The Indian drug regulator’s subject expert committee has recommended emergency use approval for Zydus Cadila’s three-dose COVID-19 vaccine, CNBC-TV18 has reported, citing sources.
The committee added that Zydus needs to submit additional data for the two-dose regimen of its vaccine, CNBC-TV18 said in a tweet on Friday.
The generic drugmaker listed as Cadila Healthcare Ltd, applied for authorisation of the vaccine ZyCoV-D on July 1, based on an efficacy rate of 66.6 percent in a late-stage trial of more than 28,000 volunteers nationwide.
If approved, Zydus Cadila’s vaccine will be the second home-grown shot to get emergency authorisation in India after Bharat Biotech’s Covaxin.
Zydus Cadila and India’s drug regulator did not immediately respond to the Reuters news agency’s request for comment.
J&J seeks nod for trial in Indian adolescents
Meanwhile, Johnson & Johnson has sought approval from Indian drug regulators to conduct a study of its COVID-19 vaccine among 12 to 17-year-olds, the company said on Friday.
Conducting vaccine clinical trials among adolescents is imperative to achieve herd immunity against the coronavirus, J&J said in an emailed statement.
The US pharma giant had received emergency use approval for its single-dose vaccine in India earlier this month, making it the fifth authorised vaccine in the country.
While J&J has a supply agreement with Indian vaccine maker Biological E Ltd to bring its shot to the country, the company had said that it was too early to give a delivery timeline.