The Drug Controller General of India (DCGI) has approved the first fully indigenously developed conjugate vaccine for pneumonia developed by the Serum Institute of India Pvt. Ltd, Pune.
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The Serum Institute first obtained the DGCI approval to conduct Phase I, Phase II and Phase III clinical trials of Pneumococcal Polysaccharide Conjugate Vaccine in India. It has also conducted clinical trials in Gambia, the Health Ministry said in a statement.
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“The committee [constituted by the drug regulator]recommended for grant of permission of market authorisation to the said vaccine. Serum Institute of India Pvt. Ltd, Pune has been granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate Vaccine. Earlier the demand for such vaccine was substantially met by licensed importers since the manufacturers were all based outside India,” the statement added.
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This vaccine is used for active immunisation against invasive disease and pneumonia caused by “streptococcus pneumonia” in infants. The vaccine is administered intramuscularly.
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According to information on the clinical trials 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 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.