitted to achieve UHC by 2030 by scaling up the global effort to build a healthier world for all. The 2023 meeting is an opportunity to take stock of progress and galvanize political support and global action towards achieving UHC targets.
On the eve of the semi-finals of the FIFA World Cup 2022™, WHO and its Goodwill Ambassador for Sport and Health, football legend Didier Drogba, led UHC Day celebrations in Doha, Qatar. This formed part of a full day of activities organized by the Education Above All Foundation to put a spotlight on the United Nations Sustainable Development Goal 3: Good health and well-being.
“I found myself in the unusual place where if I had problems on the field, help arrived quickly, and we’ve seen how vital that support can be lately. But off the field, we know, this isn’t always the case,” Didier Drogba said. “Ill-equipped clinics, unsupported health workers, and not enough medicines and vaccines put people’s well-being at risk around the world. Good health needs a team effort, so we need governments to commit to policies that support Universal Health Coverage and give everyone access to what it takes to be healthy. When we team up for health for all, we all win.”
Football enthusiasts of all ages moved to show their support for health for all as electronic dance artist and vocalist, The Mad Stuntman, performed his famous song, “I Like to Move It,” highlighting the importance of staying active and the role of sport in promoting good health and well-being.
Sherrie Silver, Rwandan-British MTV Award winning choreographer, advocate for the International Fund for Agricultural Development of the United Nations, Malaria No More Ambassador and Rwandan development advocate also led the crowd in a dance-off, called the World Cup Workout.
“On Universal Health Coverage Day, let’s all be active and play our part to make health for all our goal, said Alisson Becker, goalkeeper for Brazil and Liverpool, and WHO Goodwill Ambassador for Health Promotion.
Achieving national health goals has been hampered by the lack of a structured approach in designing and delivering a comprehensive package of health services that are tailored to local contexts.
WHO is launching a new tool named the Universal Health Coverage Service Package Delivery and Implementation or UHC SPDI Tool to support countries in designing their unique UHC health service packages. This innovative and practical online tool includes functionalities that will allow national health planners to select from a comprehensive range of health services—spanning promotive, preventive, resuscitative, curative, rehabilitative and palliative services—that people need to reach the highest attainable standard of health and well-being.
The tool is also designed to help identify human resource needs, essential medical products, infrastructure and other elements required for the effective delivery of health services. It also emphasizes first contact primary and emergency care, and highlights a primary health care approach as the basis for strengthening health systems and bringing all sectors under the vision of achieving health for all. The successful implementation of a national health service package will ultimately equip countries to accelerate progress towards UHC.
WHO also launched a digital resource for the public called, “Your life, your health: Tips and information for health and well-being.” It provides people across different life phases with trustworthy health information that they can easily access, understand and use in daily life.
The resource provides basic information, founded on WHO technical guidance, on important topics such as keeping well during pregnancy and after childbirth, or how to be healthy and active in later adulthood. It also provides information on people’s rights and skills related to accessing and using information for health and well-being.
Universal Health Coverage Day (UHC Day) on 12 December is the annual rallying point for advocates to raise their voices and share the stories of the millions of people still waiting for health, call on leaders to make smarter investments in health and remind the world about the imperative of UHC. It is an official United Nations-designated day that marks the anniversary of the unanimous endorsement of UHC in 2012 as an essential priority for international development.
The theme for UHC Day 2022 is “Build the world we want: A healthy future for all.”)
WHO and the State of Qatar have teamed up with FIFA on the Healthy 2022 World Cup project. It aims to ensure the tournament will be a healthy and safe event and that the measures implemented and lessons learned will support the delivery of healthy and safe mega sporting events in the future.
The objectives of the project are to ensure both the delivery and legacy of a healthy and safe FIFA World Cup Qatar 2022™ by setting the event as an impactful, sustainable and lasting model that promotes integration of health, security and well-being for future mega sport events.
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.
Updated data from the pivotal phase II NP30179 study in people with R/R LBCL showed glofitamab given as a fixed course induced early and durable responses that were maintained beyond the end of treatment. Most patients who had achieved a complete response (CR; a disappearance of all signs of cancer) at the end of treatment experienced durable responses, with a median CR follow-up from end of treatment of 11.5 months (95% confidence interval [CI]: 10.5-16.4). Twelve months after the end of treatment with glofitamab, 61% of patients (n=37/61) maintained a CR, 92.6% remained progression-free and only one patient (n=1/44) experienced disease progression.
Simultaneously, an earlier data cut from the phase II NP30179 study in R/R diffuse large B-cell lymphoma (DLBCL) was published online in NEJM.2
Data from this pivotal phase II study have been submitted for review to the European Medicines Agency, and submissions to additional health authorities worldwide, including the U.S. Food and Drug Administration (FDA), are ongoing.
An updated analysis from the pivotal phase II GO29781 study of Lunsumio in people with R/R FL who had received two or more prior therapies showed 60.0% (n=54/90; 95% CI: 49.1–70.2) achieved a CR and 77.8% (95% CI: 67.8–85.9) achieved an objective response (a CR or a partial response, a decrease in the amount of cancer in their body) at a median follow-up of 28.3 months. After 24 months of achieving a CR, 62.7% of patients remained in remission (95% CI: 37.7–87.7). Overall, 48.3% of patients remained progression-free (95% CI: 36.2-60.3). The median duration of response, median duration of CR, and median progression-free survival were not reached. Safety was consistent with the previous analysis of study data, with no new cytokine release syndrome (CRS) events or Grade 3 or higher adverse events (AEs) reported. CRS events were experienced by 44% of patients, and were predominately low grade and during cycle one.3
The European Commission granted conditional marketing authorisation for Lunsumio for the treatment of people with R/R FL who have received at least two prior systemic therapies in June 2022, making it the first and only fixed-duration bispecific antibody to be approved in Europe for lymphoma. Lunsumio is under Priority Review with the FDA, with a decision expected by 29 December 2022.
Roche continues to evaluate Lunsumio and glofitamab as part of its commitment to providing off-the-shelf therapies for people with lymphomas that can meet their diverse needs, including fixed-duration treatment options. Additional data presented at ASH 2022 include the following:
A subcutaneous (SC) formulation of Lunsumio (administered as an injection given under the skin) demonstrated comparable efficacy with the intravenous formulation and a manageable safety profile in people with R/R non-Hodgkin lymphoma (NHL). The most common AEs were injection site reactions (60.9%; n=53/87) and CRS events (27.6%; n=24/87), which were all Grade 1 or 2. These findings suggest that a SC formulation of Lunsumio may offer patients a treatment option that could reduce their time spent in treatment centres.
Updated results from the phase I/II G050554 study of Lunsumio monotherapy in elderly/unfit patients with previously untreated DLBCL and additional analyses from the phase I/II G040516 study of Lunsumio in combination with Polivy® (polatuzumab vedotin) in heavily pre-treated people with DLBCL continued to show promising efficacy and manageable safety, highlighting the potential of Lunsumio in these patient populations.
Results from the phase I/II NP30179 study evaluating glofitamab as a monotherapy following pre-treatment with Gazyva®/Gazyvaro® (obinutuzumab) in patients with heavily pre-treated R/R mantle cell lymphoma continued to show early, high and durable response rates in this difficult-to-treat disease. After a median follow-up of eight months, the overall response rate (ORR) was 83.8%, with the majority of patients showing durable complete responses at the data cut off (74.1%; n=20/27). The most common AE was CRS (75.5%; n=28/37), with the majority low grade.
Data from the safety and expansion cohorts of the phase Ib NP40126 study evaluating glofitamab in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in patients with previously untreated DLBCL showed, after a median follow-up of 8.5 months, a best ORR of 92.7% (n=51/55) and a complete metabolic response rate of 72.7% (n=40/55). In the safety cohort, CRS events were all low grade (Grade 1 or 2 [10.7%; n=6/56]), and serious AEs were reported in 18 patients (32.1%).
Both Lunsumio and glofitamab are being investigated as SC formulations and in phase III studies that will expand the understanding of their impact in earlier lines of treatment, with the aim of continuing to address the diverse needs and preferences of people with blood cancers. This includes the confirmatory phase III CELESTIMO study investigating Lunsumio plus lenalidomide as a chemotherapy-free option for patients with R/R FL; the phase III SUNMO study investigating Lunsumio plus Polivy versus MabThera/Rituxan in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R aggressive B-cell NHL who are ineligible for autologous stem cell transplant (ASCT); and the phase III STARGLO study evaluating glofitamab in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera/Rituxan in combination with GemOx in patients with R/R DLBCL who are ineligible for ASCT.
Glofitamab is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. Glofitamab was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T-cells, a type of immune cell, and two regions that bind to CD20, a protein on B-cells, which can be healthy or malignant. This dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of cancer cell-killing proteins from the T-cell. A robust clinical development program for glofitamab is ongoing, investigating the molecule as a monotherapy and in combination with other medicines for the treatment of people with B-cell non-Hodgkin’s lymphomas, including diffuse large B-cell lymphoma and other blood cancers.
Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual-targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab) and Lunsumio® (mosunetuzumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies glofitamab, targeting both CD20 and CD3, cevostamab, targeting both FcRH5 and CD3, Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1, and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.
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
A new World Health Organization (WHO) report reveals high levels of resistance in bacteria, causing life-threatening bloodstream infections, as well as increasing resistance to treatment in several bacteria causing common infections in the community based on data reported by 87 countries in 2020.
For the first time, the Global Antimicrobial Resistance and Use Surveillance System (GLASS) report provides analyses for antimicrobial resistance (AMR) rates in the context of national testing coverage, AMR trends since 2017, and data on antimicrobial consumption in humans in 27 countries. Within six years, GLASS achieved participation from 127 countries with 72% of the world’s population. The report includes an innovative interactive digital format to facilitate data extraction and graphics.
The report shows high levels (above 50%) of resistance were reported in bacteria frequently causing bloodstream infections in hospitals, such as Klebsiella pneumoniae and Acinetobacter spp. These life-threatening infections require treatment with last-resort antibiotics, such as carbapenems. However, 8% of bloodstream infections caused by Klebsiella pneumoniae were reported as resistant to carbapenems, increasing the risk of death due to unmanageable infections.
Common bacterial infections are becoming increasingly resistant to treatments. Over 60% of Neisseria gonorrhoea isolates, a common sexually transmitted disease, have shown resistance to one of the most used oral antibacterials, ciprofloxacin. Over 20% of E.coli isolates – the most common pathogen in urinary tract infections – were resistant to both first-line drugs (ampicillin and co-trimoxazole) and second-line treatments (fluoroquinolones).
“Antimicrobial resistance undermines modern medicine and puts millions of lives at risk,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “To truly understand the extent of the global threat and mount an effective public health response to AMR, we must scale up microbiology testing and provide quality-assured data across all countries, not just wealthier ones.”
Although most resistance trends have remained stable over the past 4 years, bloodstream infections due to resistant Escherichia coli and Salmonella spp. and resistant gonorrhoea infections increased by at least 15% compared to rates in 2017. More research is needed to identify the reasons behind the observed AMR increase and to what extent it is related to raised hospitalizations and increased antibiotic treatments during the COVID-19 pandemic. The pandemic also meant that several countries were unable to report data for 2020.
New analyses show that countries with a lower testing coverage, mostly low- and middle-income countries (LMICs), are more likely to report significantly higher AMR rates for most “bug-drug” combinations. This may be (partly) due to the fact that in many LMICs, a limited number of referral hospitals report to GLASS. These hospitals often care for the sickest patients who may have received previous antibiotic treatment.
For example, the global median AMR levels were 42% (E. Coli) and 35% (Methicilin-resistant Staphylococcus aureus – MRSA) – the two AMR Sustainable Development Goal indicators. But when only countries with high testing coverage were considered, these levels were markedly lower at 11% and 6.8%, respectively.
As for antimicrobial consumption in humans, 65% of 27 reporting countries met WHO’s target of ensuring that at least 60% of antimicrobials consumed are from the ‘ACCESS’ group of antibiotics, i.e. antibiotics which – according to the WHO AWaRE classification – are effective in a wide range of common infections and have a relatively low risk of creating resistance.
AMR rates remain difficult to interpret due to insufficient testing coverage and weak laboratory capacity, particularly in low- and middle-income countries. To overcome this critical gap, WHO will follow a two-pronged approach aiming at short-term evidence generation through surveys and long-term capacity building for routine surveillance. This will entail the introduction of representative national AMR prevalence surveys to generate AMR baseline and trend data for policy development and monitoring of interventions and an increase of quality-assured laboratories reporting representative AMR data at all levels of the health system.
Responding to trends of antimicrobial resistance requires high-level commitment from countries to boost surveillance capacity and provide quality assured data as well as action by all people and communities. By strengthening the collection of standardized quality AMR and AMC data, the next phase of GLASS will underpin effective data-driven action to stop the emergence and spread of AMR and protect the use of antimicrobial medicines for future generations.
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 meet for three days to agree next steps toward historic legal instrument, rooted in the WHO Constitution, designed to protect world from future pandemics.
- During discussions, Member States call for global agreement that takes into account equity, promotes preparedness, ensures solidarity and respects sovereignty.
- Zero draft of the pandemic accord to be ready for negotiations by Member States starting February 2023.
7 December 2022 – Geneva: Member States of the World Health Organization today agreed to develop the first draft of a legally binding agreement designed to protect the world from future pandemics. This “zero draft” of the pandemic accord, rooted in the WHO Constitution, will be discussed by Member States in February 2023.
Today’s agreement by the Intergovernmental Negotiating Body (INB), comprised of WHO’s 194 Member States, was a milestone in the global process to learn from the COVID-19 pandemic and prevent a repeat of the devastating impacts it has had on individuals and communities worldwide. The INB gathered at WHO headquarters in Geneva from 5-7 December for its third meeting since its establishment in December 2021, following a special session of the World Health Assembly.
The Body today agreed that the INB’s Bureau will develop the zero draft of the pandemic accord in order to start negotiations at the fourth INB meeting, scheduled to start on 27 February 2023. This draft will be based on the conceptual zero draft and the discussions during this week’s INB meeting. The INB Bureau is comprised of six delegates, one from each of the six WHO regions, including the Co-Chairs Mr Roland Driece of the Netherlands and Ms Precious Matsoso of South Africa.
“Countries have delivered a clear message that the world must be better prepared, coordinated and supported to protect all people, everywhere, from a repeat of COVID-19,” said Mr Driece, Co-Chair of the INB Bureau. “The decision to task us with the duty to develop a zero draft of a pandemic accord represents a major milestone in the path towards making the world safer.”
Fellow INB Bureau Co-Chair, Ms Matsoso, said government representatives stressed that any future pandemic accord would need to take into account equity, strengthen preparedness, ensure solidarity, promote a whole-of-society and whole- of-government approach, and respect the sovereignty of countries.
“The impact of the COVID-19 pandemic on human lives, economies and societies at large must never be forgotten,” said Ms Matsoso. “The best chance we have, today, as a global community, to prevent a repeat of the past is to come together, in the spirit of solidarity, in a commitment to equity, and in the pursuit of health for all, and develop a global accord that safeguards societies from future pandemic threats.”
The WHO pandemic accord is being considered with a view to its adoption under Article 19 of the WHO Constitution, without prejudice to also considering, as work progresses, the suitability of Article 21.
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.
Geneva, Switzerland –COVID-19 and climate change have exacerbated malnutrition in all its forms and threatened the sustainability and resilience of food systems around the world. At the Nutrition for Growth Summit in Tokyo on 7 – 8 December 2021, the World Health Organization has announced six new commitments to accelerate progress on the 2025 nutrition targets which have been pushed even further off course during the pandemic. These include:
Expand initiatives to prevent and manage overweight and obesity;
Step up activities to create food environments that promote safe and healthy diets;
Support countries in addressing acute malnutrition;
Accelerate actions on anaemia reduction;
Scale up quality breastfeeding promotion and support; and
Strengthen nutrition data systems, data use and capacity.
Today, one third of all people around the world are affected by at least one form of malnutrition. Over 40% of all men and women (2.2 billion people) are now overweight or obese. While unhealthy diets are linked to at least 8 million deaths per year.
“Malnutrition in all its forms is one of the world’s leading causes of death and illness,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “WHO is committed to supporting all countries to progressively expand access to essential nutrition services as part of their journey towards universal health coverage, and to strengthening sustainable food systems to support healthy diets for all people, everywhere."
Despite incremental improvements across all forms of malnutrition over the past decade, this progress has digressed with growing rates of inequity, climate crisis, conflict, and global health insecurities.
The multiple burden of malnutrition, like stunting, wasting, micronutrient deficiencies, obesity and diet related noncommunicable diseases, are increasingly co-existing within the same community, household, and even within the same individual. With current trends projecting that one in two people will be malnourished by 2025, and an estimated 40 million children will suffer from obesity or overweight in the next decade.
In marginalized communities, child malnutrition and food insecurity are on the rise. Last year, 149 million children had stunted growth due to poor diets, lack of access to clean water and health services, and other accessibility issues. Among forty-five percent of children under 5 years of age that die, undernutrition was the underlying cause of death.
While there are positive signs of progress, such as the world being on track to hit the global target to increase exclusive breastfeeding by 2025, the COVID-19 pandemic fueled the nutrition crisis. This has particularly affected women and children, and brought unprecedented challenges and diversion of resources away from the global systems for nutrition, including health, food, social protection and humanitarian assistance infrastructure.
“Today, less than 1% of global development assistance focuses on nutrition,” said Dr Francesco Branca, Director of WHO’s Department of Nutrition and Food safety. “There needs to be accelerated action to end unhealthy diets and malnutrition, and WHO’s new commitments to the Nutrition for Growth Summit reflects this. The Nutrition for Growth Summit is a tremendous opportunity to accelerate action during the 2016-2025 Decade of Action on Nutrition.”
WHO continues to work within the three important Nutrition for Growth focus areas (health, food and resilience) by strengthening the normative guidance and supporting countries in their use; by monitoring and ensuring access to nutrition data; by providing support to governments and decision makers to integrate nutrition and food systems interventions into national universal health coverage plans, multisectoral systems and fiscal policies; and by ongoing work in emergencies settings.
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.
Ms. Melinda French Gates, Co-Chair, Bill and Melinda French Gates Foundation called on the Union Minister for Health & Family Welfare, Dr. Mansukh Mandaviya, here today.
Ms. Melinda French Gates congratulated the Union Health Minister for India’s successful Covid-19 vaccination drive and praised the colossal efforts undertaken by the Government of India in managing the pandemic. She also commended the numerous initiatives of the Union Health Ministry’s recent programs and policies which have served to enhance growth and provide opportunities for women and girls more than ever before.
Dr. Mansukh Mandaviya and Ms. Melinda French Gates discussed in detail the potential and new opportunities for India’s ambitious health sector reforms, with particular emphasis on strengthening the health infrastructure and digital health mission under the aegis of Ayushman Bharat. They also discussed opportunities to leverage Indian vaccine manufacturing and digital goods for global public health, specifically in light of India’s charge of the G20 Presidency.
Dr. Mandaviya and Ms. Melinda French Gates unveiled report titled “Grassroot Soldiers: Role of ASHAs and ANMs in the COVID-19 Pandemic Management in India”. The report is a collaborative endeavor by Union Ministry of Health and Family Welfare (MoHFW), National Health Systems Resource Center (NHSRC), and the Institute for Competitiveness (IFC).
Dr. Mandaviya stated that “Our frontline healthcare workers, by taking upon the role of both caregivers and leaders during the pandemic, have emerged as our true heroes. It is important to document and share their story of addressing and managing such a huge crisis with tremendous dedication and commitment.”
The report is a comprehensive document encapsulating the experience and key role of ASHAs and ANMs in India’s pandemic response strategy, and their critical role in delivering routine health care services to the remotest corners of the country. India launched one of the largest vaccination programs in the world extending its reach to the innermost and far-flung regions of the country. As foot soldiers they touched each and every household, supported the COVID-19 management and motivated them for vaccination. They played a pivotal role in providing a range of services ranging from door-to-door surveys, vaccination, disseminating information on hygiene practices, nutrition and sanitation, reproductive and childcare services, communicable and non-communicable disease prevention and control.
The Health Minister Dr. Mansukh Mandaviya stated “Our globally heralded vaccination drive demonstrated the power of ‘whole of society’ approach in dealing with a crisis. Under the strong and capable leadership of Honorable Prime Minister Shri Narendra Modi ji, we seek to leverage the learnings from the last two years in strengthening the country’s health system to provide affordable, quality healthcare to every citizen”.
Lauding India’s progress on key health indicators, Ms. Melinda French Gates reiterated her appreciation of India’s endeavors. She said, “It is amazing how India covered more than 90 % of its population through vaccination in such a short time. India has been a champion in pioneering innovations to fight the pandemic and minimize its impact on the most vulnerable groups. The country has made rapid strides in improving health outcomes of millions of citizens, particularly in ensuring consistent progress on maternal and child health indicators. India has done remarkable work in the comprehensive primary health care system & digital health, lessons from India can be replicated across the world. The Gates Foundation stands committed to support India’s health priorities including health system strengthening and elimination of persistent diseases.”
She congratulated Dr. Mandaviya on India’s G20 Presidency.
Geneva -- A new report published today by the World Health Organization (WHO), What works to prevent online violence against children, presents ways to address the growing worldwide concern of keeping children safe online. With a specific focus on two forms of online violence: child sexual abuse including grooming and sexual image abuse; and cyber aggression and harassment in the form of cyberbullying, cyberstalking, hacking and identity theft, the report showcases strategies and best practices to better protect children.
“Our children spend more and more time online; as such, it is our duty to make the online environment safe,” notes Etienne Krug, Director of the WHO Department of Social Determinants of Health. “This new document provides for the first time a clear direction for action by governments, donors and other development partners, showing that we must address online and offline violence together if we are to be effective.”
To prevent online violence against children, the report highlights the importance of implementing educational programmes directed at children and parents. Studies have shown the effectiveness of such programmes in reducing the levels of violence victimization, perpetration and associated risk behaviors like alcohol and drug abuse.
The report recommends implementing school-based educational programmes that have multiple sessions, promote interaction among youth and engage parents. It also underscores the importance of training youth in specific life skills such as assertiveness, empathy, problem-solving, emotion management and help seeking, among others. Moreover, educational programmes are more successful when they use multiple and varied delivery formats such as videos, games, posters, infographics and guided discussions.
The report shows evidence that comprehensive forms of sex education can reduce physical and sexual aggression, in particular dating and partner violence and homophobic bullying. The effectiveness of sex education has been confirmed in countries of all income levels.
The report highlights the need for improvements in several areas including:
the need for more violence prevention programmes that integrate content about online dangers with offline violence prevention, given the overlap of these problems and the common approaches to prevention;
less emphasis on stranger danger as strangers are not the sole or even the predominant offenders in online violence against children;
more emphasis on acquaintance and peer perpetrators, who are responsible for a majority of offenses; and
more attention to healthy relationship skills, since romance and intimacy-seeking are major sources of vulnerability to online violence.
Internet access offers many possibilities for children and young people, including fostering learning, developing personal and professional skills, expressing creativity and participating in society. Governments need to find the right balance between fostering opportunities for young people through the digital environment and protecting them from harm. WHO is committed to contributing to existing efforts to better understand all forms of violence against children and help guide the international response.
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.