WHO grants Pre qualification status to Biological E 14-valent Pneumococcal Conjugate shot
Hyderabad: Biological E. Limited, a Hyderabad-based vaccine and pharmaceutical company, has announced that the World Health Organisation (WHO) has granted Pre-qualification (PQ) status to their 14-valent Pneumococcal Conjugate Vaccine (PCV), PNEUBEVAX 14 (BE-PCV-14).
PNEUBEVAX 14 becomes Biological E’s 11th WHO pre-qualified vaccine. Developed specifically to prevent invasive pneumococcal diseases, PNEUBEVAX 14 protects against infections caused by 14 different Streptococcus pneumoniae serotypes, including serotypes 22F and 33F—two strains not covered by select other PCVs. Administered to infants from six weeks of age, PNEUBEVAX 14 is designed to guard against serious diseases such as pneumonia, meningitis, and sepsis as part of the primary vaccination schedule.
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.”
