In a big respite to health professionals across India The Drug Controller General of India (DGCA) on Wednesday approved the manufacture of COVID-19 subunit vaccine – Pneumococcal Polysaccharide Conjugate Vaccine – developed by the Serum Institute of India, Pune, one of the world’s largest manufacturers of vaccines. The vaccine is administered in an intramuscular manner.
The ministry said the vaccine will be used for active immunisatiuon against invasive disease and pneumonia caused by 'Streptococcus pneumonia' among infants.The Serum Institute of India first obtained the approval of the DCGI to conduct Phase I, II and III clinical trials of the vaccine in India. These trials have since been concluded within the country. The company also conducted the clinical trials in Gambia.
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. 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. Serum Institute has also been working rigorously with the Oxford University to begin production for the COVID-19 vaccine.