All You Need To Know About ZyCoV-D— Which Could Be The Next Indigenously Developed Covid-19 Vaccine To Get Approval In India
Ahmedabad-based pharmaceutical firm Zydus Cadila would apply for emergency use of its Covid-19 vaccine by the end of May 2021.
If the company receives a green signal from the regulators for its ZyCoV-D Covid-19 vaccine then it would be India’s second indigenously-developed jab after Bharat Biotech’s Covaxin.
The firm is expecting to get approval by June this year.
The vaccine, which is in its second phase of trials, is a “plasmid DNA” vaccine that can be stored at 2-8 degree celsius.
A plasmid is a DNA molecule within a cell that is separate from the chromosomal DNA.
Such DNA can replicate independently and is commonly found in bacterial cells.
ZyCoV-D uses such a genetic material to elicit an immunogenic response in the body.
With ZyCoV-D, the Indian firm has established a DNA vaccine platform that uses a non-replicating plasmid, which carries the gene of interest.
It means that the vaccine will push the body to build antibodies against the coronavirus, as the inserted DNA sequence will match the sequence pattern of the virus.
Pankaj R. Patel, chairman of Zydus Cadila, told The Print: "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," he added.
Unlike Covaxin, which requires a Bio-Safety Level 3 lab to manufacture the jab, ZyCoV-D can be manufactured in a facility of BSL-1.
While the platform has low cold chain requirements, making it easy to distribute the vaccine, it can also be modified if the novel coronavirus mutates again.
ZyCoV-D can remain stable even at a room temperature of 25 degrees Celsius, which makes it easier to administer.
Unlike the other vaccines currently available in India, such as Covaxin and Covishield, this new candidate will be a three-dose vaccine—it is because the three-courses will offer a longer immune response and showed promising results in phase 1 and 2 testings.
However, the company is also testing a two-dose vaccine course and is expected to finish the analysis by the end of May.
Meanwhile, Zydus is collecting efficacy data from 28,000 volunteers who participated in its Phase 3 trials for the vaccine.
The participants include people with co-morbidities and children in the age group of 12-17.
Dr Sharvil Patel, who is the managing director of Zydus Cadila told India Today: "We hope to see our efficacy data in the middle of May. As soon as we see strong efficacy which correlates to the vaccine's strong immunogenicity in Phase 2, we will file for emergency use authorisation".
He said that the company is looking forward to producing a good quantity of vaccine from July onwards to make sure it is available to the people in India.
"We have submitted a lot of data already so that it will aid the regulators once we provide them with the efficacy results," Dr Patel added.
In terms of the production plan, he said that the company will start supplies in June.
Zydus aims to manufacture 240 million (24 crores) doses of ZyCoV-D in a year.
According to Dr Patel, “Initially, we will start with producing 10 million (one crore) doses a month, and subsequently, we are looking at how to double the capacity to 20 million (two crores) doses a month."
The Press Information Bureau had also tweeted a list of six upcoming Covid-19 vaccines, including ZyCoV-D, on 13 May.
It includes names like—Russia's “Sputnik V”, which will be priced at Rs 995.40 in India, “Bio E Sub vaccine” developed by Biological E and Baylor College of Medicine, Serum Institute of India’s (SII) indigenous version of the “Novavax vaccine”, Bharat Biotech’s nasal vaccine “BBV154” and a messenger RNA vaccine developed by Pune’s Gennova Biopharmaceuticals.
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