Zydus to start 2nd phase of clinical trials today

Zydus Cadila will start second phase of clinical trials of its Covid-19 vaccine candidate, ZyCoV-D, the company said. “ZyCoV-D was found to be safe and well tolerated in the phase I clinical trial. The company will now commence phase II clinical trials from the 6th of August, 2020.

“The company reports that the doses of the vaccine administered to healthy volunteers in the phase I clinical trial, which began on July 15, 2020, has been well tolerated,” Cadila Healthcare, the listed entity of the group, said in a regulatory filing.

Here is all you need to know about India’s second Covid-19 vaccine candidate by Zydus Cadilla:

1) Zydus Cadilla will now start a mid-stage trial of the vaccine candidate, ZyCoV-D, in over 1,000 healthy adult volunteers to test its effectiveness.

2) Zydus plans to complete late-stage trials for ZyCoV-D by February or March and could produce up to 100 million doses a year initially, the company’s chairman told Reuters last month.

3) The safety of the vaccine candidate in volunteers enrolled in the early-stage trial, who were administered doses since July 15, was endorsed by an independent data safety monitoring board.

4) “All the subjects in phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for 7 days thereafter and the vaccine was found to be very safe,” Zydus Cadila Chairman Pankaj R Patel said.

5) Last month, Zydus had received approval from domestic authorities to start human trials for its COVID-19 vaccine contender

6) Zydus is also among the several Indian generic drugmakers that have licensing agreements with U.S.-based Gilead Sciences to produce remdesivir, the antiviral that has been approved in the country as an emergency treatment to fight the coronavirus outbreak. Livemint