A new chapter in the fight against the ongoing epidemic of COVID-19 has begun with the Drug Controller
General of India (DCGI) giving the approval for Emergency Use Authorization (EUA) for the world’s first and India’s indigenously developed DNA-based COVID-19 vaccine to be administered in adults and children 12 years and above.
Developed by Ahmedabad-based pharma major Zydus Cadila in partnership with the Government of India’s Department of Biotechnology (DBT) under its ‘Mission COVID Suraksha’, the three-dose vaccine produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from disease as well as viral clearance.
Interim results from Phase-III Clinical Trials, in over 28,000 volunteers, showed primary efficacy of 66.6 percent for symptomatic RT-PCR positive cases. This has been the largest vaccine trial so far in India for COVID-19. The vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials. The Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).
Zydus group’s Vaccine Technology Centre (VTC), and Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology played a vital role in this success story.
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Named ZyCoV-D, the vaccine uses a section of genetic material from the virus that gives instructions to make the specific protein that the immune system recognises and responds to. The platform on which the vaccine has been developed is in the form of a rapid plug-and-play technology and can thus be easily adapted to deal with mutations in the virus.
It is sort of a game-changer, as it is an intradermal vaccine and will help those hesitant to take an injection. It will be given using PharmaJet — a needle-free applicator. Also, the vaccine can be stored at 2-8 degrees Celsius and has shown good stability at 25-degrees C for at least three months. This makes it easy to store and transport supplies to remote locations.
It is India’s first COVID-19 vaccine for adolescents in the 12-18 age groups, and sixth in the pack of vaccines for adults. It is also the second indigenous one after Bharat Biotech-ICMR’s Covaxin. The three-dose vaccine will be given at intervals of 28 days.
Reacting to the approval, Renu Swarup, Secretary, DBT, said, “It is a matter of great pride that today we have the EUA for the world’s first DNA COVID-19 vaccine ZyCoV-D by Zydus developed in partnership with the Department of Biotechnology and supported through Mission COVID Suraksha. The Indian Vaccine Mission COVID Suraksha was launched under the Atma Nirbhar Bharat package 3.0 being implemented by BIRAC, is aimed at the development of safe and efficacious COVID-19 vaccines for public health. We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development”.
Chairman of the Zydus Group, Mr. Pankaj R. Patel said, “We are extremely happy that our efforts to put out a safe, well-tolerated, and efficacious vaccine to fight COVID-19 have become a reality with ZyCoV-D. To create the world’s first DNA vaccine at such a crucial juncture and despite all the challenges, is a tribute to the Indian research scientists and their spirit of innovation. I’d like to thank the Department of Biotechnology, Government of India for their support in this mission of Atma Nirbhar Bharat and Indian Vaccine Mission COVID Suraksha.”
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 a target of vaccinating at least 90 lakh people a day and the Zydus vaccine will help in the process. Zydus is also planning to seek approval for a two-dose regimen of the vaccine.
Vaccination primarily involves stimulating the immune system with an infectious agent, or components of an infectious agent, modified in such a manner that no harm or disease is caused, but ensuring that when the host is confronted with it, the immune system can adequately neutralize it before it causes any ill effect.
For over a hundred years, vaccination has been effected by one of two approaches: either introducing specific antigens against which the immune system reacts directly; or introducing live attenuated infectious agents that replicate within the host without causing disease and synthesize the antigens that subsequently prime the immune system.
DNA vaccination marks a radically new approach. It involves the direct introduction into appropriate tissues of a plasmid containing the DNA sequence encoding the antigen(s) against which an immune response is sought, and relies on in situ production of the target antigen. This approach offers many potential advantages over traditional approaches, including improved vaccine stability, the absence of any infectious agent, and relatively easier large-scale production.
