The drug regulator reviewed the phase I, II and III clinical trial data submitted by Pune-based firm Serum Institute of India and granted market approval for Pneumococcal Polysaccharide Conjugate Vaccine.
The country’s first fully indigenously developed vaccine against pneumonia has got approval from the Drug Controller General of India (DCGI), the Union health ministry said on Wednesday.
With the help of Special Expert Committee (SEC) for vaccines, the drug regulator reviewed the phase I, II and III clinical trial data submitted by Pune-based firm Serum Institute of India and then granted the market approval for Pneumococcal Polysaccharide Conjugate Vaccine.
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.
Thereafter, the company applied for approval and permission to manufacture the vaccine.
The Special Expert Committee (SEC) recommended for grant of permission of market authorization to the said vaccine. On July 14, Serum Institute of India Pvt Ltd was granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate Vaccine, the ministry said.
“This is the first indigenously developed vaccine in the field of pneumonia,” it said.
Earlier, the demand of such vaccine was substantially met by licensed importers in the country since the manufacturers were all vaccine companies based outside India, the ministry added.