Second COVID-19 vaccine cleared for human trials

The Drug Controller General of India on Thursday approved pharmaceutical firm Zydus Cadila to start Phase I and Phase II human clinical trials of its COVID-19 vaccine. This is the second vaccine after Hyderabad-based Bharat Biotech’s COVAXIN to get the approval. Drug manufacturers around the world are racing to develop a vaccine against the novel coronavirus; a novel virus is one that has never previously been identified in humans, making the task of creating a vaccine that much harder.

In a statement to Indian stock exchanges the company said: “The vaccine showed a strong immune response in animal studies, and the antibodies produced were able to completely neutralize the wild type virus.

The company is expected to begin human trials this month in over 1,000 subjects in multiple sites in India. It also plans to ramp up its production capacity for the vaccine contender to serve Indian and global demand.

There were no safety concerns for the vaccine candidate in repeat dose toxicology studies, Zydus said. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic.