BIOBRIEF
The 31 valent shot met its primary endpoints, with strain coverage well beyond Pfizer's Prevnar 20 and Merck's Capvaxive, the two current adult pneumonia vaccines, but two more trials still gate an FDA filing.
Vaxcyte's 31-strain pneumococcal vaccine candidate cleared both primary endpoints in a pivotal adult Phase 3 trial on Monday, setting up a three-way fight with Pfizer's 20-valent Prevnar and Merck's 21-valent Capvaxive.
Pneumococcal disease covers pneumonia, meningitis, and bloodstream infections caused by Streptococcus pneumoniae bacteria. VAX-31 targets 31 of the roughly 100 known serotypes, or distinct strains, of those bacteria, against 20 in Pfizer's Prevnar 20 and 21 in Merck's Capvaxive, the two incumbents of the U.S. adult market.
According to the company, the readout validates that broader strain coverage can drive a stronger immune response without compromising safety. The full press release and an SEC 8-K filing confirm the topline hit.
Two more studies still separate Vaxcyte from an FDA filing: a co-administration trial pairing VAX-31 with a seasonal flu shot, and a study in adults who previously received a different pneumococcal vaccine.
STAT+ flagged the readout in its morning roundup, alongside a separate item: the FDA has extended its review of Novo Nordisk's experimental hemophilia A drug denecimig over manufacturing issues at one site, with no safety or efficacy concerns and no impact on other Novo products.