Zydus Cadila's 3-Dose COVID Vaccine Recommended For EUA By Indian Drug Regulator's Panel: Report

Zydus Cadila's vaccine approval will be a significant development as it can become the second indigenous COVID vaccine to get emergency use authorisation in India.

Representative Photo

New Delhi: The subject expert committee constituted to advise the Drugs Controller General of India has recommended that Zydus Cadila's three-dose COVID-19 vaccine be given emergency use authorisation, CNBC-TV18 reported citing sources on Friday.

The committee has stated that Zydus needs to submit additional data for the 2-dose regimen of its vaccine, the channel said in a tweet.

Cadila Healthcare Ltd had applied for the emergency use authorisation of the vaccine ZyCoV-D on July 1. This vaccine is up to 67 per cent effective for children aged 12 to 18 years.

Zydus Cadila's vaccine approval will be a significant development as if approved, it will become the second indigenous COVID vaccine, after Bharat Biotech's Covaxin, to get emergency authorisation in India.

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 data has shown that ZyCoV-D is safe for children in the age group of 12 to 18 years, said the company, which is planning to manufacture 100-120 million doses of the vaccine annually.

Recently, during a press briefing, NITI Aayog Member Dr. V K Paul had also informed that the DCGI is examining Zydus Cadila's COVID vaccine for children.

"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," MD of Cadila Healthcare Dr Sharvil Patel had said, as quoted by ANI.

According to Zydus Cadila, the three doses of ZyCoV-D are to be administered on day 0, day 28, and day 56. The company is also revealed that it is working on a two-dose vaccine.

Zydus Cadila and DCGI are yet to make a comment to confirm the report regarding the vaccine approval.