DCGI expert panel to review Phase 3 data of Bharat Biotech's Covaxin today

Covaxin coronavirus vaccine

 

New Delhi [India], June 22 (ANI): The Subject Expert Committee (SEC) under the drug regulator will discuss reviewing the Phase III data of Bharat Biotech's Covaxin on Tuesday.

The meeting is taking before Bharat Biotech's 'pre-submission' meeting on Wednesday with the World Health Organization (WHO), for the approval for their COVID vaccine 'Covaxin'.

According to sources, "The Subject Expert Committee will meet today to review the Phase III data of Covaxin."

The Hyderabad-based COVID vaccine manufacturing company Bharat Biotech submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend, according to government sources.

"We have received the data from the phase III trials," a senior government official confirmed.

Bharat Biotech's Covaxin is one of the three vaccines which are currently being used in India. The phase III data of its vaccine have been questioned various times and that is what makes the data crucial which will ascertain the efficacy of the vaccine.

The company has developed the vaccine in association with the Indian Council of Medical Research (ICMR).

In a press briefing a few days ago by the Union Health Ministry, Dr V K Paul, who is a member (Health) Niti Aayog and also the head of the COVID task force of the country, said that the company would be submitting the data within seven to eight days.

In May, Bharat Biotech had said that an emergency use listing (EUL) application had been submitted to WHO, with regulatory approvals expected between July and September.


(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)


Dear Reader,


Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel