The government is focusing on getting children inoculated on a priority basis. This effort may get a boost as an expert panel of India’s central drug authority has recommended granting restricted emergency use authorization or EUA to COVID-19 vaccine Corbevax for those in the age group of 12 to 18 years. However, this is subject to certain conditions. It is pertinent to mention that Corbevax has been developed by Biological E.
The government is yet to take a decision on vaccinating those aged below 15 years. Commenting on it, NITI Aayog member (Health) VK Paul recently said that the additional need for vaccination and inclusion of population for vaccination is examined constantly.
For the uninitiated, Corbevax is India’s first indigenously developed RBD protein sub-unit vaccine against COVID-19. The Drugs Controller General Of India (DCGI) has already approved Corbevax for restricted use in an emergency situation in adults on December 28.
It has not been included in the country’s vaccination drive.
“The Subject Expert Committee (SEC) on COVID-19 of the CDSCO which deliberated on the application recommended granting restricted emergency use authorization to Biological E’s Corbevax for the 12 to less than 18 years age group subject to certain conditions,” a source was quoted as saying by PTI.
The recommendation has been sent to the DCGI for final approval.
In an application sent to the DCGI on February 9, Srinivas Kosaraju, the 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.
The Corbevax vaccine is administered through an intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack.
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.