Biological E. Limited (BE), a leading Hyderabad-based vaccine and pharmaceutical manufacturer, announced that the World Health Organization (WHO) has granted Pre-qualification (PQ) status to its 14-valent Pneumococcal Conjugate Vaccine (PCV), PNEUBEVAX 14® (BE-PCV-14). This approval marks a major milestone, making it BE’s 11th WHO pre-qualified vaccine.
Broad Coverage Against 14 Pneumococcal Serotypes
PNEUBEVAX 14® protects infants from six weeks of age. It guards against invasive pneumococcal diseases caused by 14 serotypes. Notably, it includes serotypes 22F and 33F, which are absent in select other paediatric PCVs available in India. The vaccine helps prevent severe illnesses such as pneumonia, meningitis, and sepsis as part of the routine immunisation schedule.
Strong Immune Response and Cross-Protection
As per the press release, clinical data show that PNEUBEVAX 14® induces strong, functional, serotype-specific immune responses across all 14 targeted strains. Moreover, the inclusion of serotype 6B generated cross-protective immunity against serotype 6A, with 69 percent of participants seroconverting. This extended protection increases the vaccine’s real-world impact.
Additionally, PNEUBEVAX 14® demonstrated a safety profile comparable to PCV-13, with most adverse events classified as mild. The vaccine successfully met WHO TRS-977 non-inferiority criteria for shared serotypes as well as the extended coverage of 22F and 33F. All 14 serotypes achieved the primary immunogenicity endpoint, supported by strong Opsonophagocytic Activity (OPA) responses.
Leadership Perspective on WHO PQ Milestone
Ms. Mahima Datla, Managing Director of Biological E. Limited, expressed her appreciation for the recognition, stating, “We are delighted that PNEUBEVAX 14® has received WHO pre-qualification. This milestone enhances global access to high-quality pneumococcal vaccines and strengthens supply security for children who need them the most. WHO PQ broadens our reach through global immunisation efforts, and we remain committed to supporting public health partners with affordable, dependable vaccines across India and worldwide.”
Strengthening Global Immunisation Efforts
With WHO pre-qualification, PNEUBEVAX 14® is set to enhance the availability of Pneumococcal Conjugate Vaccines globally. Its broad coverage and strong clinical profile make it a valuable tool in reducing the burden of pneumococcal disease and expanding access to essential immunisation programs.