Among pneumococcal vaccines distributed domestically, MSD (U.S. Merck)'s 'Vaxneuvance,' which boasts the highest valency, will be introduced into the national immunization program for children starting April next year. Since pediatric pneumococcal vaccination has been fully supported free of charge through the National Immunization Program (NIP) since 2014, children will now be able to receive the highest valency vaccine for free.
The Korea Disease Control and Prevention Agency (KDCA) announced on the 13th that from April next year, a new 15-valent pneumococcal conjugate vaccine (PCV15), 'Vaxneuvance,' will be introduced into the national immunization program for children. Among the vaccines previously used for pediatric pneumococcal vaccination, the 13-valent vaccine (PCV13) 'Prevnar 13' will continue to be used in the national immunization program, but the 10-valent vaccine (PCV10) 'Synflorix' will be excluded from the coverage.
Vaxneuvance currently boasts the broadest coverage among pneumococcal vaccines introduced in Korea. In addition to the 13 serotypes covered by Prevnar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), which was previously the highest valency vaccine domestically, it has expanded coverage by adding serotypes 22F and 33F, recently identified worldwide as major causes of pneumococcal diseases. Pneumococcal vaccination has been part of the national immunization program for children since 2014 to prevent invasive infections such as acute otitis media, meningitis, and pneumonia. Accordingly, children currently receive a total of four doses free of charge: three primary doses at 2, 4, and 6 months of age, and one booster dose between 12 and 15 months of age.
Although a 23-valent pneumococcal vaccine has existed, Vaxneuvance is promoted as the 'highest valency vaccine approved domestically' because it is a different type of vaccine. The existing 23-valent vaccine is a polysaccharide vaccine (PPSV) made using polysaccharides from the capsule outer wall of pneumococcus, whereas Vaxneuvance is a protein-conjugate vaccine (PCV) that conjugates polysaccharides with a protein carrier to induce T-cell dependent immune responses. Moreover, PPSV is known to have no immunogenicity in children under 2 years old, so the national immunization program has used PPSV vaccines for seniors aged 65 and older, while PCVs have been used for infants and children. .
Vaxneuvance received approval from the U.S. Food and Drug Administration (FDA) in 2021 and has been authorized in 59 countries worldwide, with Korea becoming the 60th country to approve it last month. Overseas, it generated sales of $138 million (approximately 180 billion KRW) last year. Jae-yong Cho, Executive Director of the Vaccine Business Division at MSD Korea, stated, "It has the broadest coverage among vaccines approved domestically," and added, "For children receiving four doses, even if they have been vaccinated with existing vaccines, cross-vaccination is possible." The KDCA also explained that cross-vaccination between Vaxneuvance and Prevnar 13 is possible.
However, the KDCA stated that cross-vaccination with the PCV10 vaccine 'Synflorix' is not recommended. The KDCA explained, "The 10 pneumococcal serotypes included in the 10-valent vaccine are all covered by the 13-valent and 15-valent vaccines, so even if 10-valent vaccine administration is discontinued, protection against pneumococcus can be maintained equally," adding, "Therefore, new vaccinations with the 10-valent vaccine will be stopped, but if there are remaining doses in the schedule, they can be administered." Detailed information regarding changes in PCV vaccination will be provided to local governments, medical institutions, and related academic societies and associations within this month.
Jiyoung Mi, Director of the Korea Disease Control and Prevention Agency, said, "We expect that the introduction of the new pneumococcal vaccine into the national immunization program for children will enhance the protection of children's health against invasive diseases such as pneumonia," and added, "As the new vaccination will begin in April next year, the KDCA will prepare thoroughly to ensure smooth vaccination and provide guidance to the public."
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