Udayavni Special

Biological E gets nod for phase 2/3 clinical trial of its Covid vaccine on children, adolescents


Team Udayavani, Sep 3, 2021, 4:31 PM IST

 

Biological E has received approval for conducting phase II/III human clinical trial of COVID-19 vaccine candidate Corbevax on children above five years and adolescents, the Department of Biotechnology (DBT) said on Friday.

Corbevax, an RBD protein sub-unit vaccine, has been developed with supported from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC), it said.

PTI had first reported the grant of approval to Biological E for trial of its vaccine candidate on Wednesday.

The approval of the Drugs Controller General of India (DCGI) for conducting phase III comparator safety and immunogenicity trial in adults came after the Subject Expert Committee’s (SEC) review of Phase I and II clinical trials data.

”Additionally, Biological E also received approval on 01.09.2021 to initiate Phase II/III study to evaluate safety, reactogenicity, tolerability and immunogenicity of Corbevax vaccine in children and adolescents,” the DBT said.

Mahima Datla, Managing Director, Biological E. Limited, said these approvals would help support its subsequent filings with the World Health Organization (WHO) as well.

So far indigenously developed Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D has received emergency use authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.

The DCGI in July had granted permission to the Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions. The development of Corbevax was supported by the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC) from preclinical stage to phase III clinical studies, the DBT said.

”We look forward to the clinical development of candidate Corbevax for paediatric and adults,” DBT Secretary Renu Swarup said. Datla said, “We are delighted to receive these significant approvals from the DCGI. These approvals encourage our organisation to move forward and successfully produce our COVID-19 vaccine to meet the vaccination needs.

“We are grateful to BIRAC for their support and we are enthused that these approvals would help support our subsequent filings with WHO as well. We appreciate and acknowledge the contribution of all our collaborators for their continued support in this endeavour,” Datla said.

Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.

Top News

Court grants bail to former Mumbai airport MD G V Sanjay Reddy in `money-laundering’ case

Schools in Kerala to re-open in staggered manner from November 1, says CM

Air pollution one of the biggest environmental threats to human health: WHO

BJP govt in K’taka passed bill to protect temples from demolition: CT Ravi

CBI defends in HC lower court’s order refusing bail to Rana Kapoor’s wife, daughters

Bangalore rises up global startup ecosystem ranks, Delhi and Mumbai follow

Pak claims threatening email was sent to New Zealand cricket team from India

Related Articles More

Not practical to have specific teacher-pupil ratio of spl educators in gen schools: SC told

Court grants bail to former Mumbai airport MD G V Sanjay Reddy in `money-laundering’ case

Schools in Kerala to re-open in staggered manner from November 1, says CM

Air pollution one of the biggest environmental threats to human health: WHO

CBI defends in HC lower court’s order refusing bail to Rana Kapoor’s wife, daughters

MUST WATCH

Woman Denied Entry at Delhi Restaurant For Wearing Saree

Monkey came away from 22 kilometer

News Bulletin 22-09-2021

Dead fish found in pitrodi river

ANANT NAG TALKS ABOUT ACTING IN CINEMA


Latest Additions

Not practical to have specific teacher-pupil ratio of spl educators in gen schools: SC told

Court grants bail to former Mumbai airport MD G V Sanjay Reddy in `money-laundering’ case

Schools in Kerala to re-open in staggered manner from November 1, says CM

Air pollution one of the biggest environmental threats to human health: WHO

BJP govt in K’taka passed bill to protect temples from demolition: CT Ravi

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.