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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.
