India gets its first indigenous pneumonia vaccine

Aditi Tandon
Tribune News Service
New Delhi, July 15

India on Wednesday got its first indigenous pneumonia vaccine along with an apex drug regulator granting market approval for Pneumococcal Polysaccharide Conjugate Vaccine developed by Serum Institute of India.

Drug Controller General of India (DCGI) looked at the evidence from human trials to allow the first fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine for marketing in India.

Serum Institute first obtained the approval of DCGI to conduct Phase I, Phase II and Phase III clinical trials of the vaccine.

These trials have since been concluded within the country.

The said company has also conducted clinical trials in another country Gambia.

Thereafter, Serum Institute applied for approval and permission to manufacture this vaccine.

A Health Ministry statement said 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. On July 14, Serum Institute of India Pune has been granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate Vaccine. This is the first indigenously developed vaccine in the field of pneumonia,” Ministry said.

Earlier, the demand of this vaccine was met substantially by licensed importers in the country since the manufacturers were all vaccine companies based outside India.

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

The vaccine is administered intramuscularly.