Drug Controller General of India V.G. Somani has licensed the indigenous pneumococcal polysaccharide conjugate vaccine of the Serum Institute of India Pvt Ltd, and has made it the first indigenous pneumonia vaccine.
The Serum Institute was first approved by DGCI for the conduct of Pneumococcal Polysaccharide Conjugate Conjugate Vaccine in India, phase I, phase II, and phase III clinical trials. The Health Ministry stated in that statement that it conducted clinical trials in Gambia as well.
The vaccine is used as an intramuscular injection that is used in infants to immunize against respiratory disorders that pneumonia.
In 2013 the first phase of the study was performed in 34 young Indian adults according to the government’s clinical research list, while the second phase was administered in 114 toddlers 12–15 months of age. 448 infants between the ages of six and eight weeks were checked in a third phase, which was done by October last yearas reported in registry.
“With the help of the Special Expert Committee (SEC), the report along with the clinical trial evidence was checked by the Office of the Drug Controller General of India. The Committee suggested that the vaccine be permitted to be sold, “the government declaration said.
Early on, approved importers in India significantly met India’s need for a pneumococcal conjugate vaccine, as suppliers were all vaccine firms located outside India, the administration says.
This vaccine is used for active immunization from “streptococcus pneumonia” in babies against invasive diseases and pneumonia. The vaccine is given intramuscularly.
