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The Drugs Controller General of India (DCGI)’s Subject Expert Committee (SEC) has recommended Emergency Use Authorization to Hyderabad-based pharmaceutical company Biological E’s COVID-19 vaccine, Corbevax, for the age group 12 to 18 years subject to certain conditions, official sources said.
The country’s central drug authority is expected to give final approval to Corbevax, which is a two-dose vaccine, soon.
The SEC has recommended the EUA only after reviewing the safety and immunogenicity data of the clinical study of Corbevax in children and adolescents.The expected cost of the vaccine is Rs 145 excluding taxes, official sources told ANI
The Corbevax will be the second vaccine after Covaxin which has received EUA for those below 18 years of age. The Hyderabad-based pharmaceutical company will be submitting data soon for clinical trials done on children aged below 12 years, sources said.
Union Health Minister Mansukh Mandaviya on Monday informed that over 1.5 crore adolescents in the age group 15-18 years, across the nation are now fully vaccinated against the novel coronavirus infection.
According to the sources, the central government has placed an order for Corbevax. The order has been placed for five crore doses.
The government of India has placed an order for 30 crore Corbevax doses on August 21 last year.
The Hyderabad-based company is expected to deliver the doses this month. The HLL Lifecare Limited, a public sector undertaking has issued the supply order of Corbevax to Biological E. The pharmaceutical company Biological E has also received permission for heterologous booster dose trials.
