Preventive RSV antibody shot poised for NIP inclusion

KDCA reviews its potential introduction to NIP based on cost-effectiveness

Beyfortus secures evidence on medical cost savings and reduced hospitalization rates

Preventive RSV antibody injection ‘Beyfortus’

The need to include the RSV preventive antibody injection Beyfortus, which began immunization in Korea this February for infants and young children, in the National Immunization Program (NIP) is being raised.

As the inclusion of a new category, ‘preventive antibodies,’ within the traditionally vaccine-focused NIP system emerges as a key policy issue, economic evaluation and cost-effectiveness have emerged as key decision-making criteria.

According to industry sources on the 26th, a recent policy discussion forum held at the National Assembly to improve management measures for respiratory infections in infants and young children highlighted cases from major countries that have already incorporated RSV preventive antibodies for infants into their NIP frameworks. The discussions emphasized the significant disease burden RSV imposes on infants and young children.

At the forum, Young-rae Sohn, Director General of the Department of Healthcare Safety and Immunization at the Korea Disease Control and Prevention Agency (KDCA), stated, “We plan to review its support in Korea based on economic evaluation and cost-effectiveness analysis. As this could become the first case of including a preventive antibody as a new category within the National Immunization Program, we are discussing it with particular caution.”

This stance was reaffirmed during the National Assembly audit in October. Seung-kwan Lim, Commissioner of the KDCA, noted that there is growing social demand and academic support for RSV preventive antibodies, adding that the agency plans to assess priorities and the necessity of introducing such preventive measures into next year’s immunization program.

To this end, the KDCA has secured research funding to generate scientific evidence evaluating RSV disease characteristics, efficacy of preventive antibodies, and cost-effectiveness, with results expected by the end of next year.

A consistent theme across these discussions is the importance of economic evaluation and cost-effectiveness analysis. Such assessments are essential for allocating limited NIP budgets efficiently and serve as foundational evidence for policy decisions aimed at protecting all newborns and infants from RSV. The need for rigorous analysis is particularly pronounced when considering the inclusion of new preventive modalities in a national program.

The RSV preventive antibody currently under consideration for NIP inclusion is Sanofi’s Beyfortus (nirsevimab), which began administration in Korea earlier this year. Beyfortus is a monoclonal antibody indicated for all newborns and infants entering their first RSV season, as well as high-risk children up to 24 months of age, offering broad preventive coverage. A single injection provides protection for at least five months, effectively covering an entire RSV season.

Results from research evaluating the cost-effectiveness of Beyfortus have already been reported in Korea.

According to the study, the Beyfortus prevention strategy for infants entering or in their first RSV season and for infants and young children during their second RSV season (up to 24 months of age) proved more efficient than existing prevention strategies in terms of reducing healthcare costs and caregiver productivity loss.

Notably, over 90% of the overall health improvement benefits were observed in full-term infants under 1 year of age, providing evidence supporting the validity of a universal RSV prevention strategy for all infants. This economic evidence is expected to serve as a key resource in future discussions regarding the introduction of Beyfortus into the National Immunization Program (NIP).

Internationally, countries that have already introduced Beyfortus into their NIPs have reported reductions in the risk of RSV-related hospitalizations.

Chile, the first country in the Southern Hemisphere to adopt Beyfortus into a nationwide NIP, published real-world evidence based on data from 157,709 infants. The study showed a 76.41% reduction in hospitalization risk due to RSV lower respiratory tract infection and an 84.94% reduction in ICU admission risk. Importantly, while 13 RSV-related infant deaths were recorded during the same period in the previous year, no RSV-related deaths occurred among infants who received Beyfortus.

Similar outcomes were confirmed in Galicia, Spain, the first region globally to introduce Beyfortus into its NIP. Interim analysis results published in The Lancet medical journal last May found that the RSV hospitalization rate among infants under 6 months who received Beyfortus decreased by 82% compared to the unvaccinated group.

Regarding this, Professor Soo-han Choi of the Department of Pediatrics at Pusan National University Hospital stated, “While the World Health Organization (WHO) has previously issued vaccination policy recommendations centered on vaccines, in May 2025, it proposed that all countries adopt prevention strategies including preventive antibodies for infant RSV prevention.”

He added, “While Korea's National Immunization Program (NIP) policies have primarily focused on vaccines, the recent initiation of discussions on incorporating RSV preventive antibodies into the NIP is highly encouraging. If RSV preventive antibodies are included in the NIP, universal preventive benefits will be provided to all infants, leading to a substantial reduction in the national burden of RSV disease.”