First Plasmid DNA Vaccine for COVID-19 Prepares to Launch

Ahmedabad-based Zydus Cadila announced it applied for Emergency Use Authorization to the office of Drug Controller General of India (DCGI) for ZyCoV-D, its three-dose Plasmid DNA Vaccine against COVID-19.

Zydus Cadila conducted the largest clinical trial for its COVID-19 vaccine in India in over 50 centers as of July 1, 2021.

Furthermore, this was also the first time that any COVID-19 vaccine has been tested in the adolescent population (12-18 years) in India.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said in a press statement, “As the first-ever plasmid DNA vaccine for human use, ZyCoV-D has proven its safety and efficacy profile in our fight against COVID-19. The vaccine, when approved, will help not only adults but also adolescents in the 12 to 18 years age group."

"This has been possible because of the collective support of the Government, the regulators, the volunteers who had faith in the process, the investigators who conducted the multi-centric trials all through these months, the suppliers who worked closely with us, and our dedicated team of researchers and vaccine professionals who worked tirelessly on the vaccine and also manufactured the trial doses.”

In another development, Zydus Cadila has also evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit, and the immunogenicity results were equivalent to the current three-dose regimen.

Zydus acknowledges the support of the National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India, National Institute of Virology, Indian Council of Medical Research, and PharmaJet in the development of the ZyCoV-D vaccine.