The world’s first DNA plasmid vaccine, indigenously developed ZyCoV-D, the Cadila Healthcare (Zydus Cadila) three dose vaccine for Covid-19 received the emergency use authorisation from the Drugs Controller General of India (DCGI) for use in adolescents 12 years old and above.
This makes it India’s first Covid-19 vaccine to be available for this age group. The vaccine has many other firsts. For one it is based on DNA plasmid technology, secondly it will be administered using needle-free injection system (NFIS), and thirdly it remains stable in room temperatures for three months. This is also a three-dose vaccine given on day zero, day-28 and day-56.
The Cadila Healthcare stock ended down 1.38 per cent on the BSE on Friday.
Meanwhile, Zydus had also submitted immunogenicity data from a two-dose regimen (using 3 mg doses) trial to the DCGI, which shows ‘equivalent immunogenicity’ with that of the three dose regimen. Therefore, a two-dose regimen approval is also expected. Sources claim the expert panel may review more data that it has sought.
Renu Swarup, Secretary, DBT and Chairperson, BIRAC said that “It is a matter of great pride that today we have the EUA for the world’s first DNA Covid-19 vaccine ZyCoV-D by Zydus developed in partnership with the Department of Biotechnology and supported through Mission Covid Suraksha.”
Interim results from Phase-3 Clinical Trials, in over 28,000 volunteers, showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases. “This has been the largest vaccine trial so far in India for Covid-19. This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase-1 and 2 clinical trials carried out earlier. Both the Phase 1 and 2, and Phase-3 clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB),” a statement by the Ministry of Science and Technology said.
Chairman of the Zydus Group, Pankaj Patel said, “We are extremely happy that our efforts to put out a safe, well tolerated and efficacious vaccine to fight Covid-19 have become a reality with ZyCoV-D. To create the world’s first DNA vaccine at such a crucial juncture and despite all the challenges, is a tribute to the Indian research scientists and their spirit of innovation.”
Zydus has invested Rs 400-500 crore in developing the ZyCoV-D so far, which includes setting up of manufacturing plants.
“We have re-purposed an existing plant where we are now producing, and our new plant will be ready by end of July. By August, we should have a capacity to make 10 mn doses a month and by the end of this year, we would have made 50 mn doses of ZyCoV-D,” Sharvil Patel, managing director of Zydus Cadila had said earlier.
ZyCoV-D, the Covid-19 vaccine developed by Zydus Cadila has shown a 66.6 percent efficacy in interim analysis of phase 3 trials that happened during the second wave of the pandemic in India. Zydus has also claimed that its vaccine works against the Delta variant; as the trials carried out in more than 50 clinical sites spread across the country and during the peak of the second wave of COVID-19 has shown the vaccine’s efficacy against the new mutant strains, especially the delta variant.
ZyCoV-D would be administered through a needle-free injection system (NFIS). Typically, in an NFIS, a jet of fluid is accelerated to high speed, providing it significant penetrating power through a fine-diameter nozzle when placed against the skin.
Clinical trials on children above 5 years are also on the cards.
What is DNA plasmid vaccine?
Conventional active vaccines are made of a killed or weakened form of the infectious agent. DNA plasmid vaccine is a relatively new approach where a piece of DNA containing the genes for the antigens is injected. The body then learns to develop an immune response against the antigen, and when the actual pathogen attacks, the body is able to generate the specific antibodies against it. DNA vaccines, Zydus has claimed, have been shown to stimulate sustained immune responses.
BOX:
. ZyCoV-D is a plasmid DNA vaccine which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response
. 3-dose regimen – Day 0, Day 28, Day 56
. 2-dose regimen trial data shows equivalent immune response
. Will be administered through PharmaJet – needle free system Tropis
. Stored at 2-8 degree C but stable at 25 degree C for at least 3 months
. Can be made at BSL-1 labs
. Zydus invested Rs 400-500 cr on developing ZyCoV-D
. Capacity to make 10 mn doses per month from August
. Trial on children above 12 yrs over; plan to do trials on 5 yrs-plus
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