Bharat Biotech’s Covaxin Gets Approval For Restricted Emergency Use
Published On Mar 11, 2021 12:00 AM By Yamini Sharma
As per reports, Bharat Biotech’s Covid-19 vaccine, Covaxin has received the nod from DCGI’s independent panel set up, Subject Expert Committee (SEC) to advise it, for a restricted emergency use. It must be noted that Covaxin was initially granted restricted use approval in the ‘clinical trial mode’ in January 2021 by the DCGI. During that time, the phase 3 trial on 25,800 volunteers was going on.
According to a source, the decision to allow Covaxin’s restricted emergency use has been taken on the basis of interim data from phase 3 trials. Recently, the SEC met to review Bharat Biotech’s application.
Now that Covaxin will go off the clinical trial mode, it is expected to receive high acceptance. It is to be noted that in January, certain states such as Chhattisgarh and Union Territories like Chandigarh had hinted their discomfort with using Covaxin on their healthcare and frontline workers till the time complete data about the efficacy of Covaxin, the coronavirus vaccine was present.
Earlier in the month of March, Bharat Biotech had released interim data from its phase 3 clinical trials, showcasing that Covaxin had 81% efficacy.
Bharat Biotech’s Chairman and Managing Director, Krishna Ella, had shown confidence in the novel coronavirus vaccine and stated that Covaxin had showcased 100% results in animal challenge studies. In animal challenge studies, it was found that animals did not get the coronavirus diseases even when they were exposed to the pathogen after vaccination. Covaxin has also showcased to generate an immune response against the UK variant.
Covaxin, the whole virus inactivated coronavirus vaccine candidate had showcased 80.6% efficacy in a phase 3 study that covered participants between the age of 18 years and 98 years. The interim analysis comprised a preliminary review of the safety database. The safety database highlighted that severe, serious, and medically attended adverse events took place at low levels and were balanced between vaccine and placebo groups.
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Disclaimer: This article is issued in the general public interest and meant for general information purposes only. Readers are advised not to rely on the contents of the article as conclusive in nature and should research further or consult an expert in this regard.