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Biological E's 14-Valent Pneumococcal Vaccine Shows Promise in Phase 3 Trial

• A new 14-valent pneumococcal conjugate vaccine (PNEUBEVAX 14™) developed by Biological E demonstrates safety and immunogenicity in Phase 3 trial with infant participants.

• The vaccine includes two additional serotypes (22F and 33F) compared to existing vaccines, addressing the growing concern of non-vaccine serotype pneumococcal disease.

• Multi-dose formulation with 2-Phenoxyethanol preservative was evaluated in a randomized, active-controlled study across three Indian sites, following a 6-10-14 week dosing schedule.

A promising advancement in pneumococcal disease prevention has emerged as Biological E's 14-valent pneumococcal conjugate vaccine (PNEUBEVAX 14™) demonstrates positive results in a Phase 3 clinical trial. The vaccine, which expands coverage beyond current options, shows potential to address evolving challenges in pneumococcal disease prevention.

Enhanced Serotype Coverage

The novel vaccine formulation includes two additional serotypes, 22F and 33F, beyond those covered by existing vaccines. This expansion is particularly significant given the increasing prevalence of non-vaccine serotype-induced pneumococcal disease, especially among very young and elderly populations.

Clinical Trial Design and Implementation

The Phase 3 study was conducted as a single-blinded, randomized, active-controlled trial across three sites in India. The study enrolled healthy infants aged 6-8 weeks, who received vaccinations following a 6-10-14 week schedule. A total of 300 participants were randomized to receive either PNEUBEVAX 14™ or the comparator vaccine, Prevenar-13™.

Safety and Immunogenicity Profile

Initial data indicates that PNEUBEVAX 14™ maintains a favorable safety profile, with researchers monitoring various safety parameters including:
  • Solicited local reactions
  • Systemic events
  • Unsolicited adverse events (AEs)
  • Serious adverse events
The multi-dose presentation, incorporating 2-Phenoxyethanol as a preservative, demonstrated immunogenicity results that were non-inferior to the established Prevenar-13™ vaccine.

Clinical Significance

This development represents a significant step forward in addressing the evolving landscape of pneumococcal disease prevention. The expanded serotype coverage could potentially provide broader protection against invasive pneumococcal disease, particularly addressing the concerning trend of increased non-vaccine serotype infections.
The successful development of a multi-dose formulation also carries important implications for vaccine accessibility and distribution, particularly in resource-limited settings where efficient vaccine delivery systems are crucial.
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