Will RSV vaccines be included in the NIP?

Infectious Disease Control and Prevention Act for RSV vaccines proposed

Yong-ki Jeon of the Democratic Party of Korea presented a bill as representative to amend the Infectious Disease Control and Prevention Act

Mentioned the need for mandatory vaccination considering the prevalence rate of respiratory syncytial virus

With the RSV (respiratory syncytial virus) vaccine being released in Korea this year, interest in its inclusion in the National Immunization Program (NIP) has been gaining attention.

 

According to the National Assembly's legislative information system, on the 6th, Rep.

 

Yong-ki Jeon of the Democratic Party of Korea introduced a bill titled “Partial Revision of the Infectious Disease Control and Prevention Act,” which contained provisions on including RSV in the NIP.

 

Rep.

 

Jeon explained, “The current law stipulates diseases subject to mandatory vaccination for the prevention of infectious diseases with high prevalence rates and frequent outbreaks.

 

For influenza, a representative disease subject to mandatory vaccination, the prevalence rate of respiratory viruses from 2015 to 2019 was 11.7% to 21.5%.” He went on to point out that “Even though the prevalence rate of respiratory syncytial virus (RSV) and acute respiratory infections caused by RSV during the same period was 11.7% to 20.1%, indicating a risk level similar to that of influenza, mandatory vaccinations are not currently being administered for RSV.” Accordingly, the legislative intent of the bill is to contribute to improving public health through infectious disease prevention by stipulating that mandatory vaccinations be administered for acute respiratory infections as well.

 

If the bill is passed, it is expected to accelerate the inclusion of RSV vaccines into the National Immunization Program (NIP).

 

Currently, Sanofi's Beyfortus, an RSV preventive antibody for infants and young children, and GSK's Arexvy, an RSV vaccine for adults aged 60 and older, have been approved and released in South Korea.

 

Currently, the KDCA maintains that the inclusion of RSV vaccines in the NIP requires sufficient discussion and review.

 

During last year's government audit, Rep.

 

Myeong-ok Seo (People Power Party) of the National Assembly Health and Welfare Committee questioned the KDCA about the necessity of including RSV vaccines in the NIP, and the KDCA responded that it would “conduct a thorough review in the mid- to long-term through expert and vaccination committee deliberations.” In particular, the NA’s inquiry referred to Beyfortus, the only preventive antibody approved for RSV at the time.

 

Still, the KDCA also mentioned that Beyfortus is not classified as a vaccine.

 

The KDCA explained, “The NIP includes vaccines, so to introduce new formulations such as preventive antibodies into the program, there must be social consensus on the NIP itself.” RSV preventive antibodies work by injecting passive antibodies into the human body to trigger an immune response.

 

Although the goal and mechanism are similar to those of vaccines, strictly speaking, they are not traditional vaccines.

 

Under these circumstances, it appears that the KDCA is taking a cautious approach to determining whether a drug of a different class can be incorporated into such existing programs.

 

In this case, if the bill is passed, it is likely that Arexvy, which has been approved as a vaccine, will be approved.

 

According to the medical community, the Korean Society of Infectious Diseases is reportedly discussing guidelines for adult RSV vaccination.

 

However, if the proposed amendment is passed, discussions will likely take place within the broader framework of contributing to the promotion of public health through the prevention of infectious diseases.

 

With the support of the legislation, it could also have a positive impact on securing the budget necessary for NIP discussions.

 

However, the proposed amendment includes provisions regarding the submission of a cost estimation report, which may require the submission of economic evaluation data for the vaccine in the future.