India Set To Get A Second Homegrown Covid-19 Vaccine As Zydus Cadila Plans To Seek Nod for ZyCoV-D By End Of This Month

Zydus Cadila is likely to apply for emergency use authorisation (EUA) of its Covid vaccine candidate, currently under the Phase-3 efficacy trials, within the next few days.

If EUA is granted by regulators, ZyCoV-D will become the fourth available vaccine against coronavirus in India.

“We are looking to submit the data by the end of May and eventually look for an approval,” The New Indian Express quoted MD Sharvil Patel as saying.

With plans to manufacture 240 million (24 crore) doses of ZyCoV-D in a year, the drug maker is expecting to submit the efficacy data to the regulator, Drugs Controller General of India (DCGI), by the end of this month.

ZyCoV-D is a DNA-plasmid vaccine. While the vaccine does use genetic material to elicit an immunogenic response in the body, it is not using the mRNA (messenger RNA), instead, it uses the plasmid DNA. A plasmid is a small DNA molecule within a cell that is distinct from chromosomal DNA and can replicate independently and is usually found in bacterial cells.

"The plasmid DNA is introduced into the host cells, where it is translated into the viral protein and elicits a strong immune response mediated by the cellular and humoral arms of the human immune system. This plays a vital role in protection from disease as well as viral clearance," Pankaj R. Patel, chairman of Zydus Cadila, told The Print.

ZyCoV-D, unlike the other vaccines currently being used in India, will be a three-dose vaccine. The reason for the three-dose regimen is that it will offer a longer immune response and has shown better results in Phase 1 and Phase 2 testing.

The company is also testing a two-dose regimen. It is likely to finish the collection and analysis of that data by the end of May.

A study by team of scientists from India established efficacy and immunogenicity of two different concentrations of a plasmid DNA-based vaccine candidate ZyCoV-D. The findings reveal that the vaccine candidate administered via Needle Free Injection System (NFIS) can significantly induce the production of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein-specific IgG and neutralizing antibodies for a prolonged period. The study is currently available on the bioRxiv* preprint server.