Zydus Cadila says it will soon apply for the Indian drug regulator’s approval to conduct trials of ZyCoV-D on children above 2 years, said Dr Sharvil Patel, the managing director of the company.

The world’s first DNA-plasmid vaccine, the three-dose one for Covid-19 developed by Cadila Healthcare (Zydus Cadila), has received emergency-use authorisation from the Drugs Controller General of India (DCGI) for use in adolescents 12 years old and above.
This makes indigenously developed ZyCoV-D India’s first Covid-19 vaccine for this age group, and the vaccine has many firsts. It is based on DNA-plasmid technology; then, it can be administered using a needle-free injection system; and finally, it remains stable in room temperatures for three months.
This is a three-dose vaccine whose second and the third doses are 28 and 56 days, respectively, after the first.

Meanwhile, Zydus has submitted immunogenicity data from a two-dose regimen (using 3 mg doses) trial to the DCGI. The data shows “equivalent immunogenicity” with that of the three-dose regimen. Therefore, a two-dose regimen approval is also expected. Sources said the expert panel might review more data it has sought

Leave a Reply

Your email address will not be published. Required fields are marked *