Zydus Cadila has finally said it got Emergency Use Authorization (EUA) from Indian authorities to administer ZyCoV-D — the world’s first DNA-based COVID-19 vaccine — for both adults and teenagers.
This is the first time any COVID-19 vaccine has been approved for those below 18 years of age in India.
The approval has been given for a three-dose regime, though the company had recently said that it expects to get the nod for a two-dose regime.
As approved, ZyCoV-D 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,” the company said.
ZyCoV-D, is a needle-free vaccine administered using a needle free applicator.
“This is for the first time that a technologically advanced vaccine has been successfully developed on the Plasmid DNA platform for human use. 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 claimed.
The company plans to manufacture 10-12 crore doses of ZyCoV-D annually.
“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,” said Pankaj R. Patel, Chairman, Cadila Healthcare Ltd.
The company said it 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,” the Gujarat-based company said.
DNA vaccines work by injecting a piece of DNA into the human cell. This interacts with the human DNA, and resulting in the human cell producing parts of the virus — in this case, parts of the COVID-19 virus.
Because of this, the human immune system starts getting activated to attack these molecules, thus creating lasting immunity.
No major country has so far approved DNA vaccines for COVID-19. In fact, countries like the US will look keenly at the India development, as regulators there have not approved any DNA-based vaccine for humans yet.
The approval comes days after the company said it had submitted new data to the regulator as part of a rolling review of test results.
ALSO SEE: US FDA Guidance on DNA vaccine development & testing