20-valent pneumococcal conjugate vaccine set to launch

MFDS has approved the 20-valent 'Prevenar 20' a year after 15-valent vaccine's approval

Will Pfizer Korea partner with Chong Kun Dang again?…"It will be a marketing competition"

Attention has been drawn to another competitor set to launch in the market for the 'pneumococcal vaccine.' This year, the pneumococcal vaccine market has been fiercely competitive with newly released products.

 

As the 20-valent vaccine is likely to come out right after the 15-valent conjugate vaccine has entered the market after 13 years, competition between global pharmaceutical companies to take the market share is becoming intense.

 

As clinical practices draw attention to the next generation of vaccines, they expect that 'price' will be a determining factor in the non-reimbursed market.

 

According to pharmaceutical industry sources, the Ministry of Food and Drug Safety (MFDS) granted approval of Pfizer Korea's 'Prevenar 20 Prefilled Syringe (hereafter, Prevenar 20).' Prevenar 20 is Pfizer Korea's next-generation product that follows 'Prevenar 13,' which currently dominates the Korean market for pneumococcal vaccines.

 

In addition to serotype components in the 13-valent vaccine, Prevenar 20 contains seven additional serotypes, including 8, 10A, 11A, 12F, 15B, 22F, and 33F.

 

The MFDS has approved the drug's indication to prevent invasive pneumococcal disease, pneumonia, and acute otitis media caused by pneumococcus in infants, children, and adolescents aged six weeks and below 18 years old.

 

It is also used to prevent invasive pneumococcal disease and pneumonia caused by pneumococcus in adults 18 years of age and above.

 

As Prevenar 20 has been officially approved, Pfizer Korea will prepare to launch the product.

 

Pfizer Korea will likely aim to launch the product in the first half of 2025.

 

Analysis suggests that an official launch is possible when Prevenar 20 is included in the vaccine guidelines of major medical sciences organizations and the National Immunization Program (NIP).

 

The process is similar to that of MSD's 15-valent vaccine, 'Vaxneuvance,' which has been officially launched into the clinical practices.

 

MSD Korea received the official approval of Vaxneuvance from the MFDS on October 31, 2023.

 

Considering Pfizer Korea's Prevenar 20 was approved on October 31, 2024, Vaxneuvance was approved precisely a year before.

 

After the approval, Vaxneuvance was included in the Korean Society of Infectious Diseases (KSID)'s '2024 Updated Guidelines for Adult Immunization' that "KSID recommends use of the 15-valent pneumococcal conjugate vaccine (PCV15, MSD's Vaxneuvance) over the 13-valent pneumococcal conjugate vaccine (PCV13, Pfizer's Prevenar 13) for individuals subjected to adult pneumococcal conjugate vaccine (PCV) immunization." MSD launched the vaccine in April this year soon after its inclusion in the NIP, and Pfizer Korea is likely to follow a similar launching schedule.

 

"We have been trying to receive Prevenar 20's approval.

 

The specific schedule for launch has not been decided," a representative from Pfizer Korea said.

 

"We will prepare for the launch next year." "We have yet to confirm our Korean partner for Prevenar 20," a representative from Pfizer Korea said.

 

"We are in a partnership with Chong Kung Dang for Prevenar 13 for adults, and we have an agreement with 'Koreavaccine' for Prevenar 13 for young children." The industry draws attention to the competition in the pneumococcal vaccine market for the clinical practice.

 

The question is who will dominate the market, given the competition between two global pharmaceutical companies.

 

Following the withdrawal of the 10-valent PCV vaccine (Synflorix, GSK) from the Korean market, the 13-valent vaccine Prevenar 13 and the 15-valent vaccine Vaxneuvance are currently competing in the clinical practice.

 

In particular, MSD Korea chose Boryung Biopharma as its Korean partner.

 

Upon launching Vaxneuvance, MSD Korea actively engaged in sales‧marketing by hiring Paik Jong Won, a businessman, TV celebrity, and CEO of TheBorn Korea, as its commercial model.

 

According to a pharmaceutical market research firm UBIST, the number of NIP and non-reimbursed immunizations for adults in nationwide hospital‧private clinics is rising after Vaxneuvance launched in April.

 

In detail, based on UBIST, the cumulative number of PCV vaccine immunizations from April to June this year is 994 counts.

 

Among these, 809 immunizations were with Prevenar 13.

 

185 Vaxneuvance immunization was made.

 

After MSD Korea launched Vaxneuvance in April this year, they chose Paik Jong Won, TheBorn Korea CEO, as their commercial model, putting efforts into raising awareness.

 

To the right is the product photo of Prevenar 20, Pfizer Korea's pneumococcal vaccine, which is expected to launch in the first half of 2025.

 

The number of immunizations with Prevenar 20 is below that of market dominating Prevenar 13, but the number is rising.

 

Based on the assumption that Vaxneuvance has been well established in clinical practice as a new vaccine, the number of immunizations were likely increased.

 

In fact, a director of the pediatrics and adolescent clinic said, "When we used Prevenar 13 for immunizations, we had several inquiries if it's possible to switch to Vaxneuvance.

 

Since medication switching is possible during the immunization course, we answer patient inquiries." And added, "If patients have not completed the immunization schedule, medication switching is possible.

 

We had several cases of switching after inquiries." Considering changes brought by the Vaxneuvance launch this year, Prevenar 20 will likely bring changes to clinical practices such as the department of internal medicine and the department of pediatrics and adolescents.

 

Sang Hyuk Ma, a Director of Pediatrics and Adolescents at Changwon Fatima Hospital, said, "Following Prevenar 13, Vaxneuvance and the 15-valent vaccine have been introduced to South Korea.

 

We must consider clinically if a vaccine with more serotypes is appropriate for South Korea.

 

Pneumococcal serotypes tend not to mix, and serotypes common in South Korea must be accounted for vaccination." Ma added, "In other words, the vaccines were developed towards what's needed in the United States.

 

We must look into common serotypes in South Korea and discuss whether the latest vaccines are necessary for immunizations in Korean citizens, including infants and children." Gwak Kyung-Keun, the President of Seoul Physicians' Association, said, "In my opinion, there is no difference between the 15-valent and the 20-valent vaccines.

 

There is no basis for which one is more superior." Gwak anticipated, "In the end, it will be the sales‧marketing competition between companies.

 

One would argue that the 20-valent vaccine has more serotypes but will be a marketing fight without a comparison basis."