DCGI grants restricted EUA for Covid jab Corbevax for 12-18 yrs age group
New Delhi Feb 21 PTI The Drugs Controller General of India has granted restricted emergency use authorisation EUA to Biological Es COVID-19 vaccine Corbevax for the 12 to 18 years age group subject to certain conditions official sources said on Monday However the government has not taken a decision yet on vaccinating those aged below 15 years This is the third vaccine to have received EUA from the Drugs Controller General of India DCGI for the age group of 12-18 years after Zydus Cadilas ZyCoV-D and Bharat Biotechs Covaxin At present India is using Covaxin to vaccinate adolescents in the 15 to 18 years age group The health ministry recently had said additional need for vaccination and inclusion of population for vaccination is examined constantly The DCGIs approval comes after the Subject Expert Committee on COVID-19 of the CDSCO on February 14 recommended granting restricted EUA to Corbevax for the 12 to 18 years age group after deliberating on Biological Es application The DCGI had approved Corbevax which is Indias first indigenously developed RBD protein sub-unit vaccine against COVID-19 for restricted use in emergency situations in adults on December 28 It has not been included in the countrys vaccination drive The DCGI on Monday granted restricted EUA to Corbevax for the 12 to less than 18 years age group subject to certain conditions an official source said In an application sent to the DCGI on February 9 Srinivas Kosaraju the head of quality and regulatory affairs at Biological E Limited had said the firm had received approval for conducting phase 23 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 23 study which indicated that the vaccine is safe and immunogenic 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 23 clinical study considering the current pandemic and widespread of COVID-19 vaccine in India Kosaraju had said in the application The Corbevax vaccine is administered through the intramuscular route with two doses scheduled 28 days apart and is stored at two to eight degrees Celsius temperatures and presented as 05 ml single dose and 5 ml 10 doses vial pack According to the health ministry the company has conducted phase 12 and 23 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 PTI PLB ANB ANB
New Delhi Feb 21 PTI The Drugs Controller General of India has granted restricted emergency use authorisation EUA to Biological Es COVID-19 vaccine Corbevax for the 12 to 18 years age group subject to certain conditions official sources said on Monday However the government has not taken a decision yet on vaccinating those aged below 15 years This is the third vaccine to have received EUA from the Drugs Controller General of India DCGI for the age group of 12-18 years after Zydus Cadilas ZyCoV-D and Bharat Biotechs Covaxin At present India is using Covaxin to vaccinate adolescents in the 15 to 18 years age group The health ministry recently had said additional need for vaccination and inclusion of population for vaccination is examined constantly The DCGIs approval comes after the Subject Expert Committee on COVID-19 of the CDSCO on February 14 recommended granting restricted EUA to Corbevax for the 12 to 18 years age group after deliberating on Biological Es application The DCGI had approved Corbevax which is Indias first indigenously developed RBD protein sub-unit vaccine against COVID-19 for restricted use in emergency situations in adults on December 28 It has not been included in the countrys vaccination drive The DCGI on Monday granted restricted EUA to Corbevax for the 12 to less than 18 years age group subject to certain conditions an official source said In an application sent to the DCGI on February 9 Srinivas Kosaraju the head of quality and regulatory affairs at Biological E Limited had said the firm had received approval for conducting phase 23 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 23 study which indicated that the vaccine is safe and immunogenic 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 23 clinical study considering the current pandemic and widespread of COVID-19 vaccine in India Kosaraju had said in the application The Corbevax vaccine is administered through the intramuscular route with two doses scheduled 28 days apart and is stored at two to eight degrees Celsius temperatures and presented as 05 ml single dose and 5 ml 10 doses vial pack According to the health ministry the company has conducted phase 12 and 23 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 PTI PLB ANB ANB
