The world's first DNA-based vaccine, as well as India's first needle-free Covid vaccine, has received DCGI approval.

 

Image Credit: DNA India

ZyCoV-D is the first vaccine for teenagers aged 12 to 18, and the sixth in the pack for adults; plans are in the works to obtain approval for a two-dose regimen.

Gujarat's Zydus Cadila is set to launch the world's first needle-free plasmid DNA Covid-19 vaccine. On Friday, the regulator Drug Controller General of India (DCGI) granted Emergency Use Authorization (EUA) to the homegrown drugmaker's three-dose vaccination, ZyCoV-D.

The much-anticipated vaccine, ZyCoV-D, is an intradermal vaccine that will help those who are apprehensive to receive an injection. It is India's first Covid-19 vaccination for teenagers aged 12 to 18, and the sixth in a series of adult vaccines. After Bharat Biotech-Covaxin, ICMR's this is the second indigenous vaccine.

The first DNA vaccine in the world:

With ZyCoV-D, a product of Indian innovation, being the world's first DNA vaccine for human use and helping the world's largest immunisation programme, this is a historic milestone, said Pankaj R Patel, Chairman, Cadila Healthcare Ltd. (Zydus Cadila).

In the interim analysis of the late-stage phase-III clinical trials in over 28,000 volunteers — described as the largest vaccine trial for COVID-19 so far in India — ZyCoV-D showed the main efficacy of 66.6 percent for symptomatic RT-PCR positive cases. It creates the SARS-CoV-2 virus's spike protein and elicits an immunological response mediated by the cellular and humoral arms of the human immune system, both of which are important in disease prevention and viral clearance.

The PharmaJet – a needle-free applicator for painless intradermal vaccination delivery — is used to administer it at intervals of 0-28-56 days. According to the business, the vaccine is stored between 2-8 degrees Celsius and has proven good stability at 25 degrees C for at least three months.

This makes transporting and storing supplies to faraway sites much easier.


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While the corporation had begun manufacturing at risk, insiders suggest the supplies might be released into the market as early as next month, in September, though the price has yet to be determined. Cadila's MD, Sharvil Patel, recently told BusinessLine that the company intends to generate roughly a crore doses every month by the middle of August or September, and five crore doses by the end of the year. “The corporation is building a new plant that will produce roughly 10-12 crore doses every year.

It also has a production target of 20 million units for the vaccination applicator. “To date, the company has invested 500 crores in trials and manufacturing,” Patel added. The vaccine is being developed in collaboration with India's Department of Biotechnology (DBT) as part of its "Mission Covid Suraksha" programme, which is being executed by the Biotechnology Industry Research Assistance Council (BIRAC).

India should be proud of this, he said. The Indian Vaccine Mission Covid Suraksha was initiated under the Atmanirbhar Bharat package 3.0 being executed by BIRAC, (and) is targeted at creating safe and efficacious Covid-19 vaccines for public health. This is a significant step forward in our domestic vaccine development programme, putting India on the map for new vaccine development around the world, stated Renu Swarup, Secretary, DBT and Chairperson, BIRAC.

Covid-19 research consortia supported the vaccine through the National Biopharma Mission for preclinical investigations, Phase I and Phase II clinical trials, and the Mission Covid Suraksha for Phase III clinical trials.


Because of its rapid plug-and-play technology, the platform can be easily altered to deal with virus changes, such as those that have already occurred.

After Covishield from the Serum Institute of India (SII), Covaxin from Bharat Biotech, Sputnik from Russia's Gamaleya Institute, Moderna's vaccine, and the most recent Johnson and Johnson's one-dose vaccine, ZyCoV-D becomes the sixth vaccine in the Covid-19 vaccine pack to be made available in the Indian market.

India has set a lofty goal of vaccinating at least 90 lakh people each day, and the Zydus vaccine will contribute to that goal. Meanwhile, Zydus plans to apply for clearance for a two-dose immunisation regimen. DNA vaccines are a valuable kind of antigen-specific immunotherapy, according to the business, because they are safe, stable, and simple to make.

(Source: Business Line)