Covaxin generated excellent safety data, says Bharat Biotech
India | Jan 03, 2021, 08:48 PM ISTBharat Biotech claimed on Sunday that its vaccine generated excellent safety data with robust immune responses to multiple viral proteins that persist.
Bharat Biotech claimed on Sunday that its vaccine generated excellent safety data with robust immune responses to multiple viral proteins that persist.
Hours after India's drugs regulator approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, Union Health Minister Dr. Harsh Vardhan on Sunday called it a "watershed moment" in India’s famed battle against COVID-19.
As India gears up for the world's largest vaccination programme, the Drugs Controller General of India (DCGI) on Sunday quelled rumours surrounding the COVID-19 vaccines regarding impotency, rubbishing such speculations as "absolute nonsense".
The approved vaccines will be first offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.
Covid-19 vaccines- COVAXIN and COVISHIELD have been cleared for restricted use in emergency situation, DCGI, V G Somani said.
The expert panel has recommended granting permission for restricted emergency use of 'Covaxin' in "public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains.
In a significant development, Drugs Controller General of India (DGCI) on Sunday (January 3) formally approved Oxford-AstraZeneca's Covishield and Bharat Biotech's Covaxin for use in India.
The AIDAN has said it is shocked to learn about the recommendation to grant REU approval to Bharat Biotech's COVAXIN in "clinical trial mode" and "specially in the context of infection by mutant strains".
Bharat Biotech on Saturday announced successful recruitment of 23,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for phase-III clinical trial of its coronavirus vaccine 'Covaxin' across multiple sites in India.
The Drug Controller General of India (DCGI) will address a press conference today at 11 am and it is being expected that the drug controller watchdog may announce the approval of emergency use of two vaccines. The development comes after the government panels recommended — Oxford-AstraZeneca Covishield and Bharat Biotech's Covaxin — for emergency use.
An expert panel on Saturday recommended granting permission for restricted emergency use authorisation for Bharat Biotech's indigenously developed COVID-19 vaccine — Covaxin.
The analysis of the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech is still being conducted by regulator Central Drug Standard Control Organisation's (CDSCO) Subject Expert Committee and their next meeting will be held on January 1.
Covaxin, a vaccine candidate being developed by Bharat Biotech for COVID-19, can offer protection against mutations of coronavirus, Chairman andManaging Director of the city-based vaccine maker Krishna Ella said on Tuesday.
AIIMS has invited volunteers for the Phase III clinical trial of the indigenously developed COVID-19 vaccine candidate Covaxin for which it is one of the sites.
The All India Institute Of Medical Sciences (AIIMS) has invited applications for volunteers, who want to take part in the COVAXIN Phase-3 trial, which was indigenously developed by Bharat Biotech.
Hyderabad-based Bharat Biotech, which is developing the country's indigenous coronavirus vaccine in collaboration with the Indian Council of Medical Research, on Wednesday again applied to the Drug Controller General of India for the emergency use authorisation.
Covaxin, being developed in collaboration with the Indian Council of Medical Research and the National Institute of Virology, is now undergoing phase-3 trials.
Bharat Biotech is developing Indian own vaccine for coronavirus called Covaxin. Its chairman was speaking in a virtual session on 'Sero surveillance significance in immunogenicity and safety in pre and post vaccination era' organised by industry body CII.
Bharat Biotech on Tuesday announced successful recruitment of 13,000 volunteers and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of first Make in India vaccine candidate, Covaxin across multiple sites in India.
United Nations Children's Fund (UNICEF) could potentially transport up to 850 tonnes of Covid-19 vaccines per month in 2021, should such quantities become available, according to a new assessment published on Friday.
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