Biological E declares positive results from phase-III trials of Pneubevax 14 in 6-8-week old infants

Biological E. Limited (BE), based in Hyderabad, disclosed phase-III trial results for its 14-Valent Pneumococcal Conjugate Vaccine (PCV), Pneubevax 14 (BE-PCV-14), in Vaccine journal. The study evaluated Pneubevax 14's safety and immunogenicity in infants aged 6 to 8 weeks against PCV-13. Conducted at 12 sites across India, the trial involved 1,290 infants, assessing immunogenic non-inferiority and safety through anti-Pneumococcal Capsular Polysaccharide (anti-PnCPS) IgG and Opsonophagocytic Activity (OPA) one month post-vaccination. Pneubevax 14 demonstrated safety, robust immune responses against all 14 serotypes, and cross-protection against serotype 6A. Safety matched PCV-13, with mostly mild Adverse Events (AEs). The study met Non-Inferiority (NI) criteria for common and additional serotypes. Additionally, serotype 6B in Pneubevax 14 provided significant cross-protection against 6A. BE, established in 1953, is India's first private sector biological products company, supplying vaccines to 130+ countries and therapeutic products globally.