An expert panel of India’s central drug authority on Monday recommended granting restricted emergency use authorisation to Biological E’s COVID-19 vaccine, Corbevax, for age group 12 to 18 years subject to certain conditions, official sources said.
The government has still not not taken a decision on vaccinating those aged below 15 years. NITI Aayog member (Health) V K Paul at a press conference recently said that the additional need for vaccination and inclusion of population for vaccination is examined constantly.
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 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 authorisation to Biological E’s Corbevax for the 12 to less than 18 years age group subject to certain conditions,” a source said.
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.
“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 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 had said in the application.
The Corbevax vaccine is administered through 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. (PTI)
