NEW DELHI: Bharat Biotech’s anti-COVID vaccine Covaxin has shown 77.8 per cent efficacy in phase 3 clinical data trial data, which was reviewed by the Subject Expert Committee (SEC), sources said on Tuesday.
The Subject Expert Committee (SEC), which today reviewed the Phase III trial data of the Hyderabad-based firm’s Covaxin, will now send the data to the Drugs Controller General of India (DCGI) for review.
Covaxin shows 77.8 % efficacy in phase 3 trial data in review by subject expert committee (SEC): Sources
— ANI (@ANI) June 22, 2021
The review meeting took place 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 Hyderabad-based COVID vaccine manufacturing company Bharat Biotech had submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend.
“We have received the data from the phase III trials,” a senior government official had earlier 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.