First fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine got approved: DCGI

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The first completely indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine has been approved by the Drug Controller General of India. The vaccine can be used for active immunization against pneumonia and invasive disease caused by Streptococcus pneumonia in infants. 

PPSV23  or the Pneumococcal Polysaccharide Conjugate Vaccine claims to offer protection against twenty-three types of pneumonia-causing bacteria which can cause a wide range of infections like bacteremia, blood infections, meningitis, and pneumonia.   

The administration of the vaccine has been done intramuscularly. In the field of pneumonia, this has been recognized as the first indigenously developed vaccine. If the previous scenario is being described then all the vaccine manufacturing companies were situated outside India, hence the demand which rose for such vaccines was substantially fulfilled by licensed importers in the nation.

A statement was given by the Union Health Ministry the Serum Institute of India which is allocated in Pune has developed the vaccine. Firstly, the Drug Control General of India’s approval for the conduction of Phase – I, Phase – II as well as Phase -III clinical trials of Pneumococcal Polysaccharide Conjugate Vaccine was obtained by the Serum Institute.

According to the clinical trial surgery‘s information, the conduction of Phase – I trial was done on thirty-four young minds in the year 2013. The second phase was conducted on one hundred and fourteen toddlers who were twelve to fifteen months old. The conduction of the last phase of the trial was done on four hundred and eighty-four infants who were between the age group of 6 – 8 weeks. The whole procedure of trial conduction was completed last year in October

 The Serum Institute of India Private Limited was permitted to manufacture this indigenously developed vaccine on the 14th of July. The permission of market authorization for the same was granted recommendation by the Special Expert Committee i.e. SEC.

These trials have since been concluded within the country. Apart from India, the company has conducted these clinical trials in another country of Gambia as well.

The trial which was conducted in the Gambia involved two thousand two hundred and fifty infants as a part of the trial conduction. the vaccine was already pre-qualified by the World Health Organisation in 2019’s December month. {Source: The Hindu}

After all this, the company applied for approval and asked for permission to manufacture the vaccine.  

The Executive Director of Serum Institute, Dr. Rajeev Dheere said that this vaccine will be cheaper than the other vaccines that are already available in the nation’s market. He said that “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.” {Source: The Hindu}

It has been proven that pneumonia is majorly the reason od infants’ and children’s death before their age of five (globally). According to some research and reports, more than 9 lakh lives end due to this disease.  In India, pneumonia cases among children who are under five years are 0.37 episodes per year which result in forty-three million new cases according to the estimation of the National Center for Biotechnology Information (NCBI).

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