“The rolling review has been done and now it will be put up before the SEC for its recommendations,” the official told ET. “The meeting is likely to happen sometime this week.”
The company had last week approached the country’s drug regulator seeking EUA.
If it gets the nod, it would be the fifth vaccine to get EUA in India after Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Russian vaccine Sputnik V and US firm Moderna’s vaccine.
Zydus developed the vaccine, ZyCov-D with the support of the central government’s Department of Biotechnology and the Indian Council of Medical Research (ICMR). It has shown 66.6% efficacy in an interim study.
The vaccine has a needle-free application system whereby a spring-powered applicator delivers the shot.
Zydus has also submitted data evaluating a two-dose regimen for the shot to the SEC.
“The SEC will compare the data and will decide whether to give a go ahead for three-dose or two-dose vaccine,” said the official cited earlier.
Zydus said it will launch the vaccine in 45 to 60 days after regulatory approval.
It said its efficacy result is based on an interim analysis of a late-stage trial of more than 28,000 volunteers nationwide, including nearly 1,000 subjects in the age group of 12 to 18.
Immunogenicity data for the adolescent children subset will be submitted in the next four to six weeks, company MD Sharvil Patel had said last week. He said the firm is expected to produce 10 million doses by mid-August and 50 million doses by December.
Zydus is right now only focusing on providing doses for India, even as a lot of other countries have shown interest in their vaccine, Patel had said.
“There has been a lot of interest as you know that vaccines are in shortage across the world but currently with the scale of manufacturing that we are going to achieve, we are only focusing our efforts on the fact that we make these vaccines available for India,” he had said.