Drug Controller General of India (DCGI) has given approval to the first fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine. This vaccine is used for active immunization against invasive disease and pneumonia caused by “Streptococcus pneumonia” in infants.
The vaccine is administered in an intramuscular manner. This is the first indigenously developed vaccine in the field of pneumonia. Earlier the demand of such vaccines was substantially met by licensed importers in the country since the manufacturers were all vaccine companies based outside India.
Union Health Ministry in a statement said, the vaccine has been developed by Serum Institute of India, Pune. Serum Institute first obtained the approval of DCGI to conduct Phase-I, Phase-II and Phase-III clinical trials of Pneumococcal Polysaccharide Conjugate Vaccine in India.
These trials have since been concluded within the country. Besides, the Company has also conducted these clinical trials in another country – Gambia.
Thereafter, the Company applied for approval and permission to manufacture this vaccine.
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