CDSCO Panel asks Aurobindo Pharma to submit revised clinical trial protocol for Covid-19 vaccine candidate

The Subject Expert Committee, operative under CDSCO, has recommended the firm to justify the sample size and distribute the clinical trial sites geographically among many other suggestions.

Medical Dialogues had earlier reported that Aurobindo Pharma Limited and COVAXX, a US-based company, had entered into an Exclusive License Agreement to develop, commercialize and manufacture UB-612, the first Multitope Peptide-based Vaccine to fight COVID-19, for India and the United Nations Children's Fund (UNICEF) agency.

The design of the UB-612 Vaccine for Covid-19 has been specially made to allow including and presenting of multiple epitopes to elicit both B-cell (antibody) and T-cell (cellular) responses without enhancing COVID-19 disease.

It targets a critical antigen from S protein that is necessary for viral attachment along with additional viral epitopes to promote B-cell and CD8+ T-cell memory responses. The UB-612 vaccine doesn't carry any biohazard risk and it is known to be totally synthetic.

Aurobindo Pharma presented its proposal for conducting Phase II/III clinical trial of UB-612 vaccine for COVID-19 along with protocol, animal studies, and Phase I clinical trial report conducted in Taiwan.

The Subject Expert Committee in its 141^st meeting held on 03.02.2021 at CDSCO, HQ New Delhi, examined all the COVID-19 the related proposal under accelerated approval process and made some recommendations regarding the same as well.

After detailed deliberation, the committee recommended that the firm, Aurobindo Pharma, should submit the Phase II/III clinical trial protocol approved by the regulatory authority of Brazil. Further, the proposed Phase II/III clinical trial protocol should be revised with respect to the following:

1. The sample size should be justified.

2. Specify the Phase II & Phase III parts in the clinical trial.

3. Clinical trial sites should be geographically distributed.

4. The clinical trial shall be double-blind and the clinical parameters under study with respect to immunogenicity cohort shall be in line with the proposed clinical trial in Brazil.

Accordingly, SEC opined that the firm should submit a revised clinical trial protocol for further deliberation before the committee.

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