Serum Institute gets DCGI nod for pneumococcal polysaccharide conjugate vaccine

The Drug Controller General of India (DCGI) has given approval to the first fully indigenously developed pneumococcal polysaccharide conjugate vaccine. This 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. It has also conducted these clinical trials in Gambia.

Thereafter, Serum Insitute of India applied for approval and permission to manufacture this vaccine. The application along with the clinical trial data has been reviewed by the Office of Drug Controller General of India with the help of the Special Expert Committee (SEC) for vaccines.  The Committee recommended for grant of permission of market authorisation to the said vaccine.

This is the first indigenously developed vaccine in the field of pneumonia. It is used for active immunisation against invasive disease and pneumonia caused by streptococcus pneumonia in infants. The vaccine is administered in an intramuscular manner.