WHO grants Pre qualification status to Biological E 14-valent Pneumococcal Conjugate shot

Clinical studies show that PNEUBEVAX 14 has a good safety profile and induces robust, serotype-specific immune responses to all 14 targeted strains. Importantly, PNEUBEVAX 14 also elicited cross-protective immunity against serotype 6A via the inclusion of serotype 6B, resulting in 69 percent of subjects seroconverting against 6A. This extends the vaccine’s protective reach beyond the antigens included in its formulation. The safety profile of PNEUBEVAX 14 was comparable to the widely used PCV-13 formulation, with most reported adverse events being mild. PNEUBEVAX 14 met the non-inferiority criteria (NI) for shared serotypes and for the additional coverage provided by 22F and 33F, as per WHO TRS-977 guidelines. All 14 serotypes achieved the primary immunogenicity endpoint, and strong functional OPA responses were observed across serotypes common to PCV-13.

Commenting on the WHO pre-qualification, Mahima Datla, Managing Director, Biological E. Limited, said, “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, particularly for children who need them most. WHO PQ enables broader reach through global immunisation initiatives, and we remain committed to supporting public health partners in delivering affordable, reliable vaccines across India and around the world.”

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