Bharat Biotech has submitted phase 3 data to the Drug Controller General of India (DCGI) for their indigenous Covid-19 vaccine, Covaxin, according to Niti Aayog member VK Paul.
The topic will be discussed by the drug regulator’s Subject Expert Committee on Tuesday, according to a senior official.
“Phase 3 data has been submitted to the drug regulator over the weekend. Covaxin follow-up studies should be available, too, in peer-reviewed journals soon,” Paul said. The Hyderabad-based vaccine maker has released an interim analysis of its phase 3 data but has not yet published full trial results in an internationally recognised journal.
Covaxin, India’s first indigenously created COVID-19 vaccine, is one of three vaccinations now in use in the country to protect individuals from the virus.
The company has developed the vaccine in association with the Indian Council of Medical Research (ICMR).
According to Phase 3 interim analysis results, Covaxin shows a 78 percent efficacy against mild, moderate, and severe instances of COVID-19, according to Bharat
Biotech.
The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10% over the age of 60, with analysis conducted 14 days post-second dose.
In March, the vaccine maker said Covaxin demonstrated 81 per cent interim efficacy in preventing COVID-19 in those without prior infection after the second dose.
In January, DCGI had granted permission for emergency use of Covaxin based on its phase-I and phase-II clinical trial data.
In a press briefing a few days ago by the Union Health Ministry, Dr VK 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.
