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Friday, January 5, 2024

Vaxcyte Update on Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise

 Company Doses First Participants in Phase 2 Portion of Ongoing VAX-31 Phase 1/2 Study in Adults Following Independent Review of Phase 1 Safety and Tolerability Data; Topline Safety, Tolerability and Immunogenicity Data Expected in Third Quarter of 2024 --

-- Following Successful End-of-Phase 2 Meeting with FDA, Company Planning for Initiation of VAX-24 Adult Phase 3 Pivotal, Non-Inferiority Study in Second Half of 2024; Topline Data Expected in Second Half of 2025 --

-- Company Received Encouraging Input on VAX-24 Adult CMC Licensure Requirements and Plans to Seek Additional FDA Guidance as Phase 3 Program Advances --

-- Company Outlines Expected Phase 3 Timelines for VAX-24 and VAX-31 Adult Programs --

-- Enrollment in Ongoing VAX-24 Infant Phase 2 Study Continues to Progress; Topline Data from Primary Immunization Series Expected by End of First Quarter of 2025, Followed by Topline Data from Booster Dose by End of 2025 --

https://www.globenewswire.com/news-release/2024/01/04/2804307/0/en/Vaxcyte-Provides-Clinical-and-Regulatory-Progress-Update-on-Potential-Best-in-Class-Pneumococcal-Conjugate-Vaccine-PCV-Franchise.html

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