Govt panel recommends emergency use nod to Corbevax for 12-18 year olds

The subject expert committee of the Drug Controller General of India on Monday recommended approving emergency use authorisation to Biological E's covid vaccine Corbevax to be administered to age groups 12-18, news agency PTI quoted sources.

This comes at a time when the government is yet to take a decision on vaccinating children below 15 years. On January 20, Dr NK Arora, chairperson of COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI) had informed that the vaccination for children between 12 and 14 years will begin in March.

"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.

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 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.

However, Corbevax has not been included in the country's vaccination drive.

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.

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)