New Delhi: The Central Drugs Standard Control Organisation (CDSCO) today approved DNA COVID-19 vaccine (ZyCoV-D) of Ahmedabad-based pharmaceutical firm, Cadila Healthcare, for restricted use in emergency situation in India for 12 years and above.
The pharmaceutical firm had applied for emergency use authorization of its ZyCoV-D three-dose Covid-19 vaccine on July 1, 2021.
CDSCO is a department under Directorate General of Health Services, Ministry of Health & Family Welfare of the Government of India.
CDSCO approved the vaccine after evaluation of interim Phase III clinical trial results in consultation with Subject Expert Committee, it said.
Cadila today announced that the company had received the Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D the world’s first Plasmid DNA Vaccine for COVID-19.
ZyCoV-D is a three dose vaccine which will be administered first on day zero, day 28th and then on the 56th day. With this approval, India now 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.
This is for the first time that a technologically advanced vaccine has been successfully developed on the Plasmid DNA platform for human use, the company claimed. 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.
The company stated it plans to manufacture 10-12 crore doses of ZyCoV-D annually. It stated it 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,” it claimed.
Prime Minister Narendra Modi tweeted that the approval for world’s first DNA based ‘ZyCov-D’ vaccine of Zydus Universe is a testimony to the innovative zeal of India’s scientists.
In response to a tweet by CDSCO India Info, the Prime Minister 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.”
– global bihari bureau
