MSD Korea said its 15-valent pneumococcal conjugate vaccine Vaxneuvance received approval from the Ministry of Food and Drug Safety on Tuesday.

Vaxneuvance is the first pneumococcal vaccine to be authorized in Korea in 13 years and has expanded its preventative range by adding two serotypes, 22F and 33F, which are recently identified as major causes of pneumococcal diseases worldwide, to the existing 13 serotypes covered by the previous vaccine.

Vaxneuvance is suitable for vaccination from infants over six weeks old and above.

According to MSD, pneumococcus remains a high unmet medical need due to the serotype replacement phenomenon, where pneumococcal diseases are caused by serotypes not included in the currently used vaccines, which have been reported worldwide.

Pneumococcus is one of the main pathogens that cause acute otitis media, pneumonia, bacteremia, and meningitis, among other invasive infections, affecting all ages, from children to adults.

Notably, pneumonia, which was the third leading cause of death in Korea in 2021 and the leading cause of death from respiratory infections, resulted in the deaths of 740,000 infants, children, and adolescents worldwide in 2019.

"MSD has been leading the prevention of pneumococcal-related diseases through the development and supply of pneumococcal vaccines for more than 40 years," MSD Korea Managing Director Albert Kim said. “With the introduction of Vaxneuvance, a 15-valent pneumococcal conjugate vaccine, into Korea, we will be able to contribute to the improvement of public health in Korea through the prevention of a wider range of pneumococcal diseases."

As it is a new preventive treatment option available for both children and adults, the company will closely cooperate with the government to ensure rapid supply and improved accessibility, he added.

Vaxneuvance also received approval from the U.S. Food and Drug Administration (FDA) in July 2021 for adults over 18 years old and for vaccination of individuals from 6 months to 17 years old in June 2022.

The vaccine is currently authorized in 59 countries, including the U.S., Europe, Japan, Australia, Canada, and Hong Kong.

MSD takes lead in local pneumococcal conjugate vaccine market

With the approval of Vaxneuvance, industry officials expect that MSD will take the lead in the local pneumococcal conjugate vaccine market.

In Korea, pneumococcal vaccines available for adults include Pfizer’s protein-conjugate vaccine Prevnar 13 and MSD’s 23-valent polysaccharide vaccine Pneumovax 23. The number following the product name indicates the number of pneumococcal serotypes the vaccine can prevent.

Polysaccharide vaccines can prevent a wider range of antigens than protein-conjugate vaccines, but they may induce a lower immunogenicity since they do not provoke a T-cell immune response.

As a result, pharmaceutical companies are focusing on developing protein-conjugate vaccines that can prevent a broader range of serotypes than existing vaccines.

MSD is also developing a 21-valent protein-conjugate vaccine V116, which aims to prevent 21 serotypes, adding eight serotypes not covered by Prevnar 13. It is currently in phase 3 clinical trials.

Pfizer has developed a 20-valent protein-conjugate vaccine with a broader prevention range than Prevnar 13.

The vaccine was approved for use in adults in the United States in June 2021, followed by approval in infants and young children in April this year.

According to Pfizer, the 20 serotypes included in Prevnar 20 account for most pneumococcal disease cases worldwide.

However, it has not yet been approved in Korea.

Among domestic companies, SK Bioscience is jointly developing a 21-valent protein-conjugate vaccine SKYPAC, with Sanofi Pasteur. The company completed phase 2 clinical trials in July and will apply for approval by 2027.