PCV14 / Biological E Ltd - LARVOL DELTA

Safety, Immunogenicity of Co-Administered Vaccines, and Lot-to-Lot Consistency of a 14-Valent Pneumococcal Conjugate Vaccine (PNEUBEVAX 14®) Administered at 6-10-14 Weeks in Healthy Infants: A Multicenter, Phase IV Trial. (PubMed, Vaccines (Basel)) - "All participants received concomitant DTwP-HepB-IPV-Hib and oral rotavirus vaccines per routine schedule. Immune responses to co-administered routine EPI vaccines met predefined non-inferiority criteria, supporting the interpretation that BE-PCV14 did not result in clinically meaningful immune interference. Consistent immune responses across manufacturing lots further support its use in infant immunization programs."

Journal • P4 data • Infectious Disease • Pain • Pneumococcal Infections • Rotavirus Infections

IMMUNOGENICITY AND SAFETY OF BIOLOGICAL E'S 14-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PNEUBEVAX 14® IN A 3+1 INFANT-TODDLER SCHEDULE: MULTICENTRE, OPEN-LABEL, ACTIVE-CONTROLLED PHASE IV TRIAL (ISPPD 2026) - "As part of a large Phase IV post-marketing study, we evaluated the immunogenicity and safety of a 3+1 infant-toddler schedule of BE-PCV14 compared with Pfizer's Prevenar 13® (PCV13).Methods This open-label, multicentre Phase IV trial enrolled PCV-naïve infants (6–8 weeks) who received three primary doses of BE-PCV14 or PCV13 followed by a booster at 12–15 months (3+1). AE/SAE rates, SCRs, and GMCs were similar between groups, and post hoc analyses demonstrated non-inferiority of BE-PCV14 to PCV13 for all 14 serotypes.Conclusions When used in a 3+1 infant-toddler schedule (three primary doses plus booster), PNEUBEVAX 14® was non-inferior to PCV13 for the 14 serotypes, providing immunogenicity and safety comparable to PCV13 while extending serotype coverage to 15 serotypes. This extended coverage includes emerging serotypes 22F and 33F."

Clinical • P4 data • Infectious Disease • Pneumococcal Infections

IMMUNOGENICITY AND SAFETY OF BIOLOGICAL E'S 14-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PNEUBEVAX 14® IN A 2+1 INFANT SCHEDULE: MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED, SINGLE-BLIND PHASE III TRIAL (ISPPD 2026) - "We evaluated the safety and immunogenicity of a 2+1 infant booster schedule of BE-PCV14 in comparison with Pfizer's Prevenar 13® (PCV13).Methods This 1:1 randomized, single-blind, multicentre Phase III trial enrolled PCV-naïve infants (6–8 weeks), who received two primary doses of BE-PCV14 or PCV13 with a booster at 9 months (2+1). SCRs, GMCs, and rates of AEs/SAEs were similar between the two groups. Post hoc analyses showed that BE-PCV14 was non-inferior to PCV13 for all 14 serotypes by both SCR difference and GMC ratio.Conclusions When administered as a booster in a 2+1 infant schedule (two primary doses plus booster), PNEUBEVAX 14® demonstrates a comparable immunogenicity and safety profile to PCV13, while expanding coverage to 15 serotypes, including emerging serotypes 22F and 33F."

Clinical • P3 data • Infectious Disease • Pneumococcal Infections

From 10-Valent to 21-Valent Pneumococcal Conjugate Vaccines: Divergent Global Pathways and Future Directions for India. (PubMed, Indian Pediatr) - "India's pediatric PCV coverage has expanded rapidly, though unevenly, while adult uptake remains limited. While indigenous PCV10 introduction and scale-up, followed by indigenous PCV14 introduction seems a pragmatic policy for India's UIP today, sustained genomic and AMR surveillance, plus eventual transitions to broader PCVs, will be essential for long-term, adaptable immunization strategies."

Journal • Review • Infectious Disease • Pediatrics • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Immunogenicity and safety of biological E's 14-valent pneumococcal conjugate vaccine (PNEUBEVAX 14®) administered in a 2p + 1 schedule to healthy infants: a multicenter, randomized, active controlled, single-blind, phase III trial. (PubMed, Lancet Reg Health Southeast Asia) - "These findings support consideration of BE-PCV14 for routine infant immunization programmes using a 2p + 1 schedule, particularly in settings where the additional serotypes contribute to ongoing pneumococcal disease. This clinical research was exclusively funded by Biological E. Limited, Hyderabad, India."

Journal • P3 data • Infectious Disease • Pneumococcal Infections

Cost-effectiveness of a 13-valent pneumococcal conjugate vaccine compared with currently available pneumococcal conjugate vaccines in Indian children. (PubMed, IJID Reg) - "This yielded incremental cost-effectiveness ratios (ICERs) for PCV13-PFE vs PCV10-SII and PCV10-GSK of INR 18,142 and INR 304,234 per QALY, respectively, both below the willingness-to-pay threshold of INR 590,949. PCV13-PFE was cost-saving compared to PCV14-BE. From the private sector perspective, vaccinating children in India with PCV13-PFE could prevent more PD cases, save more PD-associated medical costs, and be more cost-effective than other locally available PCV options."

HEOR • Journal • Infectious Disease • Pneumococcal Infections

Cost-Effectiveness of a 13-Valent Pneumococcal Conjugate Vaccine Compared With Currently Available Pneumococcal Conjugate Vaccines in Indian Children (ISPOR-EU 2024) - "From the private sector perspective, vaccinating children with PCV13 could prevent more PD cases, save more PD associated medical costs, and was more cost-effective compared to other alternative vaccination choices."

Clinical • Cost effectiveness • HEOR • Infectious Disease • Pneumococcal Infections

Immunogenicity and safety of a 14-valent pneumococcal polysaccharide conjugate vaccine (PNEUBEVAX 14™) administered to 6-8 weeks old healthy Indian Infants: A single blind, randomized, active-controlled, Phase-III study. (PubMed, Vaccine) - "BE-PCV-14 was found to be safe and induced robust and functional serotype specific immune responses to all 14 serotypes. It also elicited cross protective immune response against serotype 6B.These findings suggest that BE-PCV-14 can be safely administered to infants and achieve protection against pneumococcal disease caused by serotypes covered in the vaccine. The study was prospectively registered with clinical trial registry of India - CTRI/2020/02/023129."

Journal • P3 data • Infectious Disease • Pediatrics • Pneumococcal Infections • Pneumonia

Presentation Title: Development of a pneumococcal conjugate vaccine and novel vaccines through research driven efforts in India (VACCINES SUMMIT 2023) - "A fourteen valent conjugate vaccine (PCV14) (Serotypes 1,3,4,5,6B,7V ,9F,14,18C,19A,19F,22F,23F, and 33F) was developed and Preclinical animal safety studies were done and the vaccine was tested in Phase1 clinical study adults for safety...This 9-year long journey was a good learning experience on how to overcome limitations to develop complex vaccines in a developing world like India. A next gen PCV24 development was also initiated."

Infectious Disease • Pneumococcal Infections