WHO issues emergency use listing for eighth COVID-19 vaccine

3 Nov

Today, the World Health Organization (WHO) issued an emergency use listing (EUL) for COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2.

WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. ‘But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”

COVAXIN® was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability. The Technical Advisory Group (TAG), convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used globally.

The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.

COVAXIN® was also reviewed on 5 October by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women).

The SAGE recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. COVAXIN® was found to have 78% efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.

Available data on vaccination of pregnant women with the vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.

WHO emergency use listing

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. 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.

See all EUL listings

SAGE

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.

See Sage interim recommendations

 

Urgent need for vaccine to prevent deadly Group B streptococcus

1 Nov
  • The global burden of Group B streptococcus is far higher than previously recognized, linked to over half a million preterm births annually, and leading to nearly 100,000 newborn deaths, at least 46,000 stillbirths, and significant long-term disability.
  • Although the bacterium is harmless for most pregnant women who carry it, it can be extremely serious when it passes to babies during pregnancy, childbirth or in the early weeks of life.
  • New vaccines are urgently needed to reduce deaths associated with Group B strep and protect the lives and health of infants around the world.

A new report from the World Health Organization (WHO) and the London School of Hygiene & Tropical Medicine (LSHTM) reveals the alarming global impact of Group B streptococcus (GBS) – a common bacterium that can be transmitted in the womb, during birth, or in the early weeks of life – leading to around 150,000 deaths of babies each year, more than half a million preterm births and significant long-term disability.

The report calls urgently for the development of maternal vaccines against GBS to reduce this toll, emphasizing they could be highly cost-effective – with significant health benefits – in all regions of the world.

Dr Phillipp Lambach, Medical Officer from WHO’s Immunization, Vaccines and Biologicals department, and report author, said: “This new research shows that Group B strep is a major and underappreciated threat to newborn survival and wellbeing, bringing devastating impacts for so many families globally. WHO joins partners in calling for urgent development of a maternal GBS vaccine, which would have profound benefits in countries worldwide.”

For the first time, this new research quantifies the major contribution of GBS to preterm births, as well as neurological impairments – such as cerebral palsy, hearing and vision loss – that can occur following GBS-associated infections.

Several GBS vaccine candidates are in development but none are yet available, despite having been in the pipeline for several decades.

Professor Joy Lawn, Director of the Maternal Adolescent Reproductive & Child Health (MARCH) Centre at LSHTM, and a contributor to the report, said: “Group B strep infection poses a serious challenge to every family affected, and in every country. Maternal vaccination could save the lives of hundreds of thousands of babies in the years to come, yet 30 years since this was first proposed, the world has not delivered a vaccine. Now is the time to act to protect the world’s most vulnerable citizens with a GBS vaccine.”

An average of 15% of all pregnant women worldwide – nearly 20 million annually – carry the GBS bacterium in their vagina, usually without symptoms. It can then spread from a pregnant woman to her unborn baby in the womb, or to newborns during labour.

Currently antibiotic prophylaxis administered to a woman during labour is the main means of preventing GBS disease in newborn infants, if the bacterium is detected during pregnancy. However, even in regions with high prophylactic coverage, there remain significant health risks, since this intervention is unlikely to prevent most GBS associated stillbirths, preterm births, or GBS disease that occurs later after birth.

Importantly the largest burden of GBS is in low- and middle-income countries, where screening and intrapartum antibiotic administration are most challenging to implement, and a vaccine is therefore most urgently needed. The highest rates of maternal GBS are found in sub-Saharan Africa (accounting for around half of the global burden), and Eastern and South-Eastern Asia.

Dr Martina Lukong Baye, Coordinator of the National Multisector Programme to Combat Maternal, Newborn & Child Mortality at the Ministry of Public Health in Cameroon, also a contributor to the report, said: “A new maternal vaccine against GBS would be a game-changer in the reduction of newborn and maternal deaths for the most affected countries - especially sub-Saharan Africa where the burden of these deaths is alarming. We plead to all stakeholders to treat this as a matter of moral priority.”

The report calls for researchers, vaccine developers and funders to accelerate development of an effective GBS vaccine that could be administered to pregnant women during routine pregnancy checkups.

Estimates suggest that if GBS vaccination reached over 70% of pregnant women, then over 50,000 GBS-related deaths could be averted annually - as well as over 170,000 preterm births. According to the report, the net monetary benefits from a year of maternal GBS vaccination could reach as high as $17 billion – accruing over several years - if vaccines are affordably priced.

The report highlights important data gaps which lead to some uncertainty around the total burden of deaths and disease caused by GBS. Infectious causes of stillbirths, for instance, are often under-investigated across countries, meaning the true contribution of GBS may be even higher still.

Debbie Forwood, whose daughter Ada was stillborn after she developed a GBS infection, said: “It is difficult to describe the breadth or depth of the grief when your child dies, or the accompanying guilt, and how it changes you, your family, and your relationships forever. Only a GBS vaccine could have saved Ada. When a vaccine can be widely rolled out, I will weep and scream with the unfairness that it came too late for her, and for all the other babies who are needlessly suffering and dying every year that it is delayed. But I will also weep with joy that in the future, many more will live, and their families will be saved from the living hell that is the death of a child.”

This report was launched at the global conference on GBS, the ISSAD conference being held by WHO and LSHTM from Wednesday 3 November to Friday 5 November 2021. This conference aims to mobilize researchers on how to close data gaps and accelerate science to reduce the impacts of this life-threatening bacterium worldwide.

For more information or interview requests, please contact Tilly Haynes, press@lshtm.ac.uk, and Laura Keenan, keenanl@who.int and mediainquiries@who.int.

 

Multimedia:

Photographs and assets related to this report and the ISSAD conference can be found here.

Publication details:

Post-embargo details for WHO-LSHTM joint report.

Post-embargo details of CID supplement.

Embargoed copies of the report and CID papers can also be found here.

Notes to Editors:

Annual burden of GBS in numbers for the year 2020

  • 19,700,000 pregnant women colonised with Group B strep
  • 518,000 GBS-associated preterm births
  • 390,000 infant GBS cases
  • 91,000 newborn deaths
  • 46,000+ stillbirths
  • 40,000 infants living with neurological impairment following GBS-associated infections
  •  

    About the report and linked papers

    The global value of Group B streptococcus vaccine report updates the current global estimates of the GBS burden, first published in 2017 by WHO with LSHTM, and funded by the Bill & Melinda Gates Foundation. For the first time, these new estimates include data on preterm births associated with GBS, as well as the risk of neurodevelopmental impairment in GBS survivors, based on new data from Denmark and five low- and middle-income countries (Argentine, India, Kenya, Mozambique and South Africa).

    Associated with this report, a series of nine papers carried out by 61 authors from 6 continents have been published in the Clinical Infectious Disease journal supplement – ‘Every Country, Every Family: Group B Streptococcal Disease Worldwide’. These papers provide more in-depth data on GBS, as well as the acute costs of GBS illness for families. Two WHO-led papers reveal programmatic readiness for uptake of a vaccine and more on the market size and sustainability.

    This report is the first outcome of the ‘Defeating Meningitis by 2030’ roadmap developed by WHO and partners, including LSHTM.

    About ISSAD

    ISSAD2021 (International Symposium on Streptococcus agalactiae Disease) is a global conference on Group B Strep: Accelerating evidence-based action, for every family, everywhere. It is being held by the World Health Organization and the Vaccine Centre and MARCH (Maternal Adolescent Reproductive & Child Health) Centre from the London School of Hygiene & Tropical Medicine. The conference is free to register online at ISSAD.org, taking place from Wednesday 3 November to Friday 5 November.

    About LSHTM

    The London School of Hygiene & Tropical Medicine (LSHTM) is a world-leading centre for research, postgraduate studies and continuing education in public and global health. LSHTM has a strong international presence with over 3,500 staff and 5,000 students working in the UK and countries around the world, and an annual research income of £180 million.

    LSHTM is one of the highest-rated research institutions in the UK, is partnered with two MRC University Units in The Gambia and Uganda, and was named University of the Year in the Times Higher Education Awards 2016. Our mission is to improve health and health equity in the UK and worldwide; working in partnership to achieve excellence in public and global health research, education and translation of knowledge into policy and practice.

    Follow @LSHTM on Twitter/Listen to LSHTM Viral Podcast

    About WHO

    Founded in 1948, WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable – so everyone, everywhere can attain the highest level of health.



     

    An appeal to G20 leaders to make vaccines accessible to people on the move

    29 Oct

    We are writing to you on behalf of the millions around the world struggling to survive the COVID-19 pandemic far from home. Some have been forced to flee wars, conflict, persecution and human rights violations. Others are on the move to escape socioeconomic hardship or the consequences of climate change.

    As strangers far from home, many are at risk of exclusion or neglect. Owing to their living situation, many face barriers accessing vaccinations, testing, treatment, care, and even reliable information.

    It is a stark reality that some of the world’s poorest countries shoulder the greatest responsibility for supporting displaced people and other people on the move. They need a reliable and adequate supply of vaccines and other critical supplies to stabilize their fragile and over-burdened health systems, to help save the lives of their citizens, migrants, as well as refugees and other displaced people they host.

    Yet the current vaccine equity gap between wealthier and low resource countries demonstrates a disregard for the lives of the world’s poorest and most vulnerable. For every 100 people in high-income countries, 133 doses of COVID-19 vaccine have been administered, while in low-income countries, only 4 doses per 100 people have been administered.

    Vaccine inequity is costing lives every day, and continues to place everyone at risk. History and science make it clear: coordinated action with equitable access to public health resources is the only way to face down a global public health scourge like COVID-19. We need a strong, collective push to save lives, reduce suffering and ensure a sustainable global recovery.

    And while vaccines are a very powerful tool, they’re not the only tool. Tests are needed to know where the virus is, treatments including dexamethasone and medical oxygen are needed to save lives, and tailored public health measures are needed to prevent transmission.

    As the leaders of the world’s largest economies, you have the power and responsibility to help stem the pandemic by expanding access to vaccines and other tools for the people and places where these are in shortest supply.

    We welcome the fact that this weekend’s summit in Rome will call for “courage and ambition” to tackle some of the greatest challenges of our time, and specifically the need to recover from the pandemic and overcome inequality. We collectively call on you, G20 leaders, to commit to:

    1. Increase vaccine supplies for the world’s poorest: We call on the world’s leading economies to fully fund and implement the Strategic Plan and Budget for the ACT Accelerator, and to distribute vaccines, tests and treatments where they are needed most. If we are to recover from the pandemic, we must — at a minimum — meet the targets to vaccinate 40 per cent of the world’s population by year-end – and 70 per cent globally by mid-2022.
    2. Ensure access to vaccines for all people on the move: We call on every country to ensure that everyone on its territory regardless of legal status – including refugees, migrants, internally displaced people, asylum-seekers, and others on the move – have access to COVID-19 vaccines, tests and treatment for COVID-19. They should adopt concrete measures to remove barriers to vaccination for everyone on their territory — for example the need for specific documents, geographical barriers,  the requirement in some settings that health care seekers are reported to immigration authorities, high fees — and fight misinformation that fuels vaccine hesitancy.
    3. Support low- and middle-income countries to combat COVID-19 with all available means: Low- and middle-income countries need comprehensive support – financial, political, technical, logistical – to vaccinate people quickly and effectively to expand access to tests and treatments, to implement tailored public health measures, and to build more resilient health systems to prepare for, prevent, detect and respond rapidly to future health emergencies.

    We urge you to take swift action to ease the pandemic’s devastating human toll.

    Yours faithfully,

    Filippo Grandi
    UN High Commissioner for Refugees  

    António Vitorino
    IOM Director General   

    Tedros Adhanom Ghebreyesus
    WHO Director-General      

    Logo-WHO

     

    World Health Organization Secretariat announcement regarding the election of the next WHO Director-General

    29 Oct

    The appointment of the next Director-General of the World Health Organization will take place at the Seventy-fifth World Health Assembly in May 2022 (WHA75). The Director-General is WHO’s chief technical and administrative officer.

    The election process began when Member States, through a circular letter sent by the WHO Secretariat in April 2021, were invited to submit proposals for candidates for the Director-General position. The deadline for submission of proposals was 23 September 2021. The date on which WHO is scheduled to publish information on candidates, including the curricula vitae and other particulars of their qualifications and experience as received from Member States, is to follow the closure of the last WHO Regional Committee meeting of the year.

    As today marks the closure of the last Regional Committee meeting, WHO can announce that a single candidate was proposed by Member States by the 23 September 2021 deadline: Dr Tedros Adhanom Ghebreyesus, who is the incumbent Director-General.

    Proposals from 28 WHO Member States, from all WHO regions, were received by the deadline: Austria, Bahrain, Barbados, Botswana, Cook Islands, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Indonesia, Ireland, Kazakhstan, Kenya, Luxembourg, Malta, Netherlands, Oman, Portugal, Rwanda, Slovakia, Spain, Sweden, Tonga, and Trinidad and Tobago.

    During the 150th session of the Executive Board in January 2022, the Board will conduct an initial screening to ensure that the candidate meets the criteria decided by the Health Assembly, interview him and then decide on the nomination by secret ballot. The nomination will be submitted to WHA75.

    The appointment will take place at WHA75 in May 2022, also by secret ballot. The term of office of the next Director-General will start on 16 August 2022. 

    A Director-General can be re-appointed once. Therefore, Dr Tedros Adhanom Ghebreyesus, the incumbent Director-General, is eligible to be proposed for a second term of five years.

     

    Note to media: The term “appointment” derives from WHO’s Constitution, Chapter V11, Article 31, here.

    Typically, candidates are proposed by one Member State, although (as has happened on this occasion) the same candidate may be proposed by multiple Member States.

     

    Online resources:

    Proposals from the 28 Member States and the candidate’s CV and statement can be found here.

    Information on process and timelines for the election of WHO Director-General, April 2021-May 2022, can be found here:

    Documents concerning the election process for the WHO Director-General are available here.

     

    On World Cities Day 2021 WHO calls on countries to build resilient and healthy cities

    28 Oct

    Well over half the world’s population already lives in towns and cities.  By 2050, that  proportion is expected to increase to almost 70%. On World Cities Day 2021, we see how this rapid urban growth presents both challenges and opportunities.

    The climate and COVID-19 crises have exacerbated existing social injustices and vulnerabilities in our communities and our health systems, especially in cities.  

    Inadequate housing and transport, poor sanitation and waste management, and air quality that fails to meet WHO guidelines are still big issues in many cities. The lack of space for safe walking, cycling and active living also make cities epicentres of the noncommunicable diseases epidemic and drivers of climate change.

    But WHO has seen cities react rapidly and innovatively to address the challenges raised by COVID-19 and keep citizens safe from the virus, including by adapting the way people travel, maintaining food security and safety, and protecting older people and marginalized populations.

    During the pandemic, many cities have strengthened existing networks and partnerships with communities to best respond to people’s needs, while strengthening multisectoral collaboration and strong leadership from the health sector.  

    WHO has been supporting cities in building and shaping these policies and actions. The Organization wants to ensure that this progress continues so that cities are better prepared to face future health emergencies.

    Cities with a strong focus on public transport, access to blue and green spaces, and where it is easy for people to walk around will be more accessible, provide more equal access to goods and services, and provide a healthier living environment.

    Urban farmers’ markets – connecting consumers with local producers of fresh fruits and vegetables – have been seen to prevent diseases and promote health, improve social well-being, while also addressing climate change and environmental degradation. They have also helped residents cope with  the effects of public health measures, such as COVID-19 lockdowns.

    What does building urban resilience look like?

    Governments should integrate health, emergency preparedness, equity, and nature considerations into urban and regional planning policies and interventions, including in economic impact and cost-benefit assessments.

    They should promote land-use policies and interventions that deliver diverse, compact, green, and well-connected cities, and secure sustained funding and resources for delivering on healthy urban environments for both humans and nature. As a priority they should also prepare – at the highest level of government in all Member States – for health emergencies in cities and urban settings.

    New ACT-Accelerator strategy calls for US$ 23.4 billion international investment to solve inequities in global access to COVID-19 vaccines, tests & treatments

    28 Oct
    • New ACT-Accelerator strategic plan sets out urgent actions to address crucial gaps in access to COVID-19 tests, treatments, vaccines and personal protective equipment in low- and middle-income countries, using the latest epidemiological, supply and market information.  
    • Delivering this plan is crucial to reaching globally agreed targets for COVID-19 tools, to help prevent at least 5 million potential additional deaths, save the global economy more than US$ 5.3 trillion, and accelerate the end of the pandemic everywhere.
    • The ACT-Accelerator needs US$ 23.4 billion until September 2022 to implement this plan, reflecting a fresh scope, advances in science and supply, and new actors joining the pandemic response.
    • The new plan also responds to the recent independent Strategic Review’s key recommendations and will be implemented alongside global health, government, civil society and private sector partners. The Access to COVID-19 Tools (ACT) Accelerator has today launched its strategic plan and budget for the next 12 months, outlining the urgent actions and funding needed to address deep inequities in the COVID-19 response, save millions of lives and end the acute phase of the pandemic.

    The Access to COVID-19 Tools (ACT) Accelerator has today launched its strategic plan and budget for the next 12 months, outlining the urgent actions and funding needed to address deep inequities in the COVID-19 response, save millions of lives and end the acute phase of the pandemic.

    Inequitable access to COVID-19 tests, treatments and vaccines is prolonging the pandemic everywhere and risking the emergence of new, more dangerous variants that could evade current tools to fight the disease. So far, only 0.4% of tests and 0.5% of vaccines administered worldwide have been used in low-income countries, despite these countries comprising 9% of the global population.

    The ACT-Accelerator partnership of leading global health agencies needs US$23.4 billion to help the most at-risk countries secure and deploy COVID-19 tools between now and September 2022. This figure pales in comparison to the trillions of dollars in economic losses caused by the pandemic and the cost of stimulus plans to support national recoveries.

    The new strategic plan, which integrates key findings of the recent Strategic Review, will see the ACT-Accelerator leverage its progress to date, to shift to a more targeted focus on addressing access gaps in underserved countries, delivering vaccines, treatments, tests and personal protective equipment where they’re most needed.

    Fully funding the new strategic plan and budget will enable the partnership to:

    • Support the vaccination objectives of 91 lower-income countries in the COVAX Advance Market Commitment (AMC) and other countries, by delivering sufficient doses and supporting vaccination campaigns to achieve 43% coverage in AMC countries – contributing to the global target of 70% coverage in all countries by mid-2022.
    • Assist the 144 countries in the Diagnostics Consortium in reaching a minimum testing rate of at least 1 per 1000 people per day, and ensuring sufficient genetic sequencing capacity globally to rapidly detect new variants of concern.
    • Ensure 120 million COVID-19 patients in low- and middle-income countries have access to existing and emerging treatments, including medical oxygen.
    • Keep 2.7 million health workers in low- and middle-income countries safe with personal protective equipment (PPE).


    Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, said: “To end the pandemic, governments, manufacturers and donors must fully fund the ACT-Accelerator to address inequities in access to COVID-19 vaccines, tests and treatments. In focusing its energies on addressing the great equity gap for these tools, the ACT-Accelerator is bolstering its role as an ally for countries side-lined by market forces in securing life-saving interventions. Fully funding the ACT-Accelerator is a global health security imperative for us all – the time to act is now.”

    The ACT-Accelerator’s plan to address inequities in access to COVID-19 vaccines, tests, and treatments will help avert more than 5 million potential deaths. It is also essential to the global economic recovery. The International Monetary Fund (IMF) estimates a loss of US $5.3 trillion in global revenues by 2026 if large parts of the world remain unprotected from COVID-19.

    The ACT-Accelerator Facilitation Council provides high-level political leadership and advice on global advocacy and resource mobilization to the initiative, and is co-chaired by Norway and South Africa.

    President Cyril Ramaphosa of South Africa said: “South Africa welcomes the launch of this new strategic plan, which seeks to address the escalating inequities in the global COVID-19 response. Nowhere is this inequity more apparent than on the African continent, where just 8% of the population has received a single dose of COVID-19 vaccine. Every delay in fully funding the ACT-Accelerator will see the pandemic prolonged, more lives will be lost and more livelihoods will be devastated. We need equitable access now to COVID-19 treatments, tests and vaccines, and this is a plan to achieve that.”

    Prime Minister Jonas Gahr Støre of Norway said: “While a new normal is emerging for people who have access to COVID-19 tools, this is still a distant prospect for the majority of the world’s population. Without access to COVID-19 tools, we will not be able to achieve full economic and social recovery. The new ACT-Accelerator strategy is key to address inequities in access to COVID-19 tools. This is a collective effort. Now we must ensure inclusive and effective implementation.”

    The new strategic plan integrates key recommendations from an independent Strategic Review of the ACT-Accelerator that was published on 8 October 2021, including to extend the mandate of the ACT-Accelerator, enhance focus on delivery, and to further strengthen engagement with low- and middle-income countries and civil society organisations to maximise impact.

    A key element of the new plan is the reconfigured Health Systems & Response Connector (HSRC). The connector will ensure closer engagement with countries and that they have the necessary technical, operational, and financial resources to deploy tools.  

    From research to rollout, the ACT-Accelerator remains the world’s only end-to-end solution for accelerating the development and fair distribution of COVID-19 tools. Through the COVAX pillar – led by Gavi, CEPI and WHO, alongside UNICEF as key delivery partner and the Diagnostics pillar led by FIND and the Global Fund the ACT-Accelerator is working to address challenges of equitable access and to help the world meet the global targets of 70% vaccination coverage by mid-2022 and minimum testing rates of at least 1 per 1000 people per day in 2022.

    Through the Therapeutics pillar – led by Unitaid and Wellcome – the ACT-Accelerator is working to provide treatments for up to 120 million COVID-19 cases expected in the next 12 months in low-income countries, lower middle-income countries and underserved upper middle-income countries, focused on equitable access to effective tools, including existing and potential new treatments and medical oxygen. The Health Systems & Response Connector priorities for the next year include connecting countries with financing, tracking needs in real time, and addressing surge staffing requirements for vaccine rollouts, with work being led by the Global Fund, the World Bank, WHO, with UNICEF and the Global Financing Facility as implementing partners.

    The ACT-Accelerator’s impact so far includes:

    • Delivering more than 425 million vaccine doses to 144 countries and territories through COVAX;
    • Halving the cost of COVID-19 rapid tests, transferring technology to low and middle-income countries, and delivering more than 128 million tests through the Diagnostics Consortium;
    • Increasing essential oxygen, personal protective equipment (PPE) and treatment supplies, including through the advance purchase of nearly 3 million doses of dexamethasone and more than US$4 billion worth of support from the Global Fund’s COVID-19 Response Mechanism (C19RM).

    To provide enough vaccines, tests and treatments for distribution to all in need, the ACT-Accelerator has also helped build a robust development pipeline of COVID-19 tools through investments in areas from research and clinical trials to product development, rapid regulatory approvals and market shaping.

    END

    Notes to Editors:

    The lead partner agencies of the ACT-Accelerator are: CEPI, FIND, Gavi, The Global Fund, UNICEF, Unitaid, Wellcome, WHO, the World Bank and The Bill & Melinda Gates Foundation.

    Breakdown of the ACT-Accelerator’s US$ 23.4 billion funding needs from October 2021 to September 2022:

    • S$7.0 billion for diagnostics
    • US$7.0 billion for vaccines
    • US$3.5 billion for therapeutics
    • US$5.9 billion for the Health Systems & Response Connector

     

     

    The Strategic Plan and Budget document can be found here.

    QUOTE SHEET

    Carl Bildt, WHO Special Envoy for the ACT-Accelerator, said: “Fully funding the ACT-Accelerator is the best way for the world to avert further economic losses caused by the pandemic. Vaccine inequity kills. Efforts on tests and treatments are seriously underfunded, blinding and weakening us in fighting this virus. We have the tools to end this pandemic, but they will only succeed in doing so if every community in every country has access to them. Equitable pandemic policy is also good economic policy and will help minimise the costs of this crisis. The time for warm words is over, the deadline to act is now.”

    Dr Richard Hatchett, CEO of CEPI, said: “The pandemic is far from over so the ACT-Accelerator, as the only global initiative dedicated to equitable access, remains critical to global health security. However, the ACT-Accelerator cannot deliver on its promises unless it receives dramatically more funding. The global community must step up and support our mission to get life-saving tools to people who need them, wherever they are in the world, so we can finally put an end to this pandemic.”

    Dr Bill Rodriguez, CEO of FIND, said: “The ACT-Accelerator has made critical updates to its strategy and plan to confront the COVID-19 pandemic. These changes acknowledge the reality of the two-track pandemic we are now fighting, and the ongoing inequity of access to the tests, treatments, and vaccines that were so quick to be developed and so slow to reach billions of people. It is also clear that no single tool is a panacea – while the roll out of vaccines must continue, it is equally important to hit the new testing targets so that we can track and defeat variants, break chains of transmission, and link people to new treatments and life-saving care.”

    Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, said: “It is vitally important that governments, donors, industry and others support the ACT-Accelerator and its efforts to remedy the inequity in access to vaccines, diagnostics, and treatments. In 2022, COVAX will be supporting countries’ vaccination objectives, focusing particularly on those that rely on it for access to safe and effective vaccines. We have seen the consequences of not having resources in place to make deals for doses: with the race to secure doses for 2022 already underway, early funding will be essential to ensuring COVAX participants can achieve equitable coverage.”

    Peter Sands, Executive Director of the Global Fund, said: “Inequity in access to COVID-19 tools remains unacceptably high while we face new variants, acute oxygen shortages and the urgent need to protect health workers in low- and middle-income countries. Only by fully funding the ACT-Accelerator and working even more closely with the countries and communities can we fill those gaps and make vaccines, personal protective equipment, tests and treatments accessible to everyone. As long as the poorest are left behind, the pandemic will not go away and any progress against COVID-19 will be at risk."

    Henrietta Fore, Executive Director of UNICEF, said: "The pathway out of the pandemic is paved by equal access to vaccines, treatments and tests. Until we achieve this, we all remain at risk. UNICEF is delivering these vital supplies where they are most needed, and helping countries prepare for their vaccination efforts. However, we cannot do this without the help and support of our donors and partners. Together, we can stop the pandemic from continuing to upend the lives of children and their families everywhere."

    Dr Philippe Duneton, Executive Director of Unitaid, said: “To fight COVID-19 we need medicines such as oral antivirals, tests and vaccines. Unitaid, the co-lead of the ACT Accelerator’s therapeutics pillar, is committed to rapidly bring state-of-the-art treatments to those in need, when approved by WHO. Getting new lifesaving medicines available to low- and middle-income countries at the same time as they come to wealthy countries, is not just key to speeding up an end to the pandemic; it’s a moral imperative. For that we need to create a quality generic market.”

    Juan Pablo Uribe, Global Director for Health, Nutrition and Population, World Bank; Director for Global Financing Facility (GFF), said: “The World Bank is an active partner of ACT-A and we fully support the newly restructured Health Systems & Response Connector (HSRC). While vaccines, tests and treatments are key to fight the pandemic, it is as important to help countries be able to effectively deploy these tools to the people who need them. That’s what the HSRC will be focusing on.”  

     

     

     

     

     

    WHO launches the third edition Health for All Film Festival call for short films

    28 Oct

    The World Health Organization (WHO) is launching the third edition of the Health for All Film Festival call for short films.

    The first two editions demonstrated its relevance for health promotion and health education and yielded great candidates and winners (Please, see the related links).

    The third call for short film (three to eight minutes of length) opens on 28 October 2021 and will close on 30 January 2022. The WHO invites independent film-makers, production companies, broadcasters, public institutions, NGOs, communities, students in public health and film schools from around the world to submit their original short film.

    The WHO prizes for the winning films have helped to increase awareness and support about some key health issues. With an average of 1250 submissions every year from 110 countries, it has also proven to be a useful global tool for a vast variety of expressions about people’s health concerns.

    “The COVID-19 pandemic is a powerful reminder that when health is at risk, everything is at risk,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “In two years, the WHO Health for All Film Festival has become an incredible platform for telling powerful stories in powerful ways about people around the world who face health challenges of all kinds, and the people who devote their lives to defending health. I can’t wait to see this year’s entries, and I look forward to another successful Health for All Film Festival this year, and many more to come.”

    A new series of about 65 short films will be presented to the public in April 2022 via WHO Youtube channel and www.who.int/film-festival.

    WHO is also calling for at least six distinguished professionals, artists and activists to join in the next jury of its film festival in March 2022. Ms Sharon Stone, critically acclaimed actress from the USA and public advocate in favour of many health and humanitarian issues, has already accepted to join this future jury. They will act as external advisors to WHO’s Director-General. This jury will also be composed of three WHO’s senior experts: Dr Ren Minghui for the Universal Health Coverage category of the competition; Dr Maria Van Kerkhove for health emergencies category; and Dr Hanan H. Balkhy for Better health and well-being.

    Three “GRAND PRIX” will be announced in May 2022, one for each main category.

    WHO also plans to award three special prizes for a student-produced film, a health innovation film, and a film about rehabilitation.

    “Storytelling is an engagement between people. It’s not just someone making a film, it’s someone watching a film.», said WHO Executive Director of Health Emergencies Programme, Dr Mike Ryan, film festival juror in 2021. “This is exactly how WHO should be transforming: Transforming how we engage with the world and this festival is just one example of how we can change our mindset.”

    For more details on this call, the awards, previous official selections and jury compositions and further information, visit the multilingual festival website



    WHO kicks off a Decade of Action for Road Safety

    28 Oct

    WHO is kicking off the Decade of Action for Road Safety 2021-2030 today in Geneva, with the ambitious target of preventing at least 50% of road traffic deaths and injuries by 2030. WHO and the UN regional commissions, in cooperation with other partners in the UN Road Safety Collaboration, have developed a Global Plan for the Decade of Action, which is released today.

    Globally, over 3500 people die every day on the roads, which amounts to nearly 1.3 million preventable deaths and an estimated 50 million injuries each year – making it the leading killer of children and young people worldwide. As things stand, they are set to cause a further estimated 13 million deaths and 500 million injuries during the next decade, particularly in low- and middle-income countries. These unacceptable numbers, both in absolute and relative terms. Road traffic crashes have remained a major cause of death globally, even though every one of those deaths and injuries is preventable.

    “The loss of lives and livelihoods, the disabilities caused, the grief and pain, and the financial costs caused by road traffic crashes add up to an intolerable toll on families, communities, societies and health systems,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, “So much of this suffering is preventable, by making roads and vehicles safer, and by promoting safe walking, cycling and greater use of public transport. The Global Plan for the Decade of Action for Road Safety lays out the practical, evidence-based steps all countries and communities can take to save lives.”

    Recognizing the importance of the problem and the need to act, governments from around the world declared unanimously – through UN General Assembly Resolution 74/299 – the Decade of Action for Road Safety 2021-2030 with the explicit target to reduce road traffic deaths and injuries by at least 50% during that period.

    “One of the best ways to save and improve lives is to make our streets safer -- but that work often doesn’t get the attention it deserves,” said Michael R. Bloomberg, founder of Bloomberg LP and Bloomberg Philanthropies and WHO Global Ambassador for Noncommunicable Diseases and Injuries. “Bloomberg Philanthropies has been working to improve road safety since 2007 by strengthening laws, increasing enforcement, redesigning streets, and using data. I’m glad to say that the WHO’s ambitious global plan for road safety includes many of the strategies that we’ve used to save lives, and it will help encourage governments around the world to make road safety the high priority it should be.”

    This Global Plan describes the actions needed to achieve that target. This includes accelerated action to make walking, cycling and using public transport safe, as they are also healthier and greener modes of transport; to ensure safe roads, vehicles and behaviours; and to guarantee timely and effective emergency care.  It is aimed to inspire countries, including governments and partners to act boldly and decisively, using the tools and knowledge gained from the last Decade of Action to change course.

    “More than 50 million people have died on the world’s roads since the invention of the automobile.  This is more than the number of deaths in World War One or some of the worst epidemics.” says Dr Etienne Krug, the Director of the Department of the Social Determinants of Health. “It is time to put in action what we know works and shift to a much safer and healthier mode of transport. This new plan will lead countries onto a more sustainable path.”

    The Global Plan outlines recommended actions drawn from proven and effective interventions, as well as best practices for preventing road trauma. It should be used as a blueprint to inform and inspire national and local plans that are tailored to local contexts, available resources and capacity. The Global Plan is aimed not only at senior policy-makers, but also other stakeholders who can influence road safety, such as civil society, academia, the private sector and community and youth leaders.

    NOTE TO EDITORS:

    The Global Plan for the Decade of Action for Road Safety 2021-2030 will be formally presented on 28 October 2021, during a virtual event to be held from 14:00 to 15:00 Geneva time. This event will provide an opportunity for the WHO Director-General and road safety stakeholders from national and municipal governments, NGOs, and youth groups to make brief remarks on its importance as a tool for preventing road traffic deaths and injuries. To join, register in advance at: https://bit.ly/3uZpYYB The event will be held in English.  

    WHO-Unitaid statement on the MPP licensing agreement for molnupiravir

    27 Oct

    WHO and Unitaid welcome the signing of a voluntary licensing agreement by the Medicines Patent Pool (MPP) and MSD to facilitate affordable access to molnupiravir, a new medicine being tested in clinical trials for treating COVID-19 in adults.

    Molnupiravir, an investigational oral antiviral medicine, was reported to reduce the risk of hospitalization in patients with mild to moderate COVID-19 by 50% in interim phase III clinical trials. It is currently being evaluated for inclusion into the WHO living guideline on COVID-19 therapeutics and is pending authorization for its use from regulatory bodies. If approved, it will be the first oral medicine for non-hospitalized mild-to-moderate COVID-19 patients.

    The MPP/MSD licensing agreement is a positive step towards creating broader access to the treatment as quickly as possible by allowing generic licensees from around the world to prepare supplies and create more affordable versions of the medicine, pending WHO recommendations and other regulatory authorizations. This will shorten the time from approval of the medicine to its availability in the 105 low- and middle-income countries covered by the licence and where there is no patent infringement and licensed know-how has not been used. We hope the company will include other key countries in the scope of the agreement in the near future.

    We commend MPP for negotiating the licence from a public health perspective – in line with WHO’s COVID-19 Technology Access Pool (C-TAP) principles, it is non-exclusive and transparent.

    We urge the manufacturer to provide data of clinical trials to WHO as soon as possible, so that the agency can evaluate the medicine for global use.

    Other companies developing vaccines, therapeutics and diagnostics should consider open and transparent licences as soon as possible, especially for other promising COVID-19 health technologies, for which we also need to ensure broad supply and affordability in all countries in order to end the pandemic. Both the Access to COVID-19 Tools Accelerator (ACT-A) and C-TAP, in partnership with MPP, are working to facilitate such licences, and look forward to an open dialogue with relevant developers.