India's first indigenous pneumonia vaccine developed by Serum Institute get DCGI nod for market
Serum Institute conducted a three-phase clinical trial of the vaccine in India along with trials in the West African nation of The Gambia.
The Drug Controller General of India (DCGI) has given its nod of approval for India's first indigenously developed vaccine against pneumonia. The vaccine has been developed and manufactured by the Serum Institute of India.
The Pneumococcal Polysaccharide Conjugate Vaccine (PPSV23) offers protection against 23 types of pneumonia-causing bacteria, which cause a range of infections including meningitis, bacteremia, pneumonia and blood infections.
Serum Institute conducted Phase I, Phase II and Phase III clinical trials of the Pneumococcal Polysaccharide Conjugate Vaccine in India and was successful. They also undertook clinical trials in the West African nation of The Gambia, reported PIB.
The first phase of the trial was conducted in 2013 in India with 34 young adults and the second phase was conducted among 114 toddlers aged between 12-15 months, according to The Print. The third phase of the clinical trials for the vaccine was conducted on 448 infants between the age of six to eight weeks old and was completed in October 2019 as per the government’s clinical trial registry.
According to a report by The Hindu, around 2,250 infants were part of the trial in the Gambia and the vaccine has been pre-qualified by the World Health Organisation (WHO) in December 2019.
After the clinical trial data was reviewed by the Office of the DCGI along with a Special Expert Committee (SEC) for vaccines, the vaccine was given approval for marketing. Serum Institue's application for permission to manufacture the vaccine in India was also granted.
"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," read a release from the Ministry of Health and Family Welfare.
The vaccine is used to immunize against infectious diseases and pneumonia caused by Streptococcus pneumonia in infants and is administered in an intramuscular injection, according to the release. The Hindu report also quotes Dr Rajeev Dhere, Executive Director of Serum Institute who 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.
According to GAVI.org, Serum Institue's vaccine has become the third supplier of pneumococcal conjugate vaccines (PCV) under the pneumococcal Advance Market Commitment (AMC), and the first developing country vaccine manufacturer to access the global PCV market. Serum will also provide 10 million doses each year to Gavi countries at only US$ 2.00 a dose, less than 1.5 percent of the public price in high-income countries.
Pneumococcal (pneumonia-causing) bacteria can spread from person to person via direct contact with respiratory secretions like saliva and mucus, according to the US Centers for Disease Control and Prevention. The bacteria can be carried in a person's nose and throat and spread to a healthy person without any symptoms of sickness presented in carriers.
People over 65 years, those who smoke cigarettes, and others who suffer from health conditions like chronic lung disease or diabetes are more affected by the disease and need to be vaccinated. Pneumonia also affects people with sicknesses that can lower the body’s resistance to infection, or those with weakened immune systems.
According to Path.org, pneumonia is the number one killer among children before their fifth birthdays worldwide. It claims more than 9,00,000 lives each year. The National Center for Biotechnology Information (NCBI) has estimated that in India pneumonia cases among under-five-year-old children is 0.37 episodes per year which result in 43 million new cases.
With inputs from wires
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