Hyderabad-based Biological E gets DCGI approval for pneumococcal conjugate vaccine
Hyderabad-based vaccine manufacturer Biological E. Limited (BE) on Friday announced that it has received approval from DCGI
Hyderabad: Hyderabad-based vaccine manufacturer Biological E. Limited (BE) on Friday announced that it has received approval from Drug Controller General of India (DCGI) for commercialisation of its 14-valent paediatric Pneumococcal Conjugate Vaccine (PCV14) against pneumococcal infection caused by Streptococcus pneumonia bacteria.
The PCV14, which could be administered to infants 6, 10 and 14 weeks of age in 3 doses, has 14 serotypes, which is the largest number of serotypes in India, offering expanded protection against two new serotypes 22F and 33F. These new serotypes have been reported recently to be causing infections. In a Phase 3 infants trial BE’s PCV14 was non-inferior to all the common serotypes present in the comparator’s vaccine, BE said.
Streptococcus pneumoniae infection remains one of the leading causes of death among children under the age of five in India and in developing countries. The PCV14 vaccine will help prevent invasive pneumococcal infection and save millions of lives worldwide, the vaccine manufacturer said.
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.
