Biological E. Limited (BE), the Hyderabad-based vaccine and pharmaceutical manufacturer, has announced that its 14-valent Pneumococcal Conjugate Vaccine, PNEUBEVAX 14® (BE-PCV-14), has received World Health Organization (WHO) pre-qualification (PQ) status.
PNEUBEVAX 14® is the company’s 11th vaccine to be pre-qualified by the WHO. It protects infants from invasive pneumococcal diseases caused by 14 different Streptococcus pneumoniae serotypes, including 22F and 33F, which are not covered by some existing PCVs. The vaccine can be administered from six weeks of age as part of routine immunisation to prevent life-threatening conditions such as pneumonia, meningitis, and sepsis.
Clinical evidence shows that PNEUBEVAX 14® has a strong safety profile and generates robust, serotype-specific immune responses across all included strains. It also offers cross-protection against serotype 6A through its inclusion of serotype 6B, with 69% seroconversion against 6A. The safety outcomes were similar to those of the widely used PCV-13, with most adverse events being mild.
The vaccine met WHO TRS-977 non-inferiority criteria for shared serotypes and demonstrated added protection from serotypes 22F and 33F. All 14 serotypes achieved their primary immunogenicity endpoints, and strong OPA (Opsonophagocytic Activity) responses were observed for serotypes that overlap with PCV-13.
What WHO Pre-Qualification Means
WHO pre-qualification is a global quality assurance process that evaluates vaccines for safety, efficacy, quality standards, and programmatic suitability. A vaccine that passes this assessment is approved for procurement by international agencies such as UNICEF, Gavi, and PAHO, enabling its use in national immunisation programs worldwide. With WHO PQ approval, PNEUBEVAX 14® is positioned to strengthen global pneumococcal disease prevention efforts and support wider immunisation coverage.
Biological E. Limited, founded in 1953, is India’s first private-sector biological products company and Southern India’s first pharmaceutical manufacturer. The company continues to develop, manufacture, and supply vaccines and therapeutics worldwide.
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