Biological E Limited (BE), the city-headquartered vaccine and pharmaceutical manufacturer, has said that its 14-valent pneumococcal conjugate vaccine, PNEUBEVAX 14, has been granted pre-qualification status by the World Health Organisation (WHO). The approval makes it BE’s 11th WHO-prequalified vaccine, strengthening the company’s position as a key global supplier of affordable, high-quality immunisation solutions.
The vaccine is designed to protect infants from invasive pneumococcal diseases caused by 14 streptococcus pneumoniae serotypes, including 22F and 33F—two strains not covered by several other PCVs currently available in India. The vaccine can be administered from six weeks of age to help prevent severe illnesses such as pneumonia, meningitis and sepsis.
Clinical data shows that the vaccine offers a robust serotype-specific immune response, meeting all primary immunogenicity endpoints. It demonstrated non-inferiority to the widely used PCV-13 for shared serotypes and additional protection from 22F and 33F, in line with WHO TRS-977 guidelines. Studies also indicate cross-protective immunity against serotype 6A through the inclusion of serotype 6B, with 69 per cent of subjects seroconverting for 6A. The safety profile was found to be similar to existing PCVs, with most adverse events reported as mild.
Welcoming the WHO endorsement, Mahima Datla, Managing Director of Biological E Limited, said the recognition would significantly expand global access to reliable pneumococcal vaccines. “This milestone enhances 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,” she said.
With WHO pre-qualification, the vaccine is now positioned to contribute to a stable global supply of pneumococcal conjugate vaccines, supporting efforts to reduce the worldwide burden of pneumococcal disease.
