The Union Health Ministry on Wednesday said that the Drug Controller General of India (DCGI) has given its approval for the first fully indigenous vaccine made in India for pneumonia. The Regulatory Board in collaboration with the Special Expert Committee (SEC) reviewed the data revealed in the first, second and third phase clinical trials of the Pneumococcal Polysaccharide Conjugate Vaccine, after which it has been approved to market. This vaccine has been created by Pune-based firm Serum Institute of India. This vaccine is to be applied intramuscular.
The ministry said the vaccine will be used in pneumonia and pneumonia caused by Streptococcus pneumonia in newborns. The Serum Institute had previously approved the vaccine from DCGI for clinical trials in India in three phases, after which it has been tried nationwide. Apart from India, the company has also tried it in Gambia. After this, the firm sent its project to the regulator to approve it and produce the vaccine.
The Ministry said that the Special Expert Committee on July 14 allowed the introduction of the first pneumonia-produced Pneumococcal Polysaccharide Conjugate vaccine in the country by the Serum Institute. The statement issued by the ministry said that before this, the demand for pneumonia vaccine was met through licensing imports because till now all the companies making the vaccine for this disease were foreign.
On the basis of government's clinical test registry, the primary phase of the trial was conducted in 2013 with 34 young Indian adults, while the second introduce 114 toddlers of 12-15 months. The third phase of trials for the pneumococcal conjugate vaccine was conducted on 448 infants between six to eight weeks old age, whereas this was completed in October last year, as per the registry.
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