BENGALURU (Reuters) – India’s drug regulator has granted emergency use authorization for Zydus Cadila’s COVID-19 vaccine, the world’s first DNA vaccine against the coronavirus, in adults and children aged 12 years and older.
The approval gives a boost to India’s immunization program, which aims to immunize all eligible adults by December, and will provide the first vaccine to those under the age of 18, as the country continues to struggle to contain the spread of the virus in some states.
The vaccine, ZyCoV-D, uses a section of the virus’s genetic material that gives instructions in the form of DNA or RNA to make the specific protein that the immune system recognizes and responds to.
Unlike most COVID-19 vaccines, which require two doses or even a single dose, ZyCoV-D is given in three doses.
The generic drug maker, listed as Cadila Healthcare Ltd, aims to manufacture 100-120 million doses of ZyCoV-D per year and has already started stockpiling the vaccine.
Zydus Cadila’s vaccine, developed in partnership with the Department of Biotechnology, is the second local vaccine to obtain emergency clearance in India after Bharat Biotech’s Covaxin.
The drugmaker said in July that its COVID-19 vaccine was effective against novel coronavirus mutants, particularly the Delta variant, and that the vaccine is administered using a needleless applicator as opposed to traditional syringes .
Regulatory nod makes ZyCoV-D the sixth vaccine authorized for use in the country where only about 9.18% of the general population has been fully vaccinated so far, according to data from Johns Hopkins https : //coronavirus.jhu.edu/region/india.
Zydus Cadila had also submitted data evaluating a two-dose regimen for the vaccine in July and plans to seek regulatory approval for the same.
The company requested authorization for ZyCoV-D on July 1, based on an efficacy rate of 66.6% in an advanced stage trial involving more than 28,000 volunteers nationwide.
(Reporting by Shivani Singh in Bangalore; Editing by Shounak Dasgupta and Maju Samuel)