BENGALURU • India’s drug regulator has granted emergency use approval for Zydus Cadila’s vaccine, the world’s first DNA shot against the coronavirus, in adults and children aged 12 years and above.
The approval gives a boost to the country’s vaccination programme, which aims to inoculate all eligible adults by December, and will provide the first shot for those under 18, as India struggles to contain the virus spread in some states.
The plasmid DNA vaccine, ZyCoV-D, uses a section of genetic material from the virus that gives instructions as either DNA or RNA to make the specific protein that the immune system recognises and responds to.
Unlike most Covid-19 vaccines, which need two doses or just a single dose, ZyCoV-D is administered in three doses.
The generic drugmaker, listed as Cadila Healthcare Limited, aims to make 100 million to 120 million doses of ZyCoV-D annually and has already begun stockpiling the vaccine.
Zydus Cadila’s vaccine, developed in partnership with India’s Department of Biotechnology, is the second home-grown shot to get emergency authorisation in the country after Bharat Biotech’s Covaxin.
The drugmaker said last month its Covid-19 vaccine was effective against the new coronavirus mutants, especially the Delta variant.
As opposed to traditional syringes, the shot is administered using a needle-free applicator akin to a spring-powered device that delivers the vaccine as a narrow stream of fluid penetrating the skin.
The regulatory nod makes ZyCoV-D the sixth vaccine authorised for use in the country where only about 9 per cent of the entire population has been fully vaccinated so far, according to Johns Hopkins data.
Zydus Cadila had also submitted data evaluating a two-dose regimen for the shot last month, and plans to seek regulatory approval for the same.
The firm had applied for the authorisation of ZyCoV-D on July 1, based on an efficacy rate of 66.6 per cent in a late-stage trial of over 28,000 volunteers nationwide.
10m Doses of ZyCoV-D that Zydus Cadila could supply monthly from October.
Describing the approval of the vaccine as a “momentous feat”, Prime Minister Narendra Modi said: “India is fighting Covid-19 with full vigour. The approval for world’s first DNA-based ‘ZyCov-D’ vaccine is a testimony to the innovative zeal of India’s scientists.”
Soon after receiving emergency use authorisation from the Drugs Controller General of India for its three-dose vaccine, Zydus Cadila yesterday said it hoped to produce 10 million doses of vaccines per month by October.
“The supply of vaccines will start in mid-September. We can scale up production of vaccines to one crore (10 million) a month from October at the new production plant,” Dr Sharvil Patel, managing director of Zydus Cadila, said at a press conference.
“We hope to supply three to five crore (30 to 50 million) doses by the end of January 2022.”
ZyCoV-D is India’s indigenously developed DNA-based vaccine for Covid-19 to be administered to all aged above 12 years old.
Dr Patel said the price of this new vaccine will be revealed this week. He added that the efficacy of the ZyCoV-D vaccine against the Delta variant is about 66 per cent.