TNNSubject expert committee (SEC) of the drug regulator has reviewed and approved phase-3 infants clinical trial data of Biological E's paediatric vaccine against streptococcus pneumonia and recommended its manufacture, the Hyderabad-based vaccine maker said on Thursday.
Streptococcus pneumoniae infection is a leading cause of child mortality under 5 years of age in India and other developing countries. If Biological E (BE) gets final approval from the Central Drugs Standard Control Organisation (CDSCO), it will be the second made-in-India pneumococcal conjugate vaccine (PCV).
Serum Institute of India (SII) had launched the first indigenous PCV, branded Pneumosil, in December 2020. BE said its PCV can be administered to infants at 6, 10 and 14 weeks of age.
It is a 14 valent vaccine that provides protection against 14 serotypes of streptococcus bacteria, giving more coverage than 's top-selling 13 valent Prevenar13 and SII's 10 valent Pneumosil.
Streptococcus pneumoniae infection is a leading cause of child mortality under 5 years of age in India and other developing countries. If Biological E (BE) gets final approval from the Central Drugs Standard Control Organisation (CDSCO), it will be the second made-in-India pneumococcal conjugate vaccine (PCV).
Serum Institute of India (SII) had launched the first indigenous PCV, branded Pneumosil, in December 2020. BE said its PCV can be administered to infants at 6, 10 and 14 weeks of age.
It is a 14 valent vaccine that provides protection against 14 serotypes of streptococcus bacteria, giving more coverage than 's top-selling 13 valent Prevenar13 and SII's 10 valent Pneumosil.
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