Vaxneuvance's 'immunogenicity' brings competitive edge

in the competitive pneumococcal vaccine market

One year after Vaxneuvance's addition to the NIP, the drug is expanding its presence in the market based on its immunogenicity.

KDCA approves Prevnar 20 for the NIP… Prevnar 20 became a competitor to Vaxneuvance after its launch.

The initial market share of each vaccine may be determined by the NIP vaccine cross-inoculation schedule.

Soo-Eun Park, Professor of pediatrics at Pusan National University Yangsan

With changes in the market for pneumococcal vaccines ahead, MSD Korea has begun to defend its market share by highlighting the “immunogenicity” of Vaxneuvance.

 

Last year, the product was launched and added to the National Immunization Program (NIP), accelerating its market penetration.

 

Celebrating its first year in the NIP, the company has been emphasizing Vaxneuvance’s clinical benefits to gain a competitive edge.

 

On the 1st, MSD Korea held a Vaxneuvance media seminar to highlight the changes and implications of Vaxneuvance’s first year as part of the NIP.

 

Vaxneuvance, which was approved at the end of 2023, has the characteristics of a 15-valent vaccine, adding serotypes 22F and 33F to the existing 13-valent vaccine.

 

The vaccine was added to the NIP a month after its approval, and NIP vaccination with the vaccine became available for children aged 2 months to under 5 years old upon its launch in April last year.

 

At the time of its launch, it quickly expanded its market presence by highlighting the addition of a new serotype.

 

The number of cross-vaccinations has also increased along with the initial vaccination with Vaxneuvance.

 

Vaxneuvance has clinical data on cross-immunization with existing PCV13 vaccines, enabling cross-vaccination.

 

Cross-immunization with the PCV13 vaccine and Vaxneuvance showed comparable immunogenicity and safety for 13 common serotypes compared to being vaccinated with a single 13-valent vaccine.

 

At the media seminar, the company highlighted Vaxneuvance’s competitiveness as its immunogenicity.

 

In other words, the company is emphasizing the need to choose a highly immunogenic product to prevent invasive pneumococcal disease (IPD), which has a high fatality rate in children.

 

The standard for immunogenicity defined by the WHO is “the ability of a vaccine to induce a measurable immune response,” and the standard for specific serotypes of immunogenicity is “IgG concentration of 0.35 ㎍/mL or higher.” Vaxneuvance has confirmed superior immunogenicity in serotypes 3, 22F, and 33F compared to an existing vaccine in a global Phase III pediatric pivotal clinical trial.

 

In addition, it showed superior immunogenicity compared to existing vaccines in serotype 3, which remains the main cause of invasive pneumococcal disease (IPD) in children, and clinical trials were also conducted on infants and toddlers in Korea to confirm its immunogenicity and stability.

 

Soo-Eun Park, professor of pediatrics at Pusan National University Yangsan (President, the Korean Society of Pediatric Infectious Diseases), said, “IPD in children under the age of 5 has decreased significantly compared to before the introduction of PCV, but it occurs most frequently in infants under the age of 1, both in Korea and abroad.

 

If the preventive effect of serotype 3 and others increases through the vaccination of infants with PCV15, we can also expect indirect prevention of IPD in the elderly.” The key is what strategy Vaxneuvance will adopt after the release of PCV20 Prevnar 20, which is expected to be released this year.

 

According to industry sources, the Korea Disease Control and Prevention Agency recently reviewed the introduction of PCV20 in the NIP for children as a result of the first vaccination expert committee meeting.

 

As a result of the deliberation by the Korea Expert Committee on Immunization Practices, it was decided that PCV20 would be introduced as a national immunization program (NIP) in the same way as PCV13 and Vaxneuvance (PCV15), which were previously covered by the NIP, in terms of the target population and standard vaccination timing.

 

At this point, it seems that cross-immunization will be the key to the early market competition.

 

Children under 6 months of age who have received one or more doses of the 13-valent vaccine can complete the vaccination schedule with Vaxneuvance.

 

According to deliberation results of the Korea Expert Committee on Immunization Practices, Prevnar 20 can be administered as the 4th booster dose after completing the 3 initial doses with Prevnar 13.

 

So infants aged 6 months or less that received their initial vaccine as Prevnar 13 will have the option to complete their vaccination with Prevnar 13 and complete their vaccination schedule with Vaxneuvance after or with an additional dose of Prevnar 20 after the basic vaccination with Prevnar 13.

 

However, based on the approved indications, no indication allows administration with Prevnar 20 after Vaxneuvance.

 

This means that it is not possible to cross-immunize with Vaxneuvance or Prevenar 20 when their initial vaccine is Vaxneuvance or Prevenar 20.

 

In response, Professor Park said, “It is difficult to say which of the current 15-valent and 20-valent vaccines is the better choice on the premise that NIP will be applied to all, and the United States has not recommended any vaccine as a priority.

 

Although the 20-valent vaccine prevents more serotypes, there are theoretical concerns about its immunogenicity over some serotypes, which require consideration.

 

In the beginning, I think it will be divided according to market choice.”