Government gives Biological E nod to study its Covid vaccine Corbevax in children, teens

The Drugs Controller General of India (DCGI) has approved Biological E for two clinical trials of its COVID-19 vaccine candidate Corbevax, according to an official notification from the ministry of science and technology on September 3.

After a subject expert committee reviewed Phase 1 and 2 clinical trial data, the Hyderabad-based pharmaceutical company gained approval for a Phase 3 comparative safety and immunogenicity trial in adults.

The DBT and BIRAC, according to the ministry, have sponsored Corbevax, an RBD protein subunit vaccine, through preclinical to Phase 3 clinical trials.

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Biological E's vaccine candidate has also received funding backing from the National Biopharma Mission, BIRAC, under the COVID-19 Research Consortia.

"This vaccine candidate has received financial support under COVID-19 Research Consortia through the National Biopharma Mission, BIRAC, in addition to getting financial help under Mission COVID Suraksha," according to the official statement.

Six vaccinations have been approved for use in the country, but only 11.28 percent of the population has been properly vaccinated, according to data from Johns Hopkins.

The Covid-19 shots for adults, created by Bharat Biotech and Zydus Cadila, are among them.

Late in August, India approved Cadila's Covid-19 vaccine, the world's first DNA coronavirus vaccine, for emergency use in children aged 12 and up.

A late-stage trial of Biological E's coronavirus vaccination in adults is currently underway.

(With inputs from agencies)