In its next-generation pneumococcal vaccine race with Pfizer, Merck hopes to gain a key edge with a pediatric approval for Vaxneuvance.
But now comes a potentially costly delay as the FDA has extended its deadline for a regulatory decision to July 1.
Before it signs off the shot for kids ages 6 weeks through 17, the U.S. regulator wants to see additional analyses of data, the company reported. In December, the FDA granted Merck priority review and assigned a Prescription Drug User Fee Act action date of April 1.
Time is of the essence as Merck is trying to beat Pfizer to the finish line in this key age group. Next-gen pneumococcal vaccines from both companies already carry FDA approvals in adults, but children make up 80% of the market for pneumococcal shots.
Pfizer’s Prevnar 13, a 13-valent vaccine, generated (PDF) $5.3 billion in sales last year and is the dominant shot on the market. Merck's Vaxneuvance, meanwhile, provides added protection as it covers 15 strains of the virus.
Pfizer’s next-gen shot, Prevnar 20, won FDA approval last summer for adults, beating Vaxneuvance to the finish line by a month.
While Merck has the lead in key pediatric demographic, it has now shrunk with Friday’s target date extension.
“We are confident in the strength of the data from our pediatric studies with Vaxneuvance and will continue to work expeditiously with the FDA to bring this important vaccine forward,” Eliav Barr, M.D., Merck’s chief medical officer, said in a release.
In October, Merck released data showing that Vaxneuvance provided more protection than Prevnar 13 and is safe for both those who have never been vaccinated and those who have gotten off schedule with Prevnar 13.
Of the 13 shared serotypes, the shots afford the same protection. The advantage of Vaxneuvance is coverage in the 22F and 33F strains of the virus.
The vaccines protect against bacteria that can cause pneumonia, meningitis and blood infections. Before the launch of COVID-19 vaccines, Pfizer's Prevnar franchise was the world's top vaccine by revenue.