GPEI-Faster, better, more equitable

Opening of the 75th World Health Assembly – 22 May 2022. © WHO

May 2022, Geneva, Switzerland – Global public health leaders convening last week at the World Health Assembly called for urgent action to end polio once and for all before a unique window of opportunity closes for good.

Recent efforts have had a clear impact on the global epidemiology of poliovirus, with endemic wild poliovirus transmission at extremely low levels, with just Pakistan and Afghanistan remaining endemic, and efforts to curb circulating vaccine-derived polioviruses (cVDPVs) showing fruit. Steps have been taken towards securing the legacy of polio eradication systems and know-how, under the Strategic Action Plan for Polio Transition. But delegates cautioned that this ‘window of opportunity’ will not remain open indefinitely, as experts pointed to recent concerning developments such as new wild poliovirus cases confirmed in Pakistan (the first cases reported in 15 months), wild poliovirus detected in south-east Africa (the first on the African continent since 2016), and polio re-emergence in Ukraine and Israel.

“Worrying developments in recent months highlight how fragile this progress is,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, addressing the Assembly. “These developments are tragic for the children affected and their families. But the reality is that in the final stages of an eradication effort, this is expected. This year, we have the real opportunity to halt wild poliovirus transmission. At the same time, we must respond faster and better to cVDPV outbreaks, to interrupt all transmission by end-2023.”

Success, however, depends on reaching remaining children who have not been immunized – the ‘zero-dose’ children at the heart of the Immunization Agenda 2030 (IA2030).

Such a need was identified at this month’s G7 joint Development and Health Ministers meeting in Berlin, Germany, where discussions focused on “supporting vaccine equity and pandemic preparedness in developing countries”. The meeting cautioned against letting global crises interfere with other development and public health priorities and urged continued support for existing efforts, including global polio eradication. Polio eradication is a clear and concrete example of the value of working in close integration with other public health and development efforts. Polio staff continue to contribute to the COVID-19 pandemic response and immunization recovery efforts, together with supporting the introduction and roll-out of COVID-19 vaccines.

Ministers and high-level delegations from 20 countries of regions affected by both WPV1 and cVDPV met with senior GPEI leaders for focused discussions on concrete ways to close the final chains of virus transmission. The meetings were chaired by Polio Oversight Board chair Dr Chris Elias from the Bill & Melinda Gates Foundation and respective WHO AFRO and EMRO Regional Directors, Dr Matshidiso Rebecca Moeti and Dr Ahmed Al-Mandhari. Key priorities were the importance of reaching zero-dose children, the challenges of complex emergencies and weak health systems, as well as the importance of inter-country coordination and collaboration.

Underscoring the urgency in giving the world one less infectious disease to worry about once and for all, WHO Director-General Dr Tedros issued a clear challenge to the Assembly: “For countries affected by polio, it is imperative that you reach every last child, and that you respond to vaccine-derived strains with the same urgency as you would to a wild strain. For countries that are now polio-free, it is crucial to accelerate efforts to use your polio assets and infrastructure to build stronger, more resilient health systems. And for all partners and donors, please help us seize the moment to raise predicable funding, for eradication and transition. I urge you to join us in Berlin this October at the pledging event* generously co-hosted by the Government of Germany. Your decision this week to support a stronger, sustainably financed WHO will enable us to sustain capacity in countries that are now polio-free and on the pathway to transition. Thank you all once again for your commitment to consigning polio to the history books.”

This call to action was echoed by Rotary International, the civil society partner of the global eradication effort. Addressing the Assembly on behalf of its 1.2 million members worldwide, Rotarian and Rotary Representative to the UN in Geneva, Professor Dr Pierre Hoffmeyer, concluded: “We call on all countries to address gaps in routine immunization levels and ensure robust surveillance to prevent further virus spread and avert future outbreaks.”

*In April 2022, GPEI partners, led by WHO Director-General, launched the ‘Investment Case for Polio Eradication’, the sister document to the Polio Eradication Strategy 2022-2026, which lays out the economic and humanitarian rationale for investing in a polio-free world, as well as the broader benefits of polio eradication. In October 2022, Germany will generously co-host a global pledging moment, giving the international development community the opportunity to publicly re-commit to this effort, including to support a stronger and sustainably-funded WHO, so that the organization can maintain its capacity to support countries in achieving and sustaining polio eradication, and continue to benefit broader public health efforts, including support for pandemic preparedness and response.

Children under 5 years vaccinated with nOPV2 in the Lakeside city of Aguegue (Oueme Department) © WHO/Benin

When it comes to stopping polio outbreaks, speed is everything. Rapid action within a specific window of time is critical. Malawi declared a public health emergency in February after uncovering a case of wild poliovirus type 1 (WPV1) – its first in 30 years. The country sprang into action, leading the charge in a multi-country vaccination response aiming to reach more than 23 million children in the sub-region with bivalent oral polio vaccine (bOPV). Three months later, neighbouring Mozambique which has been part of the same response, declared its own emergency after the virus paralyzed a child on its home soil. The country is doubling down on efforts to protect its children.

The nimble actions of the south-eastern African nations have been lauded by the GPEI as examples of what must be done to effectively quash circulation of the highly infectious poliovirus.

“Indeed Malawi has moved quickly; thus far we haven’t seen further detection of WPV1 in the country,” said Dr Modjirom Ndoutabe, Polio Programme Coordinator a.i., WHO AFRO. “It is important that further campaign rounds are carried out as planned and reach all targeted children to boost immunity in Malawi and its surrounding countries, and we’re working with governments to maintain heightened surveillance sensitivity so that we can closely track this virus through this outbreak period,” he added.

“What we’ve seen in Malawi and Mozambique following their detections, but also Tanzania, Zambia and Zimbabwe engaged in the response is encouraging. The need for speed in recognizing and communicating the public health threat and conducting quality vaccination campaigns to protect children cannot be understated,” said Aidan O’Leary, Director of WHO’s polio eradication programme.

Addressing a dual threat

Wild poliovirus is not the only form of poliovirus facing the African Region, or the world at large. Outbreaks of circulating vaccine-derived poliovirus (cVDPV) continue to pose an equally menacing threat to countries. Through rollout of a new vaccine to counter the most prevalent form of these outbreaks, cVDPV2, transmission has been stopped in the majority of countries that have deployed the tool. Additionally, a significant number of outbreaks have been recently closed following use of the traditional monovalent oral polio vaccine type 2 (mOPV2).

“WHO African Region’s Rapid Response Team (for polio) recently conducted a review of polio outbreaks over the past two years, looking at time passed since last virus detections in infected countries, surveillance quality indicators, and immunization response quality and immunity profiles of populations. I am pleased to say that 32 separate emergences of cVDPV in the Region have been declared closed across 13 countries in Africa,” said Dr Ndoutabe.

“Closure of these cVDPV outbreaks is testament to the work that has gone into achieving the high levels of vaccination coverage needed to stop transmission, and efforts to sharpen surveillance for the disease. It also illustrates the effectiveness of the vaccines we have to do the job,” said O’Leary. “Regardless of which tool is used, GPEI urges all countries affected by poliovirus to act without delay, in line with timelines contained in its SOPs for outbreak response. We must ensure that actions are commensurate with the public health emergency that polio is, despite challenges,” he reiterated.

Both viruses found in Malawi and Mozambique stem from WPV1 that was circulating in endemic Pakistan in 2019 and 2020. Though wild poliovirus cases are dwindling – currently at the lowest level in history – the fresh detections underscore both the danger of importation and the need to finish the job.

In this two-part video series, we chat with Dr Ananda Bandyopadhyay, Deputy Director of Polio Technology, Research & Analytics, BMGF, about the new tool in GPEI’s kit to combat cVDPV2: novel oral polio vaccine type 2 (nOPV2).

11 October 2021

Following careful review of safety and genetic stability data from mass immunization campaigns conducted with the novel oral polio vaccine type 2 (nOPV2), the Strategic Advisory Group of Experts on immunization (SAGE) today endorsed the transition to the next use phase for the vaccine. WHO’s independent Global Advisory Committee on Vaccine Safety (GACVS) and SAGE confirmed that there were no major safety concerns associated with nOPV2 after reviewing data from campaigns that used more than 65 million doses in Nigeria, Liberia, Congo and Benin earlier this year. Rollout of nOPV2 began in March and to date approximately 100 million doses have been administered to children across seven countries.

This decision marks the end of the vaccine’s initial use period and the removal of certain use criteria for countries affected by circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks. It means that more countries will be eligible to use the vaccine under its WHO Emergency Use Listing (EUL) recommendation, once verified for use and as supply allows.

“The move is a positive and welcome advancement as GPEI and countries strive to bring cVDPV2 outbreaks to an end, and sees the achievement of a milestone outlined in goal 2 of our strategic plan: the goal to stop cVDPV2,” commented Aidan O’Leary, WHO’s director of polio eradication. “Not only does the decision inspire further confidence in nOPV2 as a safe and effective tool, it will facilitate a smoother preparedness process for countries looking to use the vaccine in the future,” he added.

“We are very pleased with the SAGE’s endorsement of transitioning nOPV2 to the next rollout phase. Progress like this is a result of strong partnerships at every level and we must continue forging forward together, using innovative tools like nOPV2, to reach every last child and end all forms of polio for good,” said Akhil Iyer, the UNICEF Director of Polio Eradication.

Ananda Bandyopadhyay, deputy director from the Bill & Melinda Gates Foundation and co-lead of GPEI’s nOPV2 Working Group stated, “Today is an important milestone in the road to polio eradication. Innovation has always been key to progress, and this tool – the first vaccine ever to be approved under WHO’s EUL pathway – is a shining example of how the GPEI responds to challenges, but the work is far from over.” BMGF is a core partner in GPEI and has funded the development of nOPV2 from its inception.

Requirements for rollout

Prior to this transition, countries were required to meet an additional set of strict criteria to use nOPV2 during its initial use period. These were developed by GPEI and endorsed by SAGE to allow for even closer monitoring of nOPV2’s performance during its introductory phase and early large-scale uses. While countries no longer need to meet these initial use protocols, use of nOPV2 remains subject to specific post-deployment requirements under EUL, such as monitoring for safety and effectiveness.

“As we move forward into the next phase of the vaccine’s rollout, countries will still need to meet special use requirements, but they will be less onerous,” said Simona Zipursky, WHO co-lead of the GPEI’s nOPV2 Working Group. “GPEI will continue to work with all countries who wish to roll out nOPV2 to help them meet these remaining criteria,” she added.

Optimal response with available vaccine

In addition to those who have already rolled out the new tool, 16 other countries are also verified as ready to use nOPV2 by GPEI and a further 17 are in the midst of preparations. More nOPV2 campaigns are due to launch later this year, however, supply of the vaccine is limited.

Active cVDPV2 outbreaks are ongoing in more than 20 countries across Africa and Asia and there have been recent detections of the virus in Europe. COVID-19 has impacted production of the vaccine, including by limiting supplies, available personnel and manufacturer capacity. GPEI is working with nOPV2’s manufacturer, Bio Farma, to increase supply as soon as possible and is accelerating efforts to bring a second manufacturer online. A GPEI prioritization framework will guide distribution of nOPV2 for the immediate term, until supply is increased.

“We are seeing sharp rises in demand for nOPV2, which is testament to the vaccine’s field performance, and we are working to increase supply as quickly as feasible,” said O’Leary. “We must be very clear though, that outside of nOPV2, there is no shortage of effective type-2 containing oral polio vaccines, and countries should not delay in responding to an outbreak. In line with SAGE’s guidance they should respond rapidly with whichever of the vaccines (mOPV2/nOPV2) is available to them,” he said.

With nOPV2 not yet WHO-prequalified, monovalent oral polio vaccine type 2 (mOPV2) ̶ nOPV2’s counterpart and close relative ̶ remains available to countries for outbreak response. The vaccine has a track record of successfully stopping cVDPV2 transmission and from 2019 to 2020, nearly 80% of outbreaks were closed following just two rounds of immunization. Trivalent oral polio vaccine (tOPV), containing all three vaccine serotypes, may be a more appropriate tool in situations where there is co-circulation of wild polio virus type 1 (WPV1) and cVDPV2.

“All OPVs can stop outbreaks,” said O’Leary. “Regardless of which vaccine is used, the key for any successful [outbreak] response is achieving high levels of vaccination coverage and quickly. That is what we need to remain mindful of and achieve. nOPV2 is only one of the effective vaccines in our toolkit and GPEI will continue to support countries to respond as rapidly as possible to outbreaks, as per the SAGE guidance.”

Next steps for nOPV2 development

Polio remains a Public Health Emergency of International Concern (PHEIC) under International Health Regulations, enabling nOPV2’s continued use through EUL. Field data collection and analyses will be ongoing to support the vaccine’s prequalification and full licensing, expected in 2023. Among other studies, a phase III clinical trial is currently underway in the Gambia.

GENEVA, 10 June 2021 – 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.”

Media contacts:

Oliver Rosenbauer
Communications Officer, World Health Organization
Email: rosenbauero@who.int
Tel: +41 79 500 6536

Ben Winkel,
Communications Manager, Global Health Strategies
Email: bwinkel@globalhealthstrategies.com
Tel: +1 323 382 2290

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.

Watch launch the event.

Little girl receiving polio drops © WHO/AFRO

13 March 2021, Brazzaville – To rapidly and sustainably stop outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2) in African countries, a modified vaccine, known as novel oral polio vaccine type 2 (nOPV2) is now being rolled out.

Last year, on 25 August 2020, Africa made history with the African Region Certification Commission for Polio Eradication independently certifying that the Region was free of wild poliovirus. This is the second disease to be kicked out of Africa after smallpox more than 40 years ago.

This achievement is remarkable, considering that in the 1990s wild poliovirus paralysed more than 75,000 African children every single year – a situation that prompted Nelson Mandela in 1996, joined by Rotary International and other partners, to issue a stark call to action: Kick Polio Out of Africa!

All strains of wild poliovirus have now been interrupted in the continent. The last case of wild poliovirus was in August 2016.

However, this tremendous progress remains an unfinished success story. Although Africa is free of wild poliovirus, countries continue to be affected by another form of the virus, known as circulating vaccine-derived poliovirus type 2 (cVDPV2). Such strains are rare, but can occur in under-immunized communities with limited access to safe water and sanitation.

Populations that are adequately immunized are protected from both wild and vaccine-derived strains of poliovirus. However, because of gaps in immunization coverage across Africa, 20 countries have been affected by cVDPV2 outbreaks since 2018.

Now, intensified efforts are being launched to finish polio once and for all, to ensure no child in Africa will ever be paralysed by any strain of this virus.

The novel OPV2 vaccine has been in development since 2011, and in November 2020, WHO’s Prequalification Team issued an emergency use listing (EUL) recommendation enabling initial roll-out in countries affected by cVDPV2 outbreaks. Soon after the issuance of the EUL, the WHO Regional Director for Africa, Dr Matshidiso Moeti, advocated to countries to use this additional tool to stop all forms of polio in Africa.

For nOPV2 to be deployed and used under the EUL, special readiness requirements and criteria need to be met. The Polio Rapid Response Team at WHO’s Regional Office for Africa, in close coordination with other Global Polio Eradication Initiative partners, has been working intensely with countries and partners across the continent to respond to outbreaks of cVDPV2 and prepare for the roll out of nOPV2.

As countries in the Region gear up to roll out this new tool for outbreak response, with WHO’s support they are developing supply, demand and deployment plans; ensuring expedited pathways for national regulatory approvals; enhancing surveillance and laboratory capacity; investing in meeting cold-chain capacity and vaccine management requirements; ensuring vaccine safety monitoring and follow-up mechanisms are in place; and developing communication plans and engaging communities to enhance understanding of the vaccine and risks posed by cVDPV2.

These preparations continue even amidst the COVID-19 pandemic, and the existing polio eradication infrastructure has been instrumental in preparing for the nOPV2 vaccine as well as more broadly supporting COVID-19 response efforts across the continent.

Years of extensive development and preparations are now about to pay off, as nOPV2 will now be utilized for outbreak response. “This is tremendous news for Africa’s polio eradication effort, and in particular for Africa’s children who are currently at risk of lifelong paralysis due to circulating vaccine-derived poliovirus,” said Dr Moeti. “This tool can stop cVDPV2 but only if it reaches all at-risk children. We must apply the lessons from the decades of action to kick wild polio out of Africa. This will require the collective action of political leaders, traditional and religious leaders, public health experts, partners, donors, frontline health workers and of course parents and caregivers. Together, we can protect all African children from all forms of this virus.”

More information on nOPV2.

Related news

13 Novembre 2020 – Aujourd’hui, le programme de préqualification de l’Organisation mondiale de la Santé (OMS) a émis une recommandation d’autorisation d’utilisation d’urgence au titre du protocole EUL pour un nouveau vaccin antipoliomyélitique oral de type 2 (nVPO2). Le déploiement du vaccin sera ainsi autorisé pour une utilisation initiale limitée dans les pays touchés par des flambées de poliovirus circulant dérivé d’une souche vaccinale de type 2 (PVDVc2).

L’émission de cette recommandation au titre du protocole EUL pour le nVPO2 vient au terme de plusieurs mois d’analyse rigoureuse des données issues d’essais cliniques qui ont démontré l’innocuité du vaccin et une protection contre la poliomyélite comparable à celle fournie par le VPO monovalent de type 2 (VPOm2) actuellement utilisé.

Le nVPO2 est une version modifiée du VPOm2, mis au point depuis près de dix ans grâce à la collaboration d’un vaste réseau d’experts mondiaux.^[1] Outre son innocuité et son efficacité, les essais cliniques montrent que ce vaccin est génétiquement plus stable que le VPOm2, ce qui réduit nettement la probabilité qu’il retrouve une forme pouvant entraîner une paralysie dans les milieux présentant un faible niveau d’immunité. Par conséquent, le nVPO2 réduit le risque de voir apparaître de nouvelles flambées de PVDVc2, même si le VPOm2 demeure un vaccin sûr et efficace qui protège contre la poliomyélite et qui a permis d’empêcher des flambées de PVDVc2 par le passé.

Qu’est qu’une autorisation d’utilisation d’urgence ?

La procédure EUL de l’OMS, anciennement connue sous le nom de procédure d’évaluation et d’homologation en situation d’urgence de l’OMS (Emergency Use Listing, EUL), a été créée pour évaluer et répertorier les nouveaux vaccins, traitements et produits diagnostiques qui ne sont pas encore homologués afin qu’ils puissent être utilisés de façon précoce et ciblée en réponse à une urgence de santé publique de portée internationale (USPPI).

Ce mécanisme a déjà été utilisé avec succès pour accélérer la mise à disposition de produits diagnostiques pour les virus Ebola et Zika et, fin septembre, une autorisation d’utilisation d’urgence au titre du protocole EUL a été émise pour un test de diagnostic rapide de l’antigène de la COVID-19 qui donne des résultats en 30 minutes.

Pour qu’un produit reçoive une recommandation d’utilisation au titre du protocole EUL, l’OMS et des experts indépendants examinent les données cliniques existantes afin de déterminer son innocuité, sa qualité et son efficacité, et la décision d’émettre une recommandation est fondée sur une évaluation approfondie des avantages et des risques au vu de l’urgence de santé publique.

Pendant toute la durée d’utilisation d’un produit au titre du protocole EUL, on continue à recueillir des données et à les suivre de près afin de déterminer si ce produit peut recevoir une autorisation d’utilisation d’urgence au titre du protocole EUL.

Pourquoi le protocole EUL est-il utilisé pour le nVPO2 ?

Compte tenu des situations d’urgence actuelles concernant le PVDVc2 en Afrique et en Asie et du fait que la poliomyélite est considérée depuis 2014 comme une urgence de santé publique de portée internationale (USPPI), au mois de février, le Conseil exécutif de l’OMS a prié instamment les États Membres d’accélérer les procédures d’autorisation de l’importation et de l’utilisation du nVPO2 au titre du protocole EUL au vu des résultats prometteurs de ce vaccin dans la lutte contre le PVDVc2.

Les flambées de PVDVc2 se produisent lorsque la souche affaiblie du poliovirus contenue dans le vaccin antipoliomyélitique oral (VPO) peut se propager au sein de populations sous-vaccinées pendant une période prolongée et retrouver une forme pouvant entraîner une paralysie. L’année dernière, il y a eu 366 cas de PVDVc2 dans le monde. Au cours des dix premiers mois de 2020, on a recensé 588 cas (données au 28 octobre 2020).

Outre la décision du Conseil exécutif, le Groupe stratégique consultatif d’experts (SAGE) sur la vaccination a approuvé dans son principe un cadre définissant les critères d’une utilisation initiale pour permettre le déploiement rapide et ciblé du nVPO2. À la suite de sa réunion du 5 au 7 octobre, le SAGE a également approuvé, sur le principe, que le nVPO2 devienne le vaccin de choix pour lutter contre les flambées de PVDVc2, une fois que l’examen de la période initiale d’utilisation sera terminé et que toutes les conditions d’utilisation de ce nouveau vaccin seront remplies.

Des études cliniques sur le nVPO2, menées en Belgique et au Panama, ont montré que le vaccin était sûr et efficace pour protéger contre la poliomyélite, et qu’il présentait moins de risque de retrouver une forme pouvant entraîner une paralysie dans des populations sous-vaccinées.

Au cours des six derniers mois, le programme de préqualification de l’OMS a minutieusement analysé les données émanant de ces études afin de déterminer si le nVPO2 répondait aux exigences du protocole EUL. Grâce à la recommandation au titre de ce protocole, le nVPO2 constitue désormais un moyen supplémentaire de la Stratégie de lutte contre le PVDVc2 de l’IMEP.

Quelle est la période d’utilisation initiale du nVPO2 ?

Comme le précise le cadre approuvé par le SAGE, la période d’utilisation initiale durera environ trois mois après la première utilisation du nVPO2 au titre du protocole EUL, et ce vaccin sera déployé de manière mesurée dans la lutte contre les flambées de PVDVc2.

L’IMEP travaille étroitement avec les pays touchés par des flambées de PVDVc2 afin de déterminer où le nVPO2 peut être utilisé pendant la période initiale. Cette décision s’appuiera notamment sur la situation épidémiologique actuelle et sur la capacité du pays à mener la surveillance renforcée requise en termes d’innocuité et d’efficacité du nVPO2 pendant son déploiement.

Il est important de noter que toute décision d’utiliser le nVPO2 sera prise par le pays et soumise à l’accord des responsables concernés dans le pays et des autorités de réglementation nationales. Le VPOm2 restera disponible pour faire face aux flambées dans les pays qui ne répondent pas aux critères d’une utilisation initiale ou qui décident de ne pas utiliser le nVPO2 initialement.

L’utilisation initiale du nVPO2 devrait avoir lieu environ cinq à huit semaines après la publication de la recommandation d’utilisation au titre du protocole EUL, en tenant compte des processus réglementaires et des approbations définitifs, de l’achat des vaccins, de l’expédition et de l’état de préparation du pays. L’IMEP continue de travailler en étroite collaboration avec les pays à haut risque, en les aidant à se préparer à utiliser le nVPO2.

Perspectives d’avenir

On continuera à recueillir des données sur le nVPO2 pendant la période d’utilisation initiale, en plus des études en cours et de celles qui seront menées prochainement.

Parallèlement à l’utilisation initiale du nVPO2, l’IMEP poursuivra la mise en œuvre des autres volets de sa stratégie globale de lutte contre les flambées de PVDVc2. Cette stratégie consiste notamment à optimiser la riposte aux flambées en utilisant le VPOm2, à renforcer la vaccination systématique avec le vaccin antipoliomyélitique inactivé dans les zones à haut risque et à veiller à ce que les stocks de VPO soient suffisants pour que chaque enfant puisse en bénéficier.

En savoir plus sur le développement de nVPO2

^[1] Le nVPO2 a été mis au point grâce à un partenariat mondial réunissant de multiples agences et experts internes et externes à l’Initiative mondiale pour l’éradication de la poliomyélite (IMEP). Il s’agit notamment de Bio Farma, de l’Université d’Anvers, de la FIDEC (Fighting Infectious Diseases in Emerging Countries), du NIBSC (National Institute for Biological Standards and Control), de l’UCSF (University of California San Francisco), des CDC (Centers for Disease Control and Prevention des États-Unis), de PATH et de la Fondation Bill et Melinda Gates.