Drugs Controller General of India approves Covaxin for kids aged 2-18 years

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• Oct 12, 2021 | moderator

New Delhi: The Drugs Controller General of India (DCGI) approved Covaxin for kids between 2-18 years of age. This vaccine is the second COVID-19 vaccine to get recommended for children in India. 

Previously, the drugs regulator had approved ZyCoV-D for children aged 12 and above as well as adults. But, the rollout has not yet started.

In September, Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin. The trials were made on children below 18 years of age. It has presented the trial data to the Drugs and Comptroller General of India (DCGI) by the beginning of this month.

After a thorough discussion, the committee approved a grant for market permission of the Covaxin vaccine. The vaccine gets approval for 2 to 18 years for restricted use in an emergency.

India made vaccine Covaxin will be administered in two doses. It will be injected with a gap of 20 days between the 1st and 2nd dose.

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Meantime, World Health Organization (WHO) is yet to permit emergency use authorisation to Covaxin. But, Bharat Biotech had reportedly submitted all data needed for the listing to the WHO by July 9. The WHO review process, which gets close to six weeks, had started by July-end.

The officials and autonomous organisation of specialists of WHO are scheduled to meet this week. The meet will discuss the risk/benefit assessment before granting Emergency Use Listing to Covaxin. 

India developed Bharat Biotech's Covaxin is one of the six vaccines that have received emergency use authorisation from India's Drug Regulator. It is being utilised in the nationwide anti-COVID-19 vaccination programme along with Covishield and Sputnik V vaccines. 

The approval comes with conditions like- 

• The company should continue the research as per the approved clinical trial protocol.
• The firm should present updated Prescribing Information/Package Insert (PI). It should also provide a summary of product characteristics (SmPC) and the Factsheet.
• The firm should submit safety data. The AEFI and AESI should also be presented with due analysis. This submission should come within 15 days for the first two months and months after that.
• The company should submit a risk control strategy.