As 'Capvaxive,' a 21-valent pneumococcal conjugate vaccine (PCV21) developed by MSD, is anticipated to receive marketing authorization in South Korea, competition in the market is likely to heat up.

According to pharmaceutical industry sources, MSD has filed with the Ministry of Food and Drug Safety (MFDS) for marketing authorization of Capvaxive. It is expected to be approved by the second half of 2025.

Capvaxive is a vaccine designed to prevent adults from serotype that causes most of the invasive pneumococcal disease (IPD).

The safety and immunogenicity of Capvaxive were cofirnmed based on the Phase 3 STRIDE clinical trial, comparing Capvaxive to PCV20 in adults aged 18 years and above who have no prior history of pneumococcal vaccination.

Capvaxive was found to be nonequivalent to PCV20 regarding 10 serotypes (3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, 33F) that are commonly included in PCV20.

10 out of 11 serotypes (9N, 15A, 16F, 17F, 20A, 23A, 23B, 24F, 31, 35B) that are included in Capvaxive but not in PCV20 were demonstrated to be superior to PCV20.

Capvaxive was approved in the United States in June 2024 based on these study results, and it also obtained European approval in March.

There is growing attention on whether Capvaxive will obtain Korean approval during the second half of this year, as it will be the third consecutive year a new pneumococcal vaccine is approved in South Korea.

In late 2023, MSD's 15-valent vaccine, 'Vaxneuvance,' was expedited for inclusion in the pediatric National Immunization Program (NIP). Then, a year later, in October 2024, Pfizer's 20-valent vaccine, Prevenar 20, won MFDS approval.

As the 21-valent vaccine, which is the higher serotype vaccine, is expected to be introduced in less than a year, competition is likely to get intense.

If there are no setbacks to the approval process for Capvaxive, it is expected to be launched at the very end of the first half of next year.

For instance, Vaxneuvance was launched in late April, and Prevenar 20 was launched in June exclusively for adults aged 18 years and above.

The market is also highly likely to be competitive, with Vaxneuvance and Prevenar 20 competing for the pediatric NIP and Prevenar 20 and Capvaxive competing for the adult NIP.

Regarding this, MSD Korea is expected to employ a marketing strategy that differentiates its vaccine portfolio for pediatric (15-valent) and adult (21-valent) populations.

Indeed, MSD previously announced the use of tailored strategies for pediatric and adult populations during its Vaxneuvance launch 1st-anniversary media seminar.

In the long term, Pfizer's Prevenar 20, with its first-mover advantage, will be competing directly with MSD's 21-valent Capvaxive, which includes a higher number of serotypes.

Capvaxive will reportedly be preventing approximately 84-85% of adult IPD. This estimate is higher than the coverage for Prevenar 20.

In this case, Pfizer is expected to defend its position by highlighting the performance and extensive clinical experience of Prevenar 20.

Currently, Pfizer emphasizes that Prevenar 20 offers safety and convenience based on the well-established technology of Prevenar 13, validated through long-term pediatric and adult vaccinations, and with its 20-serotype coverage.

Additionally, potential competition against Sanofi-SK bioscience is another variable. Although their commercialization timeline is the latest, if they succeed in developing a 21-valent vaccine, another equally strong competitor will emerge.

Notably, the Sanofi vaccine is being developed for pediatric use, suggesting that the company will employ a future strategy to cover all age groups, from infants and young children to adults.