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SARS-CoV-2 Variants

2019 Novel Coronavirus (CDC) - Tue, 03/16/2021 - 06:00
Variants of SARS-CoV-2, the virus that causes COVID-19, have been reported in many countries around the world. Learn more about the current variants of concern.
Categories: C.D.C. (U.S.)

New research highlights risks of separating newborns from mothers during COVID-19 pandemic

WHO news - Mon, 03/15/2021 - 17:29

New research from WHO and partners shows that the COVID-19 pandemic is severely affecting the quality of care given to small and sick newborns, resulting in unnecessary suffering and deaths.

A study published in the Lancet EclinicalMedicine highlights the critical importance of ensuring newborn babies have close contact with parents after birth, especially for those born too small (at low birthweight) or too soon (preterm). However, in many countries, if COVID-19 infections are confirmed or suspected, newborn babies are being routinely separated from their mothers, putting them at higher risk of death and lifelong health complications.

This is especially the case in the poorest countries where the greatest number of preterm births and infant deaths occur. According to the report, disruptions to kangaroo mother care – which involves close contact between a parent, usually a mother, and a newborn baby - will worsen these risks.

Up to 125 000 babies’ lives could be saved with full coverage of kangaroo mother care. For babies born preterm or at low birthweight, kangaroo mother care (early, prolonged skin-to-skin contact with a parent and exclusive breastfeeding) is particularly critical. Among infants born preterm or at low birthweight, kangaroo mother care has been shown to reduce infant deaths by as much as 40%, hypothermia by more than 70%, and severe infections by 65%.

“Disruptions to essential health services during COVID-19 have severely affected the quality of care provided to some of the most vulnerable babies, and this includes their right to the lifesaving contact they need with their parents,” said Dr Anshu Banerjee, Director for Maternal, Newborn, Child and Adolescent Health and Ageing at WHO. “Decades of progress in reducing child deaths will be jeopardized unless we act now to protect and improve quality care services for mothers and newborns, and expand coverage of lifesaving interventions like kangaroo mother care.”

WHO advises that mothers should continue to share a room with their babies from birth and be able to breastfeed and practice skin-to-skin contact – even when COVID-19 infections are suspected or confirmed - and should be supported to ensure appropriate infection prevention practices.

“Much more attention is needed to ensure health practitioners and policymakers globally are aware of the need to keep mothers and babies together in these critical early days, especially for babies born too small or too soon,” said Queen Dube, Director of Health at the Ministry of Health in Malawi, one of the report authors. “Kangaroo Mother Care is one of our most cost-effective ways to protect small and sick newborns. According to our analysis, these risks by far outweigh the small chance of a newborn baby getting severe disease from COVID-19.”

“Kangaroo mother care is among the best interventions to improve a premature or low birthweight baby’s chances of survival, especially in low-income countries,” she added.

Evidence suggests that disruptions to kangaroo mother care may already be worryingly widespread. A systematic review of 20 clinical guidelines from 17 countries during the COVID-19 pandemic found that one-third recommended separation of mothers and newborns if the mother has or may have COVID-19. In a global survey of thousands of neonatal healthcare providers, published today in a related paper in the British Medical Journal (BMJ) Global Health, two-thirds of health workers in 62 countries reported they do not allow mothers with confirmed or suspected COVID-19 to practice routine skin to skin contact, while nearly one-quarter did not allow breastfeeding, even by uninfected caregivers.

Studies have reported mainly no symptoms or mild disease from COVID-19 in infected newborns, with low risk of neonatal death. This new study estimates that the risk of newborns catching COVID-19 would result in fewer than 2000 deaths.

However, infection during pregnancy may result in increased risk of preterm birth, which means it is even more important to ensure the right care is given to support preterm babies and their parents during the COVID-19 pandemic.

According to the most recent estimates, 15 million babies are born preterm (before 37 weeks) each year and 21 million are born at low birthweight (under 2.5kg). These babies face significant health risks including disabilities, developmental delays and infections, while prematurity-related complications are the leading causes of death of newborns and children under 5.

 

About the study

WHO authors have contributed to the following paper: Preterm care during the COVID-19 pandemic: A comparative risk analysis of neonatal deaths averted by kangaroo mother care versus mortality due to SARS-CoV-2 infection in The Lancet Eclinical Medicine. A related study by the COVID-19 Small and Sick Newborn Care Collaborative Group was published today in the British Medical Journal, Small and sick newborn care during the COVID-19 pandemic: global survey and thematic analysis of healthcare providers’ voices and experiences. BMJ GH. DOI:10.1136/bmjgh-2020-004347

 

Call for expression of interest – NGO representatives for ECDC’s Advisory Forum

ECDC - News - Mon, 03/15/2021 - 14:00
The European Commission has launched a call for expression of interest to appoint representatives of non-governmental organisations to ECDC’s Advisory Forum.
Categories: C.D.C. (Europe)

COVID-19 Solidarity Response Fund marks first anniversary and appeals for continued support

WHO news - Mon, 03/15/2021 - 12:58
  • The fund has raised more than US$ 242 million from more than 661 000 individuals, corporations, and other organizations to support WHO and partners’ global COVID-19 response.
  • The fund helps WHO to deploy lifesaving supplies, information and research to countries across the globe.
  • An additional US$ 1.96 billion is needed for WHO in 2021 to continue coordinating global pandemic response, more than 60% will go towards requirements for the Access to COVID-19 tools, including diagnostics, treatments and vaccines.

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 One year ago WHO created the COVID-19 Solidarity Response Fund to respond to the unprecedented show of support by individuals and companies to help WHO in the fight against COVID-19. Powered by the UN Foundation and the Swiss Philanthropy Foundation, it was developed as an innovative platform to enable private companies, individuals and other organizations to contribute directly to WHO’s efforts to prevent, detect, and respond to COVID-19 around the world.

The fund’s first year has seen unprecedented solidarity: to date, more than 661 000 donors have contributed nearly US$ 250 million. The funds have be used to  provide  millions of frontline workers with critical personal protective equipment, medical supplies, and testing kits; to  manage misinformation and the infodemic; support vulnerable populations like refugees and displaced persons; and helped accelerate the research on vaccines, tests, and treatments.

“I sincerely thank every individual, corporation and other organization for their donations to the Solidarity Response Fund,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Your generosity has made a difference. On the fund’s one-year anniversary, we have seen what we can accomplish together in times of need”.

The Solidarity Response Fund has been a critical source of funding for the WHO’s overall  response. Since the beginning of the pandemic, WHO has shipped nearly 250 million items of personal protective equipment and vital medical supplies including oxygen across more than 150 countries, strengthened hundreds of national and subnational laboratories with technical support, supplied more than 250 million COVID-19 tests; coordinated the deployment of more than 180 teams across the world; and supported more than 12 000 intensive care beds in health systems that might otherwise have been overwhelmed.

Despite this progress, current trends show that the fight is far from over. That’s why today the fund launches a renewed call for action for funds to contribute to the estimated   US$ 1.96 billion required by WHO in 2021 to respond to remaining and new challenges in the fight against COVID-19.

Contributions to the next phase of the fund will support the efforts of WHO and its partners to continue to suppress transmission, reduce exposure, counter misinformation, protect the vulnerable, reduce mortality and morbidity and accelerate equitable access to new COVID-19 tools – including through WHO’s work with the ACT-Accelerator, to scale up vaccination globally, particularly for the most vulnerable countries, and ensure the delivery of life-saving supplies.

The recently launched WHO Foundation will lead the next phase of the Solidarity Response Fund to support the continuing fight against the COVID-19 pandemic, working in collaboration with the United Nations Foundation and a global network of fiduciary partners.

“The COVID-19 Solidarity Response Fund galvanized an astonishing outpouring of global generosity beyond anything we have seen before.  We put all the resources of the UN Foundation behind this task and were overwhelmed by the global response that enabled us to get critical funds to the most urgent needs in the devastating first year of the pandemic. The Solidarity Response Fund is a true testament to the power of collective action, and what can be achieved when people from every sector and every corner of the world act together to respond to overcome a collective threat,” said Elizabeth Cousens, President and CEO of the UN Foundation.

Launched in May 2020, the WHO Foundation is an independent grant-making organization       that supports WHO’s efforts to address urgent global health challenges.

“COVID-19 has affected all of us. Every country. Every company. Every community. It was inspiring to see the world rally behind the WHO last year in the form of hundreds of thousands of contributions to its Solidarity Response Fund. That money was put to good use and saved countless lives," said Anil Soni, CEO of the WHO Foundation. "I am committed to maintaining the success of the Fund as a vehicle for individuals and corporations to power the global fight against COVID-19. This pandemic won't be over anywhere until it's over everywhere, and donations to the Solidarity Response Fund help move the world towards that goal.”

The COVID-19 Strategic Preparedness and Response Plan (SPRP), and accompanying guidelines, issued in February 2021, fully articulates the basis for WHO’s appeal. The document guides coordinated action that WHO must take at national, regional, and global levels to overcome the ongoing challenges in the response to COVID-19, address inequities, and plot a course beyond the pandemic.

“We have achieved so much over the past year. Unfortunately, the pandemic is far from over and we can’t give up the fight yet. We thank you for your contributions and seek your continued support to beat COVID-19.” added Dr Tedros. 

 

Notes to editors

 Report of WHO’s 2020 response to COVID-19.

Read more about WHO’s response to COVID-19

About the Solidarity Response Fund

The COVID-19 Solidarity Response Fund, powered by the WHO Foundation in collaboration with UNF and a global network of partners is the major way for individuals, corporations, foundations, and other organizations around the world to directly support the work of WHO and its partners to help countries prevent, detect, and respond to the COVID-19 pandemic, especially where needs are greatest.

About the WHO Foundation

The WHO Foundation is an independent grant-making foundation based in Geneva that sets out to protect the health and well-being of everyone in every part of the world, working alongside the World Health Organization and the global health community. It aims to support donors, scientists, experts, implementing partners, and advocates around the world in rapidly finding new and better solutions to the most pressing global health challenges of today and tomorrow. The Foundation will target evidence-based initiatives that support WHO in delivering Sustainable Development Goal (SDG) 3 (To ensure healthy lives and promote well-being for all). It is focused on reducing health risks, averting pandemics, better managing diseases, and creating stronger health systems. It tackles these areas by building awareness and supporting its partners, including WHO, so that every life is invested in and the world is ready for any health emergency that may arise.  

About the United Nations Foundation

The United Nations Foundation is an independent charitable organization created to be a strategic partner for the United Nations to address humanity’s greatest challenges, build initiatives across sectors to solve problems at scale, and drive global progress.

Guidance for COVID-19

2019 Novel Coronavirus (CDC) - Mon, 03/15/2021 - 06:00
CDC COVID-19 Guidance Documents
Categories: C.D.C. (U.S.)

People at Increased Risk

2019 Novel Coronavirus (CDC) - Mon, 03/15/2021 - 06:00
People Who Need to Take Extra Precautions
Categories: C.D.C. (U.S.)

14 days to World TB Day 2021

WHO news - Mon, 03/15/2021 - 04:47

14 days to World TB Day 2021
600 days to reach 2022 global TB targets
Every day counts to save more lives
The clock is ticking! 

In just fourteen days, millions around the globe will come together to commemorate World TB Day on 24 March. The theme of World TB Day 2021 - ‘The Clock is Ticking’ –conveys the sense that the world is running out of time to act on the commitments to end TB made by global leaders. This is especially critical in the context of the COVID-19 pandemic that has put End TB progress at risk, and to ensure equitable access to prevention and care in line with WHO’s drive towards achieving Universal Health Coverage.

On World TB Day, WHO is calling for action on several fronts to ensure that the commitments made to end TB are achieved:

  • Countries are urged to implement ten priority recommendations outlined in the 2020 progress report on TB issued by the United Nations Secretary-General António Guterres and developed with WHO support. The report stressed that high-level commitments and targets have galvanized global and national progress towards ending TB, but urgent and more ambitious investments and actions are required, especially in the context of the COVID-19 pandemic. WHO is urging countries to implement the  ten priority recommendations from the report to put the world on track to reach agreed targets by 2022 and beyond.
  • Essential TB services should be sustained during the COVID-19 pandemic to ensure that gains made in the fight against TB are not reversed.  All measures should be taken to ensure continuity of services for people who need preventive and curative treatment for TB, including during emergencies such as the COVID-19 pandemic. People-centred delivery of TB prevention, diagnosis, treatment and care services, including through digital technologies, should be ensured in tandem with the COVID-19 response.
  • Tackling health inequities is vital to ensure health for all. The COVID-19 pandemic has drawn attention to the deep disparities that persist between and within countries, some of which are being exacerbated and risk widening even further. People with TB are among the most marginalized and vulnerable, facing barriers in accessing care.  In alignment with World Health Day, 7 April 2021, WHO is calling for global action to address health inequities for people with TB and other diseases.
  • Systematic screening should be scaled-up to help reach all people with TB prevention and care. It is estimated that close to three million people with TB are not diagnosed or reported annually around the world. Improved TB screening using new tools and approaches to reach all people with care could help bridge this gap. Systematic screening is critical to ensure we can detect TB early in the people who need it, while also identifying people who could benefit from TB preventive treatment. WHO is releasing new guidelines on TB systematic screening along with an accompanying operational guide on 22 March
  • Ending TB requires concerted action by all sectors to provide the right services, support and enabling safe environment in the right place, at the right time. Everyone has a role to play in ending TB – individuals, communities, businesses, governments, societies.

“We are running out of time to fulfil global commitments to end TB. Even as we battle COVID-19, we must not ease up the fight against TB but redouble efforts to save more lives and end suffering,”  said Dr Tereza Kasaeva, Director of WHO’s Global TB Programme. “We need political will and accountability, financial resources, engagement from all sectors, and community ownership, and we need this now. The clock is ticking!”

WHO has developed an advocacy and communications package to support awareness building and drive action across all levels, in the lead up to and on World TB Day. Please access the package below to join us in amplifying efforts to end TB.

The World Health Organization (WHO) is organizing a special virtual talk show to commemorate World TB Day on 24 March at 13:00H CET. This will put the spotlight on TB in the midst of the ongoing COVID crisis.
Join us for an exciting event that will take place in a talk-show format with speakers connected by video on the platform of WHO’s interactive web-platform- End TB Forum. 

Key speakers will include WHO Director-General Dr Tedros Adhanom Ghebreyesus and other senior WHO leadership, Health Ministers and high-level government representatives, Heads of Agencies,  TB survivors, civil society and partners. The Show will be broadcast live, with Q&A from the audience online.

Register here

ACT-Accelerator releases prioritised strategy and budget for 2021 to change the course of the evolving COVID-19 pandemic

WHO news - Sat, 03/13/2021 - 11:50

Launched in April 2020 by the World Health Organization (WHO), European Commission, France and The Bill & Melinda Gates Foundation, the ACT Accelerator is a partnership of leading public health agencies with equity at its heart.

In under a year, the ACT Accelerator has driven real progress to accelerate the end of the COVID-19 pandemic. It has accelerated the development of COVID-19 tests, treatments, vaccines and health systems and transformed the ability to tackle COVID-19 on a global scale, but only if the world can ensure the equitable distribution of these vital tools.

However, the world continues to face an unprecedented and rapidly evolving threat from COVID-19. Three major shifts in the pandemic and the operating environment for the ACT Accelerator have necessitated a refresh of ACT Accelerator priorities, financing requirements, and investment case. First, COVID-19 vaccines are now available, but face acute supply constraints. Second, virus variants are emerging with increasingly concerning characteristics. Third, despite valuable support from governments, regulators, manufacturers, and other stakeholders, there has been insufficient investment in global solutions to scale COVID-19 tools.

The ACT-Accelerator is well positioned to respond to these challenges. In 2020, a substantial focus was on developing and evaluating a sound product portfolio by investing in R&D, product assessment, and market shaping, while laying the groundwork for large-scale procurement and in-country delivery. Now that an initial set of effective and affordable COVID-19 tools is available, resources are increasingly focused on optimizing their public health impact. In 2021, ACT Accelerator aims to fully leverage these existing tools and available volumes, then expand manufacturing, while continuing to invest in further R&D and product optimization.

The original ACT-Accelerator investment case published in September 2020 outlined a total requirement of US$ 38.1 billion to fully fund its work. Based on the refreshed strategic priorities outlined above, the Pillars have adjusted their resource needs. Despite generous donor contributions amounting to US$ 11.0 billion to date, ACT Accelerator continues to require an additional US$ 22.1 billion in 2021 to deliver on its full promise, and fund its vital work to deliver over 2 billion doses of vaccines, 900 million tests and up to 100 million of new treatment courses. The publication of a more detailed Strategy and Budget outlines the detail behind these numbers.

Tackling COVID-19 requires substantial financial investments, but the financial and economic ramifications of inaction are far greater. In January 2021, a study commissioned by the International Chamber of Commerce demonstrated that even with strong COVID-19 vaccine coverage in high-income countries, inequitable access to COVID-19 tools elsewhere would cost high-income economies an additional US$ 2.4 trillion in 2021 alone. Investing in ACT Accelerator dwarfs the potential multiplier benefits of domestic fiscal support investments. If COVID-19 transmission is uncontrolled anywhere in the world, it remains a threat to everyone everywhere in the world.

Commenting on today’s release of the Strategy and Budget, Dr Tedros Adhanom Ghebreyesus, Director-General of WHO, said: “The ACT Accelerator has made strong progress. But new viral variants, limited vaccine supply, and underinvestment have resulted in the need to refresh the strategy and budget that chart the roadmap out of the pandemic. As we approach the one-year anniversary of the ACT Accelerator, we call on all nations to come together in global solidarity. It isn’t just the right thing to do, it is also the fastest and most effective way to save lives, protect health systems and restore economies.”  

Dr Richard Hatchett, CEO of CEPI, said: “In recent weeks COVAX has begun to turn the tide on the early inequity of the global vaccine rollout. However, with the increased spread of COVID-19 variants, we have entered a new and less predictable phase of the pandemic. It is crucial that the vaccines we have developed are shared globally, as a matter of the greatest urgency, to reduce the prevalence of disease, slow down viral mutation, and bring the pandemic to an end. And in parallel, we must redouble our R&D efforts so we have the tools we need to tackle emerging variants of the virus.” 

Emma Hannay, Chief Access Officer & ACT-Accelerator Lead for FIND, said: “In less than a year, the ACT-Accelerator partnership has spurred the development and delivery of affordable, reliable rapid tests, scaled up manufacturing, and reserved important volumes for LMICs. But while we are moving quickly, so is the virus: the emergence of new variants across the globe underscores the ongoing need for equitable access to testing and strong surveillance systems so that we are not flying blind as the pandemic evolves. Detection of flare-ups and hotspot is key to stop case numbers from rebounding during vaccine roll out.”

Dr Seth Berkley, CEO of Gavi, The Vaccine Alliance, said: "Thanks to the US$6 billion committed by its donors to date, the Gavi COVAX Advance Market Commitment has been able to begin protecting at-risk groups in lower-income countries with life-saving COVID-19 vaccines. While our work is only just beginning, we can now see the benefits of a multilateral solution to this pandemic. I encourage countries and others to continue to support the ACT Accelerator's critical mission across all pillars," said Seth Berkley, CEO of Gavi, the Vaccine Alliance.”

Peter Sands, Executive Director of The Global Fund, said: “The ACT-Accelerator partnership has achieved major progress in less than a year, including the procurement of over 50 million COVID-19 tests for low- and middle-income countries. However, we now face a tough battle as new variants emerge, taking us into unknown terrain. Reducing inequities in testing is a critical, if we are to succeed in containing the spread of the virus and monitoring the emergence of new variants. We must continue to scale up the availability and deployment of rapid and affordable tests to support countries in their response to a fast-evolving pandemic.”

Henrietta Fore, UNICEF Executive Director, said: “As the production and availability of the COVID-19 vaccines ramp up, the revised strategy will ensure that countries have the resources and support they need to administer them equitably. As UNICEF supports this historic initiative, we will also continue focusing on other essential maternal and child health services, including immunization, which are critical to saving lives while we work to turn the tide on the pandemic.”

Dr Philippe Duneton, Unitaid Executive Director, said: "This new strategy reflects the epidemiological reality we are all now facing - a mutating virus that doesn't respect national borders, which threatens the effectiveness of the tools we have to fight this pandemic. Now is the moment to push ahead with a firm commitment to equitable access for all to the treatments and tests we need to defeat COVID-19, alongside the roll-out of vaccines. Research and development, country-preparedness and the procurement of proven treatments, including medical oxygen, will all be vital in the months to come."

We must ACT now, and ACT together, to end the acute phase of the pandemic.

 

Notes to Editors

The 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 AG-RDTs to LMICs.
  • 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, hosted by the World Health Organisation (WHO).

Since April 2020, the ACT-Accelerator has supported the fastest, most coordinated, and successful global effort in history to develop tools to fight a 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 poised to roll-out worldwide, low-cost high-performing antigen rapid diagnostic tests can now detect transmission anywhere, affordable therapy for severe disease can save lives in any setting, and health systems are being prepared for the roll out of tools.

Find out more: https://www.who.int/initiatives/act-accelerator

 

Essential Workers & Employees: When & How to Get Vaccinated

2019 Novel Coronavirus (CDC) - Sat, 03/13/2021 - 07:00
If you're an essential worker, it's important to find out where to get vaccinated as soon as it is available to you.
Categories: C.D.C. (U.S.)

Post Vaccine Considerations for Residents

2019 Novel Coronavirus (CDC) - Sat, 03/13/2021 - 07:00
Considerations for Long-Term Care Residents following COVID-19 Vaccination.
Categories: C.D.C. (U.S.)

Cases & Deaths by County

2019 Novel Coronavirus (CDC) - Fri, 03/12/2021 - 21:04
Find national and local rates for COVID cases and deaths in the United States.
Categories: C.D.C. (U.S.)

WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19

WHO news - Fri, 03/12/2021 - 18:00

The World Health Organization (WHO) today listed the COVID-19 vaccine Ad26.COV2.S, developed by Janssen (Johnson & Johnson), for emergency use in all countries and for COVAX roll-out. The decision comes on the back of the European Medicines Agency (EMA) authorization, which was announced yesterday.

“Every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. “But the hope offered by these tools will not materialize unless they are made available to all people in all countries. I urge governments and companies to live up to their commitments and to use all solutions at their disposal to ramp up production so that these tools become truly global public goods, available and affordable to all, and a shared solution to the global crisis.”

The vaccine from Janssen is the first to be listed by WHO as a single dose regimen, which should facilitate vaccination logistics in all countries. The ample data from large clinical trials shared by the company also shows that the vaccine is effective in older populations.

To expedite listing of the vaccine, WHO and a team of assessors from all regions adopted what is called an ‘abbreviated assessment’ based on outcomes of the EMA review, and evaluation of quality, safety and efficacy data focused on low- and middle-income country needs. The WHO assessment also considered suitability requirements such as cold chain storage and risk management plans to be implemented in countries.

While the vaccine needs to be stored at -20 degrees, which may prove challenging in some environments, it can be kept for three months at 2-8°C and it has a long shelf life of two years.

WHO will convene its Strategic Advisory Group on Immunization Experts next week to formulate recommendations on use of the vaccine. In the meantime, WHO continues to work with countries and COVAX partners to prepare for roll-out and safety monitoring. The COVAX Facility has booked 500 million doses of the vaccine.

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 has also listed the Pfizer/BioNTech, Astrazeneca-SK Bio and Serum Institute of India vaccines for emergency use.

See more on EUL


 

When to Quarantine

2019 Novel Coronavirus (CDC) - Fri, 03/12/2021 - 07:00
Quarantine If You Might Be Sick
Categories: C.D.C. (U.S.)

Sick Parents and Caregivers

2019 Novel Coronavirus (CDC) - Fri, 03/12/2021 - 07:00
If a child's parent or caregiver is sick with COVID-19, follow the steps below to help protect the child from infection.
Categories: C.D.C. (U.S.)

Recommandations sur l'identification des cas suspects de COVID-19 chez le personnel soignant et les patients hospitalisés

2019 Novel Coronavirus (CDC) - Fri, 03/12/2021 - 07:00
This document is provided by CDC and is intended for use in non-US healthcare settings. This document provides guidance on the identification or screening of healthcare workers and inpatients with suspected COVID-19.
Categories: C.D.C. (U.S.)

COVID-19 Vaccination Considerations for Persons with Underlying Medical Conditions

2019 Novel Coronavirus (CDC) - Fri, 03/12/2021 - 07:00
If you have an underlying medical condition, this can help you make an informed decision about getting a COVID-19 vaccination.
Categories: C.D.C. (U.S.)

When You Can be Around Others After You Had or Likely Had COVID-19

2019 Novel Coronavirus (CDC) - Fri, 03/12/2021 - 07:00
If you have or think you might have COVID-19, it is important to stay home and away from other people. Staying away from others helps stop the spread of COVID-19.
Categories: C.D.C. (U.S.)

COVID-19 Hospitalization and Death by Race/Ethnicity

2019 Novel Coronavirus (CDC) - Fri, 03/12/2021 - 07:00
Risk of COVID-19 hospitalization and death by race/ethnicity
Categories: C.D.C. (U.S.)

Toolkit for Childcare Programs

2019 Novel Coronavirus (CDC) - Fri, 03/12/2021 - 07:00
This toolkit provides web links, fact sheets, posters and other resources for childcare facilities and consumers.
Categories: C.D.C. (U.S.)

Guidance for SARS-CoV-2 Point-of-Care Testing

2019 Novel Coronavirus (CDC) - Fri, 03/12/2021 - 07:00
This CDC webpage provides guidance on the regulatory requirements for SARS-CoV-2 POC testing, using POC tests safely, and information on reporting POC test results.
Categories: C.D.C. (U.S.)

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