The government is moving ahead carefully on giving approval to Covaxin for use in children, particularly for those as young as 2 years.

The subject expert committee (SEC) of the Drugs Controller General of India (DCGI) had considered Bharat Biotech’s data from clinical trials conducted among children in three different age groups, including 2-6 years, 6-12 years and 12-18 years, and had recommended that DCGI give emergency use authorization for pediatric use of the vaccine in the country. Health minister Mansukh Mandaviya; however, said that there is a need to move cautiously, and consider all the safety aspects. The DCGI will seek more expert opinion before authorizing the vaccine. A senior official of the health ministry said that all aspects, in particular, adverse events following immunization (AEFI), will be considered before giving a go-ahead in India… (ET Healthworld, October 15, 2021)