In India, Covaxin was approved on 3 January 2021. It is an inactivated virus-based vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research. This vaccine has been administered to the group of 18 and above. And presently the Subject Expert Committee of India (SEC) has sanctioned a grant of market authorization to Covaxin for children in the age group of 2 to 18. Though, these vaccines will be allowed with certain rules. The SEC has sent proposals to the Drugs Controller General of India (DCGI), and it is likely to soon permit the usage of Covaxin for the 2-18 age group.
Bharat Biotech had compelled the Phase 2 and 3 trials of Covaxin on children below 18 years of age in September and presented the analysis data to the DCGI at the start of October 2021. Though these vaccines will be allowed with certain rules, and this authorization by DCGI is subjected to four conditions.
Conditions by DCGI:
- The firm should continue the study by letting the approved clinical trial protocol.
- The firm should provide update Prescribing information/ Package Insert (PI), Summary of Product Characteristics (SmPC), and Factsheet.
- The firm should submit safety data, including the data on Adverse Events Following Immunisation (AEFI) and ARSI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per requirements of New Drugs & Clinical Trials Rules 2019.
- The firm should submit a risk management plan. Further, all other conditions of the earlier approval in the age group of ≥ 18 years shall remain the same.
The approval of Covaxin was done after a comprehensive consultation. Presently, the DCGI has only approved the restricted use of Covaxin for the 2 to 18 age group. This can be a great step to increase the number of vaccinated people in the country. The authorized COVID-19 vaccines like Covaxin have been scientifically approved to work against covid. These vaccines contain SARS-Cov2 particles that have been chemically deactivated. That indicates they can no longer infect cells but still induce a protective immune response. And because the viral particles cannot cause infections, the vaccine is suitable for people across the world.
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Reference:
- www.bharatbiotech.com
- www.aninews.in