Corbevax COVID vaccine: Biological E vaccine gets DGCI approval to conduct phase 2/3 trials on children

Hyderabad-based Biological E Limited got approval from the Drug Controller General of India (DCGI) on September 2, 2021 to conduct Phase 2 & 3 clinical trials for its COVID-19 vaccine Corbevax on children aged between 5 and 18 years of age with certain conditions.

Biological E Limited has got the permission to conduct the COVID vaccine Phase 2/ 3 trials on children after a recommendation from the Subject Expert Committee. The trials will be conducted across ten locations.

Corbevax vaccine: All you need to know! 

Biological E’s anti-coronavirus shot Corbevax is an RBD protein sub-unit vaccine, which is currently undergoing phase 2/3 clinical trials on adults.

The vaccine candidate includes an antigen in-licensed from BCM Ventures along with Dynavax’s advanced adjuvant, CpG 1018 to boost immune response.

How does it work?

Biological E’s COVID vaccine candidate comprises the receptor-binding domain of the SARS-CoV-2 spike protein at three dose levels adjuvanted with CpG 1018 plus alum.

What is Corbevax's dosage gap?

Biological E’s COVID vaccine will be administered in two doses through intramuscular injection in a gap of 28 days. 

Biological E’s Phase I/II clinical trial

Biological E’s COVID vaccine Phase I/II clinical trial will evaluate the safety and immunogenicity, or ability to induce an immune response, of the vaccine candidate in about 360 healthy subjects ages 18 to 65 years. 

The vaccination schedule comprises two doses for each study participant.

Funds

The centre's Department of Biotechnology has provided financial assistance to the drugmaker in terms of grant-in-aid of over Rs 100 crore. The department 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.

Background 

The development of the COVID-19 vaccine candidate by Biological E has been supported by the centre from the preclinical stage to phase 3 studies. 

The Ministry has finalised arrangements with the Hyderabad-based vaccine manufacturer to reserve 30 crore vaccine doses. The drugmaker plans to supply the doses to the centre by December.