India’s drug regulatory authority is likely to take NSE -1.95 % up Zydus Cadila's application seeking Emergency Use Authorisation (EUA) for its Covid-19 vaccine this week. If it gets approval, it will be the first vaccine that can be given to 12-year olds and above.
The Subject Expert Committee (SEC) that advises the drug regulator on applications seeking approval for vaccines, new drugs and clinical trials will review the application, people in the know told ET. “The meeting is expected sometime this week,” a drug regulator official said.
Zydus had applied for EUA for its vaccine on July 1.
“The experts in the drug regulator authority have done their rolling review. There were some concerns regarding the immunogenicity data. Now it is for the SEC to give its recommendations,” added the official.
Zydus developed the Covid vaccine, ZyCov-D, with the support of the central government’s Department of Biotechnology and the Indian Council of Medical Research.
It has shown about 66.6% efficacy in an interim study on more than 28,000 volunteers, including nearly1,000 who are in the age group of 12-18 years.
Credit: ET | Aug 17, 2021