Expert panel recommends EUA for Zydus' three-dose Covid vaccine: Report

The committee added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine, say sources

An expert panel of India's central drug authority has recommended granting emergency use authorisation to Zydus Cadila's three-dose COVID-19 vaccine ZyCoV-D, sources said, reported news agency PTI on Friday.

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) deliberated on the application given by Zydus Cadila on Thursday and recommended granting emergency use authorisation to its three-dose coronavirus vaccine.

The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.

The Ahmedabad-based pharma major had on July 1 applied for emergency use authorisation (EUA) with the DCGI for the vaccine.

The committee, whcih met on Thursday, added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine, CNBC-TV18 said in a tweet.

The generic drugmaker, listed as Cadila Healthcare Ltd, applied for the authorisation of the vaccine ZyCoV-D on July 1, based on an efficacy rate of 66.6% 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.

The company said it has conducted the largest clinical trial for the vaccine in India in over 50 centres so far.

If approved, ZyCoV-D will be the world's first DNA vaccine against the novel coronavirus infection, developed by an Indian company and become the sixth vaccine which has been approved for use in the country after Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna and Johnson and Johnson.

Plasmid DNA-based ZyCoV-D is to be administered intradermally using a needle-free injector.

Sharvil Patel, managing director, Cadila Healthcare had said that the vaccine, when approved, would help not only adults but also adolescents in the 12 to 18 years age group.

"ZyCoV-D is the first-ever plasmid DNA vaccine for human use, it has proven its safety and efficacy profile in our fight against COVID-19," Patel had said.