Esposito Susanna, Abu-Raya Bahaa, Bonanni Paolo, Cahn-Sellem Fabianne, Flanagan Katie L, Martinon Torres Federico, Mejias Asuncion, Nadel Simon, Safadi Marco A P, Simon Arne
Pediatric Clinic, University Hospital, Department of Medicine and Surgery, University of Parma, Parma, Italy.
Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.
Front Immunol. 2021 Aug 11;12:708939. doi: 10.3389/fimmu.2021.708939. eCollection 2021.
Routine childhood vaccinations are key for the protection of children from a variety of serious and potentially fatal diseases. Current pediatric vaccine schedules mainly cover active vaccines. Active vaccination in infants is a highly effective approach against several infectious diseases; however, thus far, for some important viral pathogens, including respiratory syncytial virus (RSV), vaccine development and license by healthcare authorities have not been accomplished. Nirsevimab is a human-derived, highly potent monoclonal antibody (mAb) with an extended half-life for RSV prophylaxis in all infants. In this manuscript, we consider the potential implications for the introduction of an anti-viral mAb, such as nirsevimab, into the routine pediatric vaccine schedule, as well as considerations for coadministration. Specifically, we present evidence on the general mechanism of action of anti-viral mAbs and experience with palivizumab, the only approved mAb for the prevention of RSV infection in preterm infants, infants with chronic lung disease of prematurity and certain infants with hemodynamically significant heart disease. Palivizumab has been used for over two decades in infants who also receive routine vaccinations without any alerts concerning the safety and efficacy of coadministration. Immunization guidelines (Advisory Committee on Immunization Practices, Joint Committee on Vaccination and Immunization, National Advisory Committee on Immunization, Centers for Disease Control and Prevention, American Academy of Pediatrics, The Association of the Scientific Medical Societies in Germany) support coadministration of palivizumab with routine pediatric vaccines, noting that immunobiologics, such as palivizumab, do not interfere with the immune response to licensed live or inactivated active vaccines. Based on the mechanism of action of the new generation of anti-viral mAbs, such as nirsevimab, which is highly specific targeting viral antigenic sites, it is unlikely that it could interfere with the immune response to other vaccines. Taken together, we anticipate that nirsevimab could be concomitantly administered to infants with routine pediatric vaccines during the same clinic visit.
常规儿童疫苗接种是保护儿童免受多种严重及潜在致命疾病侵害的关键。当前的儿科疫苗接种计划主要涵盖活性疫苗。婴儿接种活性疫苗是预防多种传染病的高效方法；然而，迄今为止，对于一些重要的病毒病原体，包括呼吸道合胞病毒（RSV），疫苗研发及获得医疗保健当局的许可尚未完成。Nirsevimab是一种人源化、高效的单克隆抗体（mAb），其半衰期延长，可用于所有婴儿预防RSV。在本手稿中，我们考虑了将抗病毒单克隆抗体（如nirsevimab）引入常规儿科疫苗接种计划的潜在影响，以及联合给药的注意事项。具体而言，我们提供了关于抗病毒单克隆抗体的一般作用机制的证据，以及帕利珠单抗（唯一被批准用于预防早产儿、患有早产儿慢性肺病的婴儿和某些患有血流动力学显著心脏病的婴儿感染RSV的单克隆抗体）的使用经验。帕利珠单抗已在同时接受常规疫苗接种的婴儿中使用了二十多年，未出现任何关于联合给药安全性和有效性的警示。免疫接种指南（免疫实践咨询委员会、疫苗接种和免疫联合委员会、国家免疫咨询委员会、疾病控制和预防中心、美国儿科学会、德国科学医学协会联合会）支持帕利珠单抗与常规儿科疫苗联合使用，并指出免疫生物制品（如帕利珠单抗）不会干扰对已获许可的活疫苗或灭活活性疫苗的免疫反应。基于新一代抗病毒单克隆抗体（如nirsevimab）高度特异性靶向病毒抗原位点的作用机制，它不太可能干扰对其他疫苗的免疫反应。综上所述，我们预计nirsevimab可在同一次门诊就诊时与常规儿科疫苗同时给婴儿接种。
