Also known as: Vaxcyte
The FDA has agreed to review Moderna's mRNA flu vaccine after initially rejecting it, with a decision expected by August 2026. The reversal occurs amid a contraction in the vaccine sector, with funding drops and layoffs under the Trump administration.
Vaxcyte has initiated its Phase 3 adult program for VAX-31, a 31-valent pneumococcal conjugate vaccine, with the pivotal OPUS-1 trial enrolling 4,000 adults aged 50 and older. The company plans to submit a Biologics License Application by the end of next year.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07616934 |
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults |
RECRUITING | PHASE1 |
| NCT07425392 |
Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Prior Pneumococcal Vaccination |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT07365826 |
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age |
ACTIVE_NOT_RECRUITING | PHASE3 |
