Provide more safety, immunogenicity data: CDSCO panel tells Biological E on trial of COVID vaccine
New Delhi: Following the proposal presented by Biological E to conduct a Phase II/III clinical trial of its Covid-19 vaccine containing the SARSCoV-2 Receptor Binding Domain of SARSCoV-2 in the age group of 5 years to 17 years, the Subject Expert Committee (SEC) functional under the Central Drug Standard Organization (CDSCO) has recommended Hyderabad-based vaccine-maker to submit safety and immunogenicity data from Phase II part of the Phase II/III clinical trial in adults to the CDSCO.
This came in response to the proposal presented by Hyderabad-based vaccine-maker, Biological E, for the grant of permission to conduct a Phase II/III clinical trial of Covid-19 vaccine containing the SARSCoV-2 Receptor Binding Domain of SARSCoV-2 in the age group of 5 years to 17 years, along with interim safety and immunogenicity data (after dose 1) from the ongoing Phase-II/III clinical trial in adults with revised composition.
Corbevax, also known as BioE COVID-19, is a COVID-19 vaccine candidate developed by Biological E. Limited (BioE), Baylor College of Medicine in Houston, Texas, and Dynavax Technologies in the United States (DVAX). The vaccine candidate includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, along with Dynavax's advanced adjuvant CpG 1018.
Corbevax is a recombinant protein subunit vaccine that contains the Receptor Binding Domain of the SARS-CoV-2 Spike Protein. It simply injects the virus's spike protein into the human body in order to trigger an immunological response. When the virus attacks the body after the vaccine is administered, the body will already have an immune response in place to protect the individual against fatal illnesses.
At the 169th SEC meeting regarding examining COVID-19 related proposals under the accelerated approval process held on 29.07.2021 at CDSCO, Biological E's proposal to conduct a Phase II/III clinical trial of its Covid-19 vaccine containing SARSCoV-2 Receptor Binding Domain of SARSCoV-2 in the age group of 5 years to 17 years was thoroughly examined by the committee.
In this regard, the committee noted that the vaccine is under Phase II/III clinical trial in the age group ≥ 18 years of age and full safety and immunogenicity data is not ready for assessment.
After detailed deliberation, the committee recommended that
1. Safety and immunogenicity data from Phase II part of the Phase II/III clinical trial in adults to be submitted to CDSCO.
2. The clinical trial protocol should be revised as follows:
i. The study design should be revised to be a double-blind, placebo-controlled non-inferiority study and the noninferiority margin should be as per WHO guidelines.
ii. The safety data of the first 100 participants in the age group of 12-18 years should be evaluated by the Data and Safety Monitoring Board (DSMB) and the results submitted to CDSCO before proceeding to phase-III part.
Accordingly, the committee further directed the firm to submit the revised clinical trial protocol along with data for further review by the committee.