MSD (U.S. Merck)'s 15-valent pneumococcal conjugate vaccine 'Vaxneuvance' is being introduced in Korea.
Korea MSD announced on the 3rd that Vaxneuvance received approval from the Ministry of Food and Drug Safety as of the 31st of last month. Vaxneuvance is the first pneumococcal vaccine approved in Korea in 13 years. Vaxneuvance expands the prevention coverage by adding two serotypes, ‘22F’ and ‘33F’, which have recently been identified worldwide as major causes of pneumococcal diseases, to the existing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) covered by previous vaccines.
Vaxneuvance can be administered to all age groups, from infants aged 6 weeks and older to children, adolescents up to 17 years old, and adults aged 18 and above. It can be used to prevent invasive diseases and pneumonia caused by the respective pneumococcal serotypes in infants, children, and adolescents, as well as to prevent acute otitis media, or to prevent invasive diseases and pneumonia caused by these pneumococcal serotypes in adults aged 18 and older.
Previously, it was approved by the U.S. Food and Drug Administration (FDA) as a vaccine for adults in 2021 and for those aged 6 weeks to 17 years in 2022. Additionally, it has been authorized in 59 countries including Europe, Japan, Australia, Canada, and Hong Kong.
Pneumococcal disease caused by serotypes not included in existing vaccines, known as ‘serotype replacement phenomenon,’ has been reported worldwide, indicating a high level of unmet needs in this area. Pneumococcus is one of the major pathogens causing invasive infections such as acute otitis media, pneumonia, bacteremia, and meningitis across all age groups from children to adults. Among these, pneumonia was the third leading cause of death in Korea in 2021 and the leading cause of death from respiratory infections. Notably, in 2019, globally, 740,000 infants, children, and adolescents died from pneumonia.
Albert Kim, CEO of Korea MSD, stated, “MSD has led the prevention of pneumococcal-related diseases through the development and supply of pneumococcal vaccines for over 40 years. With the introduction of the 15-valent pneumococcal conjugate vaccine Vaxneuvance in Korea, we can contribute to improving public health in Korea by preventing a broader range of pneumococcal diseases.”
This approval was based on the results of a total of nine clinical trials conducted on adults, infants, children, and adolescents. In a double-blind, active-controlled study involving 1,205 adults aged 50 and older who had never received a pneumococcal vaccine, the immune response induced by Vaxneuvance was compared with that of the 13-valent pneumococcal vaccine (PCV13). The immune response to the 13 shared serotypes was confirmed to be non-inferior to PCV13 when evaluated by the geometric mean titer (GMT) of opsonophagocytic activity (OPA). The secondary endpoint showed that the immune response to the shared serotypes and the unique serotypes 22F and 33F was superior to PCV13.
The clinical results of major pediatric studies showed similar outcomes. After four doses of Vaxneuvance, the induced immune response was non-inferior to PCV13, and in secondary analyses, the Vaxneuvance group demonstrated superiority over PCV13 for the shared serotypes and the unique serotypes 22F and 33F.
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
