Ahmedabad, 20th August 2021 – Zydus Cadila has received the Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D the world’s first Plasmid DNA Vaccine for COVID-19. The vaccine, ZyCoV-D, is exclusively administered using the PharmaJet Tropis® Needle-free Injection System.
Speaking on this development, Mr. Pankaj R. Patel, Chairman, Cadila Healthcare Ltd., said, “This is an historic milestone with ZyCoV-D, becoming the world’s first DNA vaccine being offered for human use and supporting the world’s largest immunization drive. We are particularly happy that our vaccine will contribute to fight against COVID-19 and enable to vaccinate a larger population. I would like to thank all the researchers, clinical trial investigators, volunteers and the regulators who have supported this endeavor.”
The DCGI decision is based on data from a pivotal phase 3 clinical trial which enrolled over 28,000 volunteers. ZyCoV-D showed robust immunogenicity, tolerability, and safety. The vaccine, ZyCoV-D, uses a section of genetic material from the SARS-CoV2 virus, to elicit cells to use either DNA or RNA to make the specific protein that the immune system recognises and responds to. Unlike most COVID-19 vaccines, which need two doses or even a single dose, ZyCoV-D is administered in three doses.
More information at https://www.businesswire.com/news/home/20210823005175/en/PharmaJet-Partner-Zydus-Cadila-Announces-Emergency-Use-Authorization-Approval-for-World%E2%80%99s-First-Plasmid-DNA-COVID-19-Vaccine or https://www.reuters.com/business/healthcare-pharmaceuticals/india-approves-zydus-cadilas-covid-19-vaccine-emergency-use-2021-08-20/