India's Covaxin Vaccine gets approval by DCGI to begin trials in 2-18 years old

Dr.Reepa Agrawal
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India's Covaxin Vaccine gets approval by DCGI to begin trials in 2-18 years old 21 May, 2021

India is witnessing a nightmarish second wave of Covid-19 with sadly world’s highest one day peak of cases over 4 lakhs in the first week of May 2021 and daily deaths of more than 3000 due to the deadly SARS-Cov2 virus. This wave also affected children and young people more as compared to the first wave.

Mass vaccination drive against Covid-19 began in January 2021 in India with Covishield ( Oxford -Astrazaneca vaccine manufactured in India by Serum Institute of India ) and Covaxin . Covaxin is indigenously produced in India by Bharat Biotech and was developed in collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). It is a conventional inactivated vaccine which contains whole dead virus (BBV152) , alum , IMDG as vaccine adjuvants. IMDG is a molecule which binds to toll -like receptors 7and 8. The vaccine was found to be safe and effective in Phase 3 Clinical Trials. According to Bharat Biotech’s website , the Phase 3 Clinical trials with 25,800 participants( > 18 years of age ) demonstrated an efficacy of 78% against mild, moderate and severe Covid-19 disease. 2 doses are administered intramuscularly 4 weeks apart .Although the data of Phase 2 trial has been published in Lancet , publishing of Phase 3 trial data in scientific peer reviewed journal is awaited. According to a recent article published in Clinical Infectious Diseases- Oxford University Press, Covaxin is effective against key emerging variants including B.1.617 and B.1.17 first identified in India and U.K respectively.

Drug Controller General of India (DCGI) has now approved to begin Phase 2/3 Clinical Trials in 2-18 years old. The trial will be conducted on 525 volunteers across various sites in India using 2 doses 28 days apart administered intramuscularly. This is the first Clinical Trial in this age group to begin in India. Moderna has ongoing trial in 6 months-11 years as well as 12-18 years old. Pfizer – BionTech mRNA vaccine has got emergency use authorization in 12-15 years old by FDA recently in U.S and their trials in 6 months -12 years old are ongoing .

Vaccination and following covid appropriate precautions : double mask , physical distancing , hand hygiene , being in well ventilated areas are essential to combat COVID-19 pandemic.



References :

www.bharatbiotech.com

Pragya D Yadav, Ph.D, Gajanan N Sapkal, Ph.D, Priya Abraham, M.D, Ph.D, Raches Ella, M.S, Gururaj Deshpande, Ph.D, Deepak Y Patil, Ph.D, Dimpal A Nyayanit, Ph.D, Nivedita Gupta, Ph.D, Rima R Sahay, M.D, Anita M Shete, Ph.D, Samiran Panda, M.D., Ph.D, Balram Bhargava, D.M, V Krishna Mohan, Ph.D, Neutralization of variant under investigation B.1.617 with sera of BBV152 vaccinees, Clinical Infectious Diseases, 2021;, ciab411, https://doi.org/10.1093/cid/ciab411
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