Hyderabad: Vaccine maker Biological E Limited (BE) on Friday said it has received approval from the Drugs Controller General of India (DCGI) to manufacture and commercialise its 14-valent paediatric pneumococcal conjugate vaccine (PCV14) against S pneumoniae infection.
PCV14, which has to be administered in three doses to infants at six, 10 and 14 weeks of age, contains 14 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F). The vaccine contains the largest number of serotypes in India and offers expanded protection against two new serotypes 22F and 33F, BE said.
“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,” it explained. The company said its PCV14 is comparable in terms of serotype coverage for infants to Prevenar13 and Merck’s VAXNEUVANCE. tnn
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