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As Korea’s pediatric pneumococcal vaccine market faces a potential shake-up, MSD Korea is reinforcing its position by emphasizing the immunogenicity of its 15-valent pneumococcal conjugate vaccine, Vaxneuvance (PCV15), marking the first anniversary of its inclusion in the National Immunization Program (NIP).
MSD Korea held a media seminar on Tuesday to reflect on the significance of Vaxneuvance’s one-year presence in the NIP and to highlight its clinical strengths. The vaccine, approved in late October 2023, was swiftly added to the national immunization schedule within a month and launched in April of that year for infants aged two months to under five years.
Vaxneuvance includes two additional serotypes—22F and 33F—beyond the 13 serotypes covered by Pfizer’s long-dominant Prevnar13 (PCV13), bringing a 15-valent option into the Korean market for the first time in over a decade.
This broader serotype coverage initially helped the vaccine expand its influence through both primary and catch-up doses, supported by clinical data confirming its cross-vaccination compatibility with PCV13.
According to MSD, Vaxneuvance demonstrated comparable immunogenicity and safety across the 13 common serotypes when co-administered with PCV13. Notably, it showed superior immunogenicity in key serotypes such as 3, 22F, and 33F during a global phase 3 pediatric trial, including in Korean infants.
Professor Park Su-eun at Pusan National University Yangsan Hospital explains the importance of pneumococcal conjugate vaccines during a press conference celebrating the one-year inclusion of the vaccine in Korea’s NIP at Koreana Hotel in Jung-gu, Seoul, Tuesday.
Professor Park Su-eun at Pusan National University Yangsan Hospital explains the importance of pneumococcal conjugate vaccines during a press conference celebrating the one-year inclusion of the vaccine in Korea’s NIP at Koreana Hotel in Jung-gu, Seoul, Tuesday.
At the media seminar, Professor Park Su-eun, President of the Korean Society of Pediatric Infectious Diseases and a pediatrician at Pusan National University Yangsan Hospital, underlined the critical role of immunogenicity in preventing invasive pneumococcal disease (IPD), which remains a leading cause of morbidity in infants under one year of age.
"Although IPD incidence has declined significantly in children under five since the introduction of PCVs, infants under one remain the most vulnerable group both domestically and internationally," Park said. “Increasing protection against serotype 3 through PCV15 vaccination in infants may also contribute to herd immunity benefits for the elderly.”
Rising competition from PCV20
MSD’s grip on the market is now being challenged as Pfizer prepares to launch Prevnar20 (PCV20), its 20-valent successor. PCV20 expands coverage to seven additional serotypes beyond PCV13—namely 8, 10A, 11A, 12F, 15B, 22F, and 33F—and recently received NIP approval from Korea's National Immunization Committee (NIC).
The committee has allowed limited cross-vaccination flexibility. For infants who begin with PCV13, a single additional dose of PCV20 may be given as the fourth booster after completing the initial three-dose primary series.
However, cross-vaccination between Vaxneuvance and PCV20 is not permitted under current indications, further complicating parental choice and provider recommendations.
Infants who start with PCV13 can also complete their schedule with Vaxneuvance, while Vaxneuvance cannot be followed by PCV20. This regulatory distinction, MSD emphasizes, may provide Vaxneuvance an edge in early immunization decisions, particularly for infants under six months who have received at least one PCV13 dose.
"Under current Korean regulatory guidelines, cross-vaccination from PCV15 to PCV20 is not permitted, and the official vaccination schedule for PCV20 under the NIP has yet to be released,” Park said. “Therefore, real-world choices will likely depend on initial vaccine selection and availability."
Despite the expanded choices, Park remained cautious in selecting a clear frontrunner between PCV15 and PCV20.
“There is no head-to-head trial directly comparing the effectiveness of PCV15 and PCV20 in infants, and conducting such studies would be ethically and practically difficult,” Park said. “Each vaccine has its own advantages—PCV15 offers superior immunogenicity for serotype 3, while PCV20 covers additional serotypes that are relevant globally.”
Park added that continued surveillance of serotype prevalence by the Korea Disease Control and Prevention Agency (KDCA) will help determine which vaccine provides the most practical protection over time.
“In Korea, grandparents are often primary caregivers for infants,” Park said. “Vaccinating babies with strong protection against serotype 3 could potentially offer indirect protection to older adults, although real-world data will be needed to confirm that effect.”
Differentiated strategy across age groups
Looking ahead, MSD Korea plans to solidify its position by segmenting the market. While Vaxneuvance will target the pediatric population, the company aims to introduce its newly FDA-approved 21-valent pneumococcal vaccine, Capvaxive, for adults later this year in Korea.
Capvaxive demonstrated non-inferior immunogenicity compared to PCV20 across 10 shared serotypes in phase 3 trials and outperformed PCV20 in 10 out of 11 unique serotypes it covers.
MSD says it is preparing to submit Capvaxive for local approval within the year, with a potential NIP inclusion to be reviewed afterward.
“MSD’s strategy is to offer a tailored pneumococcal vaccine portfolio, with Vaxneuvance for infants and Capvaxive for adults,” MSD Korea Executive Business Unit Director of Vaccines Cho Jae-yong said. “We are moving forward with Capvaxive approval this year, with the goal of offering a differentiated premium vaccine for the adult population.”
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Lee Han-soo corea022@docdocdoc.co.kr
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