BRIEF—Indian approval for Biological E's 14-valent pneumococcal conjugate vaccine

Hyderabad, India-based Biological E Limited (BE) says that its 14-valent paediatric pneumococcal conjugate vaccine (investigational pneumococcal polysaccharide conjugate vaccine PCV14) against S. pneumoniae infection has received approval from the Drugs Controller General of India (DCGI) for manufacture and commercialization in India.

PCV14 may be administered to infants six, 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.

Managing director Mahima Datla commented: "We are pleased with this important approval, which 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. 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."