Hyderabad-based Biological E pneumococcal vaccine gets WHO pre-qualification status

Hyderabad: Biological E Limited (BE), a leading Hyderabad-based vaccine and pharmaceutical company, on Thursday announced a significant achievement, securing World Health Organisation (WHO) Pre-qualification (PQ) status for its 14-valent Pneumococcal Conjugate Vaccine (PCV), PNEUBEVAX 14® (BE-PCV-14).

The WHO PQ designation is a critical endorsement, enabling PNEUBEVAX 14® to be procured by United Nations agencies and global immunisation initiatives, strengthening the global supply of pneumococcal vaccines, particularly for developing countries.

Broadest coverage PCV in India

PNEUBEVAX 14® is now BE’s 11th WHO pre-qualified vaccine. Developed to combat invasive pneumococcal diseases, this new vaccine offers protection against infections caused by 14 different Streptococcus pneumoniae serotypes.

Crucially, PNEUBEVAX 14® provides the broadest coverage of any paediatric PCV currently available in India, including serotypes 22F and 33F, two strains that are not covered by select other PCV formulations. It is administered to infants from six weeks of age as part of the primary vaccination schedule to guard against severe diseases like pneumonia, meningitis, and sepsis.

Robust immunogenicity and safety profile

Clinical studies demonstrated that PNEUBEVAX 14® has a favourable safety profile and successfully induced robust, serotype-specific immune responses to all 14 targeted strains. The safety profile was comparable to the widely used PCV-13 formulation, with most reported adverse events being mild.

The vaccine met the non-inferiority criteria for shared serotypes and for its additional coverage, adhering to WHO TRS-977 guidelines. Furthermore, the inclusion of serotype 6B led to cross-protective immunity against serotype 6A, with 69 per cent of subjects showing seroconversion, further extending the vaccine’s protective reach.

Commitment to global health security

Mahima Datla, Managing Director, Biological E Limited, stated, “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.”