Zydus Cadila's Covid vaccine for children above 12 years gets EUA in India

Zydus Cadila's three-dose ZyCoV-D will be administered through needle free injection system

The world’s first DNA-plasmid vaccine, the three-dose one for Covid-19 developed by Cadila Healthcare (Zydus Cadila), has received emergency-use authorisation from the Drugs Controller General of India (DCGI) for use in adolescents 12 years old and above.

This makes indigenously developed ZyCoV-D India’s first Covid-19 vaccine for this age group, and the vaccine has many firsts. It is based on DNA-plasmid technology; then, it can be administered using a needle-free injection system; and finally, it remains stable in room temperatures for three months.

This is a three-dose vaccine whose second and the third doses are 28 and 56 days, respectively, after the first.

The Cadila Healthcare stock ended down 1.38 per cent on the BSE on Friday.

Meanwhile, Zydus has submitted immunogenicity data from a two-dose regimen (using 3 mg doses) trial to the DCGI. The data shows “equivalent immunogenicity” with that of the three-dose regimen. Therefore, a two-dose regimen approval is also expected. Sources said the expert panel might review more data it has sought.

Renu Swarup, secretary, department of biotechnology, and chairperson, Biotechnology Industry Research Assistance Council, said: “It is a matter of great pride that today we have 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.”

The 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 I/II clinical trials carried out earlier. Both the Phase 1/2 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.

Pankaj Patel, chairman of Zydus Group, 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 so far invested Rs 400-500 crore in developing ZyCoV-D. It includes setting up manufacturing plants.

“We have re-purposed an existing plant where we are now producing, and our new plant will be ready by the end of July. By August, we should have the capacity to make 10 million doses a month and by the end of this year, we would have made 50 million doses of ZyCoV-D,” Sharvil Patel, managing director of Zydus Cadila, had said earlier.

Zydus has also said 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 have shown the vaccine’s efficacy against the new mutant strains, especially the delta variant.

Typically, in a needle-free injection system, 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 a DNA-plasmid vaccine?

Conventional active vaccines are made from a killed or weakened form of the infectious agent. A 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 pathogen attacks, the body is able to generate the specific antibodies against it. DNA vaccines, Zydus has said, have been shown to stimulate sustained immune responses.

STEPPING UP THE FIGHT

 

. 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