The Drugs Controller General of India (DCGI) has granted restricted emergency use authorisation to Bharat Biotech’s indigenously developed COVID-19 vaccine Covaxin for children aged 6-12 years, news agency ANI reported.
The DCGI’s approval comes following recommendations by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO). The regulator has directed the vaccine maker to submit the safety data, including the data on adverse event with due analysis, every 15 days for the first two months and monthly thereafter, up to five months.
Covaxin has been granted Emergency Use Listing by the DCGI for the age group of 12 to 18 years. It’s currently being administered to those in the 15-18 age group. The government panel recently recommended approval of Biological E’s Covid-19 vaccine Corbevax for use in children in the 5 to 12 years age group. India began inoculating children aged 12-14 on March 16. The countrywide vaccination drive was rolled out on January 16 last year with healthcare workers getting inoculated in the first phase. Vaccination of frontline workers started from February 2 last year.
The next phase of COVID-19 vaccination commenced on March 1 last year for people over 60 years of age and those aged 45 and above with specified co-morbid conditions.
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India launched vaccination for all people aged more than 45 years from 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 1 last year.
