Cadila Healthcare (Zydus Cadila) received the Emergency Use Authorisation (EUA) yesterday from the Drug Controller General of India (DCGI) for ZyCoV-D, the world’s first and indigenously developed a ‘DNA-based’ vaccine for the treatment of Covid-19 to be administered in adults and children above the age of 12.
ZyCoV-D would thus become the fifth vaccine cleared for usage in India Covishield, Bharat Biotech’s Covaxin, Sputnik V by Russia and the US-made Moderna. It will also become the world’s first DNA-based vaccine to be approved in any country.
Three-Dose Vaccine: –
The vaccine will be administered in 3 doses – the first dose and the remaining two doses after 28 and 56 days.
When injected, the three-dose vaccine produces the spike protein of the SARS-CoV-2 virus and initiates an immune response that plays a vital role in protecting the person from the disease and viral clearance.
The Ministry of Science and Technology explained that the plasmid DNA platform is based on the ‘plug-and-play’ technology, which makes it easy to adapt and deal with the mutations in the virus, such as the Delta variant, etc.
Moreover, it is an ‘intradermal vaccine’ that is applied using a ‘needle-free injector’. Zydus claims that this needle-free system can help significantly reduce the side effects.
Most extensive Clinical Trials: –
The Phase-III Clinical Trials were conducted in over 28,000 volunteers from symptomatic RT- PCR positive cases. This has been the most prominent vaccine trial for Covid-19 in India so far.
This also marked the first time any vaccine for Covid-19 has been tested in adolescents between 12 to 18 years of India. Around 1000 people from this age group were enrolled, and the vaccine was found to be safe and well-tolerated.
Interim results from this Phase-III clinical trial showed a primary efficacy rate of 66.6%. For symptomatic RT-PCR positive cases.
Moreover, no case of moderate Covid-19 was observed in the vaccine arm post administration of the third dose indicating 100% efficacy for mild disease.
The ZyCov-D vaccine has been developed under the ‘Mission COVID Suraksha’ in partnership with the Department of Biotechnology.
ZyCoV-D has been supported under COVID-19 Research Consortia through National Biopharma Mission for Preclinical studies, Phase I and Phase II Clinical Trials, and under the Mission COVID Suraksha for Phase III Clinical Trial.
Cadila Healthcare Ltd, the generic drugmaker, had applied to authorise the ZyCov-D vaccine on 1 st July earlier this year. The company plans to manufacture 100 to 120 million doses of the ZyCoV-D vaccine annually and has also started stockpiling the vaccine.
