DCGI approves Hyd-based Biological E's paediatric pneumococcal vaccine
Mahima Datla, the managing director of Biological E. Limited, said, “The vaccine will help save the lives of millions of children in India and around the world.”
By Newsmeter Network Published on 16 Dec 2022 12:37 PM GMT
Hyderabad: Biological E Limited (BE), a Hyderabad-based pharmaceutical and vaccine company, on Friday announced that its 14-valent paediatric Pneumococcal Conjugate Vaccine, (Investigational Pneumococcal Polysaccharide Conjugate Vaccine PCV14) against S. pneumoniae infection, received approval from the Drugs Controller General of India (DCGI) for manufacture and commercialisation in India.
PCV14 may be administered to infants 6, 10, and 14 weeks of age in three doses.
Pneumonia deaths in India
Streptococcus pneumoniae infection remains one of the leading causes of death among children under the age of five in India.
BE's PCV14 vaccine will help prevent invasive pneumococcal infection. PCV14 contains 14 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) and offers protection against two new serotypes (22F and 33F). These new serotypes have been reported recently to be causing infections.
In the phase 3 infants trial, BE's PCV14 was non-inferior to all common serotypes.
The safety comparison demonstrates that the BE-PCV14 vaccine was well-tolerated and considered safe.
Mahima Datla, the managing director of Biological E. Limited, said, "The vaccine 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."
