Next-generation oral polio vaccine: The solution to reach eradication?

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"tieneTextoCompleto" => true "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Nuria Torner" "autores" => array:1 [ 0 => array:3 [ "nombre" => "Nuria" "apellidos" => "Torner" "email" => array:1 [ 0 => "nuriatorner@ateneu.ub.edu" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "CIBER Epidemiología y Salud Pública CIBERESP, Unidad de Medicina Preventiva y Salud Pública, Departamento de Medicina, Universitat de Barcelona, Barcelona, Spain" "identificador" => "af0005" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Vacuna polio oral de nueva generación: ¿solución para la erradicación?" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "f0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2173 "Ancho" => 3188 "Tamanyo" => 489342 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "al0005" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "Milestones for stopping cVDPV transmission in outbreaks and at-risk countries from 2021 to 2030 and beyond." ] ] ] "textoCompleto" => "The aim of the Global Polio Eradication Initiative (GPEI) is to ensure that no child is ever paralysed again, either by wild polioviruses or vaccine-derived polioviruses. A secondary important objective consists of ensuring that the outcome achieved can be sustained for future generations and that the infrastructure developed to eradicate polio serves to obtain public health benefits in emergency situations after the global disappearance of the disease.<a class="elsevierStyleCrossRef" href="#bb0005">1</a>The foundation of this global certification of the eradication of wild polioviruses has been achieved for 2 of the 3 types that cause polio, wild poliovirus type 2 (PV2) in 2015, and wild poliovirus type 3 (PV3) in 2019. Certification of elimination of wild poliovirus type 1 (PV1) will mark the beginning of the post-eradication era and its associated strategies. It is vital to ensure that appropriate post-eradication vaccination plans are in place to minimise the risk and consequences of a possible re-emergence of poliovirus in a post-eradication world. One of the main risks of a possible reintroduction of polio in the post-eradication period is the continued use of oral polio vaccines (OPV) in routine vaccination programmes, due to their potential to produce outbreaks of infectious vaccine-derived poliovirus variants. The OPV that has brought wild poliovirus to the brink of eradication clearly has many benefits, as the live attenuated (weakened) virus in the vaccine provides enhanced immunity in the gut, where it replicates. However, the vaccine virus is shedded in faeces and therefore in communities with poor sanitation this translates into the potential for person-to-person transmission if antigenic drift of the virus were to occur. In communities with low vaccination rates, as the virus is transmitted from one unvaccinated child to another over a long period of time (often over the course of 12–18 months), it can mutate into a form that causes paralysis in the same way as wild poliovirus does.<a class="elsevierStyleCrossRef" href="#bb0010">2</a> The mutated poliovirus can then spread in communities, giving rise to circulating vaccine-derived polioviruses (cVDPV). The inadvertent release of poliovirus from a research or diagnostic laboratory or vaccine manufacturing facility could also occur. A third risk is associated with shedding by immunocompromised carriers (iVDPV), which is currently a theoretical risk as secondary spread leading to outbreaks caused by iVDPV has never been clearly established. However, this theoretical risk also needs to be addressed. The most prevalent cVDPV is cVDPV type 2 (cVDPV2), with 723 cases reported worldwide in 2023, compared with 241 cases of cVDPV1 and no cases of cVDPV3.<a class="elsevierStyleCrossRef" href="#bb0015">3</a><a class="elsevierStyleCrossRef" href="#f0005">Fig. 1</a> shows the timeline for stopping the cVDPV transmission in outbreaks and in at-risk countries, as are the milestones for monitoring progress towards goal achievement in being completely free from cVDPV.<a class="elsevierStyleCrossRef" href="#bb0015">3</a><elsevierMultimedia ident="f0005"></elsevierMultimedia>The World Health Organisation (WHO) prequalified the novel OPV type 2 (nOPV2) in early 2024.<a class="elsevierStyleCrossRef" href="#bb0020">4</a> In late December 2023, WHO issued its first prequalification approval for a vaccine already in use under the Emergency Use Listing Procedure (EUL) regulatory pathway: the novel OPV type 2 (nOPV2). Since the rollout of this new-generation vaccine began in March 2021, the Global Polio Eradication Initiative has administered nearly 1 billion doses of nOPV2 in 35 countries, protecting millions of children from polio. Prequalification enables easier access to the vaccine for a more sustainable response to outbreaks of cVDPV2. The WHO Emergency Procedure (EUL) pathway is reserved for the use of vaccines, medicines, and diagnostic tools that have not yet been authorised during public health emergencies. Following a rigorous assessment of existing data on quality, safety, and efficacy from completed clinical trials, the pathway allows for accelerated availability of products in settings affected by these emergencies.<a class="elsevierStyleCrossRef" href="#bb0025">5</a>OPV is widely used in campaigns in lower-resource countries because it is easy to store and transport and easy to administer. However, the attenuated virus in the oral vaccine can mutate and become virulent again, especially in settings where vaccine uptake is low. To date, nOPV2 has been used in 35 countries under the EUL framework, mainly in the African region, which is the most affected by cVDPV2 outbreaks. The first nOPV2 campaigns were conducted in March 2021 in response to cVDPV2 outbreaks in Nigeria and Liberia, and other countries soon followed suit using nOPV2.<a class="elsevierStyleCrossRef" href="#bb0030">6</a>,<a class="elsevierStyleCrossRef" href="#bb0035">7</a> Throughout its clinical development and community use, nOPV2 has proven to be as safe to use and effective in stopping outbreaks as its predecessor, the monovalent oral vaccine type 2. But more importantly, this new vaccine is genetically more stable, being 80% less likely to trigger new outbreaks due to variants.<a class="elsevierStyleCrossRef" href="#bb0040">8</a>,<a class="elsevierStyleCrossRef" href="#bb0045">9</a> According to GPEI data, the new vaccine has helped achieve an 85% reduction in cVDPV2 cases in Nigeria, where it has been in use since 2021.The development of the vaccine began in 2011 through a consortium of experts led by the Bill and Melinda Gates Foundation, including the UK's National Institute for Biological Standards and Controls, the US Centers for Disease Control and Prevention, the US Food and Drug Administration, and the University of California, San Francisco.While nOPV2 has played a key role in reducing cVDPV2 cases, its success, like that of any polio vaccine, depends on the ability to rapidly implement immunisation campaigns that reach all children.According to this week's GPEI report, a circulating case of cVDPV2 was identified in Gaza earlier this month, the first case in 25 years (Polio This Week – GPEI [<a href="http://polioeradication.org">polioeradication.org</a>]). A confirmed case in Gaza has thus led to a 2-round vaccination campaign to secure receipt of 2 doses of vaccine and targeting 640 000 children that began in late August in this war-torn region.<a class="elsevierStyleCrossRef" href="#bb0050">10</a>To overcome the final challenges remaining in polio eradication, GPEI is looking for new ways to reach children living in hard-to-reach areas or in regions with war-torn conflict to promote community uptake of vaccines and improve early detection and response to outbreaks.FundingThis study did not receive any specific funding from public sector agencies, the business sector or not-for-profit entities." "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "s0005" "titulo" => "Funding" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Torner N. Vacuna polio oral de nueva generación: ¿solución para la erradicación? Vacunas. 2024. https://doi.org/10.1016/j.vacun.2024.09.003." ] ] "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "f0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2173 "Ancho" => 3188 "Tamanyo" => 489342 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "al0005" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "Milestones for stopping cVDPV transmission in outbreaks and at-risk countries from 2021 to 2030 and beyond." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bs0005" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bb0005" "etiqueta" => "1." 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