In tight next-gen pneumococcal vaccine race with Pfizer, Merck reads out topline pediatric data
The FDA is set to decide on Pfizer’s 20-valent pneumococcal conjugate vaccine for adults in June — a month before Merck’s PDUFA date for its 15-valent candidate. But the Kenilworth, NJ-based pharma isn’t going down without a fight.
On Thursday, Merck read out topline results from two Phase III pediatric studies, and the company says it’s on track to submit a supplementary BLA by the end of the year.
“Pneumococcal disease continues to cause serious illness and death worldwide in children under the age of 5, despite the positive impact of pneumococcal conjugate vaccination on pediatric case numbers,” Merck Research Labs CMO Roy Baynes said in a statement.
Merck’s candidate, V114, covers the 13 serotypes covered by Pfizer’s megablockbuster Prevnar 13, plus an additional two: 22F and 33F.
In the first pediatric trial, dubbed PNEU-PLAN, Merck pitted V114 against Prevnar 13 in 606 kids between the ages of 7 months and 17 years who hadn’t previously received a pneumococcal vaccine, or who had received partial or full regimens of an already approved PCV. Researchers reported that V114’s performance was “generally comparable” to Prevnar’s for the 13 serotypes they share. But for 22F and 33F, V114 boasted a higher immune response.
In PNEU-DIRECTION, researchers studied the interchangeability of V114 and Prevnar 13 in 900 babies between 42 and 90 days old. Immune responses seen in babies who had received a four-dose series of Prevnar 13 were comparable to those seen in babies who got a mixed regimen of Prevnar and V114 against the 13 shared serotypes.
The full results are coming at a future scientific congress, Merck said.
“Results from these studies support the potential of V114 to confer immunogenicity for PCV13 serotypes in infants who have previously received one or multiple doses of PCV13, and for the 15 serotypes in V114 in children in a catch-up setting,” Baynes said.
It’s a tight race as regulators consider both V114 and a 20-valent candidate from Pfizer (Prevnar 20) in adults 18 years and up. The FDA plans on giving Pfizer a decision in June while Merck’s PDUFA date is July 18.
Vaxcyte, formerly known as SutroVax, is in early development for a 24-strain candidate, which hopes to unseat both Pfizer and Merck. The company raised $249 million in an IPO last June and expects to submit an IND in the second half of this year.
Prevnar 13 raked in $5.8 billion in 2020, and was once the world’s best-selling vaccine, in pre-Covid times.
On Jan. 11 — the same day the FDA accepted a BLA for V114 — Merck filed a lawsuit challenging three of Pfizer’s patents relating to its pneumococcal conjugate compositions. The company has asked a judge to rule that V114 “does not and will not infringe any valid claim of these three patents.”
