Covaxin for Children Likely to Get DCGI Approval before End of Trial Period: Sources

The Central Government and the Drugs Controller General of India (DCGI) are likely to grant the emergency use authorization to the Covaxin vaccines for children.
Source: Google / Image credit: ANI News
Source: Google / Image credit: ANI News

The Central Government and the Drugs Controller General of India (DCGI) are likely to grant the emergency use authorization to the Covaxin vaccines for children. According to the sources, the administration of both the doses of the vaccine to children has been completed. Now, blood samples sent for the third time to check the effectiveness in terms of producing antibodies among children.

A total of 90 children were included in the trials in Karnataka. The Covaxin trial will take 210 days to complete. But in the present circumstances, the approval of the vaccine for children cannot wait for five-six months. He said, "Final report will come on 210th day. The government and DGCI can take calls any day after 56th day of the trial Emergency use. However, the study period will be there for 210 days. Before also, while releasing Covid vaccines for adults the government of India and DCGI did not wait till the completion of 210 days. "

Source: Google / Image credit: ANI News
Source: Google / Image credit: ANI News

Process of approval of vaccine for children:

The DCGI will grant the approval of vaccine for children in three phases. The approval will be granted for children above 12 years of age first, then for children aged between 6 and 12 years and thereafter for children aged two to six years. Sources said that during the trial, only 10-12 children felt mild fever and pain on the day of vaccination. But they recovered in a day or two. They did not find any complications related to the vaccine.

"Everyone is safe during the course of the trial except for around 10-12 children experiencing mild fever and pain on the day of vaccination and the following day. The symptoms disappeared after a day or two in them also. No vaccination related complications found," sources said.

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