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India’s second Covid-19 vaccine candidate gets approval for human trials



Gujarat-based Zydus received Indian regulators’ approval to start human studies for its vaccine candidate for Covid-19, the Pharmaceutical company said on Friday.

The potential vaccine shows a “strong immune response” in animal studies and the produced antibodies could neutralize the virus, according to a statement by Zydus, part of Cadila Healthcare Ltd, said in a statement to Indian stock exchanges.

The approval comes for Zydus days after Bharat Biotech had a similar green light for human studies for its vaccine candidate.

Zydus is going to start human trials in more than 1,000 subjects at several locations in India this month. The company also plans to increase its production capacity to satisfy Indian and global demand for vaccines.

In repeat-dose toxicology studies, Zydus says, there were no safety concerns for the vaccine candidate. Rabbits were found safe, well-tolerated, and immunogenic up to three times the intended human dose.

No commercial vaccine against Covid-19 has yet been approved, but over a dozen out of over 100 applicants worldwide are presently tested in humans and some have demonstrated potential in early-stage trials.



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