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August 26, 2021
Zydus Cadila receives Emergency Use Authorization from the Drug Controller General of India for ZyCoV-D, the only needle-free COVID Vaccine in the World.
• World’s first Plasmid DNA Vaccine for COVID-19, ZyCoV-D, will be administered in three doses.
• Apart from adults, adolescents aged 12-18 years will take the vaccine shot in India for the first time.
• Safety, efficacy, and immunogenicity of the vaccine are well-established.
• Company begins stockpiling of the vaccine.
Ahmedabad, India, August 26, 2021 — Zydus Cadila has announced that the company 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 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. In addition, ZyCoV-D is a needle-free vaccine administered using The PharmaJet®, a needle-free applicator, ensuring painless intradermal vaccine delivery.
For the first time, a technologically advanced vaccine has been successfully developed on the Plasmid DNA platform for human use. The company explained that because of its rapid plug-and-play technology, you could quickly adapt the platform to deal with viruses’ mutations, such as those already occurring. The company plans to manufacture about 120 million doses of ZyCoV-D annually.
Mr. Pankaj R. Patel, Chairman, Cadila Healthcare Ltd., said, “This is a historic milestone with ZyCoV-D, a product of Indian innovation. It is the World’s first DNA vaccine offered for human use and the World’s largest immunization drive. We are delighted that our vaccine will contribute to this fight against COVID-19 and enable the country to vaccinate a larger population, especially the 12-18 years old. I would like to thank all the researchers, clinical trial investigators, volunteers, and the regulators who have supported this endeavor.”
The company also plans to seek approval for the two-dose regimen of the vaccine. 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 quickly produced.
Zydus has acknowledged 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 ZyCoV-D vaccine.
ZyCoV-D is a Plasmid DNA vaccine that produces the spike protein of the SARS-CoV-2 virus. In addition, it elicits an immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease and viral clearance.
• Facts about ZyCoV-D
ZyCoV-D is an intradermal vaccine administered in three doses.
It will be applied using The PharmaJet® needle-free system, Tropis®, which can significantly reduce any side effects.
ZyCoV-D is stored at 2-8 degrees C but has shown good stability at temperatures of 25 degrees 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.
Also, being a Plasmid DNA vaccine, ZyCoV-D doesn’t have any problem with vector-based immunity.
The Plasmid DNA platform also allows generating new constructs quickly to deal with mutations in the virus, such as those already occurring.
The EClinical Medicine Journal of Lancet has already published the Phase I part of the Phase I/II clinical trial results.
Zydus Cadila is an Indian multinational pharmaceutical company headquartered in Ahmedabad, India. It is primarily engaged in the manufacture of generic drugs.
Source: Zydus Cadila
|GlobalGiants.Com|
The vaccine is delivered in 3 doses.
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Learn more about the COVID-19 vaccine: https://t.co/QcY4bGRA5i pic.twitter.com/kDGajqW8c9
Edited & Posted by the Editor | 9:16 AM | Link to this Post
