Biological E. Limited (BE), one of India’s leading vaccine and pharmaceutical manufacturers, has announced a major milestone with the World Health Organisation (WHO) granting Pre-qualification (PQ) status to its 14-valent Pneumococcal Conjugate Vaccine, PNEUBEVAX 14 (BE-PCV-14). This achievement marks the company’s 11th vaccine to enter the WHO PQ portfolio, strengthening its presence among global immunisation suppliers.
PNEUBEVAX 14 has been developed to protect infants from severe invasive pneumococcal diseases, including pneumonia, meningitis and sepsis. The vaccine covers 14 serotypes of Streptococcus pneumoniae, notably adding serotypes 22F and 33F—two strains that are not addressed by certain existing PCVs in the market. It is administered from six weeks of age as part of the routine primary immunisation schedule.
Clinical evaluation demonstrated that the vaccine elicits strong immune responses across all targeted serotypes, meeting WHO’s TRS-977 non-inferiority criteria. The inclusion of serotype 6B was shown to trigger cross-protection against serotype 6A, with 69% of study participants achieving seroconversion—expanding its protective scope beyond its core components. Safety data indicated that PNEUBEVAX 14 is well tolerated, with most adverse events reported as mild and comparable to those seen with established PCV-13 formulations.
Ms. Mahima Datla, Managing Director of Biological E. Limited, noted the significance of the approval, “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.”
The WHO PQ status allows PNEUBEVAX 14 to be procured for large-scale immunisation programmes supported by organisations such as UNICEF and Gavi, ensuring wider availability in low- and middle-income countries. The vaccine is expected to enhance supply stability at a time when global demand for pneumococcal vaccines remains high.
