The Drugs Controller General of India (DCGI) today gave emergency use authorisation to Bharat Biotech’s Covaxin for children between the age group of 6-12 amid an uptick in the Covid cases in schools.
The approval by the DCGI comes following recommendations by the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation(CDSCO).
The DCGI has directed the vaccine maker to submit the safety data, including the data on the adverse events, with due analysis every 15 days for the first two months. Thereafter, Bharat Biotech has been asked to submit the data monthly for up to 5 months.
Covaxin was granted Emergency Use Listing (EUL) by the DCGI for the age group of 12 to 18 years on December 24, 2021. It’s currently being administered to those in the 15-18 age group.
The DCGI has also granted emergency use authorisation to Corbevax for children between the age of 5-12 years. The vaccine is currently being administered to those in the age group of 12-14.
Further, Zydus Cadila’s vaccine ZycovD has also been approved for children above the age of 12 years for a two-dose regimen.
Taking to Twitter, Union Health Minister Mansukh Mandaviya said India’s fight against Covid has become stronger with the recent approvals.
Covid-19 vaccinations for adolescents in the age group of 15-18 years commenced on January 3 this year. The drive was later expanded to include children aged above 12 years last month.
India launched the vaccination drive for all people aged more than 45 years on April 1 last year. The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May last year.