Zydus Cadila has obtained the Drug Controller General of India (DCGI) Emergency Use Authorisation (EUA) for ZyCoV-D, its Plasmid DNA-based Covid-19 vaccine.
ZyCoV-D is an intradermal vaccine, which will be administered in three doses, first on day zero, second on the 28th day and third on the 56th day.
The vaccine is administered using The PharmaJet needle-free system, which provides painless intradermal vaccine delivery, and Tropis, which reduces side effects if any.
It works by producing the spike protein of the SARS-CoV-2 virus and triggers an immune response mediated by the cellular and humoral arms of the human immune system.
The Indian pharmaceutical firm claims that ZyCoV-D is the world’s first advanced vaccine to be developed on the Plasmid DNA platform for human use against Covid-19.
Cadila Healthcare chairman Pankaj R Patel 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.”
DNA vaccines are capable of stimulating both the humoral and cellular arms of the adaptive immune system, and they are safe, stable and can be easily produced, said the company.
Also, results from the Phase 1 part of the Phase 1/2 clinical demonstrated well-established safety, efficacy and immunogenicity of the vaccine.
Last month, Zydus Cadila has filed an application with the DCGI seeking EUA for its three-dose Plasmid DNA-based Covid-19 vaccine ZyCoV-D.
With the DCGI approval, ZyCoV-D becomes India’s first Covid-19 vaccine for adolescents aged between 12 and 18 years, apart from the adult population.
The company intends to produce 100 to 120 million doses of ZyCoV-D per annum, also plans to seek approval for the two-dose regimen of the vaccine.
Zydus has been supported by 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.
In a separate development, Zydus Cadila, through its US subsidiary Zydus Pharmaceuticals USA, has signed a license and supply agreement with Italy-based CHEMI.
Under the terms of the agreement, CHEMI will manufacture and supply the generic version of Sanofi Aventis’s product Lovenox (Enoxaparin Sodium Injection) in seven dosage strengths, while Zydus will commercialise the drug in the US.
