A generational shift seems to have begun in earnest in the pneumococcal conjugate vaccine market, as MSD’s 15-valent vaccine Vaxneuvance won approval from the U.S. Food and Drug Administration recently, following Pfizer’s Prevnar 20.

MSD’s Vaxneuvance is likely to go one step ahead in the pediatric pneumonia therapy market, which accounts for about 80 percent of the total pneumococcal vaccine sales, regaining its former reputation in the market.

The FDA authorized MSD’s pneumococcal 15-valent conjugate vaccine Vaxneuvance on Friday to prevent invasive pneumococcal disease in adults aged 18 or more, caused by 15 serotypes.

MSD’s next-generation product scored the FDA nod barely one month after  Pfizer’s Prevnar 20 nabbed the regulatory approval for adults over 18. The consecutive approvals have fueled the shift of generation in the pneumococcal polyvalent vaccine market, which had been dominated by Pfizer’s Prevnar 13 for the past 10 years.

Prevnar 13 is a blockbuster vaccine that recorded $5.95 billion in sales in 2020. Pfizer’s next-generation vaccine Prevnar 20 is a conjugate vaccine added with seven more serotypes -- 8, 10A, 11A, 12F, 15B, 22F, and 33F – on Prevnar 13.

The seven serotypes are responsible for about 40 percent of all pneumococcal disease and death cases in the United States. Pfizer plans to maintain its influence and reputation in the pneumococcal vaccine business over the past decade with Prevnar 20.

However, MSD also has a chance as it plans to supply its product earlier than Prevnar 20 to the pediatric pneumococcal vaccine market, which accounts for about 80 percent of the pneumonia vaccine market.

MSD has completed phase 3 clinical trials of Vaxneuvance in children and expects to receive FDA approval by the end of the year. The product will then begin to compete with Prevnar 13.

Vaxneuvance contains conjugates for the 13 serotypes contained in the Prevnar 13 with two additional serotypes -- 22F and 33F.

Besides, MSD’s Vaxneuvance demonstrated superior immune responses to serotypes 22F and 33F and 3, common to both Prevnar 13 and Vaxneuvance, in phase 2 and 3 clinical trials. The company’s conjugate vaccine has also shown to be non-inferior to Prevna 13 for the remaining 12 common serotypes.

That explains why the recent FDA approval for MSD pneumococcal vaccine Vaxneuvance has drawn attention to whether it could restore the reputation of the Pneumovax 23 vaccine.

Pneumovax 23 is a 23-valent pneumococcal polysaccharide vaccine to prevent pneumococcal disease caused by the 23 serotypes. MSD has been providing Pneumovax 23 globally for about 40 years. However, the company had to hand over the lead to Pfizer after the latter’s conjugate vaccine proved to have a superior immune response compared to the polysaccharide vaccine.