DCGI’s Expert Group Will Study Data Of Phase III Trial Of Covaxin
DCGI’s expert group will study the data of the third phase trial of Covaxin, the effective efficacy of the vaccine will be known.
The Phase III trial of Bharat Biotech’s Covaxine has been completed. On Tuesday, the Subject Expert Committee (SEC) under the drug regulator will discuss the data for the third phase.
This meeting is taking place ahead of India Biotech’s ‘pre-submission meeting with the World Health Organization (WHO) on Wednesday to get their corona vaccine ‘Covaxin’ approved.
According to sources, the subject expert committee will meet today to review the data for the third phase of Covaxin.
According to government sources, Hyderabad-based corona vaccine manufacturing company Bharat Biotech submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) at the end of the week.
DCGI’s expert group: Confirming this, a senior government official said, “We have received the data from Phase III trials.”
Let us tell you that one of the three vaccines of corona currently being used in India is covaxine.
Its Phase III vaccine data has been questioned several times and this is what makes the data important which will determine the efficacy of the vaccine.
The company has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR).
In a press briefing by the Union Health Ministry a few days ago.
Dr. VK Paul, Member (Health) of NITI Aayog, who also heads the country’s COVID Task Force, had said that the company would submit the data in seven to eight days.
In May Bharat Biotech said it had submitted an emergency use list (EUL) application to the WHO, with regulatory approval expected between July and September.
Bharat Biotech has submitted data of Phase III trial of Covaxin to the government: Sources.
Hyderabad-based Covid-19 vaccine maker Bharat Biotech has submitted data for the third phase of the trial of ‘Covaxin’ to the government.
Bharat Biotech has submitted the data to the Drug Controller General of India (DCGI).
A source in the Government of India has admitted that the data of the Phase-3 trial has been received by DCGI. VK Paul, member of the Union Health Ministry.
Health NITI Aayog, and head of the Covid Task Force, had said that in the next 7-8 days, the data of the third phase of the trial of Covaxin will also be published.
Serum Institute’s Vaccine Covishield and Bharat Biotech’s Vaccine Covaccine are an important part against Covid-19.
Bharat Biotech, the manufacturer of ‘Covaxin’, has prepared the corona vaccine in collaboration with the Indian Council of Medical and Research (ICMR).
