Merck’s Next-Generation Pneumonia Vaccine Gets FDA Approval

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection.

The approval comes a month after pneumonia vaccine rival Pfizer received approval for its next-gen 20-valent pneumococcal shot, Prevnar 20, on June 8. Both shots are indicated for adults aged 18 years and older.

The companies are set to go head-to-head in a high-stakes market battle involving billions of dollars — a battle Pfizer has been winning for over a decade now.

Both next-gen shots offer enhanced protection against bacteria that can cause pneumonia, blood infections and meningitis. Compared to Vaxneuvance’s targeting of 15 different strains of the bacterium, Pfizer’s shot protects against 20. This is seven more strains than its current winning vaccine Prevnar 13, which registered $5.95 billion in sales in 2020 and has been outselling Merck’s previous shot, Pneumovax 23, by almost five to one. It has been one of Pfizer’s best-selling drugs.

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Vaxneuvance, formerly known as V114, guards against infection caused by streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.

While Merck’s previous shot, Pneumovax 23, defends against 23 serotypes and has been on the market for almost four decades, the immune responses it generates are not as durable as Prevnar 13. This is why Pfizer’s Prevnar 13 has dominated the pneumonia vaccine space for more than a decade. It first received approval in 2010 and then received backing from the Centers for Disease Control and Prevention (CDC) four years later for adults over the age of 65, which led to a massive boost in sales.

Vaxneuvance’s FDA approval was based on data from Phase II and III trials that demonstrated that the shot generated immune responses superior to Pfizer’s Prevnar 13 in the shared serotype 3 and for the two serotypes Prevnar 13 doesn’t cover, 22F and 33F. The results included data from seven randomized, double-blind clinical studies, which also showed that Vaxneuvance was noninferior, or comparable, to Prevnar-13 for 13 shared serotypes. The shot was not compared to Pfizer’s newer shot, Prevnar 20.

The three serotypes (3, 22F and 33F) are “responsible for substantial disease burden in adults, which are associated with a high degree of invasiveness and antibiotic resistance,” said Roy Baynes, Merck Research Laboratories’ chief medical officer, in a statement from the company.

The vaccine is currently being tested in children in Phase III trials and the company is hoping to get FDA approval by the end of the year. This could significantly help Merck in the race to get a next-gen pneumonia vaccine to kids as children make up about 80 percent of the market for pneumococcal vaccines.

On the other hand, Pfizer hopes to keep its stronghold in the over-65 age group as it began testing Prevnar 20 together with its COVID-19 vaccine, as co-administered shots, in older adults before it got FDA approval.