Subject Expert Committee recommends EUA for BE’s Covid jab Corbevax for 12-18 years age group

The Subject Expert Committee (SEC) under India’s drug regulator today recommended granting Emergency Use Approval (EUA) to Corbevax for use in children between 12 to less than 18 year age group.

The Drug Controller General of India (DCGI) will take a final call on the SEC recommendation. Biological E, manufacturers of Corbevax had approached the drug regulator seeking emergency use approval for its vaccine-Corbevax.

“The company presented its data before the expert group on Monday,” people in the know told ET.At present children between the age group of 15-17 years are eligible to receive only Covaxin shots.

The drug regulator had on August 20 given emergency use authorisation (EUA) to a three-dose Covid-19 vaccine from Zydus Cadila, the first in India that can be given to people 12 years and above. However this jab will be first given to adults and will not be given to children immediately.

Biological E has conducted Phase III trials of their vaccines on children. Corbevax could become the next choice of vaccine for the children going forward, the same people said.

The government plans to vaccinate children between 12-14 years from February end or early March.

In September last year, Hyderabad-based pharmaceutical firm Biological E received Drug regulator’s approval for initiating the Phase II/III study to evaluate the efficacy of its vaccine in children above 5 years.

Corbevax, is a RBD protein sub-unit vaccine that has been developed with support from the Department of Biotechnology and the Biotechnology Industry Research Assistance Council (BIRAC), a PSU under the DBT.

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