Bharat Biotech’s Covaxin Cleared For 6-12 Age Group
- DCGI has granted restricted use authorisation of Covaxin for 6 to 12 years.
- The company has been asked to submit safety data every 15 days.
- Government has vehemently stated that 100 per cent vaccination is its top priority.
New Delhi: The DCGI (Drugs Controller General of India), on Tuesday, gave restricted emergency use authorization to Bharat Biotech’s Covaxin for children between the age of 6 and 12 years, as per sources. In March, the Centre had told the Delhi High Court that it will be filing a status report regarding the vaccination of children below 12 years of age. The government has vehemently stated that 100 per cent vaccination is its top priority.
Accordingly, the government started the vaccination of children above 12 years of age on March 16th. Currently, children between 12-14 years of age are being administered Corbevax “Globally, countries have fully recognized the importance of vaccinating children alongside adults, to curb and mitigate the ill effects of the pandemic and have accordingly and effectively taken measures,” a plea in High Court had, last month stated.
The company has been asked to submit safety data, including that adverse events, with due analysis every 15 days for the first two months and monthly thereafter for five months. On April 21st, the Subject Expert Committee (SEC) of DCGI asked Bharat Biotech to provide additional data on the administration of Covaxin for kids in the 2-12 years age group.