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Biological E seeks EUA for COVID vaccine Corbevax for children in 5-12 age group: Report

The Drugs Controller General of India (DCGI) is expected to give final EUA to Corbevax soon (Bloomberg) — The Drugs Controller General of India (DCGI) is expected to give final EUA to Corbevax soon **(Bloomberg)**

1 min read . Updated: 09 Mar 2022, 12:25 PM IST Livemint

Recently, the Subject Expert Committee recommended Emergency Use Authorization (EUA) for Biological E's COVID-19 vaccine Corbevax for the age group of 12 to 18 years under certain conditions.

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Hyderabad-based pharmaceutical company Biological E has applied for Emergency Use Authorisation (EUA) for its COVID-19 vaccine Corbevax for the 5-12 year age group, official sources said on Wednesday, according to a news report by ANI

The data has been submitted by the company to the Subject Expert Committee for beneficiaries between 5-12 years of age, the sources told ANI.

Earlier, Corbevax which is India's first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against COVID-19, has received emergency use authorisation (EUA) from India's drug regulator for the 12 to 18-year age group.

The Corbevax vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees’ Celsius temperature and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial and 10 mL (20 doses) vial pack

Last September, Biological E received approval to conduct a Phase II/III clinical trial on Corbevax in children and adolescents aged 5 to 18 years. Based on the no-objection certificate, Biological E initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase II/III study, which indicated that the vaccine is safe and immunogenic.

The expected cost of the vaccine is ₹145 excluding taxes. It will be administered two times within prescribed intervals.

The sources told ANI that the Central government has already purchased about 5 crore Biological E vaccines Corbevax and also delivered them to some states.

Vaccine maker Biological E applied for the phase 2 and phase 3 clinical trials during the month of September 2021 last year.

India reported 4,575 new COVID-19 cases in the past 24 hours informed the Ministry of Health and Family Welfare on Wednesday.

Meanwhile, the Ministry of Health and Family Welfare informed today, "More than 18.69 lakh doses (18,69,103) vaccine doses have been administered in the last 24 hours. With this, India's COVID-19 vaccination coverage has exceeded 179.33 crore (1,79,33,99,555) as per provisional reports till 7 am today."