Zydus Cadila receives EUA for ZyCoV-D, the only needle-free COVID vaccine in the world

Ahmedabad, August 20, 2021

Pharmaceuticals major Zydus Cadila today announced that it 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.

ZyCoV-D is a three dose vaccine which will be administered first on day zero, day 28th and then on the 56th day.

With this approval, India now has its first COVID-19 vaccine for adolescents in the 12-18 age group, besides the adult population, a press release from the company said.

ZyCoV-D is a needle-free vaccine administered using The PharmaJet, a needle free applicator, which ensures painless intradermal vaccine delivery.

The release said that this is for the first time that a technologically advanced vaccine has been successfully developed on the Plasmid DNA platform for human use. The platform, because of its rapid plug and play technology, can be easily adapted to deal with mutations in the virus, such as those already occurring.

The company plans to manufacture 10-12 crore doses of ZyCoV-D annually, it said.

Pankaj R. Patel, Chairman, Cadila Healthcare Ltd., said, “This is a 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 endeavour.”

The company said it also plans to seek approval for the two-dose regimen of the vaccine.

According to it, the main advantage of DNA vaccines is their ability to stimulate both the humoral and cellular arms of the adaptive immune system. They are a valuable form of antigen-specific immunotherapy, as they are safe, stable and can be easily produced, it said.

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

ZyCoV-D is stored at 2-8 degree C but has shown good stability at temperatures of 25 degree C for at least three months. The thermostability of the vaccine will help in easy transportation and storage of the vaccine and reduce any cold chain breakdown challenges leading to vaccine wastage.

The plasmid DNA platform provides ease of manufacturing with minimal biosafety requirements (BSL-1). • Also being a Plasmid DNA vaccine, ZyCoV-D doesn’t have any problem associated with vector based immunity.

The results of the Phase I part of the Phase I/II clinical trial have already been published in the EClinical Medicine Journal of Lancet, the release added.

NNN