Vaxcyte Gets FDA Go-Ahead on Pneumococcal Vaccine Application
By Rob Curran
Vaxcyte said Thursday that the Food and Drug Administration cleared its investigational new drug application for a pneumococcal-infection vaccine.
The San Carlos, Calif., vaccine developer plans to initiate a Phase 1/2 clinical trial, testing the VAX-31 drug candidate on adults, in the fourth quarter.
Vaxcyte anticipates reporting topline safety, tolerability and immunogenicity results in the second half of 2024, Chief Executive and co-founder Grant Pickering said.
Earlier this week, Vaxcyte expanded its collaboration with Lonza to establish global commercial manufacturing capacity for VAX-31 and VAX-24 for adults and children.
Write to Rob Curran at rob.curran@wsj.com
(END) Dow Jones Newswires
October 19, 2023 09:14 ET (13:14 GMT)
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