Zydus Cadila on Friday received an approval for the Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for its COVID-19 vaccine ZyCoV-D. It is the world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 to be administered for all above 12 years of age, said the Ministry of Science an Technology.

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) deliberated on the application given by Zydus Cadila on Thursday and recommended granting emergency use authorisation to its three-dose coronavirus vaccine.

The recommendations had been sent to the Drugs Controller General of India (DCGI) for final approval.

The Ahmedabad-based pharma major had on July 1 applied for Emergency Use Authorisation (EUA) with the DCGI for the vaccine.

The company said it has conducted the largest clinical trial for the vaccine in India in over 50 centres so far.

According to a government release, interim results from Phase-III Clinical Trials, in over 28,000 volunteers, showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases. This has been the largest vaccine trial so far in India for COVID-19. This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).

With its approval, ZyCoV-D has become the world's first DNA vaccine against the novel coronavirus infection. Developed by an Indian company, it has also become the sixth vaccine which has been approved for use in the country after Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna and Johnson and Johnson.

Plasmid DNA-based ZyCoV-D is to be administered intradermally using a needle-free injector.

Dr Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairperson, BIRAC said that “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”

Speaking on the development, Chairman of the Zydus Group, 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 has 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.”

(With PTI inputs)