The subject expert committee of the Drug Controller General of India (DCGI) recommended granting restricted emergency use authorisation to COVID-19 vaccine Corbevax for the 12-18 age group, subject to conditions, news agency PTI reported citing sources.

“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. 

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The health regulator 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.

“Corbevax vaccine is India’s 1st indigenously developed RBD protein sub-unit vaccine against #COVID19, Made by Hyderabad-based firm Biological-E. It’s a hat-trick! It’s now 3rd vaccine developed in India,” Union Health Minister Mansukh Mandaviya had tweeted while announcing DCGI’s approval for the vaccine.

The vaccine, manufactured by Hyderabad-based Biological E, is not yet part of the country’s mass vaccination program. India is yet to take a decision on whether to vaccinate children under the age of 15. Dr NK Arora, chairperson of COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI) had said in January that the country would start vaccinating children between 12 and 14 years in March. 

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India is currently administering only Bharat Biotech’s Covaxin to those in the 15-18 age group. The panel’s recommendation has been sent to the DCGI for final authorisation.

Srinivas Kosaraju, the head of Quality and Regulatory Affairs of Biological E, wrote in a February 9 application to the DCGI that the company had received approval for conducting phase 2/3 trials of Corbevax among kids aged 5-18 years of age in September. 

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“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.

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The vaccine is administered in two doses given 28 days apart. Biological E has conducted phase 1/2 and 2/3 trials of Corbevax in India, the health ministry had informed earlier. 

The Centre has already made an advance payment of Rs 1,500 crore to reserve 30 crore doses of the vaccine, according to a report in The Indian Express. 

(Written with inputs from PTI)