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June 30, 2021

Coronavirus company news summary – India to import Moderna’s Covid-19 vaccine – FDA approves Direct Biologics’ application for Phase II/III trial of Covid-19 drug

By Darcy Jimenez

The government of India has issued a registration certificate and permission to import Moderna ’s Covid-19 vaccine for restricted emergency use in adults aged 18 years and older. Moderna has also been granted emergency, condition, interim, or provisional authorisation for its Covid-19 vaccine by health agencies from more than 50 countries and is part of the World Health Organization ’s emergency use listing.

Direct Biologics, a science-based manufacturer of regenerative biologic products, announced that the US Food and Drug Administration (FDA) has approved its application for a Phase I/II trial of ExoFlo in treating mild to moderate Covid-19 under an investigational new drug (IND) protocol. This is the company’s third FDA-approved IND clinical trial, and also signifies the first FDA-approved IND that examines the use of extracellular vesicles for treating mild to moderate Covid-19.

The Russian Direct Investment Fund (RDIF) has announced positive results from the UAE Ministry of Health’s safety and efficacy data on the Russian Sputnik V Covid-19 vaccine. The vaccine was found to be 97.8% effective against the SARS-CoV-2 virus, while 100% effective against severe Covid-19 cases. The UAE had authorised the emergency use of the Russian vaccine in January 2021.

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