Biological E secures WHO prequalification for pneumococcal conjugate vaccine

vaccine

Vaccine maker Biological E (BE) on Thursday said it has secured World Health Organisation (WHO) pre-qualification for its new 14-valent pneumococcal conjugate vaccine, a regulatory milestone that paves the way for broader global distribution of the shot designed for infants.

The WHO prequalification allows the PNEUBEVAX 14 (BE-PCV-14) vaccine to be procured by United Nations agencies and global immunisation initiatives. This marks the 11th vaccine from the Hyderabad-based vaccine maker’s portfolio to achieve WHO pre-qualification status.

The vaccine is designed to protect infants from six weeks of age against invasive diseases, including pneumonia, meningitis, and sepsis. The formulation covers 14 Streptococcus pneumoniae serotypes, notably including strains 22F and 33F, which are not covered by select other pneumococcal conjugate vaccines (PCVs) currently available. According to the company, this offers the broadest coverage of any pediatric PCV available in India.

Clinical assessments indicated the vaccine met non-inferiority criteria compared to the widely used PCV-13 formulation, with a comparable safety profile. Additionally, the study showed the vaccine elicited cross-protective immunity against serotype 6A—resulting in a 69% seroconversion rate—via the inclusion of serotype 6B.

Mahima Datla, Managing Director of Biological E., said that the pre-qualification strengthens supply security for essential vaccines. "This milestone enhances global access to high-quality pneumococcal vaccines... particularly for children who need them most," Datla said.