Biological E.’s PNEUBEVAX 14® Gets WHO Pre-Qualification, Offering India’s Broadest Paediatric Pneumococcal Coverage
Biological E. Limited (BE), the Hyderabad-based vaccines and pharmaceuticals major, has announced that its 14-valent Pneumococcal Conjugate Vaccine (PCV), PNEUBEVAX 14®, has been granted pre-qualification (PQ) status by the World Health Organization (WHO). The approval marks BE’s 11th WHO-prequalified vaccine.
Hyderabad: Biological E. Limited (BE), the Hyderabad-based vaccines and pharmaceuticals major, has announced that its 14-valent Pneumococcal Conjugate Vaccine (PCV), PNEUBEVAX 14®, has been granted pre-qualification (PQ) status by the World Health Organization (WHO). The approval marks BE’s 11th WHO-prequalified vaccine.
PNEUBEVAX 14® protects against 14 Streptococcus pneumoniae serotypes, including 22F and 33F — strains not covered by select other paediatric PCVs currently available in India. Designed for administration in infants from six weeks of age, the vaccine aims to prevent serious conditions such as pneumonia, meningitis and sepsis as part of routine immunisation schedules.
According to BE, clinical trials have demonstrated that the vaccine has a strong safety profile and evokes robust serotype-specific immune responses across all 14 targeted strains. It also offers cross-protective immunity against serotype 6A through the inclusion of serotype 6B, with 69% of subjects seroconverting for 6A.
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The vaccine met non-inferiority (NI) criteria for shared serotypes and for its additional coverage of 22F and 33F, in line with WHO TRS-977 guidelines. All serotypes achieved the primary immunogenicity endpoint, and functional OPA responses were comparable to those seen in the widely used PCV-13.
Welcoming the WHO approval, Mahima Datla, Managing Director of 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.”
With the WHO’s endorsement, BE’s new PCV is expected to bolster global vaccine supply chains and support efforts to expand paediatric immunisation coverage against pneumococcal disease.
