Bharat Biotech’s Covaxin shows 77.8% efficacy in phase 3 trial data: Report
Bharat Biotech’s Covaxin is said to have shown 77.8 % efficacy in phase 3 trial data in review by Subject Expert Committee under the drug regulator, sources told ANI on Tuesday.
According to the data submitted, Covaxin has shown efficacy of 77.8% from the trial conducted on 25,800 subjects, according to a news report
The meeting took place before Bharat Biotech’s ‘pre-submission’ meeting on Wednesday with the World Health Organization (WHO), for the approval for their Covid vaccine.
The Hyderabad-based Covid vaccine manufacturing company submitted data from the phase 3 clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend, according to government sources.
Bharat Biotech’s Covaxin is one of the three vaccines, which are currently being used in India. The phase 3 data of the vaccine has been questioned several times 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 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 September.