Needle-free Covid vaccine. Zydus Cadila’s needle-free, plasmid DNA Covid vaccine gets DCGI nod

The world’s first needle-free, plasmid DNA Covid-19 vaccine is ready to roll out from Gujarat’s Zydus Cadila. The home-grown drugmaker’s three-dose vaccine, ZyCoV-D, received Emergency Use Authorization (EUA) from the regulator Drug Controller General of India (DCGI) on Friday.

The much anticipated vaccine is a breakthrough of sorts, as ZyCoV-D is an intra-dermal vaccine and will help those hesitant to take an injection. It becomes India’s first Covid-19 vaccine for adolescents in the 12-18 age group, and sixth in the pack of vaccines for adults. The vaccine is also the second indigenous one after Bharat Biotech-ICMR’s Covaxin.

World’s first DNA vaccine

“This is a historic milestone with ZyCoV-D, a product of Indian innovation becoming the world’s first DNA vaccine being offered for human use and supporting the world’s largest immunisation drive,” said Pankaj R Patel, Chairman, Cadila Healthcare Ltd (Zydus Cadila).

ZyCoV-D has shown primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases in the interim analysis of the late-stage phase-III clinical trials in over 28,000 volunteers — touted as the largest vaccine trial so far in India for COVID-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 play a vital role in protection from disease as well as viral clearance.

It is given at an interval of 0-28-56-days using The PharmaJet — a needle-free applicator for painless intradermal vaccine delivery. The vaccine is stored at 2-8 degrees Celsius and has shown good stability at 25-degrees C for at least three months, the company said.

This makes it east to transport and store for supplies to remote locations.

And while the company had started production at risk, sources say the stocks can be released into the market starting next month, i.e. September, while there’s still no word on pricing. Cadila’s MD, Sharvil Patel had recently informed BusinessLine that the company plans to produce about a crore doses a month by mid-August or September and five crore doses by December. “The company is investing in a new plant to manufacture about 10-12 crore doses annually. And it has a 20-crore production target on the applicator used to administer this vaccine. The company had invested ₹500 crore till date, between trials and manufacturing,” Patel had said. The vaccine is developed in partnership with India’s Department of Biotechnology (DBT), under its ‘Mission Covid Suraksha’ and implemented by Biotechnology Industry Research Assistance Council (BIRAC).

Calling it a matter of pride for India, Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, “The Indian Vaccine Mission Covid Suraksha was launched under the Atmanirbhar Bharat package 3.0 being implemented by BIRAC, (and) is aimed at developing safe and efficacious Covid-19 vaccines for public health. This is an important milestone in our indigenous vaccine development mission and positions India on the global map for novel vaccine development.”

The vaccine has been supported by 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.

The platform because of its rapid plug and play technology can be easily adapted to deal with mutations in the virus, such as those already occurring.

ZyCoV-D becomes the sixth in the Covid-19 vaccine pack to be made available in the Indian market, after Covishield from 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. India has set itself a steep task of vaccinating at least 90 lakh people a day and the Zydus vaccine will feed into Meanwhile, Zydus also plans to seek approval for a two-dose regimen of the vaccine. 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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