Among Domestic Approved Protein-Conjugate Vaccines, the Most Numerous 15-Valent
Existing 23-Valent Vaccine, but Not for Under 2 Years Old
MSD Also Developing 21-Valent Vaccine for Adults
MSD (Merck & Co., USA)'s '15-valent protein-conjugate (PCV15)' pneumococcal (Streptococcus pneumoniae) vaccine 'Boxnewance' has entered the domestic pneumonia prevention vaccine market, promoting its 'broad domestic prevention coverage.'
On the 20th, Jo Jae-yong, Executive Director of the Vaccine Business Division at MSD Korea, spoke at the "Box New Vans Domestic Approval Commemorative Press Conference" held at Seoul Square in Jung-gu, Seoul. [Photo by Lee Chun-hee]
Pneumonia is known as a high-risk disease, ranking third among causes of death in South Korea in 2021, following cancer and heart disease (44 deaths per 100,000 population). Its mortality rate is even higher than that of brain diseases such as stroke. Although it dropped to fourth place last year, this was analyzed as a temporary effect due to COVID-19 temporarily taking third place. The most common cause of pneumonia is Streptococcus pneumoniae. It is known that 27-44% of bacterial pneumonia cases are caused by Streptococcus pneumoniae, and when the bacteria invade normally sterile areas such as blood vessels and the brain, it can lead to invasive pneumonia, causing complications such as bacteremia and meningitis.
Accordingly, the importance of the pneumococcal vaccine is recognized, and it is one of the vaccines that, unlike typical national immunization programs (NIP) targeting infants and young children, is exceptionally applied to adults along with the influenza vaccine. Since immunity tends to decline with age, those aged 65 and older can receive the vaccine free of charge. The market size is also expected to continue growing. Globally, it is projected to grow from $7.4688 billion (approximately 9.6534 trillion KRW) in 2019 to $8.4734 billion (approximately 11 trillion KRW) next year, and the domestic market also boasts a considerable size of 57.2 billion KRW last year.
Until now, the dominant player in the domestic pneumonia market has been Pfizer's 'Prevnar 13.' Leveraging the existing maximum approved valency of 13-valent protein-conjugate vaccine, it recorded sales of 40.9 billion KRW last year, boasting an overwhelming market share in the 70% range.
MSD's 'Boxnewance' has thrown down the gauntlet. Starting with FDA approval in the United States in 2021, it has been authorized in 59 countries worldwide and was approved in Korea last month as the 60th country. It already recorded sales of $138 million (approximately 180 billion KRW) overseas last year. In addition to the 13 serotypes of Prevnar (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), it added serotypes 22F and 33F, which have recently been identified globally as major causes of pneumococcal disease, thereby expanding the prevention coverage. Jae-yong Cho, Executive Director of the Vaccine Business Unit at MSD Korea, explained, "It has the broadest coverage among vaccines approved domestically," adding, "For children who receive four doses, even if they have been vaccinated with existing vaccines, cross-vaccination is possible."
Although there have been 23-valent pneumococcal vaccines, Boxnewance emphasizes the 'highest approved valency domestically' because the vaccine types differ. While the existing 23-valent vaccine is a polysaccharide vaccine (PPSV) made using polysaccharides from the pneumococcal capsule, Boxnewance is a protein-conjugate vaccine (PCV) that conjugates polysaccharides with a protein carrier to induce T-cell-dependent immune responses. Professor Su-eun Park emphasized, "PPSV has no immunogenicity in children under 2 years old," and added, "The reason PCV is always emphasized is because it can be used in children under 2 years old." This is also why currently PPSV 23-valent is used for elderly vaccination in the NIP, while PCVs (10-valent and 13-valent) are used for infant and child vaccination.
PCV developers are rapidly increasing the number of serotypes included. Increasing valency is not simply a matter of adding more serotypes. Executive Director Jae-yong Cho emphasized, "Including more serotypes can reduce the immunogenicity of already included serotypes," and added, "Despite adding serotypes 22F and 33F, Boxnewance has achieved non-inferior safety and immunogenicity for the existing serotypes."
On the 20th, Professor Park Soo-eun of the Department of Pediatrics and Adolescents at Busan National University Children's Hospital spoke at the "BoxNewVance Domestic Approval Commemorative Press Conference" held at Seoul Square in Jung-gu, Seoul. [Photo by Lee Chun-hee]
One advantage highlighted is the high immunogenicity against serotype 3, which, despite being included in existing vaccines, still causes many cases. Professor Su-eun Park of the Department of Pediatrics at Pusan National University Children's Hospital explained, "Looking at the serotype-specific incidence of pneumonia in Korea, among those included in PCV13, serotype 3 was the highest, and serotypes 22F and 33F accounted for 6.5% among others," adding, "In domestic clinical trials, Boxnewance showed immunoglobulin (Ig) G antibody concentrations of 0.35 μg/mL or higher, close to 100%, for most of the 15 serotypes included in the vaccine."
The highest valency PCV internationally approved is Pfizer's 'Prevnar 20,' which has 20 valencies. It was approved by the U.S. FDA in 2021 and has applied for approval with the Korean Ministry of Food and Drug Safety. It includes all 15 serotypes contained in Boxnewance plus five additional serotypes: 8, 10A, 11A, 12F, and 15B.
MSD is also developing additional vaccines. The adult-targeted PCV21 'V116' recently completed phase 3 clinical trials, and a pediatric vaccine 'V117' is being developed separately. Kyung-sun Yang, Medical Director at MSD Korea, explained, "When developing vaccines with many serotypes, there is a limitation where immune interference may prevent achieving the same level of immunity as existing vaccines," adding, "Therefore, we aim to develop vaccines tailored for children and adults respectively."
MSD Korea plans to supply Boxnewance within this year. The supplier is in discussions with various companies, including Boryung Biopharma, which currently supplies the Prodiax23 vaccine.
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