New Delhi: As the whole world is struggling to find a vaccine to tackle the pandemic coronavirus, India has found success of a different kind. It has managed to produce its first fully indigenously developed vaccine against pneumonia. The vaccine has got approval from the Drug Controller General of India (DCGI), the Union Health Ministry said Wednesday.
The DCGI with the help of Special Expert Committee (SEC) for vaccines, reviewed the phase I, II and III clinical trial data of the vaccine. It was submitted by Pune-based firm Serum Institute of India. The DCGI then gave 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. It will also be used to fight pneumonia caused by ‘Streptococcus pneumonia’ among infants.
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 SEC recommended for grant of permission of market authorisation to the said vaccine. July 14, Serum Institute was granted permission to manufacture the domestically developed vaccine, the ministry said. “This is the first indigenously developed vaccine in the field of pneumonia,” the Health Ministry said in a statement.
Earlier, the demand of the vaccine to fight pneumonia was substantially met by licensed importers in India. This was because the manufacturers were all vaccine companies based outside India, the ministry added.