New Delhi: India's drug regulator has granted emergency use authorisation for Biological E's COVID-19 vaccine Corbevax for those aged five to 12 years and Bharat Biotech's Covaxin for children in the age group of six to 12 years, official sources said on Tuesday. The approval by the Drugs Controller General of India (DCGI) comes following the recommendations by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation(CDSCO).
The DCGI has also given its approval to the ZyCoV-D vaccine for children above 12 years of age. The DCGI has also 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. The approval of Covid19 vaccines for children comes at a time when positive cases are being reported from different schools across India.
"India's fight against the Covid19 pandemic has been further strengthened with the approval of these two vaccines for children below 12 years of age," said Dr Mansukh Mandaviya, Union Health Minister. The SEC had last week reviewed the application of both the companies seeking emergency use authorisation for Corbevax and Covaxin for use in children of five to 12 years and six to 12 years age group, respectively. Biological E's Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years. Covaxin has been granted Emergency Use Listing (EUL) by the DCGI for the age group of 12 to 18 years on December 24, 2021.
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 on 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.