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.
Read More at https://www.business-standard.com/article/current-affairs/world-s-first-dna-plasmid-vaccine-gets-dcgi-nod-for-use-on-12-years-plus-121082001233_1.html
Comments