CDSCO Expert Panel Recommends Emergency Use Of Covaxin For Children Aged Between 2-18
After a meeting yesterday, SEC has sent its recommendation to the Drug Controller General of India for their approval.
New Delhi: The Subject Expert Committee of CDSCO (Central Drugs Standard Control Organisation) has approved giving Covaxin to children aged 2 to 18 years according to official sources.
After a meeting yesterday, SEC has sent its recommendation to the Drug Controller General of India for their approval.
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Phase II and III trials were conducted in India on children aged 2 to 18 years in September and the trial data was submitted to the Drugs and Comptroller General of India (DCGI) at the beginning of this month, reported Mint.
Speaking to ANI, Dr Sanjay K Rai, a professor at Centre for Community Medicine, All India Institute of Medical Sciences (AIIMS), said, "Covaxin's trial was done on three age groups. The first group examined was between 12 -18 years, the second group was between 6- 12 years and the third age group was between 2-6 years."
"At first, we finished the examination of people aged between 12- 18 years and then subsequently other groups. Covaxin’s vaccine safety and immunogenicity are almost the same. However, the final results of these trials are awaited. We had already carried out trials on the adult population. For children, we are waiting for the results," said the doctor.
Dr Rai also noted that globally it is observed that in children, SARS-CoV-2 isn't fatal.
"Only a very mild infection is present. In a few children, it's milder than the common cold. Currently, we don't have any justification on whether Zydus Cadila, Bharat Biotech, Pfizer, or Moderna...which is the mildest. These vaccines are reducing the severity of the infection but not the infection," he said.
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