India drug regulator approves vaccines for emergency use in children aged 5 to 12text_fields
New Delhi: India's drug regulator on Tuesday granted emergency use authorisation for Biological E's COVID-19 vaccine Corbevax for those aged five to 12 years, ZycovD (Zydus Cadila vaccine) for children above the age of 12 years, and Bharat Biotech's Covaxin for children in the age group of six to 12 years.
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).
This comes nearly a week after the Subject Expert Committee (SEC) of DCGI recommended the use of Biological E's Corbevax in children aged 5-12 years. Biological E Limited, Corbevax vaccine was India's first indigenously developed Receptor Binding Domain (RBD) Protein subunit vaccine against COVID-19.
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 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
Further, Zydus Cadila's vaccine ZycovD has also been approved for children above the age of 12 years for a two-dose regimen.
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.