Bharat Biotech’s Covaxin has shown 77.8% efficacy after the Subject Expert Committee (SEC) under the drug regulator reviewed its Phase III trials data on Tuesday, according to sources.
The Hyderabad-based Covid vaccine manufacturing company had submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend.
Bharat Biotech’s ‘pre-submission’ meeting with the World Health Organization (WHO) will take place on Wednesday for its approval of Covaxin.
Covaxin is one of the three vaccines currently being used in India. The phase III data of its vaccine has been questioned various times and this is what makes the data that ascertains the efficacy of the vaccine crucial.
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.
