August 6, 2025 — Vaxcyte, Inc. is moving forward with its VAX-31 adult program after interactions with the FDA, including an end-of-Phase 2 meeting. The company is finalizing its Phase 3 clinical program to validate VAX-31 as a potential new standard-of-care adult PCV. A pivotal, non-inferiority study is expected to begin in the fourth quarter of 2025, with topline data anticipated in 2026.
The FDA has provided input on VAX-31 adult CMC licensure requirements, facilitating progression to Phase 3. Multiple VAX-31 adult Phase 3 program data readouts are expected in 2026 and 2027 to support a Biologics License Application submission. For the VAX-31 pediatric program, the company is modifying its ongoing infant Phase 2 dose-finding study to add a VAX-31 optimized dose arm (4.4mcg/3.3mcg) and discontinuing enrollment of the low dose arm. Enrollment in the modified study is expected to proceed by the end of the third quarter of 2025, with topline data from both the primary immunization series and booster dose by the end of the first half of 2027.
Vaxcyte remains focused on disciplined capital allocation, streamlining its early-stage pipeline to prioritize resources for PCV programs and further extend its cash runway. The company reported approximately $2.8 billion in cash, cash equivalents, and investments as of June 30, 2025.
Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte, stated that the company is laser-focused on advancing the development of VAX-31 in both adults and infants. Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte, noted the company’s strong balance sheet and continued disciplined approach to capital allocation.
Key second quarter and recent highlights include the FDA’s expansion of VAX-31’s adult Breakthrough Therapy designation to include the prevention of pneumonia, in addition to IPD. In July, Chris Griffith joined Vaxcyte as Chief Business and Strategy Officer.
Patrick Ryan, Executive Director, Corporate Affairs, Vaxcyte, Inc., 415-606-5135, media@vaxcyte.com
Jeff Macdonald, Executive Director, Investor Relations, Vaxcyte, Inc., 917-371-0940, investors@vaxcyte.com
Source: Vaxcyte, Inc.
