Indian pharmaceutical giant- Zydus Cadila has reportedly announced that its plasmid DNA vaccine candidate to prevent coronavirus, ZyCoV-D was found to be safe, immunogenic, and well-tolerated during the Phase I and II clinical study.
According to reliable sources, the Phase II trial of ZyCoV-D was carried out on more than 1000 healthy adult volunteers as a part of Phase I/II dose-escalation, randomized, multi-centric, double-blind placebo-controlled study.
Notably, the trial was reviewed by an independent DSMB (Data Safety Monitoring Board), and the findings were submitted to the CDSCO (Central Drugs Standard Control Organization) for regular updates on the outcome.
Reportedly, Cadila is now planning to initiate the Phase III clinical trials with nearly 30,000 volunteers, once it receives the required approvals.
In a statement, Mr. Pankaj R. Patel, Chairman, Zydus Group, said that the company had ensured safety throughout the clinical trial and the vaccine has proven to be safe. After the completion of the Phase III trial, the company aims at accelerating the production of its vaccine on a large scale, he further added.
According to a statement by the company, Zydus Cadila has established the DNA vaccine platform in India. This platform is likely to showcase enhanced vaccine stability which showcases lower cold chain requirements, making the vaccine ideal for use across remote areas of the country.
It is worth mentioning that, during the fiscal quarter in September 2020, the pharmaceutical company’s consolidated net profits increased by 411% to be valued at USD 5.77 million or INR 423.60 crore and recorded a 16% jump in net sales to USD 51.27 million or INR 3,762.30 crore as compared to the readings in Q2 September 2019.