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DCGI gives market approval for Pneumococcal Polysaccharide Conjugate Vaccine

DCGI gives market approval for Pneumococcal Polysaccharide Conjugate Vaccine

Drug Controller General of India (DCGI) has given market approval to the first fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine. This vaccine has been developed by M/s. Serum Institute of India Pvt. Ltd, Pune.

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Key-Points

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. The Company has also conducted these clinical trials in another country i.e. Gambia. 

This vaccine is used for active immunization against invasive disease and pneumonia caused by “Streptococcus pneumonia” in infants.  The vaccine is administered in a intramuscular manner.

The pneumococcal conjugate vaccine (PCV13) and the pneumococcal polysaccharide vaccine (PPSV23) protect against pneumococcal infections.

The bacteria that cause these infections spread through person-to-person contact. They can lead to serious infections like pneumonia, blood infections, and bacterial meningitis.

PCV13 protects against 13 types of pneumococcal bacteria, which cause the most common pneumococcal (new-muh-KOK-uhl) infections in kids. PPSV23 protects against 23 types. These vaccines prevent infections in children who get them, and help stop the infections from spreading to others.

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