Today, the World Health Organization (WHO) issued an emergency use listing (EUL) for CONVIDECIA, a vaccine manufactured by CanSino Biologics, China, 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 as a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
CONVIDECIA was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan, programmatic suitability and a manufacturing site inspection conducted by WHO. The Technical Advisory Group for Emergency Use Listing, 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 and that the benefits of the vaccine far outweigh risks.
CONVIDECIA is based on a modified human adenovirus that expresses the spike S protein of SARS-CoV-2. It is administered as a single dose.
CONVIDECIA was also reviewed earlier this month 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 shots, specific groups such as pregnant and lactating women).
The SAGE recommends use of the vaccine as a single (0.5ml) dose, in all age groups 18 and above.
CONVIDECIA was found to have 58% efficacy against symptomatic disease and 92% against severe COVID-19.
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 consistently meets the necessary standards of quality, safety and efficacy for broader availability.
See all EUL listings
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.
CORRIGENDUM. Please note this webpage was updated on 23 May 2022 to give the efficacy rate after 28 days.
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Seventy-fifth World Health Assembly to focus on “Health for Peace, Peace for Health” for recovery and renewal
In a world threatened by conflict, inequities, the climate crisis and pandemics, the Seventy-fifth session of the World Health Assembly will stress the importance of building a healthy and peaceful planet by harnessing science, data, technology and innovation.
This year’s session of the Health Assembly will focus on the theme of “Health for Peace, Peace for Health” and will run from the 22-28 May at the Palais des Nations in Geneva. It will include the appointment of the next WHO Director-General.
“The pandemic has undermined progress towards the health-related targets in Sustainable Development Goals and laid bare inequities within and between countries,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Sustained recovery will require more than ‘getting back on track’ and reinvesting in existing services and systems. We need a new approach, which means shifting priorities and focusing on the highest-impact interventions.”
The Seventy-fifth World Health Assembly will kick off with a high-level segment on 22 May with speeches from the elected Health Assembly President, Heads of State, special guests, an address by the WHO Director-General and the presentation of the Director-General’s Health Awards. The Director-General’s speech will set out WHO’s five priorities going forward, expanding from the vision delivered at the Executive Board meeting held in January 2022.
Ahead of the Health Assembly, on 20 May, WHO will publish the latest set of World Health Statistics, its annual compilation of health statistics for WHO’s 194 Member States. The latest edition summarizes trends in life expectancy and causes of death and reports on progress towards global health/development goals for 2020.
The 2020-2021 Results Report, also published before WHA, summarizes the Organization's achievements and challenges in implementing the programme budget.
The Health Assembly will discuss global strategies on food safety, oral health, and tuberculosis research and innovation. It will also discuss the report of the Working Group on WHO Sustainable financing.
Other key topics under discussion include:
- strengthening WHO preparedness for and response to health emergencies;
- an implementation road map 2023–2030 for the global action plan for the prevention and control of noncommunicable diseases;
- an Intersectoral Global Action Plan on epilepsy and other neurological disorders 2022-2031;
- prevention of sexual exploitation, abuse and harassment;
- poliomyelitis; and
- the Global Health for Peace Initiative.
Agenda items will be discussed in Committee A, which deals with predominantly programme and budget matters, and Committee B, which deals mainly with administrative, financial and legal matters. Details can be found in the provisional agenda. The venues at the Palais des Nations are: Plenary -- room XIX; Committee A -- room XX; and Committee B -- room XVII.
Assembly delegates, partner agencies, representatives of civil society and WHO experts will also discuss priorities for public health in a series of strategic roundtables. Discussions can be followed online here.
The Health Assembly is WHO’s highest decision-making body, setting out the Organization’s policy and approving its budget. WHA is attended by delegations from all WHO 194 Member States. The Health Assembly’s agenda is prepared by the Programme, Budget and Administration Committee of the Executive Board, which will meet on 18-20 May, 2022.
The Health Assembly is open to Member States, Associate Members, Observers, invited representatives of the UN and other participating inter-governmental organizations and non-State actors.
A preliminary timetable is available here: Preliminary daily timetable for the Seventy-fifth World Health Assembly.
Media accreditation for the World Health Assembly
Journalists who wish to attend the World Health Assembly and who are NOT accredited to the United Nations should request media accreditation from the United Nations Information Service by registering on the INDICO registration platform.
Updates on the Health Assembly will be posted on the WHO website and relevant materials will be sent to the global media list. Register for updates.
A daily journal will be available here.
Photographs and videos
Information on the WHO Photo Service and videos for media can be obtained from Chris Black on mobile +41 79 472 6054 or email firstname.lastname@example.org.
Despite the the COVID-19 pandemic, the World Health Organization’s 2020-2021 Results Report tracks WHO’s significant achievements across the global health spectrum. Released ahead of the World Health Assembly next week, the report details such accomplishments as the delivery of more than 1.4 billion vaccine doses via the COVAX facility, the recommendation for broad use of the world’s first malaria vaccine and WHO’s response to some 87 health emergencies, including COVID-19.
During 2020-2021, WHO led the largest-ever global response to a health crisis, working with 1600 technical and operational partners, and helped galvanise the biggest, fastest and most complex vaccination drive in history. The Organization spent US$1.7 billion on essential supplies to the COVID-19 response.
“Even as WHO has responded to the most severe global health crisis in a century, we have continued to support our Member States in addressing many other threats to health, despite squeezed budgets and disrupted services,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.
“As the world continues to respond to and recover from the pandemic in the years ahead, WHO’s priority is to invest even more resources for our work in countries, where it matters most,” he continued. “Ensuring WHO has sustainable, predictable and flexible financing is essential for fulfilling our mission to promote health, keep the world safe and serve the vulnerable.”
The ACT-A partnership delivered over 1 billion COVID-19 vaccine doses by January 2022. The global rollout of crucial health materials included nearly US$500 million worth of personal protective equipment; US$ 187 million in oxygen supplies, US$4.8 million in treatments and 110 million diagnostic tests.
However, much remains to be done for the world to get on track for WHO’s target of each country vaccinating 70% of its population by July 2022.
WHO’s performance beyond pandemic
The Results Report reveals noteworthy achievements beyond the pandemic. Mandatory policies prohibiting the use of trans fatty acids (a hazardous food compound linked to cardiovascular disease), are in effect for 3.2 billion people in 58 countries. Among these countries, 40 have best practice policies, including Brazil, Peru, Singapore, Turkey and the United Kingdom. WHO’s REPLACE initiative aims for a world free of trans-fats by the end of 2023.
Thanks to implementation of measures mandated by WHO's Framework Convention on Tobacco Control, tobacco use is decreasing in 150 countries, saving lives and livelihoods.
Due to efforts to scale up life-saving interventions guided by WHO guidelines, 15 countries have achieved elimination of mother-to-child transmission of HIV and/or syphilis.
And WHO’s recommendation of widespread use of the world’s first malaria vaccine (RTS,S) has been delivered to over 1 million children. It is expected to save 40 000 to 80 000 lives a year, when used with other malaria control interventions.
A voice for health equity
The report demonstrates WHO’s crucial role as the world’s global health guardian, speaking up for health equity in a world of widening inequalities.
The grave costs of the pandemic were felt everywhere. The report portrays a world which is clearly further off track to reach crucial global health goals. Due to myriad disruptions caused by the COVID-19 pandemic, countries have fallen behind on WHO’s “Triple Billion targets” that provide critical pathways to attain the Sustainable Development Goals (SDGs) by 2030.
Progress on Universal health coverage and healthier populations are at about one quarter or less the pace needed to reach the Sustainable Development Goals by 2030, and no country was fully prepared for a pandemic of such scale.
COVID-19 also caused huge disruptions to health services: 117 of 127 countries surveyed reported disruption to at least one essential health service because of COVID, whilst the average disruption across those countries was a staggering 45%.
Going forward, fulfilling the triple billion targets will be WHO’s overriding goal, as a measurable means of reducing health equity gaps.
Key role of sustainable financing
The Results Report details WHO’s efforts towards transparency and accountability, providing details of expenditure. The WHO Programme Budget for 2020-2021 was $5 840.4 million. In fact, financing reached US $7 916 million, due to COVID-19 emergency operations. The surplus was thanks to the generosity of donors, including 12 Member States which contributed approximately 71% of the total financing.
Nonetheless, the largest share of WHO financing is earmarked by donors through specified voluntary contributions. Flexible funds constituted only 20% of total financing in 2020-2021.
If WHO is to play its full role in achieving the SDGs, delivering on universal health coverage, reducing the burden of ill health and protecting 1 billion more people from health emergencies, the share of regular, stable, predictable financing must increase.
Note to Editors
WHO’s Triple Billion targets, by 2023: 1 billion more people benefitting from universal health coverage; 1 billion more people better protected from health emergencies; 1 billion more people enjoying better health and well-being.
Almost one billion children and adults with disabilities and older persons in need of assistive technology denied access, according to new report
A new report published today by WHO and UNICEF reveals that more than 2.5 billion people need one or more assistive products, such as wheelchairs, hearing aids, or apps that support communication and cognition. Yet nearly one billion of them are denied access, particularly in low- and middle-income countries, where access can be as low as 3% of the need for these life-changing products.
The Global Report on Assistive Technology presents evidence for the first time on the global need for and access to assistive products and provides a series of recommendations to expand availability and access, raise awareness of the need, and implement inclusion policies to improve the lives of millions of people.
“Assistive technology is a life changer – it opens the door to education for children with impairments, employment and social interaction for adults living with disabilities, and an independent life of dignity for older persons,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. “Denying people access to these life-changing tools is not only an infringement of human rights, it’s economically shortsighted. We call on all countries to fund and prioritize access to assistive technology and give everyone a chance to live up to their potential.”
“Nearly 240 million children have disabilities. Denying children the right to the products they need to thrive doesn’t only harm individual children, it deprives families and their communities of everything they could contribute if their needs were met,” said UNICEF Executive Director Catherine Russell. “Without access to assistive technology, children with disabilities will continue to miss out on their education, continue to be at a greater risk of child labor and continue to be subjected to stigma and discrimination, undermining their confidence and wellbeing.”
The report notes that the number of people in need of one or more assistive products is likely to rise to 3.5 billion by 2050, due to populations ageing and the prevalence of noncommunicable diseases rising across the world. The report also highlights the vast gap in access between low- and high-income countries. An analysis of 35 countries reveals that access varies from 3% in poorer nations to 90% in wealthy countries.
Affordability is a major barrier to access, the report notes. Around two thirds of people with assistive products reported out-of-pocket payments for them. Others reported relying on family and friends to financially support their needs.
A survey of 70 countries featured in the report found large gaps in service provision and trained workforce for assistive technology, especially in the domains of cognition, communication and self-care. Previous surveys published by WHO note a lack of awareness and unaffordable prices, lack of services, inadequate product quality, range and quantity, and procurement and supply chain challenges as key barriers.
Assistive products are generally considered a means to participate in community life and in wider society on an equal footing with others; without them, people suffer exclusion, are at risk of isolation, live in poverty, may face hunger, and be forced to depend more on family, community and government support.
The positive impact of assistive products goes beyond improving the health, well-being, participation and inclusion of individual users – families and societies also benefit. For example, enlarging access to quality-assured, safe and affordable assistive products leads to reduced health and welfare costs, such as recurrent hospital admissions or state benefits, and promotes a more productive labour force, indirectly stimulating economic growth.
Access to assistive technology for children with disabilities is often the first step for childhood development, access to education, participation in sports and civic life, and getting ready for employment like their peers. Children with disabilities have additional challenges due to their growth, which requires frequent adjustments or replacements of their assistive products.
The report makes recommendations for concrete action to improve access, including:
- Improve access within education, health and social care systems
- Ensure availability, safety, effectiveness and affordability of assistive products
- Enlarge, diversify and improve workforce capacity
- Actively involve users of assistive technology and their families
- Increase public awareness and combat stigma
- Invest in data and evidence-based policy
- Invest in research, innovation, and an enabling ecosystem
- Develop and invest in enabling environments
- Include assistive technology in humanitarian responses
- 10.Provide technical and economic assistance through international cooperation to support national efforts.
Note to Editors:
Assistive technology is an umbrella term for assistive products and their related systems and services. Assistive products can enhance performance in all key functional domains such as mobility, hearing, self-care, vision, cognition and communication. They may be physical products, such as wheelchairs, prosthetics or spectacles, or digital software and apps. They may also be adaptations to the physical environment, for example portable ramps or grab-rails.
People in need assistive technology include people with disability, older people, people with communicable and noncommunicable diseases including neglected tropical diseases, people with mental health conditions, people with gradual functional decline or loss of intrinsic capacity and many people affected by humanitarian crises.