Biological E’s paediatric pneumococcal vax gets DCGI approval

Vaccine maker Biological E., on Friday, said its 14-valent paediatric Pneumococcal Conjugate Vaccine (Investigational Pneumococcal Polysaccharide Conjugate Vaccine PCV14) against Streptococcus pneumoniae infection has received approval from the Drugs Controller General of India (DCGI) for manufacture and commercialisation in India.

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

Managing Director Mahima Datla said, “We are pleased with this important approval, which will help save the lives of millions of children in India and around the world. The PCV14 will contribute for prevention of invasive pneumococcal disease.”

“With this endorsement, India has another essential paediatric vaccine. We will be working with regulators in other countries to make our vaccine available globally,” she said.

The company, in a release, said that PCV14 may be administered to infants 6, 10 and 14 weeks of age in three doses.

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 contains the largest number of serotypes in India and offers expanded protection against two new serotypes 22F and 33F. These new serotypes have been reported recently to be causing infections. The Hindu