Playing catch-up with Merck, Pfizer scores pediatric approval for Prevnar 20

With its next-generation pneumococcal vaccine, Pfizer has been playing catch-up with Merck in the indication’s key age group—infants. Thursday, Pfizer got to the finish line 10 months after its rival, but with a shot that offers more protection.

The FDA approval of Prevnar 20 covers children ages 6 weeks to 17 years and gives Pfizer a chance to continue to control a market it has dominated for two decades.

Prevnar 20 is Pfizer’s follow-on to Prevnar 13, offering protection against seven additional serotypes. Merck’s next-gen shot, Vaxneuvance, is a 15-valent vaccine.

In the U.S., the seven additional serotypes covered by Prevnar 20 have shown to be associated with antibiotic resistance and heightened disease severity, according to Pfizer. In children 5 and younger, the seven serotypes account for 37% of the incidence of pneumococcal disease.

Merck hoped that reaching the pediatric market first with a more protective shot than Prevnar 13 would spark lots of business. While Vaxneuvance has been contributing to Merck's top line, its sales have recently declined quarter over quarter.

Vaxneuvance registered sales of $138 million in the fourth quarter of last year and $106 million in the first quarter of this year.

As for Pfizer's offerings, the Prevnar franchise generated $6.3 billion in 2022, a 20% increase from 2021. Pfizer has yet to report its first-quarter sales for this year.

Pneumococcal vaccines offer protection against bacteria that can cause pneumonia, meningitis and blood infections. The Centers for Disease Contol and Prevention recommends that infants receive doses at ages 2 months, 4 months, 6 months and 12 through 15 months. Children make up 80% of the pneumococcal vaccine market.

Meanwhile, Pfizer may have more to worry about from another company in the space. Last May, in an effort to crack the market, GSK acquired Affinivax and its 24-valent vaccine in a $3.3 billion buyout. A phase 3 trial is underway for its pneumococcal candidate AFX3772.

In phase 2 and 3 studies that support the submission, Prevnar 20 was tested in more than 4,300 children, including 3,500 infants. In January of this year, the FDA accepted Pfizer’s request for a priority review, which sliced four months off the review timeline.