S pneumoniae infection treatment: DCGI nod to Biological E 14-valent paediatric Pneumococcal Conjugate Vaccine

The primary immunogenicity objective of demonstrating non-inferiority with anti-PnCPS IgG antibody concentrations against each of the 12 common serotypes of BE-PCV14 vaccine in terms of subjects seroconverted and the ratio of geometric mean concentrations against corresponding serotypes in active comparator was met. Non-inferiority was demonstrated with anti-PnCPS IgG antibody concentrations against unique serotypes 22F and 33F specific to BE-PCV14.

The immune response to serotype 6A not present in BE's PCV14 was also achieved through cross-protection from vaccine serotype 6B present in BE-PCV14. The safety comparison demonstrates that the BE-PCV14 vaccine was well-tolerated and considered safe.

BE's PCV14 is comparable in terms of serotype coverage for infants to the two globally approved pneumococcal conjugate vaccines Prevenar13 and Merck's VAXNEUVANCE.

Mahima Datla, Managing Director, Biological E. Limited, said, "We are pleased with this important approval, which will help save the lives of millions of children in India and around the world. BE's PCV14 will contribute to the prevention of invasive pneumococcal disease. With this endorsement, our country has another essential paediatric vaccine. We will be working with regulators in other countries to make our vaccine available globally."