NEW DELHI: India has got its first locally developed pneumonia vaccine, reducing its dependence on imports for immunization against a disease that contributes to most deaths in children under five years of age.
The Drugs Controller General of India (DCGI) on Tuesday approved Pneumococcal Polysaccharide Conjugate Vaccine developed by Serum Institute of India. The Pune based company can now manufacture the vaccine in India for use.
This vaccine is used for active immunization against invasive disease and pneumonia caused by “Streptococcus pneumonia” in infants.
India accounted for the second highest number of deaths in under-five children in 2018 because of pneumonia. According to Unicef, India reported 1,27,000 under five deaths due to pneumonia in 2018.
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.
The regulatory approval is based on clinical evidence secured by the company after conducting Phase I, Phase II and Phase III clinical trials of the vaccine.
Serum Institute has conducted these trials in India as well as in Gambia.
While immunization against the disease has improved in India led by government initiatives and awareness programmes, many children – mainly female children – are still left out of the coverage.
Experts say a locally made vaccine is likely to make the vaccine more accessible and affordable.