India gives Biological E nod to study its COVID-19 vaccine in children, teens

BENGALURU – India has granted homegrown drugmaker Biological E permission to begin midstage studies of its COVID-19 vaccine in children and adolescents, according to an official statement on Friday.

The Drugs Controller General of India (DCGI) gave the approval to the Hyderabad-based pharmaceutical company on Sept. 1, the statement https://pib.gov.in/PressReleseDetail.aspx?PRID=1751664 said.

The company will study the safety and tolerability of its vaccine, CORBEVAX, in this population, it added.

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So far, six vaccines have been authorized for use in the country where only about 11.28% of the entire population has been fully vaccinated so far, according to Johns Hopkins data https://coronavirus.jhu.edu/region/india.

Of these, the COVID-19 shots for adults by Bharat Biotech and Zydus Cadila have been indigenously developed.

In late August, India also approved Cadila’s COVID-19 vaccine, the world’s first DNA shot against the coronavirus, for emergency use in children aged 12 years and above.

Biological E. is also running a late-stage trial of its vaccine in adults.