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-31 and VAX-24. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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:
- March 23, 2026
- Indication:
- For the Prevention of Invasive Pneumococcal Disease
Announcement
Vaxcyte, Inc. announced the completion of enrollment in the VAX-31 OPUS-1 Phase 3 pivotal, noninferiority trial with approximately 4,000 participants and the OPUS-2 Phase 3 trial evaluating VAX-31 concomitantly administered with a seasonal influenza vaccine in approximately 1,300 participants.
AI Summary
Vaxcyte announced it has completed enrollment in two Phase 3 studies of its pneumococcal conjugate vaccine VAX-31. The OPUS-1 pivotal, noninferiority trial enrolled approximately 4,000 participants to compare VAX-31 head-to-head with Capvaxive® (PCV21) and Prevnar 20® (PCV20) for safety, tolerability and immune response.
In OPUS-1, adults 50 and older were randomized 1:1:1 to receive VAX-31, PCV21 or PCV20, while adults 18–49 were randomized 3:1 to VAX-31 or PCV20 as the safety comparator. Safety and tolerability are being followed for six months, and topline safety, tolerability and immunogenicity data are expected in the fourth quarter of 2026.
OPUS-2, with about 1,300 participants, is evaluating VAX-31 given at the same time as a seasonal influenza vaccine to assess real-world performance and immune responses when coadministered. Results from OPUS-2 are expected in the first half of 2027.
Read Announcement- Drug:
- VAX-31
- Announced Date:
- March 18, 2026
- Indication:
- For the Prevention of Invasive Pneumococcal Disease
Announcement
Vaxcyte, Inc. announced the publication of results from the positive VAX-31 adult Phase 1/2 clinical study in the journal The Lancet Infectious Diseases.
AI Summary
Vaxcyte announced that results from its positive VAX-31 adult Phase 1/2 clinical study were published in The Lancet Infectious Diseases. The study showed robust opsonophagocytic activity and IgG immune responses against all 31 pneumococcal serotypes at every dose tested. VAX-31 was generally well tolerated, with local and systemic reactions mostly mild-to-moderate and resolving within days, and no serious adverse events attributed to the vaccine. Results were reported to be similar in safety profile to the comparator PCV20.
These findings support Vaxcyte’s carrier-sparing platform and the decision to advance the high-dose VAX-31 into a comprehensive Phase 3 adult program. VAX-31 is designed to cover about 95% of invasive pneumococcal disease and roughly 88% of pneumococcal pneumonia in U.S. adults aged 50+, potentially providing broader protection than current vaccines. Topline data from the OPUS-1 pivotal trial are expected in the fourth quarter of 2026.
Read Announcement- Drug:
- VAX-31
- Announced Date:
- February 11, 2026
- Indication:
- For the Prevention of Invasive Pneumococcal Disease
Announcement
Vaxcyte, Inc. announced that the first participants were dosed in the OPUS-3 Phase 3 trial evaluating VAX-31, the Company's next-generation 31-valent pneumococcal conjugate vaccine (PCV) candidate, in adults who have previously received pneumococcal vaccination.
AI Summary
Vaxcyte announced that the first participants have been dosed in OPUS-3, a Phase 3 trial testing VAX-31, the company’s next-generation 31-valent pneumococcal conjugate vaccine. OPUS-3 enrolls adults who have previously received a pneumococcal vaccine and will evaluate how VAX-31 performs in this population. VAX-31 is designed to broaden protection against invasive pneumococcal disease and pneumococcal pneumonia compared with current vaccines.
The trial will assess safety and tolerability for six months after the initial dose. The primary immunogenicity goal at Month 1 is to measure serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) and geometric mean fold rises (GMFRs) for all 31 serotypes plus serotype 20B. A secondary objective will describe serotype-specific IgG geometric mean concentrations (GMCs) and GMFRs.
Vaxcyte expects topline data from OPUS-3 and OPUS-2 (testing coadministration with a seasonal influenza vaccine) in the first half of 2027; OPUS-1 topline results are expected in the fourth quarter of 2026.
Read Announcement- Drug:
- VAX-31
- Announced Date:
- December 8, 2025
- Indication:
- For the Prevention of Invasive Pneumococcal Disease
Announcement
Vaxcyte, Inc. announced that the first participants were dosed in the OPUS (OPA-based Pivotal U.S. Study) Phase 3 pivotal, noninferiority trial evaluating VAX-31 for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults.
AI Summary
Vaxcyte announced that the first participants were dosed in OPUS, its Phase 3 pivotal, noninferiority trial evaluating VAX-31 to prevent invasive pneumococcal disease (IPD) and pneumonia in adults. The trial design was finalized in consultation and alignment with the U.S. Food and Drug Administration and is expected to enroll about 4,000 participants at roughly 50 U.S. sites, with separate cohorts for adults aged 50+ and 18–49.
OPUS is a randomized, double‑blind, active‑controlled study directly comparing VAX-31 with Capvaxive (PCV21) and Prevnar 20 (PCV20) on safety, tolerability and immune responses. The main goals are to show noninferior immune responses for serotypes shared with the comparators and superiority for serotypes unique to VAX-31, using standard lab measures of antibody activity. Safety will be followed for six months and immune responses assessed one month after vaccination.
VAX-31 is a 31‑valent candidate designed to cover about 95% of IPD and 88% of pneumococcal pneumonia in U.S. adults 50+, potentially adding 14–34% IPD and 19–31% pneumonia coverage versus current vaccines. Topline OPUS results are expected in the fourth quarter of 2026 and will underpin the planned BLA submission.
Read Announcement- Drug:
- VAX-31
- Announced Date:
- September 3, 2025
- Indication:
- For the Prevention of Invasive Pneumococcal Disease
Announcement
Vaxcyte, Inc. announced advancement of the modified VAX-31 infant Phase 2 randomized, dose-finding study to the third and final stage.
AI Summary
Vaxcyte announced that its modified VAX-31 infant Phase 2 study has advanced into the third and final stage. This randomized, double-blind, active-controlled trial is comparing the safety, tolerability and immune response of VAX-31—a 31-valent pneumococcal conjugate vaccine—with the standard Prevnar 20 in healthy infants.
In this stage, the study added an Optimized Dose arm where most serotypes are set at 4.4 µg and the balance at 3.3 µg, and it has closed enrollment in the Low Dose arm. The Middle and High Dose arms continue as planned. Approximately 900 infants will be enrolled to assess key immune responses after three primary doses and a booster.
Vaxcyte plans to release topline safety and immunogenicity data from the primary series and booster by the end of the first half of 2027. If successful, VAX-31 could cover about 92% of invasive pneumococcal disease and 93% of acute otitis media in U.S. children under five.
Read Announcement- 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
VAX-24 FDA Regulatory 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.
Read Announcement
