This section highlights FDA-related milestones and regulatory updates for drugs developed by Vaxcyte (PCVX).
Over the past two years, Vaxcyte has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VAX-24 and VAX-31. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
VAX-24 - FDA Regulatory Timeline and Events
VAX-24 is a drug developed by Vaxcyte for the following indication: Pneumococcal Conjugate Vaccine (PCV).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VAX-24
- Announced Date:
- March 31, 2025
- Indication:
- Pneumococcal Conjugate Vaccine (PCV)
Announcement
Vaxcyte, Inc. shared positive topline results from its Phase 2 dose-finding study evaluating the safety, tolerability and immunogenicity of VAX-24, the Company's 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), compared to Prevnar 20® (PCV20) in healthy infants.
AI Summary
Vaxcyte, Inc. reported encouraging topline results from its Phase 2 study for VAX-24, a 24-valent pneumococcal conjugate vaccine designed to prevent invasive pneumococcal disease in healthy infants. The study compared VAX-24 to the market standard Prevnar 20® and found that VAX-24 was well-tolerated at all doses tested, with a safety profile similar to Prevnar 20®. All doses, including a mid dose of 2.2mcg, generated strong immune responses following a three-dose primary immunization series. Interim booster data further showed robust memory responses across all doses, and the dose-dependent responses were consistent with little evidence of carrier suppression. Based on these positive results, Vaxcyte has selected the mid dose as the optimal formulation and plans to advance it to a potential Phase 3 infant program, pending further study outcomes.
Read Announcement- Drug:
- VAX-24
- Announced Date:
- March 30, 2025
- Indication:
- Pneumococcal Conjugate Vaccine (PCV)
Announcement
Vaxcyte, Inc. announced it will hold a webcast and conference call tomorrow, March 31, 2025, at 8:00 a.m.
AI Summary
Vaxcyte, Inc. announced that it will host a webcast and conference call on March 31, 2025, at 8:00 a.m. Eastern Time. During this call, the company will present topline results from its VAX-24 infant Phase 2 study. The study is designed to evaluate the safety, tolerability, and immune response of VAX-24, a new 24-valent pneumococcal conjugate vaccine candidate aimed at preventing invasive pneumococcal disease in healthy infants. Participants can join the call by dialing 800-445-7795 for domestic access or 785-424-1699 if calling internationally, using the conference ID PCVX0331. A live webcast will also be available on Vaxcyte’s investor relations page, and the recording will remain archived on their website for 30 days after the event.
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VAX-31 - FDA Regulatory Timeline and Events
VAX-31 is a drug developed by Vaxcyte for the following indication: For the Prevention of Invasive Pneumococcal Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VAX-31
- Announced Date:
- February 25, 2025
- Indication:
- For the Prevention of Invasive Pneumococcal Disease
Announcement
Vaxcyte, Inc. provided a business update.
AI Summary
Vaxcyte, Inc. provided an update on its vaccine development plans. The company successfully completed the Phase 2 adult study for its 31-valent conjugate vaccine, VAX-31. Based on the positive results, Vaxcyte is on track to start a Phase 3 pivotal non-inferiority study in mid‑2025, with topline safety, tolerability, and immunogenicity data expected in 2026. Additionally, the progress of its VAX-31 infant program was highlighted; the Phase 2 study for infants has advanced to its second and final stage, with primary immunization results anticipated by mid‑2026 and booster data to follow approximately nine months later.
The company’s strong financial position, bolstered by approximately $2.2 billion raised through follow‑on equity offerings and over $3.1 billion in cash, supports these clinical initiatives and positions Vaxcyte for continued advancement in its vaccine franchise.
Read Announcement- Drug:
- VAX-31
- Announced Date:
- February 5, 2025
- Indication:
- For the Prevention of Invasive Pneumococcal Disease
Announcement
Vaxcyte, Inc. announced that the first study participants have been dosed in the second and final stage of the ongoing Phase 2 study of VAX-31 in healthy infants.
AI Summary
Vaxcyte, Inc. recently announced that the first study participants have been dosed in the second and final stage of its ongoing Phase 2 study of VAX-31, a 31-valent pneumococcal conjugate vaccine candidate designed for healthy infants. This milestone comes on the back of a blinded review of the Stage 1 safety and tolerability data. The study is set to evaluate the safety, tolerability, and immune response of VAX-31 compared to an established vaccine. Approximately 750 infants are expected to participate, receiving a primary immunization series of three doses administered at two, four, and six months of age, followed by a booster dose at 12-15 months. Topline data for the primary series is anticipated in mid-2026, with booster data to follow about nine months later, marking an important step in expanding vaccine coverage against invasive pneumococcal disease in young children.
Read Announcement- Drug:
- VAX-31
- Announced Date:
- December 3, 2024
- Indication:
- For the Prevention of Invasive Pneumococcal Disease
Announcement
Vaxcyte, Inc. announced the initiation of the Phase 2 study of VAX-31 in healthy infants and that the first study participants have been dosed.
AI Summary
Vaxcyte, Inc. announced the start of its Phase 2 study for VAX-31, a 31-valent pneumococcal conjugate vaccine, in healthy infants. The company has already dosed the first study participants as part of this clinical trial. The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 compared with an existing vaccine. Topline data from the primary three-dose immunization series is expected in mid-2026, with additional data from a booster dose to be released about nine months later. VAX-31 is designed to cover roughly 94% of invasive pneumococcal disease and about 93% of acute otitis media in U.S. children under five. This new vaccine candidate could potentially offer broader protection against current and past bacterial strains compared to standard vaccines.
Read Announcement- Drug:
- VAX-31
- Announced Date:
- September 2, 2024
- Indication:
- For the Prevention of Invasive Pneumococcal Disease
Announcement
Vaxcyte, Inc. announced it will hold a webcast and conference call tomorrow, September 3, 2024, at 8:00 a.m. Eastern Time to present topline results from the Phase 1/2 study evaluating the safety, tolerability and immunogenicity of VAX-31, the Company's 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in healthy adults aged 50 and older.
AI Summary
Vaxcyte, Inc. announced a webcast and conference call scheduled for tomorrow, September 3, 2024, at 8:00 a.m. Eastern Time. During the call, the company will present topline results from its Phase 1/2 study on VAX-31, a 31-valent pneumococcal conjugate vaccine candidate. This study evaluates the safety, tolerability, and immunogenicity of VAX-31 in healthy adults aged 50 and older, focusing on its potential to prevent invasive pneumococcal disease.
Investors and interested parties can participate in the call by dialing 800-225-9448 (domestic) or 203-518-9708 (international) and using the conference ID PCVX0903. Additionally, a live webcast will be available on Vaxcyte’s investor relations page, with the event remaining accessible as an archive on the company website for 30 days.
Read Announcement
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