New Delhi: Ahmedabad-based pharmaceutical firm Zydus Cadila is likely to begin supplying ZyCoV-D, a Covid-19 vaccine manufactured by it, from June.
ZyCoV-D will be the country’s second indigenously-developed vaccine against the novel coronavirus, after Bharat Biotech’s Covaxin.
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.
“Our vaccine trial for ZyCoV-D, which is a plasmid DNA vaccine, is progressing well. We are looking to submit the data by the end of May and eventually look for approval in June,” Dr. Sharvil Patel, managing director, Zydus Group told ThePrint.
ZyCoV-D is a three-dose vaccine.
“We hope to see our efficacy data this month. As soon as we see strong efficacy, which correlates to the strong immunogenicity in Phase II [of the clinical trials], we will look to file for an Emergency User Authorisation.”
Aim to produce 24 crore doses a year
The vaccine is likely to hit the market soon after the approvals are received — which is June according to Zydus Cadila’s expectations.
“We will start supplies in the month of June. We plan to manufacture 240 million doses of ZyCoV-D in a year,” said Patel.
The company plans to begin with manufacturing one crore doses a month and eventually double the production, and may collaborate with other manufacturers to boost the capacity.
“Initially we will start off with producing 10 million (1 crore) doses a month, and subsequently we are looking at how to double the capacity to 20 million (2 crore) doses a month,” he said.
The vaccine is also being tested on adolescents, which will of help should the country decide to open vaccination for those in this age category.
“We have included the elderly, those with co-morbidities, and also children in the age group of 12-17 years in the trials,” said Patel.
How it works
ZyCoV-D is a ‘DNA vaccine’ that works against the major viral membrane protein, responsible for the novel coronavirus’ entry into body cells.
It is based on plasmid DNA, a small, circular and extrachromosomal bacterial DNA, used in genetic engineering.
The plasmid DNA has the unique property of self-replication, owing to which it can be used in different kinds of molecular genetic research, such as gene therapy, gene transfer and recombinant DNA technology.
Zydus Cadila has recruited over 28,000 volunteers for the trials for ZyCoV-D and claims it to be “by far the largest trial [for Covid vaccine] being done in the country right now.”
“The Phase III trials of our vaccine will be truly representative of the efficacy of the vaccine against many of the known variants [of the virus], as different variants have surfaced in this wave [of the pandemic]. So the trial outcomes will have more representative efficacy data than any other vaccine,” said Patel.
As India struggles to fight the deadly second Covid wave, with daily infections crossing four lakh in the beginning of April according to official data, the company has already begun discussions with other vaccine and drug manufacturers that can help boost the production of ZyCoV-D.
“We are in the process of agreement with one or two Indian manufacturers to boost the capacity. However, technology transfer is challenging and a time-taking process,” said Patel, without disclosing the name of the companies they are in talks with.
(Edited by Poulomi Banerjee)