Vaxcyte Reports Bacterial-Infection Vaccine Met Primary Endpoints in Phase 3 Trial

By Kelly Cloonan

Vaxcyte said its pneumococcal conjugate vaccine candidate met all primary endpoints in a recent Phase 3 trial.

The vaccine company said Monday it will use the study results to file an application with the Food and Drug Administration in the first half of 2028 to get permission to market the drug.

Vaxcyte is developing VAX-31 to prevent invasive pneumococcal disease (IPD) and pneumococcal pneumonia, two types of bacterial infections. In the Phase 3 trial, the vaccine met all prespecified primary immunogenicity endpoints across all age groups studied.

The results show VAX-31 can cover a broader range of bacterial strains than existing vaccines like Pfizer's Prevnar 20 and Merck's Capvaxive while maintaining the magnitude of immune responses, the company said.

That combination "sets a new benchmark for the class and gives us confidence in its potential for approval," Chief Executive Grant Pickeringsaid.

The company said it would announce results from further Phase 3 trials of the drug in the first half of 2027 to support its plans to submit a biologics license application in the first half of 2028.

The stock jumped about 64% to $92.67 in premarket trading on Monday. As of Friday's market close, shares were up 22% year to date.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

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October 05, 2026 07:01 ET (11:01 GMT)