Hyderabad-based Biological E has received the nod to move ahead with its clinical trials for children’s vaccine.

The company has the Drugs Controller General of India’s (DCGI) permission to conduct Phase II / III trials of its vaccine candidate on children in the age group of 5 to 18 years, a Health Ministry source told BusinessLine.

The development comes even as Zydus Cadila’s needle-free Plasmid DNA vaccine received emergency approvals recently for use in adults and children. Others in the fray running trials on Covid-19 vaccines in children or adolescents, as the case may be, include Bharat Biotech, Serum Institute (on the Novavax vaccine) and, more recently, Johnson and Johnson.

Parents anxious

Vaccines for children assume significance as multiple States reopen schools for children, and parents remain anxious to get their children vaccinated.

Meanwhile, Biological E will initiate Phase II / III trials across 10 locations in the country.

While the company did not comment on the development, a source said the regulator had granted permission based on recommendations made by the Subject Expert Committee on Covid-19.

Contracted supplies

“The Covid-19 vaccine of Biological-E is currently undergoing Phase III clinical trial after showing promising results in Phase I and III clinical trials (in adults). The vaccine being developed by Biological-E is a RBD protein sub-unit vaccine, and is likely to be available in the next few months,” said the government in a statement in June.

In fact, the Centre has already contracted for the supply of 30 crore doses of the Biological E vaccine, Corbevax. These vaccine doses will be manufactured and stockpiled by Biological-E from August-December 2021, the Centre had then said.

The Biological E Covid-19 vaccine candidate has been supported by the government from the preclinical stage to Phase III studies, said the statement.

The Department of Biotechnology has not only provided financial assistance in terms of grant-in-aid of over ₹100 crore, but has also partnered with Biological E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad, it added.