COVID19: Biological E receives approval for a vaccination phase 2/3 clinical trial on children

The Department of Biotechnology (DBT) announced on Friday that Biological E has gained authorization to undertake a phase II/III human clinical study of COVID-19 vaccine candidate Corbevax on children and adolescents over the age of five. (3rd September)

Corbevax, a BD protein subunit vaccine, was developed with funding from the Department of Biotechnology and the PSU Biotechnology Industry Research Assistance Council (BIRAC), according to the announcement.

On Wednesday, PTI reported that Biological E had been granted permission to test its vaccine candidate.

The Drugs Controller General of India (DCGI) approved the conduct of phase III comparative safety and immunogenicity trial in adults following a review of Phase I and II clinical trial data by the Subject Expert Committee (SEC).

“In addition, on September 1, 2021, Biological E got authorization to begin a Phase II/III trial to examine the safety, reactogenicity, tolerability, and immunogenicity of the Corbevax vaccine in children and adolescents,” the DBT stated.

According to Mahima Datla, Managing Director of Biological E. Limited, these approvals will help support the company’s forthcoming filings with the World Health Organization (WHO).

So far, Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D has acquired emergency use authorization from the drug regulator, making it the country’s first vaccine to be administered to children aged 12 to 18.

The DCGI granted the Serum Institute of India (SII) authorization in July to undertake phase 2/3 trials of Covovax on children aged 2 to 17 years with specified circumstances.

The Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC) sponsored the development of Corbevax from the preclinical stage to phase III clinical research, according to the DBT.

“We look forward to the clinical development of candidate Corbevax for pediatric and adult patients,” stated DBT Secretary Renu Swarup.

Data stated, “We are overjoyed to have received these important clearances from the DCGI. These approvals urge our organization to press forward with the production of our COVID-19 vaccine in order to meet the vaccination needs.”

“We are appreciative to BIRAC for their assistance, and we are optimistic that these approvals will help support our forthcoming applications with WHO. We appreciate and recognize the contributions of all of our collaborators, as well as their ongoing support in our endeavor “Datla stated.

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