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

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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.

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.