HYDERABAD: Biological E. Limited (BE), a Hyderabad-based pharma and vaccine company, on Friday said that its 14-valent paediatric Pneumococcal Conjugate Vaccine 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 aged 6, 10 and 14 weeks in 3 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. BE's PCV14 Vaccine will help prevent invasive pneumococcal infection and save millions of lives worldwide.
BE’s 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. In a Phase 3 infants trial BE’s PCV14 was non-inferior to all the common serotypes present in the comparator’s vaccine.
Mahima Datla, the managing director of Biological E. Ltd, said, “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."
