First: Zydus Cadila needle-free COVID vaccine gets DCGI nod, PM Modi says momentous feat

With this, ZyCoV-D has become the world's first and India's indigenously developed DNA based vaccine for COVID-19 to be administered in humans including children and adults 12 years and above.

Now, India has its first COVID-19 vaccine for the adolescents in the 12-18 age group, besides the adult population. ZyCoV-D, is a needle-free vaccine administered using The PharmaJet a needle free applicator, which ensures painless intradermal vaccine delivery.

Prime Minister Narendra Modi on Friday hailed it as a "momentous feat" and said the approval to the world's first DNA-based vaccine against the coronavirus is a testimony to the innovative zeal of India's scientists.

This approval came after 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.

In light of the SEC recommendation, the Drugs Controller General of India (DCGI) has finally approved DNA COVID-19 vaccine (ZyCoV-D) of M/s Cadila Healthcare for restricted use in emergency situation in India for 12 years and above.

In addition to this, the Ministry of Science and Technology revealed that 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).

This 3 dose vaccine which when injected 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. The plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring.

In respect to the approval, the CDSCO tweeted, "After evaluation of interim Phase III clinical trial results in consultation with Subject Expert Committee, CDSCO has approved DNA COVID-19 vaccine (ZyCoV-D) of M/s Cadila Healthcare for restricted use in emergency situation in India for 12 years and above."

In response, Prime Minister Narendra Modi said;

"India is fighting COVID-19 with full vigour. The approval for world's first DNA based 'ZyCov-D' vaccine of @ZydusUniverse is a testimony to the innovative zeal of India's scientists. A momentous feat indeed."

In continuation, Dr. Renu Swarup, Secretary, DBT, and Chairperson, BIRAC, addressed the success of this invention, saying, "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, Pankaj R. Patel, Chairman, Cadila Healthcare Ltd., said "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 immunization drive. We are particularly happy that our vaccine will contribute to this fight against COVID-19 and enable the country to vaccinate a larger population especially in the age group of 12-18 years. I would like to thank all the researchers, clinical trial investigators, volunteers and the regulators who have supported this endeavour."

Furthermore, Zydus Cadila said in a statement that the firm aims to produce 10-12 crore doses of ZyCoV-D each year. In addition to this, the company also plans to seek approval for the two dose regimen of the vaccine. The main advantage of DNA vaccines is their ability to stimulate both the humoral and cellular arms of the adaptive immune system. They are a valuable form of antigen-specific immunotherapy, as they are safe, stable and can be easily produced.

Developed in partnership with the Department of Biotechnology, Government of India under the 'Mission COVID Suraksha' and implemented by BIRAC, ZyCoV-D has been supported under 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.

Zydus Cadila, in its release acknowledges the support of National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India, National Institute of Virology, Indian Council of Medical Research and PharmaJet in the development of ZyCoV-D vaccine.

In addition, Vaccine Technology Centre (VTC), vaccine research centre of the Zydus group, Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT and Interactive Research School for Health Affairs (IRSHA), Pune, GCLP Lab set up under the Department of Biotechnology - National Biopharma Mission (NBM) also played a vital role in this success story.