Vaxcyte (PCVX) has reported significant progress in the development of its 31-valent pneumococcal conjugate vaccine, VAX-31, across both adult and infant clinical programs. The OPUS-2 Phase 3 trial has begun dosing the first participants with the VAX-31 vaccine in combination with an approved seasonal flu vaccine for adults over 50 who have not previously received a pneumococcal vaccine. Moreover, Vaxcyte plans to start another Phase 3 trial, OPUS-3, for adults who have been vaccinated against pneumococcus, in the first quarter of next year.
For the infant indication, Vaxcyte has finished enrolling participants in its Phase 2 study, aimed at determining the appropriate dosage of VAX-31 for infants. The company anticipates releasing topline safety and efficacy results from both the OPUS-2 and OPUS-3 studies in the first half of 2027. These results will be key for a planned Biologics License Application (BLA) submission. Additionally, data from the OPUS-1 trial is expected by the end of this year. Vaxcyte's efforts in these trials have been conducted in coordination with the FDA.
https://www.gurufocus.com/news/8545245/vaxcyte-pcvx-advances-vax31-vaccine-trials
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