Korean clinical trial of MSD’s V114 is being conducted

for children

100 healthy infants in Korea participated, challenging Prevenar 13, which dominates the market

MSD's pneumococcal vaccine candidate is conducting phase III clinical trials for infants in Korea.

 

It is noteworthy whether MSD will become a strong competitor in the Korean pneumococcal vaccine market dominated by Pfizer's Prevenar 13.

 

On the 21st, the MFDS approved a phase III clinical trial plan for the pneumococcal vaccine candidate V114 Prefilled Syringe of MSD Korea.

 

It is phase III clinical trial that evaluates the safety and immunogenicity of four doses of V114 in healthy infants.

 

It is conducted for only 100 domestic infants at 18 medical institutions nationwide.

 

V114 is a 15-valent vaccine that prevents 15 pneumococcal viruses.

 

Clinical trials were conducted in adults and children.

 

After the new pneumococcal vaccine, which has completed clinical trials overseas and is waiting for approval.

 

In Korea, Pfizer's 13-valent pneumococcal vaccine, Prevenar 13, dominates the market.

 

It recorded ₩40.4 billion in sales based on IQVIA last year, leading GSK's pneumococcal vaccine Synflorix pfs inj (₩6.1 billion) by a large gap.

 

This year, sales volume increased further to prevent pneumonia due to COVID-19.

 

SK Bioscience developed a generic for Prevenar 13 but withdrew the license because it could not pass the patent.

 

SK Bioscience, together with Sanofi, is focusing on the next-generation pneumococcal vaccine.

 

Pfizer is also committed to developing new vaccines to meet competitors' challenges.

 

Already, a 20-valent vaccine is about to be approved by the US Food and Drug Administration (FDA).

 

On the 10th, foreign media reported that the FDA will review the 20-valent pneumococcal vaccine '20vPnC', which Pfizer is developing, as the subject of priority evaluation.

 

Accordingly, FDA approval is expected in the first half of next year.

 

However, it was found that clinical trials for children have not yet been completed.

 

In the case of pediatric vaccines, MSD's V114 is more imminent for commercialization, so it is expected that Korea will complete phase III and apply for approval.

 

Interest is focused on whether the MSD V114 will compete with the Prevenar 13.