Written By: Longjam Dineshwori | Updated : July 2, 2021 10:17 AM IST
If approved, Zydus’ plasmid DNA vaccine will be the second home-grown shot, after Bharat Biotech's Covaxin.
Zydus Cadila, a leading Indian Pharmaceutical company, has sought the approval of the Drugs Controller General of India (DCGI) for emergency use authorisation of its needle-free plasmid DNA vaccine against Covid-19. Called ZyCoV-D, it is a three-dose intradermal vaccine that has been found to be 66.6 per cent effective for symptomatic RT-PCR positive cases in clinical trials. If approved for use, it will become the world's first DNA vaccine against Covid-19 and the second home-grown shot, after Bharat Biotech's Covaxin. It will also be the fifth Covid-19 vaccine to receive DCGI nod for use in India after Covishield, Covaxin, Sputnik V and Moderna.
Dr Sharvil Patel, Managing Director, Cadila Healthcare, said the vaccine, when approved, can be administered to not only adults but also adolescents in the 12 to 18 years age group. The vaccine was tested in the adolescent population in the 12-18 years age group in India and was found to be safe and very well tolerated, the company said in a statement. Further, the company claims that ZyCoV-D will lead to a significant reduction in any kind of side effects.
When injected, ZyCoV-D produces the spike protein of the SARS-CoV-2 virus and stimulates an immune response, which play a vital role in protection from disease as well as viral clearance, the company explained in its statement.
The vaccine had shown a robust immunogenicity and tolerability and safety profile in both the Phase I/II and Phase III clinical trials, which were monitored by an independent Data Safety Monitoring Board.
Regarding the thermostability of the vaccine, the company said that the vaccine should be stored at 2-8 degrees Celsius, but it has shown good stability at temperatures of 25 degrees Celsius for at least three months. The means easy transportation and storage, which will reduce any cold chain breakdown challenges and thus vaccine wastage. What's more, the plasmid DNA platform makes manufacturing easy with minimal biosafety requirements (BSL-1) as well as allows generating new constructs quickly to deal with mutations in the virus.
Evaluation of a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit has also shown immunogenicity results equivalent to the current three-dose regimen, the company added.
The Indian government had on Tuesday cleared Moderna's Covid vaccine for emergency use in the country, allowing the Mumbai-based pharma major Cipla to import the vaccine for restricted emergency use in India. Moderna had earlier announced that its COVID-19 vaccine is 94 percent effective in preventing Covid-19, which is higher than Sputnik (91 per cent), Covaxin (77.8 per cent) and Covishield (74 per cent).
Meanwhile, the DCGI has asked Dr Reddy's Laboratories to submit safety, immunogenicity and efficacy data from the Phase 3 clinical trial of Sputnik Light in Russia for consideration of marketing authorisation of the vaccine in India. Sputnik Light is a single-dose Covid-19 vaccine from the makers of Sputnik V.
