Govt Panel Recommends Emergency Approval For Covid Vaccine Corbevax For 12-18 Age Group

On December 28 last year, the Drugs Controller General of India (DCGI) granted emergency use authorisation to Corbevax, India's first indigenously manufactured RBD protein sub-unit vaccine.

New Delhi: An expert panel of India's central drug authority recommended on Monday that Biological E's Covid-19 vaccine, Corbevax, be granted restricted emergency use authorisation for the age group 12 to 18 years, PTI reported.

The government has still not not taken a decision on vaccinating those aged below 15 years. From January 3, the government has started vaccinating adolescents in the age group of 15-18 years.

On December 28 last year, the Drugs Controller General of India (DCGI) granted emergency use authorisation to Corbevax, India's first indigenously manufactured RBD protein sub-unit vaccine against Covid-19, for restricted use in adults.

However, it is yet to be included in the country's immunisation campaign. 

"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 was quoted by PTI in its report.

The recommendation has been forwarded to the DCGI for approval.

In a February 9 application to the DCGI, Srinivas Kosaraju, the head of Quality and Regulatory Affairs at Biological E Limited, stated that the company had received approval for conducting Phase 2/3 clinical study of Corbevax in 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," Kosaraju had said.

"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," he 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.

(With PTI Inputs)