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The World Health Organization (WHO) is launching target product profiles to drive the rapid development of novel tuberculosis (TB) preventive treatment. The target product profiles characterise the most important product attributes to be considered for developing the best suited TB prevention treatments in future.

One quarter of the global population is estimated to be infected with TB and are at greater risk of developing TB disease, especially those with weakened immunity. Treatment of TB infection, also known as TB preventive treatment , aims to prevent the development of TB disease, and is one of the critical components of WHO’s End TB Strategy. At the United Nations High-level Meeting on TB in 2018, countries committed to provide TB preventive treatment to at least 30 million people by 2022.

“Existing options for TB preventive treatment still present a number of operational limitations that prevent wide-scale implementation” said Dr Tereza Kasaeva, Director, WHO Global TB Programme. “To successfully expand TB preventive treatment to the millions in need, we urgently require new drug regimens that are more effective, cheaper, shorter, easier to administer and better tolerated, than those currently available.”

The optimization of future TB preventive treatment regimens requires consideration of the efficacy and safety of the regimen components, their potential for drug-drug interactions, their propensity to generate drug resistance, and their use in specific patient populations - such as people living with HIV, pregnant women and children.

“The target product profiles identify the key product attributes to be considered for the development of best and most suitable TB prevention treatments” said Dr Christian Lienhardt, Director of Research at the Institute for Research on Sustainable Development (IRD), in Montpellier, France and who coordinated the compilation of the target product profiles. “This document should assist in aligning treatment developers’ performance and operational targets with programmatic needs at country level”.

The launch of the target product profiles is being accompanied by a live Webinar 26 August from 15h00 to 17h00 CEST,during which they will be presented to the audience, followed by a live Q&A. Speakers include Tereza Kasaeva, Director of WHO’s Global TB Programme, Saskia den Boon, Technical Officer at the WHO Global TB Programme, Christian Lienhardt from the Institute for Research on Sustainable Development (IRD) in Montpellier, France, Nim Arinaminpathy from Imperial College London, UK, Kevin Schwartzman from McGill University in Montreal, Canada and Alberto Matteelli from the University of Brescia, Italy. 

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* The webinar recording will be updated on this page soon.

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• Nine CEPI-supported candidate vaccines are part of the COVAX initiative, with a further nine candidates under evaluation, and procurement conversations on-going with additional producers not currently receiving research and development (R&D) funding through COVAX – giving COVAX the largest and most diverse COVID-19 vaccine portfolio in the world
  
• 80 potentially self-financing countries have submitted non-binding expressions of interest to the Gavi-coordinated COVAX Facility, joining 92 low- and middle-income economies that are eligible to be supported by the COVAX Advance Market Commitment (AMC)
  
• Goal of bringing the pandemic under control via equitable access to COVID-19 vaccines needs urgent, broadscale commitment and investment from countries

172 economies are now engaged in discussions to potentially participate in COVAX, a global initiative aimed at working with vaccine manufacturers to provide countries worldwide equitable access to safe and effective vaccines, once they are licensed and approved. COVAX currently has the world’s largest and most diverse COVID-19 vaccine portfolio - including nine candidate vaccines, with a further nine under evaluation and conversations underway with other >

COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance, and the World Health Organization (WHO) – working in partnership with developed and developing country vaccine manufacturers. 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->

In order to be able to secure enough doses of vaccines to protect the most vulnerable populations, such as health workers and the elderly, the next step for the partnership is to confirm potential self-financing participants’ intent to participate by 31 August and to turn these into binding commitments to join the COVID-19 Vaccine Global Access Facility (COVAX Facility) by 18th of September, with first upfront payments to follow thereafter, and no later than 9th of October 2020.

“Equal access to a COVID-19 vaccine is the key to beating the virus and paving the way for recovery from the pandemic,” said Stefan Löfven, Prime Minister of Sweden. “This cannot be a race with a few winners, and the COVAX Facility is an important part of the solution – making sure all countries can benefit from access to the world’s largest portfolio of candidates and fair and equitable distribution of vaccine doses.”

The COVAX Facility is a Gavi-coordinated pooled procurement mechanism for new COVID-19 vaccines, through which COVAX will ensure fair and equitable access to vaccines for each participating economy, using an allocation framework currently being formulated by WHO. The COVAX Facility will do this by pooling buying power from participating economies and providing volume guarantees across a range of promising vaccine candidates, allowing those vaccine manufacturers whose expertise is essential to large scale production of the new vaccines, to make early, at-risk investments in manufacturing capacity – providing participating countries and economies with the best chance at rapid access to doses of a successful COVID-19 vaccine.

The success of COVAX hinges not only on countries signing up to the COVAX Facility, but also filling key funding gaps for both COVAX R&D work and a mechanism to support participation of lower-income economies in the COVAX Facility.

“COVID-19 is an unprecedented global health challenge that can only be met with unprecedented cooperation between governments, researchers, manufacturers and multilateral partners,” said Dr Tedros Adhanom Ghebreyesus, Director-General of WHO. “By pooling resources and acting in solidarity through the ACT Accelerator and the COVAX Facility, we can ensure that once a vaccine is available for COVID-19, it’s available equitably to all countries.”

CEPI is leading COVAX vaccine research and development work, which aims to develop three safe and effective vaccines which can be made available to countries participating in the COVAX Facility. Nine candidate vaccines are currently being supported by CEPI; seven of which are currently in clinical trials. Governments, vaccine manufacturers (in addition to their own R&D), organizations and individuals have committed US$ 1.4 billion towards vaccine R&D so far, but an additional US$1 billion is urgently needed to continue to move the portfolio forward.

A further nine candidates vaccines which complement the current CEPI portfolio are currently being evaluated for inclusion in COVAX.  Furthermore, COVAX will consider procuring vaccines that complement the portfolio from any producer in the world; conversations are already underway with a number of additional manufacturers not receiving R&D support from CEPI to procure their vaccines if they are successful. Maximizing the portfolio of vaccines increases the probability of success as individual vaccines historically have a high failure rate.

“In the scramble for a vaccine, countries can act alone – creating a few winners, and many losers - or they can come together to participate in COVAX, an initiative which is built on enlightened self-interest but also equity, leaving no country behind,” said Richard Hatchett, CEO of CEPI. “Only by taking a global view can we protect those most at risk around the world from the terrible effects of this disease. COVAX can deliver the vaccines that could end the pandemic, but it needs countries to step forward both to join the COVAX Facility, and also to address the serious funding shortfalls, including for R&D. The decisions that are taken now about COVID-19 vaccines have the power to change our future. We must be courageous and ambitious in striving for a multilateral solution.”

A collaboration between Serum Institute of India (SII), Gavi and the Bill & Melinda Gates Foundation announced earlier this month will ensure up to 100 million doses of AstraZeneca or Novavax’s candidate vaccines, if successful, will be available to low- and middle-income economies through the COVAX Facility at just US$ 3 per dose. The arrangement also provides an option to secure additional doses if COVAX sees a need for it. Separate agreements between Gavi, CEPI and AstraZeneca, announced in June, guarantee a further 300 million doses of their candidate vaccine, if successful, for the COVAX Facility.

In addition, in June Gavi launched the COVAX Advance Market Commitment (AMC), a financing instrument aimed at supporting the participation of 92 lower and middle income economies in the COVAX Facility. The COVAX AMC has raised more than US$ 600 million against an initial target of securing US$ 2 billion seed funding from sovereign donors as well as philanthropy and the private sector, needed by the end of 2020. Funding the COVAX AMC will be critical to ensuring ability to pay is not a barrier to accessing COVID-19 vaccines, a situation which would leave the majority of the world unprotected, with the pandemic and its impact continuing unabated.  

80 higher-income economies, which would finance the vaccines from their own public finance budgets, have so far submitted Expressions of Interest ahead of the 31 of August deadline for confirmation of intent to participate. They will partner with 92 low- and middle-income countries that will be supported by the AMC if it meets its funding targets. Together, this group of 172 countries represents more than 70% of the world’s population. Among the group are representatives from every continent and more than half of the world’s G20 economies.

“The momentum we are witnessing behind this unprecedented global effort means there could be light at the end of the tunnel: A vaccine is our best route to ending the acute phase of the pandemic and the COVAX effort is the best way to get there,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “For higher-income countries it represents a win-win: not only will you be guaranteed access to the world’s largest portfolio of vaccines, you will also be negotiating as part of a global consortium, bringing down prices and ensuring truly global access. Signing up to the COVAX Facility gives each country its best chance at protecting the most vulnerable members of their populations – which in turn gives the world its best chance at mitigating the toll this pandemic has taken on individuals, communities and the global economy. To make this end-to-end vision a reality, we need countries to make end-to-end commitments: funding R&D, signing up to the Facility, and supporting the COVAX AMC.”

The COVAX Facility is coordinated by Gavi, the Vaccine Alliance, and forms a key part of COVAX – the vaccines pillar of the ACT Accelerator, a ground-breaking global collaboration involving vaccine manufacturers to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. The overall aim of COVAX is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world. It will achieve this by sharing the risks associated with vaccine development, and where necessary investing in manufacturing upfront so vaccines can be deployed at scale as soon as they are proven to be safe and effective, and pooling procurement and purchasing power to achieve sufficient volumes to end the acute phase of the pandemic by 2021.

The goal of COVAX is by the end of 2021 to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO prequalification. These vaccines will be offered equally to all participating countries, proportional to their populations, initially prioritising healthcare workers then expanding to cover vulnerable groups, such as the elderly and those with pre-existing conditions. Further doses will then be made available based on country need, vulnerability and COVID-19 threat. The COVAX Facility will also maintain a buffer of doses for emergency and humanitarian use, including dealing with severe outbreaks before they spiral out of control. 

 

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Notes to editors

The full list of CEPI-supported candidate vaccines is as follows:

• Inovio, United States of America (Phase I/II)
• Moderna, United States of America (Phase III)
• CureVac, Germany (Phase I)
• Institut Pasteur/Merck/Themis, France/ United States of America /Austria (Preclinical)
• AstraZeneca/University of Oxford, United Kingdom of Great Britain and Northern Ireland (Phase III)
• University of Hong Kong, China (Preclinical)
• Novavax, United States of America (Phase I/II)
• Clover Biopharmaceuticals, China (Phase I)
• University of Queensland/CSL, Australia (Phase I)

The nine candidate vaccines that are currently being evaluated for inclusion in the COVAX Facility include two from China, two from the United States of America, one from the People's Republic of Korea, one from the United Kingdom of Great Britain and Northern Ireland and one global, multi-manufacture partnership. Two of these are in Phase I trials, two are tech transfers and the remainder are at the discovery stage.

The 80 countries that have submitted expressions of interest to the Gavi-coordinated COVAX Facility include 43 that have agreed to be publicly named: Andorra, Argentina, Armenia, Botswana, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Dominican Republic, Estonia, Finland, Greece, Iceland, Iraq, Ireland, Israel, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Mauritius, Mexico, Monaco, Montenegro, New Zealand, North Macedonia, Norway, Palau, Portugal, Qatar, the People's Republic of Korea, San Marino, Saudi Arabia, Seychelles, Singapore, South Africa, Switzerland, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland and Venezuela.

In July the Gavi Board agreed on the 92 economies that will be supported the COVAX Advance Market Commitment (AMC). The full list is as follows:

• Low income: Afghanistan, Benin, Burkina Faso, Burundi, Central African Republic, Chad, the Democratic Republic of the Congo, Eritrea, Ethiopia, Gambia, Guinea, Guinea-Bissau, Haiti, Democratic People’s Republic of Korea, Liberia, Madagascar, Malawi, Mali, Mozambique, Nepal, Niger, Rwanda, Sierra Leone, Somalia, South Sudan, Syrian Arab Republic, Tajikistan, Togo, Uganda, United Republic of Tanzania  and Yemen.
• Lower-middle income: Angola, Algeria, Bangladesh, Bhutan, Bolivia, Cabo Verde, Cambodia, Cameroon, Comoros, Congo, Côte d'Ivoire, Djibouti, Egypt, El Salvador, Eswatini, Ghana, Honduras, India, Indonesia, Kenya, Kiribati, Kyrgyztan, Lao People’s Democratic Republic, Lesotho, Mauritania, Micronesia, Moldova, Mongolia, Morocco, Myanmar, Nicaragua, Nigeria, Pakistan, Papua New Guinea, Philippines, São Tomé and Principe, Senegal, Solomon Islands, Sri Lanka, Sudan, Timor-Leste, Tunisia, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Zambia and Zimbabwe
• Additional IDA eligible: Dominica, Fiji, Grenada, Guyana, Kosovo, Maldives, Marshall Islands, Samoa, St. Lucia, St. Vincent and the Grenadines, Tonga and Tuvalu.

About Gavi, the Vaccine Alliance

Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate half the world’s children against some of the world’s deadliest diseases. Since its inception in 2000, Gavi has helped to immunise a whole generation – over 760 million children – and prevented more than 13 million deaths, helping to halve child mortality in 73 developing countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningitis and yellow fever vaccines.  After two decades of progress, Gavi is now focused on protecting the next generation and reaching the unvaccinated children still being left behind, employing innovative finance and the latest technology – from drones to biometrics – to save millions more lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.gavi.org and connect with us on Facebook and Twitter.

The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Bill & Melinda Gates Foundation and other private sector partners. View the full list of donor governments and other leading organizations that fund Gavi’s work here.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated nine partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging rapid response platforms already supported by CEPI as well as new partnerships.

Before the emergence of COVID-19, CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).  

About WHO

The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.

For updates on COVID-19 and public health advice to protect yourself from coronavirus, visit www.who.int and follow WHO on Twitter, Facebook, Instagram, LinkedIn, TikTok, Pinterest, Snapchat, YouTube

 

 

 

Today, the Africa Regional Certification Commission certified the WHO African Region as wild polio-free after four years without a case. With this historic milestone, five of the six WHO regions – representing over 90% of the world’s population – are now free of the wild poliovirus, moving the world closer to achieving global polio eradication.

Only two countries worldwide continue to see wild poliovirus transmission: Pakistan and Afghanistan.

The Global Polio Eradication Initiative (GPEI) congratulates the national governments of the 47 countries in the WHO African Region for today’s achievement.

“Ending wild polio virus in Africa is one of the greatest public health achievements of our time and provides powerful inspiration for all of us to finish the job of eradicating polio globally,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “I thank and congratulate the governments, health workers, community volunteers, traditional and religious leaders and parents across the region who have worked together to kick wild polio out of Africa.”

Strong leadership and innovation were instrumental in stopping the wild poliovirus in the region. Countries successfully coordinated their efforts to overcome major challenges to immunizing children, such as high levels of population movement, conflict and insecurity restricting access to health services, and the virus’s ability to spread quickly and travel across borders.

In addition, the continued generosity and shared commitment of donors – including governments, the private sector, multilateral institutions and philanthropic organizations – to achieving a polio-free world helped build the infrastructure that enabled the African region to reach more children than ever before with polio vaccines and defeat wild polio. 

“During a challenging year for global health, the certification of the African region as wild poliovirus-free is a sign of hope and progress that shows what can be accomplished through collaboration and perseverance,” said Rotary International President Holger Knaack. “Since 1996, when Nelson Mandela joined with Rotary, the Global Polio Eradication Initiative, and governments of the African region we’ve achieved something remarkable. Today’s milestone tells us that polio eradication is possible, as long as the world remains committed to finishing the job. Let us work together to harness our collective energies to overcome the remaining challenges and fulfil our promise of a polio-free world.”

The resources and expertise used to eliminate wild polio have significantly contributed to Africa’s public health and outbreak response systems. The polio programme provides far-reaching health benefits to local communities, from supporting the African region’s response to COVID-19 to bolstering routine immunization against other vaccine-preventable diseases.

While this is a remarkable milestone, we must not become complacent. Continued commitment to strengthening immunization and health systems in the African region is essential to protect progress against wild polio and to tackle the spread of type 2 circulating vaccine-derived poliovirus (cVDPV2), which is present in 16 countries in the region. Pockets of low immunity mean such strains continue to pose a threat and the risk is magnified by interruptions in vaccination due to COVID-19, which have left communities more vulnerable to cVDPV2 outbreaks.

The GPEI calls on countries and donors to remain vigilant against all forms of polio. Until every strain is eradicated worldwide, the incredible progress made against polio globally will be at risk.

The WHO African Region’s success against wild polio has shown the world that progress against some of the biggest global health challenges is possible. The GPEI is grateful for every person, partner, donor and country who helped bring about this incredible achievement.

 

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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.

For information and multimedia content on the WHO African Region’s efforts to eradicate wild polio, please visit africakicksoutwildpolio.com. For more information on the global effort to end polio, visit polioeradication.org. 

 

 

Accurate, standardized recording and reporting of data are essential for disease control activities. Surveillance is the continued collection, collation and analysis of data and the timely dissemination of information to decision-makers for action to be taken. The new forms being introduced will also help in collecting high-quality data on Buruli ulcer to monitor progress towards the targets of the new WHO road map for neglected tropical diseases 2021–2030.

First published in 2000, the BU 01 (clinical) and BU 02 (register) forms have been used by all countries in which Buruli ulcer is endemic to report standardized data to WHO. In 2012, following progress including the use of antibiotics, the forms were revised and the BU 03 (laboratory form) was added.

The forms have been revised again after further progress and lessons learnt during the past 8 years. For the first time, the Buruli ulcer scoring form has been included to sharpen the accuracy of clinical diagnosis. 

The main modifications to the new forms include:

• for BU 01, a change in the recommended treatment regimen, with the introduction of clarithromycin instead of streptomycin, and the harmonization of some of the clinical variables with the other skin NTDs;
• for BU 02, the inclusion of the variables used to calculate the clinical score, along with variables on laboratory results and treatment completion; and
• for BU 03, the inclusion of fluorescent thin-layer chromatography to detect mycolactone as one of the provisional recommended diagnostic tests to confirm Buruli ulcer.

 

WHO will organize a virtual workshop on 27 and 28 August 2020 to introduce the updated paper and electronic forms to national control programmes, laboratory and health facility staff to ensure a common understanding in filling of the forms.

1a. Skin NTDs - BU 01 - clinical and treatment form

1b. MTNc – UB 01 - Fiche clinique et thérapeutique

2a. Skin NTDs - BU02 - Registers

2b. MTNc  ̶  UB02 – Registres

3a. Skin NTDs – BU 03  - Laboratory form

3b. MTNc – UB03 - Formulaire pour laboratoire

4a. Score - epidemiological and clinical diagnosis

4b. Score - diagnostic épidémiologique et clinique

 

If you are a close contact of someone with COVID-19 or you are a resident in a community where there is ongoing spread of COVID-19 and develop symptoms of COVID-19, call your healthcare provider and tell them about your symptoms and your exposure.