DCGI Approves BE’s 14-Valent Pneumococcal Conjugate Vaccine
Biological E. Limited Receives Authorization to Manufacture and Market the 14-valent Vaccine against Streptococcus pneumoniae Infection in India
Hyderabad, December 16, 2022: Biological E. Limited (BE), a Hyderabad-based Pharmaceutical and Vaccine Company today 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 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 14 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F). 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.
The primary immunogenicity objective of demonstrating non-inferiority with anti-PnCPS IgG antibody concentrations against each of the 12 common serotypes of BE-PCV14 vaccine in terms of subjects seroconverted and the ratio of geometric mean concentrations against corresponding serotypes in active comparator was met. Non-inferiority was demonstrated with anti-PnCPS IgG antibody concentrations against unique serotypes 22F and 33F specific to BE-PCV14.
The immune response to serotype 6A not present in BE’s PCV14 was also achieved through cross protection from vaccine serotype 6B present in BE-PCV14. The safety comparison demonstrates that the BE-PCV14 vaccine was well-tolerated and considered safe.
BE’s PCV14 is comparable in terms of serotype coverage for infants to the two globally approved pneumococcal conjugate vaccines Prevenar13 and Merck’s VAXNEUVANCE.
Ms. Mahima Datla, Managing Director, Biological E. Limited, said, "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."
ABOUT BIOLOGICAL E. LIMITED
Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines and 5 USFDA approved Injectables in its portfolio.
Hyderabad, December 16, 2022: Biological E. Limited (BE), a Hyderabad-based Pharmaceutical and Vaccine Company today 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 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 14 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F). 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.
The primary immunogenicity objective of demonstrating non-inferiority with anti-PnCPS IgG antibody concentrations against each of the 12 common serotypes of BE-PCV14 vaccine in terms of subjects seroconverted and the ratio of geometric mean concentrations against corresponding serotypes in active comparator was met. Non-inferiority was demonstrated with anti-PnCPS IgG antibody concentrations against unique serotypes 22F and 33F specific to BE-PCV14.
The immune response to serotype 6A not present in BE’s PCV14 was also achieved through cross protection from vaccine serotype 6B present in BE-PCV14. The safety comparison demonstrates that the BE-PCV14 vaccine was well-tolerated and considered safe.
BE’s PCV14 is comparable in terms of serotype coverage for infants to the two globally approved pneumococcal conjugate vaccines Prevenar13 and Merck’s VAXNEUVANCE.
Ms. Mahima Datla, Managing Director, Biological E. Limited, said, "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."
ABOUT BIOLOGICAL E. LIMITED
Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines and 5 USFDA approved Injectables in its portfolio.