DCGI panel asks Bharat Biotech to provide additional data on Covaxin for 2-12 years old
No recommendations have been made as of now, sources told ANI.
New Delhi: The Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) has asked Bharat Biotech for additional data on its COVID-19 vaccine, Covaxin, for administering it to children aged between 2-12 years, sources said.
This development comes after the Subject Expert Committee discussed recommendations for the restricted emergency of Covaxin in children aged between 2-12 years.
No recommendations have been made as of now, sources told ANI.
However, the SEC, after a meeting on Thursday, has recommended restricted emergency use of Biological E's COVID-19 vaccine, Corbevax, in children aged 5-12 years, said sources. Now DCGI will be giving approval for its emergency use authorisation.
The Corbevax vaccine is currently being administered to children in the age group of 12-14 years.
Read also: Price reduction: Bharat Biotech Covaxin price slashed to Rs 225 per dose
The vaccination drive for children in the age group of 15-18 years commenced on January 3 this year. They are being administered Covaxin.
The drive later expanded on March 16 to include children aged between 12-14 years. They are being administered Corbevax.
Overall, India is currently administering two COVID-19 vaccines to children above 12 years.
Read also: Bharat Biotech partner Ocugen to commercialize Covaxin in Mexico
COVAXIN, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.
The vaccine is developed using Whole-Virion Inactivated Vero Cell derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.
Read also: Biological E gets CDSCO panel nod for Corbevax EUA for 5-11 years old
