The drug regulatory body of India will consider emergency use approval for Zydus Cadila’s Covid-19 vaccine this week and the Subject Expert Committee (SEC) will examine the data submitted by the company.
On July 1, the company had sought emergency use approval of ZyCoV-D, its DNA vaccine against Covid-19 for those aged 12 years and above, from the Drugs Controller General of India (DCGI). It had presented interim results from Phase-III clinical trials in over 28,000 volunteers. The study is said to have demonstrated safety and efficacy in the interim data.
The study was carried out “during the peak of the second wave of Covid-19 (in India), reaffirming the vaccine’s efficacy against the new mutant strains especially the Delta variant,” Zydus said in a statement.
If the committee is satisfied with the submitted data and documents, the vaccine will be approved for emergency use soon, officials said.