Coadministration of Anti-Viral Monoclonal Antibodies With Routine Pediatric Vaccines and Implications for Nirsevimab Use: A White Paper.

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.
Competing Interests: SE: Research support from GSK, Sanofi, and Vifor. Speaker’s fees from GSK, Janssen, Pfizer, Novartis, Sanofi Pasteur, and MSD in the past 3 years. BA is supported by the Canadian Health and Research Institute Vanier Canada scholarship. PB received grants for epidemiological and HTA research projects from GlaxoSmithKline, MSD, Sanofi Pasteur, Pfizer, Seqirus and Astra Zeneca, and fees for taking part in advisory boards on different vaccines from the same companies plus Janssen. FM has received honoraria from GSK, Pfizer, Sanofi Pasteur, MSD, Seqirus, and Janssen for taking part in advisory boards and expert meetings, and for acting as speaker in congresses outside the scope of the submitted work. FM has also acted as principal investigator in RCTs of the above-mentioned companies as well as Ablynx, Regeneron, Roche, Abbot, Novavax, and Medimmune, with honoraria paid to his institution. FM research activities received support from the Instituto de Salud Carlos III (Proyecto de Investigación en Salud, Acción Estratégica en Salud): project ReSVinext ISCIII/PI16/01569/Cofinanciado FEDER and project Enterogen (ISCIII/PI19/01090). KF is a member of the Australian Technical Advisory Group on Immunisation (ATAGI) but the views in this manuscript are her own and not necessarily those of ATAGI. KF has received honoraria as a member of the vaccine advisory boards for Seqiris and Sanofi Pasteur in the last 5 years. AM has received research grants from NIH, Janssen and Merck AND fees for participation in advisory boards from Janssen, Sanofi-Pasteur, Merck and Roche. MS reports research grants and personal fees for advisory boards from GSK, Pfizer, Sanofi-Pasteur, Janssen and Seqirus. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
(Copyright © 2021 Esposito, Abu-Raya, Bonanni, Cahn-Sellem, Flanagan, Martinon Torres, Mejias, Nadel, Safadi and Simon.)