Drug firm Zydus Cadila is likely to launch its three-dose COVID-19 vaccine, ZyCoV-D, in June. It will be the third or fourth vaccine -- depending on when Sputnik V is introduced -- for COVID-19 immunisation in the country.
The vaccine, ZyCoV-D, is also India’s second indigenously developed coronavirus vaccine after Hyderabad-based Bharat Biotech’s Covaxin.
How Does ZyCoV-D Work?
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.
The vaccine is also more rugged than mRNA vaccines and will be stored between 2-8 degrees Celsius. It can remain stable even at a room temperature of 25 degrees Celsius, which will make it much easier to administer. The vaccine is also expected to be easy to modify if needed to combat emerging variants of the novel Coronavirus.
How Many Doses?
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.
When Will it be Approved?
Zydus will likely submit its application for emergency use authorisation to the Drugs Controller General of India (DGCI) within this month. The company is currently collecting efficacy data from its 28,000 volunteers who participated in the Phase 3 trials for the vaccine. Volunteers also included children in the age group of 12-17 and people with co-morbidities that aggravate COVID-19 infections.
"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. We hope to produce a good quantity of the vaccine from July onwards to make sure it is available to the people. That is the need of the hour right now," Dr. Sharvil Patel, managing director of Zydus Cadila told India Today.
"We have submitted a lot of data already so that it will aid the regulators once we provide them with the efficacy results. We are, hence, expecting to get the approval in May itself," Dr. Patel added.
What About Production?
Zydus aims to produce 24 crore doses a year and the vaccine is expected to be available in the market as soon it is approved. The company is looking to produce well over two crore doses a month and is also in talks with other manufacturers to boost production capacity. The Ahmedabad-based pharmaceutical company will begin production with a target of one crore doses, before doubling production within a month.
"We will start supplies in the month of June. We plan to manufacture 240 million (24 crore) doses of ZyCoV-D in a year. Initially, we will start off with producing 10 million (one crore) doses a month, and subsequently, we are looking at how to double the capacity to 20 million (two crore) doses a month," Dr. Patel said.
(Edited by : Shoma)