BackCovaxin: DCGI's expert panel approves Bharat Biotech's Phase 3 efficacy trial data
According to the data submitted, Covaxin has shown the efficacy of 77.8% from the trial conducted on 25,800 subjectsThe meeting took place before the company's 'pre-submission' meeting on Wednesday with WHO
PremiumThe Subject Expert Committee (SEC) under India's drug regulator on Tuesday approved Bharat Biotech' phase-3 trial efficacy data for its Covid-19 vaccine 'Covaxin.'
According to the data submitted, Covaxin has shown the efficacy of 77.8% from the trial conducted on 25,800 subjects, reported ANI citing sources.
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 '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.
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