DCGI’s expert panel to review data of Covaxin's Phase III clinical trials
The Subject Expert Committee (SEC) under the drug regulator will review the data of Phase III clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin on Tuesday.
The meeting is being held before Bharat Biotech’s pre-submission meeting on Wednesday which will be held with the World Health Organization (WHO) for the approval for their COVID-19 vaccine ‘Covaxin’.
Also Read | PGIMER names Delta variant as main circulating strain in Chandigarh during second wave
As per the sources, “the Subject Expert Committee will meet on June 21 to review the Phase III data of Covaxin.”
Also Read | Battlegrounds Mobile India (BGMI) download link revealed on Google Play Store
The Hyderabad-based Bharat Biotech has submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend.
A senior government official said that “We have received the data from the phase III trials."
Bharat Biotech’s Covaxin is one of the 3 vaccines currently being used in India. The phase III data has been questioned various times. Thus, the data would be crucial which will ascertain the efficacy of the vaccine.
The vaccine has been developed in association with the Indian Council of Medical Research (ICMR).
A few days ago, the Union Health Ministry, had stated that the company would be submitting the data within seven to eight days.
In May, Bharat Biotech had stated that an emergency use listing (EUL) application was submitted to WHO.
Click here to follow PTC News on Twitter
-PTC News
