Written By: Longjam Dineshwori | Updated : December 17, 2022 9:08 AM IST
The way biological and biotechnological research is carried out has changed due to systems biology. The way biological and biotechnological research is carried out has changed due to systems biology. Systems biotechnology uses physical methods to develop bioprocesses for synthesising valuable pharmaceuticals, industrial and fine chemicals, fuels, polymers, and other materials.
The Drugs Controller General of India (DCGI) has approved a 14-valent paediatric Pneumococcal Conjugate Vaccine, developed by Biological E. Limited (BE), for manufacture and commercialisation in the country. The vaccine is designed to protect infants against Streptococcus pneumoniae infection or S. pneumoniae infection, which is considered as one of the leading causes of death among children below five in India and other developing countries.
The Hyderabad-based Pharmaceutical and Vaccine Company announced the DCGI approval of its Investigational Pneumococcal Polysaccharide Conjugate Vaccine (PCV14) on Friday.
Expressing her happiness on receiving the DCGI's approval, Mahima Datla, Managing Director, Biological E. Limited, said that the vaccine will save the lives of millions of children in India and around the world, by preventing invasive pneumococcal disease.
The PCV14 vaccine is going to be another essential paediatric vaccine in the country. The company is also in the process of getting approval from regulators in other countries to make the vaccine available globally, Datla said.
The BE-PCV14 vaccine contains the largest number of serotypes in India and offers expanded protection against two new serotypes 22F and 33F, which have been reportedly causing infections recently. In total, it comprises 14 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F). The vaccine will be given to infants in 3 doses at 6, 10 and 14 weeks of age.
The Phase 3 trial of BE's PCV14 vaccine showed that it was non-inferior to all the common serotypes present in a comparator's vaccine. Moreover, the study was demonstrated non-inferiority with anti-PnCPS IgG antibody concentrations against 22F and 33F serotypes, which are specific to the BE-PCV14 vaccine. In terms of safety, the company says the BE-PCV14 vaccine is proven to be well-tolerated and safe.
Biological E. Limited (BE) claims that its vaccine is equivalent to the two globally approved pneumococcal conjugate vaccines Prevenar13 and Merck's VAXNEUVANCE in terms of serotype coverage for infants.
