GENNOVA PHARMA DENIES VIOLATION OF CLINICAL TRIAL PROTOCOL ON JABS

NEW DELHI: Gennova Biopharmaceuticals — the maker of India’s first mRNA vaccine candidate — has debunked the allegations of violation of clinical trial protocol while testing its anti-coronavirus disease vaccine, saying the company was in regular touch with the national drugs regulator. “Regulators continuously review the data during various stages starting from pre-clinical studies to Phase III trials and seeking clarifications is a standard process,” spokesperson of the Pune-based pharma company said in a statement. “Gennova is in communications with the regulatory agency and submitting all necessary data and information required for product approval.”

The spokesperson added that the “product development using innovative technologies like mRNA, a fourth-generation vaccine platform stable at 2-8 degrees Celsius, is a challenging journey during pandemic times”.

The company applied for emergency use authorisation for its vaccine — GEMCOVAC-19 — in March.The mRNA vaccines do not use conventional model to immunise, rather they carry molecular instructions to the host body to make the protein through a synthetic RNA of the virus. The host body then produces the viral protein that is recognised by the immune system.

A government document on ‘legal position with respect to amendment to protocol’ stated they “did not inform in time either after phase II trial or before submission of marketing authorisation application, however, made major changes in approved protocol and not complied of NDCT Rules, 2019”.