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 emergency situation among adults on December 28.
In an application sent to DCGI on February 9, Srinivas Kosaraju, head of Quality and Regulatory Affairs of Biological E Limited, said the firm had received approval for conducting phase 2/3 clinical study of Corbevax among children and adolescents aged 5-18 years in September.
“Based on the no-objection certificate, Biological E has initiated the clinical study in October 2021 and has evaluated the available safety and immunogenicity results of the ongoing phase 2/3 study, which indicated that the vaccine is safe and immunogenic.
“The proposed application is for obtain
read the full story about Biological E seeks EUA for its Corbevax vaccine for 12-18 years age group
#theheadlines #breakingnews #headlinenews #newstoday #latestnews #aajtak #ndtv #timesofindia #indiannews