India's first mRNA Covid-19 vaccine gets nod to start phase 1 trials


 

The Central Drugs Standard Control Organisation on Wednesday permitted Pune-based Gennova Biopharmaceuticals to conduct Phase 1/2 clinical trials, along with animal toxicity data, for its mRNA Covid-19 vaccine candidate.

It is India's first messenger RNA (mRNA) Covid vaccine candidate. Globally, US-based pharma giant Pfizer Inc has developed its mRNA vaccine.

The permission was granted after the Subject expert Committee (SEC) for vaccines recommended for grant of permission in a review meeting on Wednesday, a document carrying the recommendations and accessed by IANS showed.

"After detailed deliberation, the committee recommended for grant of permission to conduct Phase 1/2 clinical trial subject to the condition that the interim results of Phase 1 study shall be submitted to the committee before proceeding to the next phase," the document read. Read More

 

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