Biological E's Covid-19 vaccine gets regulatory nod for kids trial

The Indian drug regulator has approved a human trial of Biological E’s Covid-19 vaccine for efficacy on kids above 5 years besides permitting the phase-III clinical trial of the same vaccine on adults to check its ability to protect them from serious diseases and death.

On September 1, the Hyderabad-based company received the Drugs Controller General of India's approval to initiate the phase II/III trial to evaluate safety, reactogenicity, tolerability and immunogenicity of Corbevax vaccine in children and adolescents.

This would be the third Covid-19 vaccine trial for children in India following the Zydus Cadila shot that has received the regulatory nod for use in 12-18 year olds and Bharat Biotech’s ongoing Covaxin trial.

Read | 'Covaxin for children may get DCGI nod before trial period'

Additionally, the DCGI approved the phase III protective efficacy trial in adults following the Subject Expert Committee’s review of phase I and II clinical trial data.

Developed jointly with Baylor College of Medicine, Houston, the BioE shot is a RBD (receptor binding domain) protein sub-unit vaccine that has been found safe and triggered immune response in the phase-I/II of clinical trials involving 360 healthy subjects in the age bracket of 18-65 years. It’s schedule consists of two intramuscular shots 28 days apart.

The vaccine candidate has been supported by the Centre from the preclinical stage with the Department of Biotechnology not only providing a financial assistance of more than Rs 100 crore but also partnering with the company to conduct all animal challenge and assay studies at Translational Health Science Technology Institute, Faridabad.

“The DBT is committed to the development of safe and efficacious Covid-19 vaccines. We look forward to the clinical development of candidate Corbevax for paediatric and adults," DBT Secretary Renu Swarup said in a statement.

Earlier, the Union Health Ministry inked a pact with the firm to reserve 30 crore doses for which the government made an advance payment of Rs 1,500 crore. The government’s aim was to procure the doses between August and December in order to meet the target of vaccinating 94.47 crore adults by the year end.