PNEUBEVAX 14 Wins WHO Pre-Qualification
- Biological E’s PNEUBEVAX 14 gains WHO nod for global use
- Vaccine offers broad serotype coverage and strong immunity
Hyderabad: PNEUBEVAX 14 Wins WHO Pre Qualification as Biological E. Limited announced that the World Health Organisation has granted pre-qualification status to its 14-valent Pneumococcal Conjugate Vaccine. The Hyderabad-based company said the vaccine, known as PNEUBEVAX 14® or BE-PCV-14, has now become its 11th WHO pre-qualified product. The approval marks an important step in improving access to pneumococcal vaccines for global immunisation programmes.
The company said PNEUBEVAX 14® protects infants against 14 Streptococcus pneumoniae serotypes. These include serotypes 22F and 33F, which are not covered by several other pneumococcal conjugate vaccines. The vaccine is given from six weeks of age as part of the primary schedule and helps guard against pneumonia, meningitis and sepsis. Officials added that the formulation aims to prevent invasive pneumococcal diseases and expand protection for young children.
Clinical studies showed a strong serotype-specific immune response across all 14 targeted strains. Researchers also found that the inclusion of serotype 6B produced cross-protective immunity for serotype 6A. According to the data, 69 percent of subjects seroconverted against 6A. Meanwhile, the company said the safety profile of PNEUBEVAX 14® was similar to the widely used PCV-13, with most reactions reported as mild. The vaccine met non-inferiority criteria for shared serotypes and for the added coverage of 22F and 33F under WHO TRS-977 guidelines. All serotypes reached the primary immunogenicity endpoint, and strong functional OPA responses were recorded.
Commenting on the WHO approval, Managing Director Mahima Datla 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.”
Officials stated that with WHO pre-qualification, PNEUBEVAX 14® is positioned to support a stable supply of pneumococcal vaccines and help reduce the global disease burden. Biological E. Limited, founded in 1953, develops and manufactures vaccines and therapeutics. The company supplies vaccines to more than 140 countries and has a portfolio that includes 11 WHO-approved vaccines and 10 USFDA-approved generic injectables. It has also expanded into specialty injectable products and novel vaccine development for global markets.
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