World Health Organization Corporate news releases, statements, and notes for media issued by the World Health Organization.
- Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectivenesson Jun 11 2021 at 08:04
Healthcare professionals and public health authorities have a central role in discussing vaccination against COVID-19 with their patients. Vaccines play a critical role in preventing deaths, hospitalisation caused by infectious diseases. Emerging data on effectiveness indicates that licenced COVID-19vaccines are contributing to controlling the spread of the disease. Until widespread vaccination has been achieved, both vaccinated and unvaccinated people need to be aware of the additional protective behaviours required to control the pandemic locally.The global impact of the COVID-19 pandemic has resulted in an unprecedented level of public interest in vaccines. This includes a focus on the development of vaccines and their regulatory review and safety monitoring. Much of this coverage has taken place through mass and social media. Reports of adverse events (side effects) have led some people to express concerns about getting vaccinated, delay getting vaccinated or even be strongly opposed to vaccination. There are also differences in individual confidence in national safety monitoring systems. Another challenge in communicating the importance of COVID-19 vaccination is that younger adults are typically less clinically affected by COVID-19 infection and so may see limited value in getting vaccinated, including until further data confirms that vaccines prevent transmission and that vaccines are effective against variants. Clear and consistent communication is therefore essential to support people in making the choice to be vaccinated. We appreciate that you, your colleagues and your patients may have a number of questions around the development, regulatory review and ongoing safety monitoring of COVID-19 vaccines.PurposeThis joint International Coalition of Medicines Regulatory Authorities (ICMRA)* and WHO statement aims to help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines. It explains how vaccines undergo robust scientific evaluation to determine their safety, efficacy and quality and how safety is closely and continually monitored after approval.Vaccination has been shown to contribute to reducing deaths and severe illness from COVID-19, and to reduce the transmission of COVID-19. Vaccinating as many people as possible and reducing the spread of disease is important. Vaccination of a significant proportion of the population also protects vulnerable people, including those who cannot receive vaccines, or the small proportion of people who might remain at risk of infection after vaccination. Failure to vaccinate widely also enables continued circulation of the virus and the generation of variants, including some that may pose a greater risk. Widespread vaccination will help prevent people from having to go to hospital and contribute to fewer people getting sick, ultimately alleviating the burden of COVID-19 on healthcare systems. It will also help allow a return to normal societal functioning and the re-opening of economies.Vaccines and the regulatory processHow do regulatory authorities evaluate COVID-19 vaccines?Regulators rigorously evaluate scientific and clinical evidence provided by vaccine manufacturers. Vaccine manufactures are legally obliged to follow defined standards in the data they provide, and their clinical research and manufacturing operations are subject to regulatory oversight. Either full or summary data from clinical trials is made available following vaccine evaluation. Each vaccine is thoroughly assessed for safety, efficacy and pharmaceutical quality to determine whether it can be approved for use. Regulators use available scientific evidence from preclinical laboratory research, human clinical trials, and manufacturing information to assess benefits and risks of candidate vaccines.Regulators may seek additional expert advice from independent scientific advisory committees to help inform their decision on whether to approve a vaccine. These committees are made up of experts in science, medicine (including infectious diseases) and public health, and often include consumer and healthcare professional representatives.Public health agencies have a different role than regulatory authorities. They develop and deliver vaccination programmes, often working with their expert immunisation technical advisory committees. This includes prioritising and designating populations for vaccination with specific vaccines, issuing additional recommendations and providing information more broadly about vaccines and immunization. They also collaborate with regulators to monitor the safety of vaccines after they are approved for use. Globally, the public can have confidence in the rigour of the process used to scientifically evaluate the safety, efficacy and quality of vaccines before they are approved for use in the wider population. Safety evidence prior to potential regulatory authorisation:Safety evidence is an essential part of each regulatory submission for a COVID-19 vaccine. It is gathered during all phases of the vaccine development process. Robust assessment of safety is carried out in the clinical trials and submitted to regulators for review as part of the approval process.All adverse events need to be examined and reported in the regulatory submission by the companies for a marketing licence. Typically, regulators will require that participants in clinical trials have been followed for at least 1-2 months after receiving their final vaccine dose. Generally, based on previous experience with vaccines, most adverse events occur within such timeframes, though rare adverse events might not be recognised until after wide population use. There will also be longer-term (for example for 6-12 months or more) follow-up of those who participated in the earlier phases of the clinical trials of each vaccine. Many trial participants will also be followed for at least one year to assess the duration of protection and longer-term safety of individual vaccines, and safety data from these longer-term trials will be carefully reviewed by regulators as part of post-approval monitoring of safety.Efficacy:Apart from information on the types of immune responses induced by the vaccine, companies must submit data from well-designed clinical trials to regulators to demonstrate that the vaccine prevents COVID-19. The data showed there were sufficient numbers of people included in the clinical trials receiving the vaccine so that the efficacy of the vaccine can be accurately measured (generally at least 10 000 and usually 15 000 or more people who receive the vaccine, in addition to those in the control arm). Populations in clinical trials should include a range of age groups and people with co-morbidities. Given the disproportionate impact of COVID-19 on older people, COVID-19 vaccine clinical trials have included significant numbers of older participants. Vaccine clinical trials for a new candidate vaccine showed that vaccines very significantly reduced COVID-19 in people who were vaccinated, compared to a control group of people who did not receive the vaccine, through a reduction in numbers of laboratory confirmed SARS-CoV-2 infections. Quality:Any COVID-19 vaccine that receives regulatory authorisation must be manufactured according to internationally accepted stringent regulatory standards of good manufacturing practices (GMP). Regulators review data to confirm that the manufacturing process at each production site is well-controlled and consistent. This will include data on the composition and purity of the vaccine and its potency, as well as data on every step of manufacturing and on the controls used to ensure that each batch of vaccine is consistently of a high quality. Data on vaccine stability must also be provided before a vaccine can be approved. After approval, batches may also undergo evaluation by individual national regulatory authorities to ensure they meet national requirements, before they can be supplied.Monitoring safety and effectiveness after vaccine approval:After a vaccine is approved for use, regulators conduct robust effectiveness monitoring as well as monitoring of safety and risk minimisation activities (pharmacovigilance). They need to continuously monitor vaccine safety to ensure that the benefits of the vaccine continue to outweigh the risks. Regulators do this by:Reviewing and analysing adverse events reported by healthcare professionals and consumers and requiring industry vaccine companies (sometimes called “sponsors”) to report to regulators on adverse events received both within the regulator’s home country and globally;Many regulators will implement enhanced passive surveillance systems. These include systems to rapidly compare numbers of suspected side effects reported with vaccines to the numbers of events expected to occur by chance, and include access to near real-time data on vaccine usage in different settings. Several regulators also implemented traceability systems for different vaccine brands and batches;Taking rapid action to mitigate risks, also considering the information about emerging safety issues shared among regulators and researchers through international collaboration;Reviewing medical literature and other sources of new safety information;Requiring vaccine manufacturers to continue safety surveillance from the ongoing clinical trials of their products; andMany regulators also require vaccine manufacturers to have risk management plans describing how they will monitor and minimise risks, including further epidemiological studies, associated with their vaccines. It is very important that healthcare professionals not only diligently report any adverse events they see in their patients, but also encourage people who are vaccinated to immediately report adverse events to their healthcare professionals or to the medicines regulator in countries where direct reports from members of the public are accepted by the regulator. Reporting all relevant events helps regulators assess the possible role of the vaccine in causing the adverse event and assists in identifying safety issues relating to newly introduced vaccines.As part of the safety monitoring and review of all suspected side effects reporting for vaccines, regulators have developed lists of “Adverse Events of Special Interest”. These lists include some events that have been associated with other vaccines (for example anaphylaxis). Others are included on these lists because they are serious events that are important to monitor extremely closely, even though there is no evidence that they are causally associated with specific vaccines. Having information on the background rates of these events that would be expected in people who have not received a vaccine will help ensure that any increased reporting of these events can be quickly detected and thoroughly investigated by regulators. The widespread use of COVID-19 vaccines, including in the elderly and in patients with underlying health conditions, will unfortunately mean that there will be deaths and serious illnesses that are purely coincidental and unrelated to vaccinations. The job of each regulator, together with the relevant medical experts and vaccine manufacturers is to determine causality. There will be a special focus on monitoring safety in some groups of people, such as pregnant women, persons with severe pre-existing illness, older people, children, and in people also receiving vaccines for prevention of other diseases. Regulators, often in collaboration with public health authorities, are able to take decisive action if a safety issue is identified. These actions might include: issuing safety communications for patients, healthcare professionals and the community; updating the product information or consumer information for the vaccine; preventing the release of a particular batch of vaccine; and, taking other regulatory actions such as restriction of vaccine authorisation to a particular subgroup of the community or revocation of authorisation.Commonly reported adverse eventsThe most commonly-reported events with COVID-19 vaccines are expected vaccine side effects, such as headache, fatigue, muscle and joint pain, fever and chills and pain at the site of injection. The occurrence of these adverse events is consistent with what is already known about the vaccines from clinical trials. Adverse events of special interestRegulators approve and maintain an approval of a vaccine only if they determine that the known and potential benefits of the vaccine outweigh its known and potential risks. Anaphylaxis is a very rare side effect that may occur with any vaccine. There have been some other reported adverse events which include facial weakness, seizures, loss of sense of taste or small and cardiac events, but none are confirmed to be causally related to the vaccines.mRNA vaccines The major adverse event of special interest reported for these vaccines, which include the Pfizer and Moderna vaccines is anaphylaxis. Regulators carefully review the reports of possible anaphylaxis to determine whether they are consistent with true anaphylaxis and whether they may have been caused by the vaccine. Anaphylaxis reports remains very rare (in the order of 10 cases per million vaccinated). Guidance on the management of possible anaphylaxis is included in the Product Information/Label for these vaccines. Routine vaccination procedures include keeping people under observation for at least 15 minutes after vaccination and having appropriate medical treatment on hand so that anaphylaxis can be rapidly managed. These vaccines should not be given to people with a known history of a severe allergic reaction to any of the vaccine components. A second dose of mRNA vaccine should not be given to those who have experienced anaphylaxis to the first dose.There have been some other reported adverse events, which include unusual bleeding and blood clotting disorders, facial weakness, seizures, loss of sense of taste or smell and cardiac events. Regulators monitor and carefully review if there is a causal relationship between the vaccines with those adverse events, and, if appropriate, they will be included in Product Information / Product Label of vaccines of concern. Adenovirus vector vaccinesThese include the AstraZeneca, Janssen, Gamaleya and CanSino Biologics vaccines. Internationally, the AstraZeneca and Janssen COVID-19 vaccines have been associated with a very rare and unusual clotting syndrome involving thromboembolic events (blood clots) with thrombocytopenia (low blood platelet count). This condition has been termed Thrombosis with Thrombocytopenia Syndrome (TTS). Medicines regulators are meeting regularly to share information about cases to better characterise this risk and understand this syndrome. Less information is available internationally about adverse events following the Gamaleya and CanSino Biologics vaccines.The overall number of reports received of blood clots in the veins or arteries (including venous thrombosis or venous thromboembolism) occurring without thrombocytopenia is no higher than the expected background population rate for the more common type of blood clots in most countries.The spontaneous reporting rates of thromboembolic events with thrombocytopenia vary by country and the precise incidences are difficult to estimate, but for the AstraZeneca vaccine, based on substantial use in Europe and the United Kingdom, the frequency of such events is very rare. Available estimates are of the order of 10-15 per million people vaccinated (note that for some countries this statistic is based on the numbers of reports of suspected cases of TTS rather than numbers of confirmed cases). Thromboembolic events with thrombocytopenia have also been reported in the United States for the Janssen vaccine, at a rate of about 2-3 per million doses administered. National regulators are continuing to monitor the issue closely and to publish up to date information on the numbers of cases reported and the latest estimates of the incidence.The cases of thromboembolic events with thrombocytopenia after vaccination were mainly reported for younger rather than older individuals. This, together with the risk of serious illness or death associated with COVID-19 being much higher in middle-aged and older people, has led public health authorities in some countries to recommend that vaccination with the Astra Zeneca vaccine not be initiated in younger individuals. Healthcare professionals should be alert to the signs and symptoms of thromboembolism and thrombocytopenia as well as coagulopathies after vaccination as TTS requires specific management. Vaccinated individuals should be instructed to seek immediate medical attention if they develop symptoms such as a severe or persistent headache, blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain or unusual skin bruising and/or petechiae (tiny purple, red, or brown spots on the skin) mostly occurring within around 4-20 days after vaccination, although some cases have been reported later than 20 days post vaccination. This information is in the Product Information / Product Label of the vaccines as approved by regulators. Questions and Answers on COVID-19 vaccinesQ: How have the vaccines been developed so quickly? Does this mean that their safety and efficacy has been compromised?A: The speed of development of COVID-19 vaccines has been unprecedented for several reasons, but the safety and efficacy requirements for vaccines have not been compromised, Vaccine development was facilitated by:The massive financial investment by governments, industry and philanthropic organisations in vaccine development and the re-direction of much of the global research and commercial infrastructure for the development and manufacture of vaccines. Governments also enabled companies to take the commercial risk of manufacturing some vaccine stocks ahead of regulatory approvals. New technologies adapted from the development of other vaccines – mRNA vaccines were developed for COVID-19 very rapidly after the sequence of the COVID-19 virus was determined, but the underlying technology had been under development since much longer and production could be scaled up very quickly. The adenovirus technology used for adenovirus vector vaccines was first tested with SARS, MERS and Ebola virus over the last 20 years, and so was able to be adapted quickly to COVID-19, which has several similarities to these viruses.Clinical trial successes - it has been possible to rapidly recruit large numbers of volunteers into clinical trials and, with unfortunately high rates of infection in several countries, to complete trials with 10,000-50,000 people in a short period of time. Under normal circumstances, it may take many months or even a few years to carry out trials of this size to determine whether a vaccine is effective.Very close collaboration - between regulators, industry and clinical researchers enabled clear indications of regulatory requirements and early access to results. Intensive and insightful research - researchers predicted that the “spike protein” on the virus would be a good target for vaccine development, and almost all vaccines have been designed to induce a response to this protein. So far, the spike protein has produced a strong immune response in those vaccinated, and for those vaccines that have reported clinical results are highly protective from COVID-19 disease.Q: Will mRNA vaccines affect the DNA of vaccine recipients?A: No. The mRNA in the vaccine has not been shown to incorporate itself into the genes of vaccine recipients and breaks down in the weeks after vaccination. mRNA vaccines contain genetic instructions for our cells, which only read them and provide copies of the SARS-CoV2 spike protein. This enables the body’s natural immune systems to cause a response in vaccine recipients if they are later exposed to the virus.Q: How long will COVID-19 vaccination provide protection for immunised people?A: We do not yet know how long protection from any of these vaccines lasts. We will get better insights over the next 12 months.The duration of protection provided by vaccines can vary. For example, the seasonal influenza vaccine is given annually, because the influenza virus mutates, and protection wanes over a number of months. Other vaccines, such as those for rubella or measles provide multi-year or even life-long protection from disease. Mutations in key viral proteins can mean that virus variants emerge. The SARS-CoV-2-coronavirus is prone to mutations that creates variants, some of which have become established in a number of regions of the world. The scientific community and regulators are very actively monitoring whether the current vaccines can continue protecting people from infection with new variants. A number of vaccine developers are currently developing vaccines against the range of variants, and it is likely that booster shots with these vaccines will increase protection against known variants. Regulators have agreed that review of data on vaccines against variants will be facilitated based on assessment of immune response to the variant, in the same way that new seasonal influenza vaccines are evaluated each year.Q: Why are there so many vaccine candidates?A: As the global seriousness of the pandemic became rapidly apparent, development of effective vaccines for COVID-19 became the top priority of many pharmaceutical companies and medical research institutes. There was also unprecedented government and private sector investment in vaccine development. There is now a wide range of technologies for developing new vaccines - and many of the organisations developing COVID-19 vaccines have particular experience in one or more of these technologies. This has ensured that there would still be vaccines available if some were not approved for reasons of efficacy, safety or manufacturing challenges.Q: What if many people start getting a reaction from a particular COVID-19 vaccine?A: Short-term reactions, such as soreness at the injection site, fatigue or headache are common following any vaccination with COVID-19 vaccines. These reactions usually pass in a day or two. If new evidence becomes available that suggests that a specific serious adverse event may be linked to a particular COVID-19 vaccine then regulators will take action, working collaboratively on a global basis and liaise with public health authorities. The type of actions that can be taken depend on the nature of the adverse event, and could range from issuing safety warnings for patients, healthcare professionals and the community; updating the product information or consumer information for the vaccine to show contraindications for the use in particular patients (e.g. those with certain co-morbidities); to closely monitoring adverse events in certain groups of patients; preventing the release of a particular batch of vaccine through to temporary suspension of the use of the vaccine until more is known.Q: How are regulators speeding up the time it takes to authorise a COVID-19 vaccine?A: Many regulators globally have implemented faster access pathways for COVID-19 vaccines, without compromising on strict standards of safety, quality and efficacy. Some countries have Emergency Use Authorisation pathways which assess the available data at the time of authorisation. Exercising these provisions is a matter for those countries, taking into account the benefits versus risks in the context of the prevailing domestic pandemic situation. Different countries may coin this pathway or authorisation routes differently but essentially, they follow the same principles. Other countries have implemented accelerated/priority, conditional or provisional approval schemes. Under normal circumstances, regulatory assessment begins once all information to support registration is available. For COVID-19 vaccines, many regulators have agreed to accept data on a rolling basis to enable early evaluation of data as it becomes available. Regulators will only be in a position to make a provisional approval decision for a vaccine once there is sufficient data to support adequately the safety, quality and effectiveness of the vaccine for its intended use. If a decision is made to grant provisional or conditional approval, it will be based on the requirement for the sponsor to submit more comprehensive, longer term clinical data, stability data and other information with agreed timelines.Q: Did our country approve this COVID-19 vaccine, or are we relying on another country’s approval?A: Most countries are carrying out independent regulatory evaluations on the submitted data for each vaccine. However, to ensure a more efficient use of resources and expertise, regulators in different countries are communicating closely on safety, efficacy and quality data and discussing technical issues as they may arise. In many cases principles of WHO Good Reliance Practices and collaborative mechanisms leverage the output of other regulators. Q: Why weren’t very rare blood clots with low platelets with the AstraZeneca or Janssen vaccines picked up during clinical trials?A: Thromboembolic events with concurrent thrombocytopenia are very rare – with estimates based on the number of spontaneous reports suggesting an overall incidence on the order of 10-15 cases per million doses. The clinical trials of these vaccines included large numbers of people, often with 10,000 to 20,000 individuals in the active vaccine arms, but even in trials of this size it was statistically unlikely that such very rare events would be detected. This shows the importance of continual safety monitoring during the use of these vaccines, to allow very rare events to be detected and investigated further. -------------------------------------------------------------------------------About ICMRAICMRA brings together the heads of 30 medicines regulatory authorities* from every region in the world, with the WHO as an observer. Medicines regulators recognise their role in facilitating access to safe and effective high-quality medicinal products essential to human health and well-being. This includes ensuring that benefits of vaccines outweigh their risks.ICMRA is an international executive-level coalition of key regulators from every region in the world. It provides a global strategic focus for medicines regulators and gives strategic leadership on shared regulatory issues and challenges. Priorities include coordinated response to crisis situations. Members of ICMRA include: Therapeutic Goods Administration (TGA), Australia; National Health Surveillance (ANVISA), Brazil; Health Products and Food Branch, Health Canada (HPFB-HC), Canada; China National Medical Products Administration (NMPA), China; European Medicines Agency (EMA) and European Commission - Directorate General for Health and Food Safety (DG - SANTE), European Union; French National Agency for Medicines and Health Products Safety (ANSM), France; Paul-Ehrlich-Institute (PEI), Germany; Health Product Regulatory Authority (HPRA), Ireland; Italian Medicines Agency (AIFA), Italy; Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan; Ministry of Food and Drug Safety (MFDS), Korea; Federal Commission for the Protection against Sanitary Risks (COFEPRIS), Mexico; Medicines Evaluation Board (MEB), Netherlands; Medsafe, Clinical Leadership, Protection & Regulation, Ministry of Health, New Zealand; National Agency for Food Drug Administration and Control (NAFDAC), Nigeria; Health Sciences Authority (HSA) Singapore; Medicines Control Council (MCC), South Africa; Medical Products Agency, Sweden; Swissmedic, Switzerland; Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom; Food and Drug Administration (FDA), United States. Associate members include: Argentina national Administration of Drugs, Foods and Medical Devices (ANMAT); Austrian Medicines and Medical Devices Agency (AGES), Colombia National Food and Drug Surveillance Institute (INVIMA); Cuba Center for State Control of Medicines, Equipment and Medical Devices (CECMED); Danish Medicines Agency (DKMA); Israel Ministry of Health (MOH); Poland Office of Registration of Medicinal Products and Biocidal Products (URPLWMiPB); Portugal National Authority of Medicines and Health Products (INFARMED); Russia Federal Service for Surveillance in Healthcare (Roszdravnadzor); Saudi Food and Drug Authority (SFDA); Spanish Agency of Medicines and Medical Devices (AEMPS).About the World Health Organization 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 149 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 reaffirm commitment to ending polio at launch of new eradication strategyon Jun 9 2021 at 11:12
Today, the Global Polio Eradication Initiative (GPEI) will launch the Polio Eradication Strategy 2022-2026: Delivering on a Promise at a virtual event, to overcome the remaining challenges to ending polio, including setbacks caused by COVID-19. While polio cases have fallen 99.9% since 1988, polio remains a Public Health Emergency of International Concern (PHEIC) and persistent barriers to reaching every child with polio vaccines and the pandemic have contributed to an increase in polio cases. Last year, 1226 cases of all forms of polio were recorded compared to 138 in 2018. In 2020, the GPEI paused polio door-to-door campaigns for four months to protect communities from the spread of COVID-19 and contributed up to 30,000 programme staff and over $100 million in polio resources to support pandemic response in almost 50 countries. Leaders from the two countries yet to interrupt wild polio transmission—Pakistan and Afghanistan—called for renewed global solidarity and the continued resources necessary to eradicate this vaccine-preventable disease. They committed to strengthening their partnership with GPEI to improve vaccination campaigns and engagement with communities at high risk of polio.Dr Faisal Sultan, Special Assistant to the Prime Minister of Pakistan on Health, said, “We are already hard at work with our GPEI partners to address the final barriers to ending polio in Pakistan, particularly through strengthening vaccination campaigns and our engagement with high-risk communities. Eradication remains a top health priority and Pakistan is committed to fully implementing the new GPEI strategy. We look forward to working with international partners to achieve a polio-free world.”The 2022-2026 Strategy underscores the urgency of getting eradication efforts back on track and offers a comprehensive set of actions that will position the GPEI to achieve a polio-free world. These actions, many of which are underway in 2021, include:further integrating polio activities with essential health services—including routine immunization—and building closer partnerships with high-risk communities to co-design immunization events and better meet their health needs, particularly in Pakistan and Afghanistan;applying a gender equality lens to the implementation of programme activities, recognizing the importance of female workers to build community trust and improve vaccine acceptance;strengthening advocacy to urge greater accountability and ownership of the program at all levels, including enhanced performance measurement and engagement with new partners, such as the new Eastern Mediterranean Regional Subcommittee on Polio Eradication and Outbreaks; and,implementing innovative new tools, such as digital payments to frontline health workers, to further improve the impact and efficiency of polio campaigns. “With this new Strategy, the GPEI has clearly outlined how to overcome the final barriers to securing a polio-free world and improve the health and wellbeing of communities for generations to come,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization and member of the Polio Oversight Board. “But to succeed, we urgently need renewed political and financial commitments from governments and donors. Polio eradication is at a pivotal moment. It is important we capitalise on the momentum of the new Strategy and make history together by ending this disease.”Dr Wahid Majrooh, Acting Minister of Public Health for Afghanistan, said, “Afghanistan is fully committed to implementing the new GPEI strategic plan and eradicating polio from its borders. Together we have come so far. Let us take this final step together and make the dream of a polio-free world a reality.” In addition to eradicating wild polio, GPEI will strengthen efforts to stop outbreaks of circulating vaccine-derived poliovirus (cVDPV) that continue to spread in under-immunized communities across Africa and Asia. This includes deploying proven tactics used against wild polio, improving outbreak response and streamlining management through the launch of new global and regional rapid response teams and broadening the use of a promising new tool – novel oral polio vaccine type 2 (nOPV2) – to combat type 2 cVDPVs, the most prominent variant. H.E. Félix Tshisekedi, President of the Democratic Republic of the Congo, said “As Chair of the African Union, I call on every government to increase their commitment to protecting the gains of our monumental efforts and finishing the job against polio in Africa. Only then, we will be able to say we delivered on our promise of a safer, healthier future for all our children.”Select countries began using nOPV2 in March of this year after WHO issued an Emergency Use Listing recommendation for the vaccine last November. Clinical trials have shown that nOPV2 is safe and effective against type 2 polio, while having the potential to stop cVDPV2 outbreaks in a more sustainable way compared to the existing type 2 oral polio vaccine. In addition to supporting the COVID-19 response, polio assets and infrastructure have historically helped tackle the emergence of health crises in several countries around the world, including the Ebola outbreak in Nigeria in 2014. Without the support needed for the new GPEI Strategy, there is a risk not only that polio could resurge, but also that countries will be more vulnerable to future health threats. Additional quotes:Henrietta Fore, Executive Director, UNICEF: “We will not allow the fight against one deadly disease to cause us to lose ground in the fight against polio and other childhood diseases. Renewed government and donor support will enable us to reach and immunize over 400 million children against polio every year and ensure that no family has to live with the fear of their child being paralyzed by this deadly disease ever again.”Rochelle P. Walensky, MD, MPH, Director, CDC: “As the GPEI’s support for the COVID-19 response shows, polio infrastructure is vital to helping countries tackle emerging health threats. The U.S. CDC is committed to achieving polio eradication and delivering, through the GPEI’s new strategy, on the promise we made to protect the world’s children. To improve health equity, we must ensure that polio assets are secured and that countries are increasing their immunization coverage through integrated service delivery and demand for vaccines.”Seth Berkley, CEO, Gavi, the Vaccine Alliance: “Polio eradication is possible and essential. Through the increased integration of polio activities with essential immunization and health services, including our joint work to extend the health system to reach “zero-dose” children and missed communities with all routine vaccines, we believe that we can better meet the needs of high-risk communities and secure a polio-free world together.”Mike McGovern, Chair, Rotary’s International PolioPlus Committee: “More than 19 million people are walking today who would have otherwise been paralysed by polio, thanks to the incredible progress we’ve made in protecting children with polio vaccines since 1988. When Rotary helped found the GPEI, we made a commitment to ensure that no child or family should live in fear of polio ever again. We are committed to delivering on this promise and urge governments and donors to help us achieve a polio-free world.” Chris Elias, President, Global Development, Bill & Melinda Gates Foundation: “After setbacks in recent years, and indications that some donors may reduce funding to the GPEI, there has never been a more important moment than right now in the history of polio eradication. With adequate support for the new strategy, we can secure a world where no child will be paralyzed by polio ever again and we urge all donors to stay committed and consign this disease to history.”Note for editors:The Global Polio Eradication Initiative is a public-private partnership led by national governments with six core partners – the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention (CDC), UNICEF, the Bill & Melinda Gates Foundation and Gavi, the Vaccine Alliance. The virtual event to launch the GPEI 2022-2026 Strategy will take place from 1400-1500 CEST on 10 June. To watch and for more information on the global effort to end polio, visit polioeradication.org.
- New WHO guidance seeks to put an end to human rights violations in mental health careon Jun 9 2021 at 07:58
Globally, the majority of mental health care continues to be provided in psychiatric hospitals, and human rights abuses and coercive practices remain all too common. But providing community-based mental health care that is both respectful of human rights and focused on recovery is proving successful and cost-effective, according to new guidance released today by the World Health Organization. Mental health care recommended in the new guidance should be located in the community and should not only encompass mental health care but also support for day-to-day living, such as facilitating access to accommodation and links with education and employment services. WHO’s new “Guidance on community mental health services: promoting person-centred and rights-based approaches” further affirms that mental health care must be grounded in a human rights-based approach, as recommended by the WHO Comprehensive Mental Health Action Plan 2020-2030 endorsed by the World Health Assembly in May 2021. Much faster transition to redesigned mental health services required“This comprehensive new guidance provides a strong argument for a much faster transition from mental health services that use coercion and focus almost exclusively on the use of medication to manage symptoms of mental health conditions, to a more holistic approach that takes into account the specific circumstances and wishes of the individual and offers a variety of approaches for treatment and support,” said Dr Michelle Funk of the Department of Mental Health and Substance Use, who led the development of the guidance. Since the adoption of the Convention on the Rights of Persons with Disabilities (CRPD) in 2006, an increasing number of countries have sought to reform their laws, policies and services related to mental health care. However, to date, few countries have established the frameworks necessary to meet the far-reaching changes required by international human rights standards. Reports from around the world highlight that severe human rights abuses and coercive practices are still far too common in countries of all income levels. Examples include forced admission and forced treatment; manual, physical and chemical restraint; unsanitary living conditions; and physical and verbal abuse. The majority of government mental health budgets still goes to psychiatric hospitalsAccording to WHO’s latest estimates, governments spend less than 2% of their health budgets on mental health. Furthermore, the majority of reported expenditure on mental health is allocated to psychiatric hospitals, except in high-income countries where the figure is around 43%. The new guidance, which is intended primarily for people with responsibility for organizing and managing mental health care, presents details of what is required in areas such as mental health law, policy and strategy, service delivery, financing, workforce development and civil society participation in order for mental health services to be compliant with the CRPD. It includes examples from countries including Brazil, India, Kenya, Myanmar, New Zealand, Norway and the United Kingdom of community-based mental health services that have demonstrated good practices in respect of non-coercive practices, community inclusion, and respect of people’s legal capacity (i.e. the right to make decisions about their treatment and life). Services include crisis support, mental health services provided within general hospitals, outreach services, supported living approaches and support provided by peer groups. Information about financing and results of evaluations of the services presented are included. Cost comparisons provided indicate that the community-based services showcased produce good outcomes, are preferred by service users and can be provided at comparable cost to mainstream mental health services.“Transformation of mental health service provision must, however, be accompanied by significant changes in the social sector,” said Gerard Quinn, UN Special Rapporteur on the Rights of Persons with Disabilities. “Until that happens, the discrimination that prevents people with mental health conditions from leading full and productive lives will continue.”
- WHO validates Sinovac COVID-19 vaccine for emergency use and issues interim policy recommendationson Jun 1 2021 at 14:49
WHO today validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use, giving countries, funders, procuring agencies and communities the assurance that it meets international standards for safety, efficacy and manufacturing.
- New US$50 billion health, trade and finance roadmap to end the pandemic and secure a global recoveryon Jun 1 2021 at 12:41
The heads of the world’s predominant global financing, health and trade agencies have united to urge government leaders to urgently finance a new US$50 billion roadmap to accelerate the equitable distribution of health tools to help end the pandemic.
- The Seventy-fourth World Health Assembly closeson May 31 2021 at 16:48
More than 30 resolutions and decisions were adopted at this year's World Health Assembly in different areas of public health: decisions on diabetes, disabilities, ending violence against children, eye care, HIV, hepatitis and sexually transmitted infections, local production of medicines, malaria, neglected tropical diseases, noncommunicable diseases, nursing and midwifery, oral health, social determinants of health and strategic directions for the health and care workforce.In his closing remarks, WHO Director-General Dr Tedros Adhanom Ghebreyesus reminded delegates that the theme of this Assembly was “Ending this pandemic, preventing the next: building together a healthier, safer and fairer world”"We’re very encouraged that cases and deaths are continuing to decline globally, but it would be a monumental error for any country to think the danger has passed," said Dr Tedros urging countries to commit to supporting the targets to achieve vaccination of at least 10% of the population of all countries by the end of September, and at least 30% by the end of the year."One day – hopefully soon – the pandemic will be behind us but we will still face the same vulnerabilities that allowed a small outbreak to become a global pandemic.""That’s why the one recommendation that I believe will do most to strengthen both WHO and global health security is the recommendation for a treaty on pandemic preparedness and response."Dr Tedros echoed the message that a strong WHO needs to be properly financed as it has been amplified by all the expert reviews that reported to this Assembly. Dr Tedros urged Member States to seize this pivotal moment and chart a course to a sustainable financial model.Today, the Assembly focused on following issues:Strengthening WHO preparedness for and response to health emergenciesCOVID-19 and other major disease outbreaks, as well as continuing humanitarian situations, highlight the need for a stronger collective and coordinated approach to preparedness and response to health emergencies.Member States today agreed to meet again in November, at a special session of the World Health Assembly, to consider developing a WHO global agreement.“We need a generational commitment that outlives budgetary cycles, election cycles and media cycles, that creates an overarching framework for connecting the political, financial and technical mechanisms needed for strengthening global health security,” he said. Such a treaty would “foster improved sharing, trust and accountability, and provide the solid foundation on which to build other mechanisms for global health security.”Member States also agreed on a Resolution reaffirming WHO’s role as the directing and coordinating authority in health during emergencies and beyond, and to aid governments towards achieving resilient health systems and universal health coverage. The Resolution provides recommendations to WHO to strengthen current and future work notably via convening a Member States’ Working Group on Strengthening WHO preparedness and response to health emergencies, open to all Member States, to review recommendations from the various reports received at this Assembly. The Working Group is tasked with reporting to next year’s Assembly. The Resolution calls on Member States to provide WHO with sustainable financing, while continuing their response to the pandemic and strengthening preparedness capacities, including strengthening their workforce, research activities, surveillance systems, while adopting a One Health Approach; while continuing to work in a spirit of global cooperation, sharing reliable information, countering infodemics and stigmatization; and ensuring response efforts do not exacerbate other health challenges. The Director-General thanked Member States for approving this “historic resolution,” and their support for a strengthened WHO. “The reports of the IPPPR, the IHR Review Committee and the IOAC are unanimous in their view that the world needs a stronger WHO at the centre of the global health architecture…As the reports all say and many Member States have emphasised, a paradigm shift in the quantity and quality of funding for the Secretariat is a key issue.”Resolution on Strengthening WHO Preparedness for and response to health emergencies can be found here: https://apps.who.int/gb/ebwha/pdf_files/WHA74/A74_R7-en.pdfDecision on a Special session of the World Health Assembly to consider developing a WHO convention, agreement or other international can be found here: https://apps.who.int/gb/ebwha/pdf_files/WHA74/A74(16)-en.pdfMental health during public health emergenciesCountries are increasingly showing greater recognition of the importance of this area. For example, during the pandemic, the number of countries with a functioning multisectoral mental health and psychosocial support coordination platform in humanitarian emergencies has doubled while 90% of Member States responding to a WHO survey in early 2021 reported that mental health and psychosocial support were included in their COVID-19 response plans.In 2020, a wide range of resources were developed in many languages by WHO in collaboration with partners, including: a stress management guide for the general public; a guide for COVID-19 responders on basic psychosocial skills; and a toolkit to help older adults maintain mental well-being. In addition, WHO has collaborated on the elaboration of the first-ever programme for rapid deployment of experts in mental health and psychosocial support during public health and humanitarian emergencies. Launched in January 2020, more than 20 deployments have been undertaken to date.Delegates to the World Health Assembly endorsed the Comprehensive Mental Health Action Plan 2013-2030, including the plan’s updated implementation options and indicators. For the first time, the plan includes an indicator on preparedness for providing mental health and psychosocial support during emergencies.Related links:All documents related to the Seventy-fourth World Health Assembly, including resolutions and decisions can be found here: https://apps.who.int/gb/e/e_wha74.html --------------Please note that following the WHA, the meeting of the Executive Board will take place on 2 June. The provisional agenda, list of EB members can be found here:https://apps.who.int/gb/e/e_eb149.htmlhttps://apps.who.int/gb/gov/en/composition-of-the-board_en.html
- Update from the Seventy-fourth World Health Assembly – 29 May 2021on May 29 2021 at 17:18
New resolutions on:Local production of medicinesEnding violence against childrenAddressing social determinants of health Strengthening local production of medicines and other health technologies to improve accessMember State requests for WHO’s support in strengthening local production have been increasing in recent years. The COVID-19 pandemic has only served to highlight even more the urgent need for enhancing quality manufacturing capacity in all regions of the world, including for innovative, highly effective health products such as mRNA technologies. Such capacity is necessary to address or even avert future public health emergencies and to improve access to health products in general through stronger health systems.Sponsored by more than 100 countries, today’s resolution specifically calls for a more comprehensive, all-of-government approach, national strategies and action plans, an enabling business environment, human capital development, multi-stakeholder collaboration and engagement in regional and global networks.WHO has already committed to holding the first ever World Local Production Forum in June this year, convening countries, partners and other stakeholders to discuss strategies to promote local production to improve access to health products during the current pandemic and beyond. Related linksInnovation, access and use Ending violence against children Today’s resolution on Ending violence against children through health systems strengthening and multisectoral approaches aims to strengthen health sector capacity to prevent and respond to violence against children.The health sector plays a major role in documenting the extent of the problem of violence against children; delivering and monitoring prevention approaches and providing services to mitigate the consequences of exposure to violence.The new resolution lists a range of actions to be taken by governments and the WHO Secretariat, in collaboration with other stakeholders, to ensure the health and well-being of children.Every year, about 1 billion children are affected by physical, sexual or psychological violence, suffering injuries, disabilities and death as well as the negative impact of witnessing violence between parents or caregivers. In addition to the immediate and lifelong harmful consequences to individuals and families, violence against children undermines investments in health and education and erodes the productive capacity of future generations. COVID-19-related stay-at-home measures have highlighted children’s vulnerability to violence within family settings.The new resolution invites countries to scale-up the implementation of two WHO-led technical packages, INSPIRE: Seven strategies for ending violence against children and RESPECT women: a framework for preventing violence against women, developed to help countries achieve the Sustainable Development Goals (SDG) on ending violence against children (SDG 16.2) and violence against women and girls (SDG 5.2).The first-ever Global status report on preventing violence against children 2020 measured countries’ progress on preventing and responding to violence against children. The report highlighted substantial achievements at global, regional and country levels, while also emphasizing an urgent need to accelerate prevention efforts if the SDG targets to end violence are to be achieved. The resolution invites the WHO Secretariat to prepare the second and third global status reports on violence against children in 2025 and 2030.Related linksViolence against children Tackling social determinants of healthThe goal of this resolution is to reduce the glaring health inequities recently highlighted by the COVID-19 pandemic, through stronger action to tackle the social determinants that play such a prominent role in defining people’s ability to live healthy lives.These include the conditions people live in, as well as their access to power, money, and resources, including healthcare. They are often driven by discrimination and persecution, such as racism, sexism, classism and war. And they impact every aspect of health.Children from the poorest households in low- and middle-income countries (LMICs) are twice as likely to die before their 5th birthday as those from the richest households. People in rich countries live as many as 16 years longer than those in poor ones.The World Health Assembly adopted resolutions on social determinants of health in 2009 (following the report of the WHO Commission on Social Determinants of Health) and in 2012 (following the World Conference on Social Determinants of Health and the Rio Political Declaration on the Social Determinants of Health).The social and health inequalities exposed by COVID-19 have led to renewed interest by Member States in WHO’s work on social determinants of health, and this new resolution.The resolution aims to strengthen action globally and within countries on the social determinants of health; to reduce health inequities by involving all sectors in taking concrete action to improve living conditions and reduce social inequalities; and improve monitoring of social determinants and health inequities. The resolution lists actions to be taken by governments, civil society, international organizations, intergovernmental organizations, the private sector and the WHO Secretariat, including in continuing efforts to combat the COVID-19 pandemic and in future recovery efforts. Related linksSocial determinants of healthWorld Health Day 2021: Building a fairer, healthier world
- World Health Assembly approves development of implementation roadmap for achieving SDG target on noncommunicable diseaseson May 29 2021 at 06:13
The World Health Assembly has asked the World Health Organization to develop an implementation roadmap for 2023-2030 in support of the prevention and control of noncommunicable diseases (NCDs).The roadmap will provide a basis for countries to decide on priority activities and pathways to accelerate progress towards achievement of SDG target 3.4 in the next 10 years.Target 3.4 of the Sustainable Development Goals is to reduce premature mortality from NCDs by one third by 2030 relative to 2015 levels. Only 17 countries are currently on track to meet that target for women and 15 for men. Actions relating to the achievement of other SDG 3 targets, such as those relating to the reduction of tobacco use and universal health coverage, will be included in the roadmap. WHO will consult widely internally and externally, including with people living with NCDs, during the development of the roadmap. Lessons learned from the work of WHO and key partners already undertaken to prevent and control NCDs, including in the context of the COVID-19 pandemic, will be taken into consideration. The roadmap will be submitted for consideration to the World Health Assembly in May 2022, following review by the Executive Board at its January 2022 session and subsequent consultations with Member States. Related links Mid-point evaluation of the implementation of the WHO global action plan for the prevention and control of noncommunicable diseases 2013–2020: executive summary – April 2021Political declaration of the third high-level meeting of the General Assembly on the prevention and control of non-communicable diseases – January 2021More on noncommunicable diseases
- World Health Assembly Resolution paves the way for better oral health careon May 29 2021 at 05:54
More than 3.5 billion people suffer from oral diseases. Untreated dental caries (tooth decay) in permanent teeth is the most common. Severe periodontal (gum) disease affects almost 10% of the global population and more than 530 million children suffer from dental caries of primary teeth. Oral diseases disproportionally affect the poor and socially-disadvantaged populations. Most oral diseases have been linked with other noncommunicable diseases such as cardiovascular diseases, diabetes, cancers, pneumonia, obesity and premature birth. Most oral health conditions are largely preventable and can be treated in their early stages but treatment is often not affordable as usually not part of universal health coverage packages. The use of fluoride, which can substantially reduce the risk of dental caries, remains inaccessible in many parts of the world. The World Health Assembly approved today a historic Resolution on oral health. The Resolution urges Member States to address key risk factors of oral diseases shared with other noncommunicable diseases such as high intake of free sugars, tobacco use and harmful use of alcohol, and to enhance the capacities of oral health professionals. It also recommends a shift from the traditional curative approach towards a preventive approach that includes promotion of oral health within the family, schools and workplaces, and includes timely, comprehensive and inclusive care within the primary health-care system. During the discussion, clear agreement emerged that oral health should be firmly embedded within the noncommunicable disease agenda and that oral health-care interventions should be included in universal health coverage programmes. The World Health Assembly delegates asked WHO: to develop, by 2022, a draft global strategy on tackling oral diseases for consideration by WHO governing bodies in 2022 and by 2023; to translate the global strategy into an action plan for oral health; to develop “best buy” interventions on oral health; and to explore the inclusion of noma (a disease which is fatal for 90% of children affected) within the roadmap for neglected tropical diseases 2021-2030. WHO was asked to report back on progress and results until 2031 as part of the consolidated report on noncommunicable diseases.Related linksProposed Resolution on oral health – January 2021Consolidated report by the Director-General to the May 2021 World Health Assembly (Report on oral health: page 18)More on oral health
- New WHA Resolution to bring much needed boost to diabetes prevention and control effortson May 29 2021 at 05:05
More than 420 million people are living with diabetes, a number that is expected to rise to 578 million by 2030. One in two adults living with diabetes type 2 are undiagnosed. Globally, 100 years after the discovery of insulin, half of the people with type 2 diabetes who need insulin are not receiving it. Between 2000 and 2016, there was a 5% increase in premature mortality from diabetes. By contrast, during the same period, there was a decrease in premature mortality for all other main noncommunicable diseases. In addition, people living with diabetes have a higher risk of becoming severely ill and dying from COVID-19.The Resolution agreed by the World Health Assembly today urges Member States to raise the priority given to the prevention, diagnosis and control of diabetes as well as prevention and management of risk factors such as obesity.It recommends action in a number of areas including: the development of pathways for achieving targets for the prevention and control of diabetes, including access to insulin; the promotion of convergence and harmonization of regulatory requirements for insulin and other medicines and health products for the treatment of diabetes; and assessment of the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for diabetes medicines and health products.Delegates at the Assembly requested WHO to develop recommendations and provide support for strengthening diabetes monitoring and surveillance within national noncommunicable disease programmes and to consider potential targets. WHO was also asked to make recommendations on the prevention and management of obesity. All recommendations are to be submitted to the World Health Assembly for consideration in 2022. WHO was requested to provide guidance to Member States on the design and implementation of policies for diabetes prevention and control and to develop recommendations for adequate, predictable and sustained financing of diabetes prevention and control. Delegates asked WHO to submit a report on the implementation of the Resolution to the Health Assembly through the Executive Board, on an annual basis and as a component on the report on noncommunicable diseases, from 2022 to 2031.Related linksDraft Resolution on reducing the burden of noncommunicable diseases through strengthening prevention and control of diabetes – May 2021 More on diabetes Global Diabetes Compact
- Update from the Seventy-fourth World Health Assembly – 28 May 2021on May 28 2021 at 19:22
New resolutions on the health and care workforce and strategic directions for nursing and midwifery Decisions on patient safety; health, environment and climate change; chemicals management; coordination of work on noncommunicable diseases Global Action Plan for Healthy Lives and Wellbeing for All Prevention of sexual exploitation, abuse and harassment Protect, safeguard and invest in the health and care workforceThe COVID-19 pandemic has underscored the critical role of all health and care workers at the forefront of the pandemic, who have faced multiple risks related to their health, well-being and safety. The resolution on Protecting, safeguarding and investing in the health and care workforce calls for action to guarantee that investments in our workforce ensure they are: skilled, trained, equipped, supported and enabled. It stresses the need for decent pay, recognition, a safe working environment, and protection of their rights.The resolution highlights the need to: enable all health and care workers to access COVID-19 vaccines, Personal Protective Equipment, decent work conditions, and equitable labour protection that is free from all forms of discrimination accelerate multisectoral collaboration and sustained investments in health workforce education, skills and jobs drive the implementation, measurement and reporting on the WHO Global Strategy on Human Resources for Health and the WHO Global Code of Practice on International Recruitment of Health Personnel prepare a global health and care worker compact. It mandates the Director-General to update and strengthen implementation of WHO’s action plan on health employment and inclusive economic growth, working with Member States and relevant partners. The Global Strategic Directions for Nursing and Midwifery 2021–2025 and its accompanying resolution provide policy recommendations on education, jobs, leadership, and service delivery that will help countries ensure that their nurses and midwives have maximum impact on population health outcomes. These policies are derived from the evidence published in the State of the World’s Nursing Report (2020) and the State of the World’s Midwifery Report (2021). 2021 is the International Year of the Health and Care Workers. At the heart of this Year is the recognition that in order to manage the pandemic, maintain health services, improve health workforce readiness, education and learning, and roll out COVID-19 vaccination equitably, the world must protect and invest in health and care workers.Related linksHealth workforce Year of Health and Care WorkersDecision on Patient Safety aims to eliminate avoidable harm in health care globallyDelegates agreed on concrete action to eliminate avoidable harm in health care by adopting the first ever “Global Patient Safety Action Plan 2021–2030”. Every year, millions of patients suffer injuries or die due to unsafe health care globally, with 134 million adverse events occurring annually in low- and middle-income countries alone, contributing to 2.6 million deaths. Even in high-income countries, about 1 in 10 patients is harmed while receiving hospital care. It is estimated that almost half of these events can be prevented.In 2019 a WHA resolution on global action on patient safety recognized patient safety as a key global health priority, requesting WHO to consult with countries and stakeholders to formulate a global patient safety action plan.Today’s decision provides strategic and practical direction to countries to formulate policies and implement interventions at all levels and settings aimed at improving patient safety. The action plan outlines priority actions to be taken by governments, civil society, international organizations, intergovernmental organizations, WHO and, most importantly, by health care facilities across the world. WHO will work in cooperation with Member States in the development of their respective implementation plans, according to their national context.Related linksFactsheet: Patient SafetyPhoto story: 10 facts on patient safeGlobal strategy on health, environment and climate changeImportant steps have already been taken to implement the 2019 WHO global strategy on health, environment and climate change: the transformation needed to improve lives and well-being sustainably through healthy environments. These include the manifesto for a green and healthy recovery from COVID-19, a plan of action on biodiversity and health; advocacy for water, sanitation and hygiene in health-care facilities; launch of the Hand Hygiene for All Global Initiative; health messages for the upcoming COP-26 (UN Climate Change Conference of Parties); the global campaign to prevent lead poisoning; various regional action plans and fora to support country action on health and environment. WHO has provided support to a number of countries on health and environment related projects. Delegates at the WHA have now decided to report on progress on the strategy in 2, 4, and 8 years’ time. Related linkWHO global strategy on health, environment and climate change: the transformation needed to improve lives and wellbeing sustainably through healthy environments International Chemicals Management and the role of the health sector Delegates also decided to report again in 2 years’ time on progress towards the implementation of the WHO Chemicals Road Map, highlighting the critical role of health in sound chemicals management, and need to mainstream chemicals management into all health programmes. They also requested the Secretariat to update the road map to prepare recommendations regarding the Strategic Approach and the sound management of chemicals and waste beyond 2020. Related links: 10 chemicals of public health concern WHO chemical safety webpageExtension of the Global Coordination Mechanism for Noncommunicable DiseasesThe Global Coordination Mechanism (GCM) for Noncommunicable Diseases will be extended until 2030. The GCM was established in 2014. A number of measures have been recommended to improve its effectiveness. These include development of a workplan for the delivery of the 5 functions for which the GCM has responsibility. The plan will include a clear vision, a robust results framework, performance and outcome indicators and clarity on how the mechanism will carry out its functions in a way that is integrated with WHO’s ongoing work on NCDs. The plan will be submitted to the World Health Assembly in 2022, after consideration by the Executive Board. Practical tools for sharing knowledge and disseminating information about innovative activities from a variety of stakeholders working at country level will be developed. So will a global stock-take of action from various stakeholders at country level, together with guidance to Member States on engagement with non-State actors, including on the prevention and management of potential risks. Advice will be provided to civil society on how to develop national multi-stakeholder responses to NCDs and hold governments to account; and the capacity of people living with NCDs to participate in the co-creation of whole-of-society responses to NCDs will be strengthened. Related linksFinal evaluation of the global coordination mechanism on the prevention and control of noncommunicable diseases. Executive summary – April 2021 Options paper on the global coordination mechanism on the prevention and control of noncommunicable diseases Mid-point evaluation of the implementation of the WHO global action plan for the prevention and control of noncommunicable diseases 2013–2020 Global Coordination Mechanism on the Prevention and Control of NCDs More on noncommunicable diseases Global Action Plan for Healthy Lives and Wellbeing for All – SDG GAPDelegates highlighted that the COVID-19 pandemic has reversed a decade of progress on SDG targets and underscored the need to redouble efforts by accelerating implementation of SDG3 GAP, WHO’s 13th general programme of work, and the Primary Health Care special programme. There was wide support for the SDG3 GAP and WHO's convening role. Delegates noted the GAP’s key role in strengthening primary health care and advancing progress towards the targets set out in the Global Strategy on Women's, Children's and Adolescents' health. They also emphasized its focus on country-level impact and its critical role in supporting equitable and resilient recovery. Related links:2021 Progress report on the Global Action Plan for Healthy Lives and Well-being for All Information on The Global Action Plan for Healthy Lives and Well-being for AllPrevention of sexual exploitation and abuse At the Strategic briefing Preventing sexual exploitation and abuse: from policy to practice in health emergencies, the Secretariat outlined what WHO is doing across all levels of the organization to prevent sexual exploitation and abuse (PSEA) and harassment.WHO is committed to taking a comprehensive, holistic and survivor-centred approach to PSEA and sexual harassment, and is taking actions in the areas of policy, capacity-development and operations. PSEA focal points in Ukraine, Guinea and Bangladesh informed Member States of their work in crisis settings for communities and staff, including regular and mandatory PSEA training for WHO staff, implementation of hotlines to safely report complaints, designation of trusted community focal points, and continued liaison with partner agencies in prevention efforts.The Director-General addressed the 5th meeting of Committee B on Agenda item 30.2 – the report of the Internal Auditor on preventing sexual exploitation, abuse and harassment (A74/36). The Director-General assured Delegates that they will receive regular monthly updates on the investigations of the Independent Commission on allegations of sexual exploitation and abuse during the response to the 10th Ebola outbreak in the Democratic Republic of the Congo.The Secretariat will also provide quarterly briefings to Member States, as required by the Executive Board, and have dedicated agenda items on this topic for future WHO governance meetings. In addition, WHO will:establish a WHO task team, led by a senior female staff member, to accelerate the implementation of organization-wide WHO policies and procedures, adopting a holistic approach to prevention and management of sexual exploitation and abuse and sexual harassment. The task team will also oversee the implementation of the Independent Commission recommendations;establish an informal consultative group of external experts who can advise on ‘best in class’ approaches, recognizing that Member States and other entities have valuable experience and expertise that WHO can draw upon.Director-General’s introductory remarks on agenda item 30.2, report A74/36 on the prevention of sexual exploitation, abuse and harassment, and the report of PBAC A74/51
- Update from the Seventy-fourth World Health Assembly – 27 May 2021on May 27 2021 at 19:09
New resolutions on diabetes, health for people with disabilities; malaria; oral healthDecisions on eye care; HIV, Hepatitis and STIs; neglected tropical diseases, noncommunicable diseasesWHO programme budget approved 2022-2023RESOLUTIONSDiabetesA new resolution urges Member States to raise the priority given to the prevention, diagnosis and control of diabetes as well as prevention and management of risk factors such as obesity.It recommends action in a number of areas including: the development of pathways for achieving targets for the prevention and control of diabetes, including access to insulin; the promotion of convergence and harmonization of regulatory requirements for insulin and other medicines and health products for the treatment of diabetes; and assessment of the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for diabetes medicines and health products.Delegates asked WHO to develop recommendations and provide support for strengthening diabetes monitoring and surveillance within national noncommunicable disease programmes and to consider potential targets. WHO was also asked to make recommendations on the prevention and management of obesity and on policies for diabetes prevention and controlMore than 420 million people are living with diabetes, a number that is expected to rise to 578 million by 2030. One in two adults living with diabetes type 2 are undiagnosed. Globally, 100 years after the discovery of insulin, half of the people with type 2 diabetes who need insulin are not receiving it.Related linksDraft Resolution on reducing the burden of noncommunicable diseases through strengthening prevention and control of diabetes – May 2021More on diabetesGlobal Diabetes CompactWHO global disability action plan 2014–2021: better health for all people with disabilityOver 1 billion people currently live with some form of disability. This number is rising as populations expand and age, and due to the increasing number of people living with noncommunicable conditions. Today’s resolution on the highest attainable standard of health for persons with disabilities aims to make the health sector more inclusive by tackling the significant barriers many people with disabilities face when they try to access health services. These include: Access to effective health services: persons with disabilities often experience barriers including physical barriers that prevent access to health facilities; informational barriers that prevent access to health information; and attitudinal barriers leading to discrimination which severely affects the rights of persons with disabilities. Protection during health emergencies: persons with disabilities are disproportionately affected by public health emergencies such as the COVID-19 pandemic because they have not been considered in national health emergency preparedness and response plans. Access to public health interventions across different sectors: public health interventions do not reach persons with disabilities because the information has not been provided in an accessible way and the specific needs and situation of persons with disabilities have not been reflected in the interventions.It also aims to improve collection and disaggregation of reliable data on disability to inform health policies and programmes.The resolution lists a range of actions to be taken by the WHO Secretariat including developing a report on the highest attainable standard of health for persons with disabilities by the end of 2022; implementing the United Nations disability inclusion strategy across all levels of the organization; supporting the creation of a global research agenda on health and disability; and providing Member States with technical knowledge and capacity-building support necessary to incorporate a disability- inclusive approach in the health sector.Related links:Disability and Health fact sheetQ&A: The Convention on the Rights of Persons with DisabilitiesRecommitting to accelerate progress towards malaria elimination Today’s resolution aims to reinvigorate efforts to end malaria, a preventable and treatable disease that continues to claim more than 400,000 lives each year, mainly children under the age of 5 living in sub-Saharan Africa.Despite a period of unprecedented success in global malaria control, with an estimated 7.6 million deaths and 1.5 billion cases averted since 2000, the global gains in combatting malaria have levelled off in recent years. In 2019, there were some 229 million new cases of malaria, an annual estimate that has remained virtually unchanged since 2015. The new resolution urges Member States to step up the pace of progress against malaria through plans and approaches that are consistent with WHO’s updated Global technical strategy for malaria 2016-2030 and its Guidelines for malaria. It also calls on countries to extend investment in and support for health services, ensuring no one is left behind; sustain and scale up sufficient funding for the global response to malaria; and boost investment in the research and development of new tools.The updated global malaria strategy reflects lessons learned and experiences from the last 5 years, including the stalling of global progress and the impact of the COVID-19 pandemic. Its guiding principles emphasize the need for country leadership of malaria responses; equitable and resilient health systems; and interventions tailored to local data and evidence.Related links:Updated WHO global malaria strategyWHO Guidelines for malariaMalaria fact sheetWorld malaria report 2020 Improving oral health careA new resolution on oral health urges Member States to address key risk factors of oral diseases shared with other noncommunicable diseases such as high intake of free sugars, tobacco use and harmful use of alcohol, and to enhance the capacities of oral health professionals.It also recommends a shift from the traditional curative approach towards a preventive approach that includes promotion of oral health within the family, schools and workplaces, and includes timely, comprehensive and inclusive care within the primary health-care system. Delegates agreed that oral health should be firmly embedded within the noncommunicable disease agenda and that oral health-care interventions should be included in universal health coverage programmes. More than 3.5 billion people suffer from oral diseases - mostly in poor and socially-disadvantaged populations. Most oral diseases have been linked with other noncommunicable diseases such as cardiovascular diseases, diabetes, cancers, pneumonia, obesity and premature birth. One major problem is that oral health is not covered by many universal health coverage packages.WHO is asked to develop a draft global strategy on tackling oral diseases for consideration in 2022 and by 2023 to translate that strategy into an action plan and recommend “best buy” interventions.Related linksMore on oral health DECISIONSEye care: global targets for effective coverage of refractive errors and cataract surgery Today’s decision to adopt the global targets for effective coverage of refractive errors and cataract surgery to be achieved by 2030 ̶ namely, a 40 per cent increase in coverage of refractive errors and a 30 per cent increase in coverage of cataract surgery ̶ will play a key role in increasing global eye care coverage in the future while delivering quality services. Interventions that address the needs associated with uncorrected refractive error and unoperated cataract are among the most cost-effective and feasible health interventions available. Key challenges in meeting the growing demand for these interventions include the ability to provide services for underserved populations and ensuring quality service delivery.Globally, more than 800 million people have distance impairment (i.e. myopia and hypermetropia) or near vision impairment (i.e. presbyopia) that could be addressed with an appropriate pair of spectacles. An estimated 100 million people have moderate-to-severe distance vision impairment or blindness that could be corrected through access to cataract surgery. These figures are expected to increase since presbyopia and cataract development are an inevitable part of ageing, while projected increases in myopia in the younger population will be driven largely by lifestyle factors such as reduced time spent outdoors and greater time spent on intensive near vision activity.Achieving these targets requires the combined and proactive efforts of all stakeholders including governments, civil society, international organizations, intergovernmental organizations and the WHO Secretariat working together in innovative ways to address the population eye care needs. These needs do not just relate to cataract and refractive errors but are also associated with a range of other common eye conditions such as glaucoma and diabetic retinopathy. Related link:Blindness and vision impairment fact sheetGlobal Health Sector Strategies on HIV, Viral Hepatitis and Sexually Transmitted Infections HIV, viral hepatitis and sexually transmitted infections present ongoing and persistent public health challenges and, combined, are responsible for more than 1 million new infections per day and 2.3 million deaths per year. With current health sector strategies for these areas ending this year, delegates at the 74th World Health Assembly today requested the development of new strategies to bridge the gap to 2030. Many of the health-related Sustainable Development Goals health targets have not been met, with progress further disrupted by COVID-19, yet the reduction in the incidence of hepatitis B infection is on track. There has also been continued expansion of HIV and hepatitis C treatment, and coverage of interventions such as syphilis screening of pregnant women in antenatal care and human papillomavirus vaccination, are increasing.New strategies will build on these successes while also addressing significant gaps in reaching the communities most severely affected and at higher risk. WHO will now launch a series of virtual briefings and stakeholder consultations to inform the strategies’ development process. Related links:The Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021 was released earlier this month and contains updated estimates for Hepatitis and STIs and key recommendations for countries to accelerate progress.HIV/AIDSWorld Neglected Tropical Disease (NTD) DayDelegates today agreed to dedicate 30 January as World NTD Day. The day will be an important opportunity to engage a wide range of partners at global, national, and local level to help accelerate the end of NTDs and build on the growing momentum to end the suffering associated with these devastating diseases. One key action will be to work with everyone to prioritize the implementation of programmes across sectors in a cohesive and integrated manner.World NTD Day will also be an opportunity to engage young people to scale up much-needed awareness raising and contribute to efforts in implementing the new NTD road map for 2021-2030. The roadmap aims to relieve the devastating health, social and economic impact these diseases have on more than 1 billion people, many of them poor and living in remote rural areas, urban slums or conflict zones.Related links:Neglected Tropical DiseasesWHO CampaignsNew implementation roadmap for achieving SDG target on noncommunicable diseasesDelegates at the World Health Assembly have asked the World Health Organization to develop an implementation roadmap for 2023-2030 to support the prevention and control of noncommunicable diseases (NCDs).The roadmap will provide a basis for countries to decide on priority activities and pathways to accelerate progress towards achievement of SDG target 3.4 in the next 10 years.Target 3.4 of the Sustainable Development Goals is to reduce premature mortality from NCDs by one third by 2030 relative to 2015 levels. Only 17 countries are currently on track to meet that target for women and 15 for men. Actions relating to the achievement of other SDG 3 targets, such as those relating to the reduction of tobacco use and universal health coverage, will be included in the roadmap. WHO will consult widely internally and externally, including with people living with NCDs, during the development of the roadmap. Lessons learned from the work of WHO and key partners already undertaken to prevent and control NCDs, including in the context of the COVID-19 pandemic, will be taken into consideration. The roadmap will be submitted to the World Health Assembly in May 2022, following review by the Executive Board at its January 2022 session and subsequent consultations with Member States.Related links:Mid-point evaluation of the implementation of the WHO global action plan for the prevention and control of noncommunicable diseases 2013–2020: executive summary – April 2021Political declaration of the third high-level meeting of the General Assembly on the prevention and control of non-communicable diseases – January 2021More on noncommunicable diseasesProgramme Budget 2022-2023 Today, delegates discussed and approved the Organization’s proposed 2022-2023 budget (A74/5 Rev.1) of US$6 121.7 million. The base budget (part which covers the strategic priorities as well as the enabling functions) presents a 16% increase over the 2020-2021 one. Several delegations supported this “ambitious increase” as a reflection of the urgent need for a strong and well-funded WHO, especially following the COVID-19 crisis.In line with the Thirteenth Programme of Work [https://www.who.int/about/what-we-do/thirteenth-general-programme-of-work-2019---2023] and WHO’s Triple Billion Targets [https://www.who.int/data/triple-billion-dashboard], the budget supports the Organization’s 3 strategic priorities: ensuring one more billion people in each category have universal health coverage, better protection from health emergencies, and better health and well-being. Member States also discussed the WHO Results Framework Report, as well as the updates and recent report by the Working Group on Sustainable Financing.Delegates called for a more flexibly, predictably- and sustainably-financed WHO and stressed that an increase in resources must be accompanied by robust monitoring of progress and measurable results. The budget will be financed by assessed (US$ 956.9 million) and voluntary contributions (US$ 5 164.8million). WHO’s increasing dependency on voluntary contributions to finance essential work was a concern to representatives of several Member States. Related links:Program Budget Web Portal How WHO is fundedTriple Billion
- COVAX Joint Statement:
Call to action to equip COVAX to deliver 2 billion doses in 2021on May 27 2021 at 16:57
Countries that are advanced in their vaccination programmes are seeing cases of COVID-19 decline, hospitalisations decrease and early signs of some kind of normality resume.However, the global picture is far more concerning. At no point in this pandemic have we seen such an acute need to look to the future challenges and not rest on the patchy achievements made so far.We are seeing the traumatic effects of the terrible surge of COVID-19 in South Asia – a surge which has also severely impacted global vaccine supplies.We are also witnessing why access to vaccines before a surge occurs is so important. For that reason, we must focus on ensuring countries who have not benefitted from these life-saving tools do so now, and with urgency.As the global mechanism for equitable access to COVID-19 vaccines, COVAX has proven it works. Designed and implemented in the midst of an unprecedented global public health crisis, it has delivered over 70 million doses to 126 countries and economies around the world since February – from remote islands to conflict settings – managing the largest and most complex rollout of vaccines in history. Over 35 countries received their first COVID-19 vaccine doses thanks to COVAX. However, the terrible surge of the virus in India has had a severe impact on COVAX’s supply in the second quarter of this year, to the point where, by the end of June we will face a shortfall of 190 million doses. Even though COVAX will have larger volumes available later in the year through the deals it has already secured with several manufacturers, if we do not address the current, urgent shortfall the consequences could be catastrophic. But we can meet this challenge with concerted action and global leadership.Millions of dollars and doses were committed to COVAX on 21 May, bringing the total of doses pledged so far to more than 150 million. At the World Health Assembly, governments have been united in recognising the political and financial urgency of supporting COVAX with doses and dollars. It is now imperative to build on this momentum to secure full funding for COVAX and more vaccines – right now – for lower income countries at the Advance Market Commitment Summit on 2 June. If the world’s leaders rally together, the original COVAX objectives – delivery of 2 billion doses of vaccines worldwide in 2021, and 1.8 billion doses to 92 lower income economies by early 2022 are still well within reach.But it will require governments and the private sector to urgently unlock new sources of doses, with deliveries starting in June, and funding so we can deliver. COVAX has the infrastructure in place to facilitate and coordinate this complex global effort.To enable COVAX to deliver on the promise of global equitable access, we call for the following immediate actions: Fund the Gavi COVAX Advance Market Commitment (AMC). The AMC mechanism is how COVAX provides doses to lower income economies. Thanks to the generosity of its donors, the AMC has already secured 1.3 billion doses for delivery in 2021. This is enough to protect the most at-risk population groups: health workers, the elderly and those with underlying health conditions. We need an additional $2 billion to lift coverage in AMC countries up to nearly 30%, and we need it by June 2 to lock in supplies now so that doses can be delivered through 2021, and into early 2022.Share doses, now. The pandemic has just taken a frightening new turn, as a deadly surge of cases rages across South Asia and other hotspots. Countries with the largest supplies should redirect doses to COVAX now, to have maximum impact. We are starting to see countries stepping forward with doses, with the United States and Europe collectively pledging to share 180 million doses. But we still need more, we need them to go through COVAX, and we need them to start moving in early June. At least one billion doses could be shared by wealthy countries in 2021. COVAX’s need for doses is greatest right now. Countries with higher coverage rates, which are due to receive doses soon should swap their places in supply queues with COVAX so that doses can be equitably distributed as quickly as possible. Free up supply chains by removing trade barriers, export control measures, and other transit issues that block, restrict or slowdown the supply and distribution of COVID-19 vaccines, raw materials, components and supplies. Now more than ever, at the peak of the pandemic, we need ambitious, global solutions. When it comes to worldwide vaccine distribution, COVAX is the only initiative capable of rising to the challenge of this moment. It’s understandable that some countries want to press ahead and vaccinate all of their populations. By donating vaccines to COVAX alongside domestic vaccination programmes, the most at-risk populations can be protected globally, which is instrumental to ending the acute phase of the pandemic, curbing the rise and threat of variants, and accelerating a return to normality. COVAX is hugely appreciative to France, Germany, Italy, New Zealand, Spain, Sweden and the United Arab Emirates for their initial commitments to donate doses through COVAX, and to Canada for funding to support the design and operationalization of the COVAX dose sharing mechanism. We also welcome announcements by the United States, Norway, Croatia, Romania, Australia and Portugal to donate doses to countries in need and we put COVAX forward as the proven mechanism for global, rapid and equitable distribution to facilitate this.Since COVAX was established in mid-2020, it has had the support and resources of 192 of the world’s economies. This tremendous vote of confidence has enabled us to demonstrate our ability to deliver an unprecedented global rollout. It’s time to finish the job.Dr Richard Hatchett Chief Executive Officer, Coalition for Epidemic Preparedness Innovations (CEPI)Dr Seth Berkley Chief Executive Officer, Gavi, the Vaccine Alliance Dr Tedros Adhanom Ghebreyesus Director-General, World Health Organization (WHO) Ms Henrietta Fore Executive Director, UNICEF Notes to editorsThe goal of sharing at least 1 billion excess doses by the end of 2021 is based on a Bill & Melinda Gates Foundation analysis of current projections of excess doses globally. Even under conservative estimates, the analysis finds that after sharing 1 billion doses, wealthy countries would have sufficient doses to vaccinate 80% of their populations 12 years and older in 2021. About COVAXCOVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-convened by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (Gavi) and the World Health Organization (WHO) – working in partnership with UNICEF as key implementing partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.CEPI’s role in COVAXCEPI is leading on the COVAX vaccine research and development portfolio, investing in R&D across a variety of promising candidates, with the goal to support development of three safe and effective vaccines which can be made available to countries participating in the COVAX Facility. As part of this work, CEPI has secured first right of refusal to potentially over one billion doses for the COVAX Facility to a number of candidates, and made strategic investments in vaccine manufacturing, which includes reserving capacity to manufacture doses of COVAX vaccines at a network of facilities, and securing glass vials to hold 2 billion doses of vaccine. CEPI is also investing in the ‘next generation’ of vaccine candidates, which will give the world additional options to control COVID-19 in the future.Gavi’s role in COVAXGavi is leading on procurement and delivery at scale for COVAX: coordinating the design, implementation and administration of the COVAX Facility and the Gavi COVAX AMC and working with its Alliance partners UNICEF and WHO, along with governments, on country readiness and delivery. As part of this role, Gavi hosts the Office of the COVAX Facility to coordinate the operation and governance of the mechanism as a whole, manages relationships with Facility participants, and negotiates advance purchase agreements with manufacturers of promising vaccine candidates to secure doses on behalf of the 190 economies participating in the COVAX Facility. It also coordinates design, operation and fundraising for the COVAX AMC that supports 92 lower-income economies, including a no-fault compensation mechanism that will be administered by WHO. As part of this work, Gavi supports governments and partners on ensuring country readiness, providing funding and oversight of UNICEF procurement of vaccines as well as partners’ and governments work on readiness and delivery. This includes support for cold chain equipment, technical assistance, syringes, vehicles, and other aspects of the vastly complex logistical operation for delivery.WHO’s role in COVAXWHO has multiple roles within COVAX: It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. Its Strategic Advisory Group of Experts (SAGE) on Immunization develops evidence-based immunization policy recommendations. Its Emergency Use Listing (EUL) / prequalification programmes ensure harmonized review and authorization across member states. It provides global coordination and member state support on vaccine safety monitoring. It developed the target product profiles for COVID-19 vaccines and provides R&D technical coordination. WHO leads, together with UNICEF, the Country Readiness and Delivery workstream, which provides support to countries as they prepare to receive and administer vaccines. Along with Gavi and numerous other partners working at the global, regional, and country-level, the CRD workstream provides tools, guidance, monitoring, and on the ground technical assistance for the planning and roll-out of the vaccines. Along with COVAX partners, WHO has developed a no-fault compensation scheme as part of the time-limited indemnification and liability commitmentsUNICEF’s role in COVAXUNICEF is leveraging its experience as the largest single vaccine buyer in the world and working with manufacturers and partners on the procurement of COVID-19 vaccine doses, as well as freight, logistics and storage. UNICEF already procures more than 2 billion doses of vaccines annually for routine immunisation and outbreak response on behalf of nearly 100 countries. In collaboration with the PAHO Revolving Fund, UNICEF is leading efforts to procure and supply doses of COVID-19 vaccines for COVAX. In addition, UNICEF, Gavi and WHO are working with governments around the clock to ensure that countries are ready to receive the vaccines, with appropriate cold chain equipment in place and health workers trained to dispense them. UNICEF is also playing a lead role in efforts to foster trust in vaccines, delivering vaccine confidence communications and tracking and addressing misinformation around the world.About ACT-AcceleratorThe Access to COVID-19 Tools ACT-Accelerator, is a new, ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.The ACT-Accelerator is not a decision-making body or a new organisation, but works to speed up collaborative efforts among existing organisations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organisations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.
- WHO supports people quitting tobacco to reduce their risk of severe COVID-19on May 27 2021 at 13:44
WHO Director-General Special Awards for World No Tobacco Day announced: Minister of Health India and University of Bath for exceptional achievement in tobacco control.Smokers face a 40 – 50% higher risk of developing severe disease and death from COVID-19.WHO partners with Viber, WhatsApp, FB Messenger, WeChat and AI company Soul Machines to reach billions with free digital quitting tobacco aids.The World Health Organization’s 'Commit to Quit’ tobacco campaign has made resources from its Quitting Toolkit freely available to more than a billion tobacco users, less than 5 months into the year-long campaign.WHO launched the campaign to support those millions of tobacco users who are actively taking steps to save their lives, but still need help to succeed. The campaign is currently working directly with 29 focus countries. Each country agreed with WHO on selected activities, including, running national awareness campaigns, releasing new digital tools, revising policies, engaging youth, training health workers, opening new cessation clinics, supporting nicotine replacement therapies through WHO partners, establishing national toll-free quit lines, making quitting courses available, and more.“Smokers have up to a 50% higher risk of developing severe disease and death from COVID-19, so quitting is best thing smokers can do to lower their risk from this coronavirus, as well as the risk of developing cancers, heart disease and respiratory illnesses,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “We urge all countries to play their part by joining the WHO campaign and creating tobacco-free environments that give people the information, support and tools they need to quit, and quit for good.”“To help tobacco users to commit to be quitters and winners, we are using digital aids to release the WHO Quit Challenge chatbot and Artificial Intelligence digital health worker Florence, and making advocacy material available in 30 languages,” added Dr Rüdiger Krech, Director Health Promotion, WHO. The Quit Challenge gives daily notifications of tips and encouragement for up to 6 months to help people remain tobacco free. It is available for free on WhatsApp, Viber, Facebook Messenger and WeChat. Globally, roughly 39% of men and 9% of women use tobacco. The highest tobacco use rates among men are currently found in the Western Pacific region at 49%, and among women in Europe at 19%.Director-General’s Tobacco Control AwardsDr Tedros Adhanom Ghebreyesus has given special recognition awards for tobacco control to the Minister of Health and Family Welfare of India, Dr Harsh Vardhan and to the Tobacco Control Research Group at the University of Bath, United Kingdom.Dr Harsha Vardhan was instrumental in the 2019 national legislation that bans E-cigarettes and heated tobacco products (HTPs) in India. The Tobacco Control Research Group in United Kingdom has worked relentlessly to expose tobacco industry attempts and tactics to weaken, block or delay tobacco control, thereby helping secure policy change nationally and globally.Note to editors: *The campaign focus countries are: Arab Republic of EgyptDemocratic Republic of Timor-LesteFederal Democratic Republic of EthiopiaFederal Republic of Germany Federal Republic of NigeriaFederative Republic of BrazilHashemite Kingdom of JordanIslamic Republic of Iran Islamic Republic of PakistanKyrgyz RepublicPeople’s Republic of BangladeshPeople’s Republic of China, Republic of IndiaRepublic of IndonesiaRepublic of KazakhstanRepublic of KenyaRepublic of the Philippines, Republic of PolandRepublic of SenegalRepublic of South AfricaRepublic of SurinameRepublic of TurkeyRepublic of UzbekistanRepublic of the SudanRussian FederationSocialist Republic of Viet NamUnited Mexican StatesUnited States of AmericaUkraine WHO would like to thank our partners that supported the campaign: Allen Carr’s EasyWay, Amazon Web Services, Cipla, Facebook and WhatsApp, Google, Johnson & Johnson Consumer Health, Praekelt.org, Soul Machines Limited, and Viber.
- WHO and Switzerland launch global BioHub for pathogen storage, sharing and analysison May 24 2021 at 09:22
The World Health Organization (WHO) and the Swiss Confederation today signed a Memorandum of Understanding to launch the first WHO BioHub Facility as part of the WHO BioHub System, which was announced in November 2020. This facility will enhance the rapid sharing of viruses and other pathogens between laboratories and partners globally. Based in Spiez, Switzerland, the facility will serve as a centre for the safe receipt, sequencing, storage and preparation of biological materials for distribution to other laboratories, in order to inform risk assessments, and sustain global preparedness against these pathogens. “Close international collaboration to ensure the timely sharing of epidemiological and clinical data as well as biological materials is of utmost importance. Switzerland supports the WHO BioHub initiative in its initial phase by providing the necessary infrastructure of a Swiss biosafety laboratory in Spiez. With this, we hope to contribute to the establishment of an international exchange system for SARS-CoV-2 and other emerging pathogens,” said Swiss Federal Councillor Alain Berset. Currently, most pathogen sharing is done bilaterally between countries and on an ad hoc basis, which can be slow, and leave some countries without access to the benefits and tools. The BioHub will enable Member States to share biological materials with and via the BioHub under pre-agreed conditions, including biosafety, biosecurity, and other applicable regulations. This will ensure timeliness and predictability in response activities. “The COVID-19 pandemic and other outbreaks and epidemics have underscored the importance of rapidly sharing pathogens to help the global scientific community assess the risk and develop countermeasures such as diagnostics, therapeutics and vaccines,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “The BioHub System is an important step towards facilitating this flow of information. We thank the Swiss Government for its support in establishing the first BioHub Facility.” In parallel, WHO will broaden its BioHub System for the use of biological materials by qualified entities – such as manufacturers – for the development of medical by-products for fair allocation to countries. WHO is currently running a pilot phase, using SARS-COV-2 and its variants, to test the feasibility and operational arrangements for sharing such materials with the facilities of the BioHub System. Following results from the pilot project, the BioHub will expand from SARS-COV-2 and its variants, to other pathogens, and connect partners with other repositories and laboratory networks in 2022.
- G20 leaders boost support of the Access to COVID-19 Tools (ACT) Accelerator but urgent and immediate action is needed to maintain momentumon May 21 2021 at 18:54
World leaders today met at the Global Health Summit, co-hosted by the European Commission and Italy as part of its G20 presidency, to adopt an agenda to overcome the COVID-19 pandemic, and develop and endorse a Rome Declaration of principles, at a time when the virus is surging and spreading uncontrollably in many parts of the world.With nine people losing their lives to COVID-19 every minute, and as the risk of even more transmissible and dangerous variants increases, the Global Health Summit comes at a critical juncture. The future of the pandemic is in the hands of the G20 leaders. The ACT-Accelerator was launched just over a year ago in response to the G20’s call for a global mechanism to accelerate the development of tests, treatments and vaccines and to ensure their equitable distribution. Hosted by the World Health Organization, the ACT-Accelerator offers the only end-to-end multilateral solution to speeding up an end to the acute phase of the COVID-19 pandemic. The ACT-Accelerator welcomes the commitments made at the Global Health Summit and will work with countries to operationalize rapidly these pledges, both financial and – crucially – for over 100 million doses of scarce vaccine. Current financial commitments are reflected in the ACT-Accelerator interactive funding tracker. However, a significant funding gap remains. Speeding up an end to the pandemic through the ACT-Accelerator would cost less than 1% of what governments are spending on stimulus packages to treat the consequences of the pandemic. As the economic and social costs of the pandemic continue to escalate, the case for global solidarity, grows even stronger. The world now needs the G20 to ACT.The Rome Declaration, released at the end of the Summit, reaffirmed leaders’ support for the ACT-Accelerator and underlined the necessity to share the financial burden and close the funding gap, in order for the ACT Accelerator to fulfil its mandate for the equitable allocation and delivery of tests, treatments and vaccines to defeat the pandemic. Of vital importance, the group also emphasized its support for global sharing of vaccine doses approved for emergency use by the World Health Organization (WHO) and through COVAX. Carl Bildt, Special Envoy for the ACT-Accelerator and former Prime Minister of Sweden, said: “Today’s commitments are welcome – but more action is needed now, not in weeks or months, to change the course of the pandemic. While some countries have moved beyond just words, by donating vaccines and pledging to fully finance the ACT-Accelerator, further action is needed from G20 and G7 leaders if we are to stop this virus from spreading and mutating further. We all have substantial work ahead of us.” Dr Tedros Adhanom Ghebreyesus, Director General of WHO, said: “We now have an opportunity to fix the global imbalance. First, we need to close the 18.5 billion US dollar funding gap for the ACT Accelerator. Second, we need countries to donate tens of millions of doses of vaccines immediately through COVAX – which is the agreed global mechanism for distributing vaccines. We welcome the generous announcements made today; in the coming weeks and months, we will need hundreds of millions more doses. We need companies to help make donations happen fast, and to give COVAX the first right of refusal on all uncommitted doses now, in 2021. Third, we must urgently and dramatically scale up production of all of these tools, through voluntary licensing, sharing technology and know-how, and waiving intellectual property rights. We are at a critical juncture. The creation of the ACT Accelerator represents a historic, forward-thinking effort based on the principles of solidarity and equity. Let’s seize the moment and finish the job we started.” Today’s commitments come at a critical point in the pandemic. Only through concerted and rigorous testing to control virus spread, access to life-saving oxygen and dexamethasone to save lives, and vaccines to protect people – can bring this pandemic under control. A massive disparity in access to tests, treatments and vaccines between the world’s richest and poorest countries is prolonging the pandemic in all parts of the world. Funding the work of the ACT-Accelerator now would speed up an end to the pandemic everywhere. Testing rates in high-income countries are 100x the rates in low-income countries, contributing to unmonitored and uncontrolled spread of the virus. Fully funding the work of the ACT-A Diagnostics Pillar would significantly increase testing in low- and middle-income countries and build sequencing capacity to ensure newly emerging virus variants can be quickly identified and managed.High-income countries have administered nearly 100x more vaccine doses per inhabitant than low-income countries, leaving millions of healthcare workers and vulnerable populations unprotected in the world’s poorest countries. Fully funding the Gavi COVAX Advance Market Commitment (AMC) and sharing vaccines through ACT-A’s COVAX Facility would protect 27% of the populations in the AMC92 countries by the end of 2021. The drastic undersupply of oxygen is risking millions of lives across the world. Fully funding the work of the ACT-A Therapeutics Pillar would save up to 4 million lives with the delivery of life-saving oxygen to those that need it most, and fund research into new treatments to fight the disease.Health systems are in many countries unprepared for the roll out of COVID-19 tools, and health workers in low- and middle-income countries are frequently unprotected due to lack of PPE. Fully funding the Health Systems Connector would protect 2 million healthcare workers on the frontlines in LICs with supplies of PPE and help prepare health systems for the roll out of tools to fight COVID-19.Global solidarity against COVID-19 isn’t just the right thing to do. It’s the fastest and most effective way to defeat the pandemic and get all our lives and economies back to normal.------------------------------------------------- Notes to EditorsThe Access to COVID-19 Tools (ACT) Accelerator is the proven, up-and-running global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.The ACT-Accelerator is not a decision-making body or a new organization but works to speed up collaborative efforts among existing organizations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organizations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.The ACT-Accelerator comprises four pillars: diagnostics, therapeutics, vaccines and health system strengthening. The diagnostics pillar, co-convened by the Global Fund and FIND, is focused on ensuring equitable access to new and existing tests, supporting country uptake and deployment and strengthening the diagnostic portfolio with R&D investments in low-cost, easy-to-use and quality tests. In 2021, it is focused on procuring and distributing at least 900 million molecular and antigen rapid tests to low- and middle-income countries.The therapeutics pillar is led by Unitaid and Wellcome. Therapeutics can play a role in all stages of COVID-19 disease: to prevent infection; suppress symptoms and spread of infection to others; treat or prevent symptoms; as a life-saving treatment for severe symptoms; and as a treatment that can speed up recovery. The aim in the next 12 months is to develop, manufacture and distribute millions of treatment doses, helping COVID-19 sufferers to recover from the disease.The vaccines pillar, convened by CEPI, Gavi and WHO, is speeding up the search for an effective vaccine for all countries. At the same time, it is supporting the building of manufacturing capabilities, and buying supply, ahead of time so that at least 2 billion doses can be fairly distributed to the most high risk and highly exposed populations globally by the end of 2021.The health systems connector pillar, led by the World Bank, the Global Fund and WHO, is working to ensure that these tools can reach the people who need them.Cross-cutting all of these is the workstream on Access & Allocation, led by WHO.Since April 2020, the ACT-Accelerator has supported the fastest, most coordinated, and successful global effort in history to develop and rollout tools to fight a new disease. With significant advances in research and development by academia, private sector and government initiatives, the ACT-Accelerator has advanced our understanding of what works to fight the disease. It has transformed our ability to tackle COVID-19 on a global scale: vaccines are being rolled-out worldwide, low-cost high-performing antigen rapid diagnostic tests can now detect transmission anywhere, affordable therapies for severe disease can save lives in any setting, and health systems are being strengthened to help roll out these tools.
- New international expert panel to address the emergence and spread of zoonotic diseaseson May 20 2021 at 08:56
International organizations have come together to launch a new One Health High-Level Expert Panel to improve understanding of how diseases with the potential to trigger pandemics, emerge and spread.The panel will advise four international organizations - the Food and Agriculture Organization of the United Nations (FAO); the World Organisation for Animal Health (OIE); the United Nations Environment Programme (UNEP); and the World Health Organization (WHO) - on the development of a long-term global plan of action to avert outbreaks of diseases like H5N1 avian influenza; MERS; Ebola; Zika, and, possibly, COVID-19. Three quarters of all emerging infectious diseases originate in animals.It will operate under the One Health Approach, which recognizes the links between the health of people, animals, and the environment and highlights the need for specialists in multiple sectors to address any health threats and prevent disruption to agri-food systems.Key first steps will include systematic analyses of scientific knowledge about the factors that lead to transmission of a disease from animal to human and vice versa; development of risk assessment and surveillance frameworks; identification of capacity gaps as well as agreement on good practices to prevent and prepare for zoonotic outbreaks.The panel will consider the impact of human activity on the environment and wildlife habitats. Critical areas will include food production and distribution; urbanization and infrastructure development; international travel and trade; activities that lead to biodiversity loss and climate change; and those that put increased pressure on the natural resource base - all of which can lead to the emergence of zoonotic diseases. The panel will guide development of a dynamic new research agenda and draw up evidence-based recommendations for global, regional, national and local action.Dr Tedros Adhanom Ghebreyesus, WHO Director-General said: “Human health does not exist in a vacuum, and nor can our efforts to protect and promote it. The close links between human, animal and environmental health demand close collaboration, communication and coordination between the relevant sectors. The High-Level Expert Panel is a much-needed initiative to transform One Health from a concept to concrete policies that safeguard the health of the world’s people.” Dr QU Dongyu, FAO Director General, told the panel: "This panel will contribute to advancing the One Health agenda, by helping to better understand the root causes of disease emergence and spread, and informing decision-makers to prevent long-term public health risks. I encourage it to be a shining example of silo-breaking, systems thinking and open dialogue. Expectations for collective action and the need for effective collaboration have never been higher.”Dr Monique Éloit, Director General of the World Organisation for Animal Health noted: “The COVID-19 pandemic is a stark reminder that collaboration across sectors is absolutely critical for global health. The newly established One Health High-Level Expert Panel will contribute to bringing together diverse scientific expertise. United, we will better anticipate global health threats and work to control risks at the animal source. Our Organisation is proud to provide high-level expertise, along with our partners, to develop science-based ‘One Health’ strategies and programmes.Inger Andersen, Executive Director of UNEP observed: "To end the triple planetary crisis of climate change, biodiversity loss and pollution that threaten our peace and prosperity, we have to understand that human, animal and planetary health go hand in hand. We must do more to promote transformative actions that target the root causes of nature’s destruction. The One Health High-Level Expert Panel is an important step in recognizing the complex, multidisciplinary issues at the interface of human, animal, and environmental health.The Ministers for Foreign Affairs of France and Germany also joined the public launch of the One Health High-Level Expert Panel:Mr Jean-Yves Le Drian, Minister for Europe and Foreign Affairs, France commented: "The COVID-19 pandemic, whose zoonotic origin is strongly suspected, underlines how closely human, animal and environmental health are linked. It demonstrates the importance of the ‘One Health’ approach. It is in this context that France, together with Germany, proposed the creation of such a Panel at the meeting of the Alliance for Multilateralism organized on the occasion of the Paris Peace Forum on 12 November 2020."Mr Heiko Maas, Minister for Foreign Affairs, Germany, said: “COVID-19 has painfully reminded us that the health of humans, animals and the environment around the world is closely connected: Nobody is safe until everybody is safe. This is what we have to bear in mind to prevent future pandemics. The establishment of the One Health High-Level Expert Panel thus marks an important step in the right direction. Germany and France will continue to support the panel’s work.”
- World Health Assembly to focus on ending COVID-19 pandemic and preparing for next oneon May 20 2021 at 08:15
In a year when COVID-19 threatens the health and well-being of everyone on the planet, the seventy-fourth session of the World Health Assembly (WHA) will stress the urgency of ending the current pandemic and preventing the next one by building a healthier, safer and fairer world.The Health Assembly is WHO’s highest decision-making body and is attended by delegations from all around the world. It will also be open to Associate Members, Observers, invited representatives of the UN and other participating inter-governmental organizations, and non-State actors. This year’s session will run from 24 May to 1 June 2021, and be held virtually. Over the past year, cases of COVID-19 rose 40-fold to 162 million globally, while the number of deaths has increased 11 times, to more than 3.3 million.The pandemic has hit all countries hard, but its impact has been harshest on those communities which were already vulnerable, who are more exposed to the disease, less likely to have access to quality health care services and more likely to experience adverse consequences (such as loss of income) as a result of measures implemented to contain the pandemic.“A crisis often brings out the best in people and organisations,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “From the WHO Strategic Preparedness and Response Plan to our technical guidance, the Solidarity Trial, the UN Supply Chain Task Force, the OpenWHO.org learning platform and initiatives like the Access to COVID-19 Tools Accelerator, including its COVAX partnership, and the Solidarity Response Fund, WHO has given countries effective and evidence-informed tools to prevent infections, save lives and maintain essential health services. I am especially proud of the incredible work that WHO staff have done all over the world in the past 17 months to support countries to put these tools to work.”But the pandemic is far from over and the global response is at a critical phase. Stark contrasts still undermine progress, with vaccine inequity being one of the most urgent issues, posing a threat to ending the pandemic and to global recovery – over 75% of all vaccine doses have been administered in only 10 countries; the lowest income countries have administered less than half a percent of global doses."This year's World Health Assembly will play a vital role in shaping the global health architecture of the future, and in strengthening WHO to fulfil its mission and mandate", added Dr Tedros.The Assembly’s agenda will focus on the health-related Sustainable Development Goals and WHO’s Triple Billion targets of one billion more people benefitting from universal health coverage; one billion more better protected from health emergencies; and one billion more enjoying better health and well-being.WHO’s results report, will also be presented during WHA. A high-level segment will take place on 24 May (10:00 -12:00 CEST) with participation from Heads of State and Governments and special guests, as well as an address by the WHO Director-General.The Assembly’s two Committees - Committee A, which deals with predominantly programme and budget matters and Committee B, which deals mainly with administrative, financial and legal matters – will then consider the individual agenda items. Highlights include:Proposed programme budget 2022–2023WHO’s work in Health Emergencies, the COVID-19 response, including mental health preparedness for and response to the COVID-19 pandemicGlobal strategy and plan of action on public health, innovation and intellectual propertyGlobal action on patient safetyWHO global strategy on health, environment and climate changeNoncommunicable diseasesAntimicrobial resistanceImmunization Agenda 2030Health in the 2030 Agenda for Sustainable DevelopmentGlobal Strategic Directions for Nursing and MidwiferyPoliomyelitisWHO transformationThree reports on COVID-19 response will be presented at the Assembly: the Health Emergencies Programme’s Independent Oversight and Advisory Committee (IOAC), the Independent Panel for Pandemic Preparedness and Response and the Review Committee on the Functioning of the International Health Regulations (2005) during the COVID-19 Response.The Assembly will be webcast live with interpretation in the WHO ’s six official languages. Proceedings can be followed at: https://www.who.int/about/governance/world-health-assembly/seventy-fourth-world-health-assemblyProvisional agenda in six languages: https://apps.who.int/gb/ebwha/pdf_files/WHA74/A74_1-en.pdfMedia accreditation for the World Health AssemblyJournalists are reminded that the World Health Assembly is webcast live. Given the COVID-19 situation, journalists are not allowed on WHO premises.Updates will be posted on the WHO website: www.who.int and relevant materials will be sent to the global media list. To register: https://confirmsubscription.com/h/d/18DFE0FD1CC9DA69Photographs and VideosInformation 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.Social mediaWHO will provide regular updates from the World Health Assembly via Twitter – follow @WHO and hashtag #WHA74. and available at @WHO and WHO’s Facebook page.Updates and visuals will also be posted on WHO’s corporate social media accounts: Instagram (https://goo.gl/Sa1EwW), LinkedIn (https://www.linkedin.com/company/world-health-organization/) and YouTube (https://goo.gl/GszTPk).Provisional/preliminary list of Participants at the WHA74 will be issued on Sunday 23 May 2021 and can be found at: https://apps.who.int/gb/e/e_wha74.html.Following the closure of the WHA74, the 149th session of the Executive Board will take place on 2 June 2021.The Executive Board session will be webcast live with interpretation in the WHO ’s six official languages. Proceedings can be followed at: https://www.who.int/about/governance/executive-board/executive-board-149th-session
- WHO issues new guidance for research on genetically modified mosquitoes to fight malaria and other vector-borne diseaseson May 18 2021 at 13:57
New guidance from the World Health Organization (WHO) sets essential standards to inform future research and development on genetically modified mosquitoes, particularly in addressing issues relating to ethics, safety, affordability and effectiveness.
- Dynamic WHO dashboard for island states highlights barriers and progress on climate change and healthon May 18 2021 at 02:48
A new SIDS dynamic data report showcases the progress made by island states to date in addressing health and climate change challenges
- Long working hours increasing deaths from heart disease and stroke: WHO, ILOon May 13 2021 at 11:24
Long working hours led to 745 000 deaths from stroke and ischemic heart disease in 2016, a 29 per cent increase since 2000, according to the latest estimates by the World Health Organization and the International Labour Organization published in Environment International today. In a first global analysis of the loss of life and health associated with working long hours, WHO and ILO estimate that, in 2016, 398 000 people died from stroke and 347 000 from heart disease as a result of having worked at least 55 hours a week. Between 2000 and 2016, the number of deaths from heart disease due to working long hours increased by 42%, and from stroke by 19%.This work-related disease burden is particularly significant in men (72% of deaths occurred among males), people living in the Western Pacific and South-East Asia regions, and middle-aged or older workers. Most of the deaths recorded were among people dying aged 60-79 years, who had worked for 55 hours or more per week between the ages of 45 and 74 years.With working long hours now known to be responsible for about one-third of the total estimated work-related burden of disease, it is established as the risk factor with the largest occupational disease burden. This shifts thinking towards a relatively new and more psychosocial occupational risk factor to human health.The study concludes that working 55 or more hours per week is associated with an estimated 35% higher risk of a stroke and a 17% higher risk of dying from ischemic heart disease, compared to working 35-40 hours a week.Further, the number of people working long hours is increasing, and currently stands at 9% of the total population globally. This trend puts even more people at risk of work-related disability and early death.The new analysis comes as the COVID-19 pandemic shines a spotlight on managing working hours; the pandemic is accelerating developments that could feed the trend towards increased working time.“The COVID-19 pandemic has significantly changed the way many people work,“ said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. "Teleworking has become the norm in many industries, often blurring the boundaries between home and work. In addition, many businesses have been forced to scale back or shut down operations to save money, and people who are still on the payroll end up working longer hours. No job is worth the risk of stroke or heart disease. Governments, employers and workers need to work together to agree on limits to protect the health of workers.”“Working 55 hours or more per week is a serious health hazard,” added Dr Maria Neira, Director, Department of Environment, Climate Change and Health, at the World Health Organization. “It’s time that we all, governments, employers, and employees wake up to the fact that long working hours can lead to premature death”.Governments, employers and workers can take the following actions to protect workers’ health: governments can introduce, implement and enforce laws, regulations and policies that ban mandatory overtime and ensure maximum limits on working time;bipartite or collective bargaining agreements between employers and workers’ associations can arrange working time to be more flexible, while at the same time agreeing on a maximum number of working hours;employees could share working hours to ensure that numbers of hours worked do not climb above 55 or more per week. Note for editors:Two systematic reviews and meta-analyses of the latest evidence were conducted for this study. Data from 37 studies on ischemic heart disease covering more than 768 000 participants and 22 studies on stroke covering more than 839 000 participants were synthesized. The study covered global, regional and national levels, and was based on data from more than 2300 surveys collected in 154 countries from 1970-2018.
- WHO lists additional COVID-19 vaccine for emergency use and issues interim policy recommendationson May 7 2021 at 16:09
WHO today listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG). “The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products. “We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.”WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. The EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions.In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility. The Sinopharm product is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell). Its easy storage requirements make it highly suitable for low-resource settings. It is the also first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change color as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79%, all age groups combined. Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. Nevertheless, WHO is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons. There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations. WHO therefore recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust.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.WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020; two AstraZeneca/Oxford COVID-19 vaccines on 15 February 2021, produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India; and COVID-19 vaccine Ad26.COV2.S developed by Janssen (Johnson & Johnson) on 12 March 2021.ListingsWHO has also listed the Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Janssen and Moderna vaccines for emergency use.See EUL listingsSAGESAGE 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 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 has issued recommendations on Pfizer (8 January 2021), Moderna (25 January 2021), AstraZeneca (21 April 2021), and Janssen COVID (17 March 2021) vaccines, as well as issued a framework for access and population prioritization roadmap. SAGE and EUL are complementary but independent processes. The EUL process is centered on determining if a manufactured product is quality-assured, safe and effective. SAGE is policy oriented. Policy recommendations for a vaccine are only of value to a vaccination campaign when the product has been listed or authorized for use. In the context of COVID-19 and due the pressing need for vaccines, the Secretariat of SAGE and the EUL team have been working in parallel to allow WHO EUL and policy recommendations, based on the available evidence, to be issued in a synchronized manner. The SAGE Interim Recommendations can be found at this location: https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-materials
- Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and WHOon May 7 2021 at 08:00
ICMRA1 and WHO call on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines (whether full or conditional approval, under emergency use, or rejected). Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest.The COVID-19 pandemic has brought into sharp focus the need for information and data to support academics, researchers and industry in developing vaccines and therapeutics; to support regulators and health authorities in their decision-making; to support healthcare professionals in their treatment decisions; and to support public confidence in the vaccines and therapeutics being deployed.While some initiatives have met with stakeholder support (e.g. WHO International Clinical Trials Registry Platform, US NIH ClinicalTrials.gov database, Health Canada Clinical Information Portal, EMA Clinical Trials Register and Japan Registry of Clinical Trials), not all past efforts have been successful. Often this was because they were unsustainable due to reliance on goodwill or lack of appropriate resourcing.2The common aim of these initiatives is to ensure that results of research are accessible to all those involved in health care decision-making. The priority should be for new innovative medicines and vaccines. This improves transparency and strengthens the validity and value of the scientific evidence base. To succeed, initiatives need multi-stakeholder engagement aimed at finding solutions that deliver benefits for public health.Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted. In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymisation can be used.The first benefit is public trust. Regulators are opening their decisions to public scrutiny demonstrating confidence in their work.Another benefit is the possible check of data integrity, a scientific necessity and an ethical must. Data must be robust, exhaustive and verifiable, through peer-review. Data integrity is priceless. Wrong regulatory decisions, made on selected or unreliable data, will affect the patients who receive that medicine.Lack of public access to negative trials has been identified as a source of bias, which weakens the conclusions of systematic reviews and provides a false sense of reassurance on the safety or efficacy of the medicine.Publication of data allows science to advance faster, by avoiding repetition of unnecessary trials and waste of resources (human and financial). This also brings benefits by improving the efficiency of development programmes and reducing both development costs and time. Publication of data also allows secondary analyses (and meta-analysis) which have a different or complementary focus.Many public bodies have made open access a requirement as data are a common good. Providing access to data is also owed to trial participants who contributed physically and took the potential research risks.Not all data are of high quality, and increased public scrutiny should eventually improve the overall quality of data. Resources however are needed for data sharing, and systems for such access need to be established. Standardisation of data will allow better analyses but is not a requirement.While there may be a small risk of misuse of data (piracy or data mining for unfair commercial purpose) and misinterpretation, trial data can be put in context when published with the regulatory review of such data.Data must be published at the time of finalisation of the regulatory review. It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market. Some regulators regularly publish the data that support positive approvals, but fewer do this for rejections, while this should avoid false expectations, misuse (accidental or not) and safety issues. Many completed trials on publication platforms only disclose protocols while results remain partial, outdated or unpublished.ICMRA and WHO are conscious of concerns that some stakeholders may have as regulators move to greater levels of transparency, but we remain confident of the overwhelming positive public health benefits of doing so.Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how essential to public trust access to data is. ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.__________________________________________________________1 ICMRA is a voluntary coalition of leaders of medicines regulatory authorities that provides strategic directions for enhanced cooperation, improved communication and effective global crisis response mechanisms.2 E.g. Past declarations and private initiatives abandoned or not followed through include: -- Walsh F (26 February 2013), "Drug firm Roche pledges greater access to trials data" -- Alltrials Campaign, https://www.alltrials.net/ (most recent data from March 2019) -- WHO and multi-party Joint statement on public disclosure of results from clinical trials, 18 May 2017 (accessed here, March 2021).
- Global experts of new WHO Council on the Economics of Health For All announcedon May 6 2021 at 11:20
Initial 11 members are distinguished experts in economics, health, government, finance and development from around the world.Council’s focus is on new strategies to shape economies and financial systems with the objective of building healthy societies that are just, inclusive, equitable and sustainable. It will incorporate lessons learned during the COVID-19 pandemic.Council will hold its first meeting on 6 May 2021 led by Chair Mariana Mazzucato, Professor of the Economics of Innovation and Public Value and Founding Director in the Institute for Innovation and Public Purpose at University College London. WHO is convening 11 leading figures in economics, health and development from around the world as the first members of the WHO Council on the Economics of Health for All. The Council’s role is to provide independent advice to the Director-General on addressing interrelated health and economic challenges and mapping out a way forward that supports communities and countries to build healthy societies. To do so, it will provide recommendations for a new approach to shape the economy that supports health for all as an overall goal, including more equitable and effective health systems.“I am delighted that WHO is convening this talented and driven group of global experts as the WHO Council on the Economics of Health for All, which is Chaired by the distinguished economist Professor Mariana Mazzucato,” said Dr Tedros. “I established this Council precisely to gather leading experts in economics, policy development and health, and to benefit from their knowledge and skill. I urge them to advise on a new way forward that ensures health is at the heart of all government action and investment decisions. We must value and invest in health as our most important commodity. ”The Council is holding its inaugural meeting today, kickstarting a robust and wide-ranging process to gather insights and develop actionable plans and forward looking practices built on real-world examples and lessons learned from the COVID-19 pandemic.Patron of the Council, H.E. Sanna Marin, Prime Minister of Finland, said the new body will provide strong support to WHO and countries in addressing the interconnected issues of public health and the economy.Prime Minister Marin said: “The pandemic has had a momentous impact on health, economies and societies around the world. At the same time, it has shown that, with the right approach, it is possible to protect the vulnerable, to safeguard both health and the economy. It has underlined the meaning of global solidarity and the importance of putting people at the centre of decision-making. The participation of women in the policy design and at the heart of response and recovery is essential.” She added: “We strongly believe that this Council will provide invaluable advice to both to the Secretariat and the Member States.”In addition to Professor Mariana Mazzucato, as Chair, the inaugural members of the council are Professor Senait Fisseha, Professor Jayati Ghosh, Vanessa Huang, Professor Stephanie Kelton, Professor Ilona Kickbusch, Linah Kelebogile Mohohlo, Dr Zélia Maria Profeta da Luz, Kate Raworth and Dame Marilyn Waring. Additional members may be appointed. Dr Vera Songwe will join as a special guest.“The COVID-19 pandemic has shone the brightest light ever on the great lack of capacity and alignment among essential sectors in society in how they respond to the interlinked health and economic challenges people face in their daily lives,” said Professor Mazzucato, Council Chair, Professor of the Economics of Innovation and Public Value and Founding Director in the Institute for Innovation and Public Purpose at University College London. “Government capacities for protecting public health and, in turn, safeguarding and boosting economies require interlinked strategies, investment and political commitment. Health for all must be at the heart of government investment and innovation decisions—and it must be governed with the common good in mind. The Council will work to address these many challenges and offer the world a path forward.”The WHO Council aims to reframe health for all, as a global objective, and ensure that national and global economies and finance are structured in such a way to deliver on this ambitious goal. This includes advice on what can be done and practical tools in four important areas: new ways to measure and value health for all, build up public sector capacity to drive transformative change and innovate towards achieving population health goals, and, to ensure financial systems invest in creating health. This requires a transformation in financing for health, not as a cost but a long-term investment for a “healthy society,” grounded in the fundamental truth that health and the economy are interdependent.
- WHO Director-General commends United States decision to support temporary waiver on intellectual property rights for COVID-19 vaccineson May 5 2021 at 21:51
WHO Director-General Dr Tedros Adhanom Ghebreyesus praised the commitment by the United States administration of President Joe Biden and Vice-President Kamala Harris to support the temporary waiver of intellectual property on COVID-19 vaccines in a bold move to end the pandemic as quickly as possible.