The world’s first needle-free, plasmid DNA COVID-19 vaccine is ready to roll out from Zydus Cadila, Gujarat. The domestic drugmaker’s three-dose vaccine, ZyCoV-D, received an emergency use authorization (EUA) from India’s regulatory drug controller general (DCGI) on Friday.
The much-awaited vaccine is a breakthrough of sorts, as ZyCoV-D is an intra-dermal vaccine and will help those who are hesitant to take injections. It has become India’s first COVID-19 vaccine for adolescents aged 12-18, and the sixth in the pack of vaccines for adults. The vaccine is also the second indigenous after Bharat Biotech-ICMR’s Covaccine.
World’s first DNA vaccine
Pankaj R Patel, President, Cadila Healthcare Limited (Zydus Cadila) said, “This is a historic milestone with ZyCoV-D, a product of Indian innovation, becoming the world’s first DNA vaccine for human use. And supporting the world’s largest vaccination campaign.” .
ZyCoV-D has shown a primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases in an interim analysis of late-stage Phase-III clinical trials in over 28,000 volunteers – the highest test for COVID-19 in India so far. The largest vaccine trial is believed to be. 19. When administered, it produces the spike protein of the SARS-CoV-2 virus and elicits an immune response mediated by the cellular and humoral arms of the human immune system, which provides protection against disease as well as play an important role in viral clearance.
It is given at 0-28-56-day intervals using a needle-free applicator – Pharmajet for painless intradermal vaccine delivery. The company said the vaccine is stored at 2-8°C and has shown good stability at 25°C for at least three months.
This makes it the former for transportation and storage of supplies to remote places.
And while the company had started production at risk, sources say that the stock could be released in the market from next month i.e. September, while there is still no word on the pricing. Cadila MD Sharvil Patel recently informed business Line That the company plans to produce about 10 million doses a month by mid-August or September and 50 million by December. “The company is investing in a new plant to manufacture around 10-12 crore doses annually. And it has a production target of 200 million on the applicator used to administer this vaccine. The company had so far invested ₹500 crore between testing and manufacturing,” Patel had said. The vaccine has been developed in partnership with India’s Department of Biotechnology (DBT), under its ‘Mission COVID Suraksha’ and implemented by the Biotechnology Industry Research Assistance Council (BIRAC).
Describing it as a matter of pride for India, Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, “Indian Vaccine Mission COVID Suraksha was launched under Atmanirbhar Bharat Package 3.0, which is being implemented by BIRAC, (and) its purpose is to secure and develop. Effective COVID-19 vaccines for public health. This is an important milestone in our indigenous vaccine development mission and puts India on the global map for new vaccine development.
The vaccine is supported by the National Biopharma Mission for preclinical studies, Phase I and Phase II clinical trials and the Covid-19 Research Consortia under Mission COVID Suraksha for Phase III clinical trials.
Due to its rapid plug and play technology, the platform can be easily adapted to deal with mutations in viruses, such as are already occurring.
ZyCoV-D became the sixth in the COVID-19 vaccine pack to be made available in the Indian market, after Kovishield from Serum Institute of India (SII), Covaxin from Bharat Biotech, Sputnik from Russia’s Gamalya Institute, Moderna’s Vaccine and the most recent Johnson & Johnson’s single dose vaccine. India has set itself a daunting task of vaccinating at least 9 million people a day and the Zydus vaccine will add to that. DNA vaccines are a valuable form of antigen-specific immunotherapy, as they are safe, stable and can be easily produced, the company said.
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