India is all set to get its second indigenously developed vaccine by June, as Ahmedabad-based pharmaceutical firm Zydus Cadila gears up to submit efficacy data and phase III trial statistics to the Drugs Controller General of India (DCGI) by the end of this month. The safety of Cadila’s ZyCoV-D vaccine has been established already during the candidate’s phase II trials. As the country reels under a demand-supply mismatch of Covid-19 vaccines presently, a go ahead for ZyCoV-D will act as a shot in the arm for the country’s vaccination campaign.
“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. Zydus Cadila’s Covid-19 vaccine will be a three-dose regimen, as such a prolonged regimen has been found to 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.
According to CNBC TV 18, Zydus Cadila is looking to produce 24 crore doses a year and the vaccine is expected to be available in the market as soon it is approved which executives of the firm believe could be as soon as in June. 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.
An added advantage of the vaccine is that it has already been tested on adolescents as well, which will make it the first vaccine eligible to be administered to individuals between the age of 12 and 17. Zydus Cadila is said to have recruited over 28,000 volunteers for the trials for ZyCoV-D and claims it to be “by far the largest trial being done in the country right now.” Patel was quoted as saying by The Print, “The Phase III trials of our vaccine will be truly representative of the efficacy of the vaccine against many of the known variants, as different variants have surfaced in this wave. So, the trial outcomes will have more representative efficacy data than any other vaccine,” said Patel.
ZyCoV-D is a DNA-plasmid vaccine. 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,” Patel remarked.
Apart from Zydus Cadila’s Covid-19 vaccine which is slated to be approved soon, multiple jabs are being developed by various firms in the country. India’s Biological E. Ltd, for instance, will soon start Phase III trials of its COVID-19 vaccine and plans to produce 75 million to 80 million doses a month from August. Serum Institute of India (SII) is working on another vaccine candidate – Covovax, which is slated to go for Phase III trials this month. Bharat Biotech, meanwhile, is already working on a nasal anti-Covid-19 vaccine. Additionally, Hyderabad-based Dr Reddy’s Labs has the rights to supply 12.5 crore doses of the Russia-made Sputnik V vaccine.
The country’s vaccine shortage woes are expected to be alleviated soon, as many firms begin introducing their jabs to the market. According to VK Paul, the head of the national task force on Covid-19, India will have enough coronavirus vaccine doses to inoculate all citizens by December. “Overall, 216 crore doses of vaccines will be manufactured in India between August and December, for India and for Indians. There should be no doubt that vaccines will be available for all as we move forward,” Paul said Thursday.