India’s drug regulator has granted emergency use approval for Zydus Cadila’s COVID-19 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 India’s vaccination programme, which aims to inoculate all eligible adults by December, and will provide the first shot for those below 18, as the country still struggles to contain the virus spread in some states.
The 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 even a single dose, ZyCoV-D is administered in three doses.
The generic drugmaker, listed as Cadila Healthcare Ltd, 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 the Department of Biotechnology, is the second home-grown shot to get emergency authorisation in India after Bharat Biotech’s Covaxin.
The drugmaker said in July its COVID-19 vaccine was effective against the new coronavirus mutants, especially the Delta variant, and that the shot is administered using a needle-free applicator as opposed to traditional syringes.
ZyCoV-D is not very sensitive to temperature, unlike its competitors. The prescribed storage temperature is between 2 to 8 degrees centigrade but has shown good stability at temperatures of 25 degrees centigrade as well for at least three months.
The regulatory nod makes ZyCoV-D the sixth vaccine authorised for use in the country where only about 9.18 percent of the entire population has been fully vaccinated so far, according to Johns Hopkins University data.
Zydus Cadila had also submitted data evaluating a two-dose regimen for the shot in July 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 percent in a late-stage trial of more than 28,000 volunteers nationwide.
NEEDLE FREE SYSTEM
It is an intradermal vaccine, which is applied using The PharmaJet needle-free system.
Needle-free injectors deliver the vaccine using a narrow stream of fluid to penetrate the skin and deliver the vaccine to the proper tissue depth.
The company says this methodology can eliminate chances of needlestick injury and will also lead to a significant reduction in any kind of side effects.
It will also help people suffering from trypanophobia, a common condition marked by an irrational fear of blood or needles.
It’s estimated that fear of needles affects up to 25 percent of adults.