Hyderabad (Andhra Pradesh) [India], November 20 : Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, announced on Thursday that its 14-valent Pneumococcal Conjugate Vaccine (PCV), PNEUBEVAX 14® (BE-PCV-14), has received World Health Organization (WHO) pre-qualification (PQ) status.
PNEUBEVAX 14® is BE's 11th vaccine to achieve WHO pre-qualification and is designed to protect infants from invasive pneumococcal diseases caused by 14 different Streptococcus pneumoniae serotypes, including serotypes 22F and 33F, which are not covered by certain other PCVs, as per a release.
The vaccine can be administered to infants from six weeks of age as part of the primary immunisation schedule to prevent serious conditions such as pneumonia, meningitis, and sepsis.
Clinical studies indicate that PNEUBEVAX 14® has a strong safety profile and induces robust, serotype-specific immune responses across all 14 targeted strains.
Notably, the vaccine also provides cross-protective immunity against serotype 6A through the inclusion of serotype 6B, with 69 per cent of subjects seroconverting against 6A.
The safety profile was comparable to the widely used PCV-13 formulation, with most adverse events being mild.
According to the release, the vaccine met the non-inferiority criteria (NI) for shared serotypes and the additional coverage provided by 22F and 33F, in line with WHO TRS-977 guidelines.
All 14 serotypes achieved the primary immunogenicity endpoint, and strong functional OPA responses were observed for serotypes common to PCV-13.
Commenting on the achievement, Mahima Datla, Managing Director of Biological E. Limited, 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."
With WHO pre-qualification, PNEUBEVAX 14® is expected to support a stable and accessible supply of Pneumococcal Conjugate Vaccines, contributing to efforts to expand immunisation coverage and reduce the global burden of pneumococcal disease.
Biological E. Limited, founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. The company develops, manufactures, and supplies vaccines and therapeutics.