Vaxcyte reports positive Phase 3 results for VAX‑31 pneumococcal vaccine
Vaxcyte announced that its 31‑valent pneumococcal conjugate vaccine VAX‑31 met all primary endpoints in the OPUS‑1 pivotal adult Phase 3 trial. The study showed non‑inferior immunogenicity to PCV20 and PCV21 across age groups and superiority for three unique serotypes, with a safety profile similar to comparators. The company plans to file a Biologics License Application in the first half of 2028 and expects further trial data in early 2027. CEO Grant Pickering said the data validate the carrier‑sparing platform.
Why it matters
The positive data support Vaxcyte’s BLA filing timeline in 1H 2028, potentially adding a higher‑valent option to the adult pneumococcal market. Analysts note the results could drive significant stock moves, as seen in pre‑market gains of 30‑57%.
Key facts
- 1VAX‑31 met all prespecified primary immunogenicity endpoints in adults 50+ and non‑inferiority criteria (>0.667 LBCI) for 28 shared serotypes. globenewswire.com
- 2VAX‑31 achieved superiority (LBCI >2.0) for three unique serotypes. globenewswire.com
- 3The trial enrolled 4,047 participants. investing.com
- 4VAX‑31 was well tolerated with a safety profile similar to PCV20 and PCV21. globenewswire.com
- 5Vaxcyte expects to file a Biologics License Application in the first half of 2028. globenewswire.com
- 6Additional OPUS‑2 and OPUS‑3 results are expected in the first half of 2027. globenewswire.com
Summary written by AlphAI from 15 of 15 sources. Not investment advice. Figures are as stated by the linked sources.