Vaxcyte reports positive Phase 3 results for VAX-31 pneumococcal vaccine
Vaxcyte said its Phase 3 OPUS-1 study of VAX-31 achieved its co-primary non-inferiority goals against Pfizer's Prevnar 20 and Merck's Capvaxive in adults aged 50 and older. The candidate performed better than both comparator vaccines on three serotypes unique to VAX-31. Vaxcyte expects additional late-stage data in the first half of 2027 to support a regulatory submission in the first half of 2028.
Why it matters
The results advance VAX-31 toward a potential entry into the adult pneumococcal-vaccine market and raise competitive pressure on Pfizer and Merck's marketed products. Leerink Partners said the data could give VAX-31 a competitive advantage over future adult pneumococcal vaccine rivals.
Key facts
- 1The OPUS-1 study enrolled 3,572 adults 50 years or older, plus a smaller cohort of 475 adults ages 18–49. biospace.com
- 2VAX-31 was non-inferior to the comparator vaccines across the 28 serotypes addressed by one or both comparators. biospace.com
- 3VAX-31 was superior to both comparator vaccines on three serotypes that are unique to the candidate. biospace.com
- 4The study met all 32 prespecified co-primary endpoints. investing.com
- 5Vaxcyte expects OPUS-2 and OPUS-3 results in the first half of 2027 and a regulatory filing in the first half of 2028. biospace.com
Open questions
- Vaxcyte's stated plan calls for a regulatory filing in the first half of 2028, while BofA Securities cited an estimated VAX-31 launch year of 2029.
Summary written by AlphAI from 9 of 9 sources. Not investment advice. Figures are as stated by the linked sources.