New Delhi: The CDSCO (Central Medicines Standards Control Organization) expert committee has approved the administration of Covaxin to children between the ages of 2 and 18, according to official sources.
After a meeting yesterday, the SEC sent its recommendation to the Drug Controller General of India for approval.
Phase II and III trials were conducted in India on children aged 2 to 18 in September and trial data was submitted to the Drugs and Comptroller General of India (DCGI) earlier this month, Mint reported.
Speaking to ANI, Dr. Sanjay K Rai, professor at the Center for Community Medicine, All India Institute of Medical Sciences (AIIMS), said: “The Covaxin for children trial was performed on three age groups. The first group examined was between 12 and 18 years old. The second group was between 6 and 12 years old and the third age group was between 2 and 6 years old. “
“First, we finished examining people aged 12 to 18, and then other groups. The safety of the vaccine and the immunogenicity of Covaxin are almost the same. However, the final results of these trials are awaited. We had already performed 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 is not fatal.
“Only a very mild infection is present. In some children, it is milder than the common cold. Currently, we have no justification as to whether Zydus Cadila, Bharat Biotech, Pfizer, or Moderna which is more benign. These vaccines reduce the severity of the infection but not the infection, ”he said.