PharmaJet®, the maker of innovative, needle-free injection technology, today announced that its partner, 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, a product of Indian innovation 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 this fight against COVID-19 and enable the country to vaccinate a larger population especially in the age group of 12-18 years. 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. Included in the trial were adolescents in the 12-18 age group, a first for a COVID-19 vaccine trial in India. ZyCoV-D exhibited robust immunogenicity, tolerability, and safety.
Chris Cappello, President and CEO, PharmaJet, said, “We congratulate our partner Zydus Cadila for achieving this critical milestone. The Emergency Use Authorization (EUA) is a huge step forward to help in the eradication of COVID-19. It demonstrates the power of DNA-based vaccines and broadens the use of needle-free jet injection. We are proud to be part of the development and commercialization of the first ever plasmid-based DNA vaccine.”
Source: Company Press Release
