The Drug Controller General of India (DCGI) approved the first indigenous vaccine against pneumonia on 15th July, 2020. The vaccine was prepared and manufactured by Serum Institute of India (SII), a Pune-based firm. The DCGI, along with special expert committee for vaccine, reviewed the vaccine trials for phase one, two and three. The vaccine passed all the phases of trials successfully, after which it got the approval.
SII has not only conducted trials for this vaccine in India, but also in the West African nation of the Gambia. The DCGI, with the help of Special Expert Committee (SEC) for vaccines has approved the vaccine for marketing.
According to The Print, first trial was conducted in 2013 on 34 young adults, while the second trial was conducted on 114 infants aged from 12-15 months. The third trial, conducted on 448 infants, was completed in 2019. According to a report in The Hindu, the trial in the Gambia was conducted on 2,250 toddlers. The vaccine was pre-qualified by the World Health Organisation in 2019.
The approved vaccine is administered in the form of intramuscular injection. Pneumococcal Polysaccharide Conjugate Vaccine (PPSV23) gives full protection against various infectious diseases, as well as pneumonia caused by the bacterium Streptococcus pneumonia.
Dr Rajeev Dhere, Executive Director of SII, said that the price of the vaccine will be lower than those that already exist in the Indian market. “We expect to sell 100 million doses each year within the next three years. Of this, 40-50 million doses per year will be in India alone. The private market for the vaccine will be minuscule compared with the public market,” he added.
A press release by the Ministry of Health and Family Welfare reported this approval, saying:
“Serum Institute of India Pvt. Ltd, Pune has been granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate Vaccine, the first indigenously developed vaccine in the field of pneumonia. 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.”
Pneumonia is the number one killer among children before their fifth birthday worldwide. It claims more than 9,00,000 lives each year. The National Center for Biotechnology Information has estimated that India reports 0.37 episodes of pneumonia among below-five-year-old children per year, which result in 43 million new cases annually.