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Coadministration of Anti-Viral Monoclonal Antibodies With Routine Pediatric Vaccines and Implications for Nirsevimab
Susanna Esposito1, Bahaa Abu-Raya2, Paolo Bonanni3
1Pediatric Clinic, University Hospital, Department of Medicine and Surgery, University of Parma, Parma, Italy.
Insights
Nirsevimab, a new monoclonal antibody, offers protection against respiratory syncytial virus (RSV) for all infants. It is anticipated to be safe and effective when given alongside routine childhood vaccines.
Area of Science:
- Pediatrics
- Immunology
- Infectious Diseases
Background:
- Routine childhood vaccinations are crucial for preventing serious diseases.
- Current pediatric schedules lack vaccines for certain viruses like respiratory syncytial virus (RSV).
- Monoclonal antibodies (mAbs) offer a new approach for viral prophylaxis.
Purpose of the Study:
- To evaluate the potential introduction of nirsevimab, an anti-viral mAb, into routine pediatric immunization schedules.
- To assess the safety and efficacy of coadministering nirsevimab with routine pediatric vaccines.
- To review the mechanism of action of anti-viral mAbs and past experiences with palivizumab.
Main Methods:
- Review of evidence on the mechanism of action of anti-viral mAbs.
- Examination of safety and efficacy data of palivizumab coadministration with routine vaccines.
- Analysis of nirsevimab's specific mechanism targeting viral sites.
Main Results:
- Palivizumab has been safely coadministered with routine pediatric vaccines for over two decades.
- Existing immunization guidelines support coadministration of palivizumab with routine vaccines.
- Nirsevimab's highly specific mechanism suggests no interference with routine vaccine responses.
Conclusions:
- Nirsevimab is a promising monoclonal antibody for RSV prophylaxis in all infants.
- Coadministration of nirsevimab with routine pediatric vaccines is anticipated to be safe and effective.
- Nirsevimab can likely be administered concurrently with routine immunizations during the same clinic visit.
Abstract:
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.
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