Covaxin: Bharat Biotech submits interim phase 3 results to drugs regulator | Latest News India - Hindustan Times
close_game
close_game

Covaxin: Bharat Biotech submits interim phase 3 results to drugs regulator

Mar 10, 2021 12:04 PM IST

The company reportedly has asked for a review of the clinical trial mode condition that was put in place by DCGI VG Somani before granting their vaccine emergency-use authorisation

Vaccine major Bharat Biotech submitted the initial results of the phase 3 trials of Covaxin, its anti-Coronavirus disease (Covid-19) vaccine that has shown nearly 81% efficacy against the viral disease, to the national drugs regulator.

Covaxin is a two-dose vaccine administered to an individual 28 days apart. (REUTERS)
Covaxin is a two-dose vaccine administered to an individual 28 days apart. (REUTERS)

The company reportedly has asked for a review of the clinical trial mode condition that was put in place by the Drugs Controller General of India (DCGI) VG Somani before he granted the vaccine emergency-use authorisation.

Hindustan Times - your fastest source for breaking news! Read now.

“The company submitted the interim phase 3 trials report three-four days ago, and in the next subject expert committee meeting, the matter will be heard,” confirmed a senior official in the central drugs standard control organisation (CDSCO), requesting not to be named.

The subject expert committee of CDSCO is likely to meet on Thursday.

Also Read | 17,921 new cases of Covid-19 take India’s tally to above 11.26 million; 133 deaths recorded in 24 hours

The company was granted restricted emergency-use approval on January 3 under clinical trial mode for want of phase 3 efficacy data.

Under clinical trial mode, the company has to follow all measures that are usually followed when an individual is given a vaccine shot during a clinical trial such as taking informed consent, close active follow-up of the recipient for a stipulated time etc.

Covaxin is a two-dose vaccine administered to an individual 28 days apart.

The company announced its interim phase 3 results on March 3.

Bharat Biotech’s Covaxin is one of the two vaccines approved for restricted use in India currently. The other one is Oxford-AstraZeneca vaccine that is being locally manufactured by Serum Institue of India as Covishield.

Meanwhile, The Lancet Infectious Diseases on Tuesday published the interim phase 2 trial results of Covaxin that show a two-fold increase in antibody titres than phase 1.

Also, side effects were observed only in 10-12% participants, which, according to the company, is six times less than other Covid-19 vaccines in use under emergency-use authorisation.

Unveiling Elections 2024: The Big Picture', a fresh segment in HT's talk show 'The Interview with Kumkum Chadha', where leaders across the political spectrum discuss the upcoming general elections. Watch now!

Get Current Updates on India News, Election 2024, Arvind Kejriwal News Live, Bihar Board 10th Result 2024 Live along with Latest News and Top Headlines from India and around the world.
SHARE THIS ARTICLE ON
Share this article
  • ABOUT THE AUTHOR
    author-default-90x90

    Rhythma Kaul works as an assistant editor at Hindustan Times. She covers health and related topics, including ministry of health and family welfare, government of India.

SHARE
Story Saved
Live Score
OPEN APP
Saved Articles
Following
My Reads
Sign out
New Delhi 0C
Thursday, March 28, 2024
Start 14 Days Free Trial Subscribe Now
Follow Us On