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.

Centers for Disease Control and Prevention as a Strategic Agent in the Pediatric Vaccine Market: An Analytical Approach

Problem definition: Pediatric vaccine markets in the United States are vulnerable to the development of monopolies due to few manufacturers and high research and development costs. This work addresses how the government can ensure the cost-effective procurement of pediatric vaccines by all U.S. children from private manufacturers. The Centers for Disease Control and Prevention’s (CDC) significant patronage of pediatric vaccines affords them leverage in negotiating public-sector prices that prevent the formation of monopolies, but existing vaccine pricing literature excludes the CDC as a rational player. Academic/practical relevance: We combine optimization and game theoretic techniques to address cost-effective immunization of all U.S. children. Methodology: Our optimization model from the CDC’s perspective minimizes negotiated government costs while ensuring adequate national vaccination levels, linking dynamics in public and private sectors, and incorporating competitive manufacturer behavior. The optimization model embeds an extant game theoretic price model to capture competitive interactions among manufacturers in the private sector, where they compete independently of the CDC. The model is validated in an extended case study of the Infanrix–Daptacel vaccine duopoly. Results: The study indicates that dissimilar products advantageously segment markets with asymmetric manufacturers. Furthermore, markets are at lower risk when high-capacity manufacturers have moderate target profits, especially in cases of high demand and asymmetry. We demonstrate that our model can help restabilize a market that experiences a vaccine shortage and that the CDC might mitigate the same shortage using strategies that depend on which manufacturer is limited. We also underline scenarios in which the CDC may be able to prevent monopolies through financial incentives to manufacturers. The results support a paradigm shift from annual contracts to ongoing negotiations, which would enable the CDC to exercise control over high-risk markets. Managerial implications: Our study demonstrates an analytical approach for managerial government officials to influence pediatric vaccine prices via the procurement of public-sector goods.

Pediatric Vaccines: A Clinical Decision Support Chart

This handy visual aid guides clinicians in discussions with patients and parents about the importance of vaccines, the diseases they help prevent, and the various vaccines recommended. https://shop.aap.org/pediatric-vaccines-paperback/