ZyCoV-D developed by Zydus Cadila receives emergency use authorization
- EP News Service
- Aug 20, 2021
NEW DELHI: Cadila Healthcare Limited (also known as Zydus Cadila) has received approval for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for its three dozes COVID-19 vaccine, ZyCoV-DZyCoV-D which is perhaps the worlds first DNA vaccine for the virus which will be administered using a needle-free system, Tropis.
With the approval for DZyCoV-D by the Subject Expert Committee (SEC) of the regulator, India now has six vaccines that have been approved for COVID-19 including Covishield, Covaxin, Sputnik V, Moderna's vaccine, and J&J's single-dose vaccine. The SEC has added that Zydus Cadila needs to submit additional data for the 2-dose regimen of its vaccine.
ZyCov-D, which is being developed in partnership with the Department of Biotechnology and the Indian Council of Medical Research, can be stored at 2-8 degrees Celsius and at 25 degrees Celsius for up to three months. Being a needle-free system, the intradermal vaccine ZyCoV-D can significantly reduction in any kind of side effects on the spot of administration.
Zydus Cadila had applied for its Covid vaccine to be approved for emergency use on July 1, having conducted the largest clinical trial for its ZyCoV-D vaccine, including on population in the age group of 12-18 which was the first time that any COVID-19 vaccine was tested in the adolescent population.
According to a press release by the Ministry of Science & Technology, interim results from phase-III clinical trials, in over 28,000 volunteers, showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).
Speaking on the development, Chairman of the Zydus Group, Pankaj R Patel said, "We are extremely happy that our efforts to put out a safe, well-tolerated and efficacious vaccine to fight COVID-19 has become a reality with ZyCoV-D. To create the world’s first DNA vaccine at such a crucial juncture and despite all the challenges, is a tribute to the Indian research scientists and their spirit of innovation."