NEW DELHI: The Drug Controller General of India V.G. Somani has approved Serum Institute of India Pvt Ltd’s indigenous pneumococcal polysaccharide conjugate vaccine, making it the first indigenously developed vaccine against pneumonia, the government said in a statement on Wednesday.
The company’s vaccine is used for immunization against invasive disease and pneumonia in infants and is administered as an intramuscular dose.
Serum Institute received the approval from the DCGI on Tuesday after a three-phase trial in India and Gambia, the government said.
As per the government’s clinical trial registry, the first phase of the trial was conducted in 2013 in 34 young Indian adults, while the second phase in 114 toddlers of 12-15 months.
The third phase of trials for the pneumococcal conjugate vaccine was conducted on 448 infants between the age of six to eight weeks old, and this was completed in October last year, as per the registry.
“The application along with the clinical trial data has been reviewed by the Office of Drug Controller General of India with the help of Special Expert Committee (SEC) for vaccines. The Committee recommended for grant of permission of market authorization to the said vaccine," the government statement said.
Earlier, India’s demand for the pneumococcal conjugate vaccine was substantially met by licensed importers in the country since the manufacturers were all vaccine companies based outside India, the government said.
Other pneumococcal conjugate vaccines include Wyeth Pfizer’s Prevenar 13, and GlaxoSmithKline plc’s Synflorix.
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