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COVID-19: Biological E seeks DCGI emergency use nod for Corbevax for 12-18 years old
The Corbevax vaccine is administered through intramuscular route with two doses scheduled 28 days apart.
New Delhi: Biological E has sought emergency use authorisation from India's drug regulator for its COVID-19 vaccine Corbevax for the 12 to 18 years age group, official sources said on Sunday.The Drugs Controller General Of India (DCGI) has already approved Corbevax, which is India's first indigenously developed RBD protein sub-unit vaccine against COVID-19, for restricted use in...
New Delhi: Biological E has sought emergency use authorisation from India's drug regulator for its COVID-19 vaccine Corbevax for the 12 to 18 years age group, official sources said on Sunday.
"The proposed application is for obtaining permission for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results (of the ongoing phase 2/3 clinical study) considering the current pandemic and widespread of COVID-19 vaccine in India," Kosaraju said in the application.
According to the Health Ministry, the company has conducted phase 1/2, 2/3 clinical trials of its COVID-19 vaccine in the country. Further, it has conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine, it said.
Read also: Biological E receives Govt purchase order for 5 crore Corbevax doses
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751