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India’s drug regulatory committee said on Friday it had asked Hyerderbad-based vaccine maker Bharat Biotech to submit efficacy data from ongoing Phase 3 trials of its Covid-19 vaccine candidate ” Covaxin ”.
The Central Drugs Standard Control Organization (CDSO) expert committee said in a statement: “The company is to submit efficacy and safety data from the ongoing Phase III clinical trial in the adult with age subgroup analysis “.
In the statement, the expert committee noted that Bharat Biotech had “presented its proposal for the conduct of a phase III clinical trial of the whole virion vaccine, inactivated against the corona virus (BBV152) in the age group ≥ 5 years to ≤ 18 years, as well as the clinical trial protocol. “
Further, the SEC also added, “The trial design should be reviewed in Phase II / III. Sample size and other consequential changes should be made to the protocol, accordingly.”
After the necessary modifications, Bharat Biotech is also invited to submit a revised clinical trial protocol for consideration by the committee.
Meanwhile, the Indian government authorized the emergency use of two Covid-19 vaccines developed by AstraZeneca and the University of Oxford and by Bharat Biotech last month as it launched its mega Covid vaccination campaign. -19 from January 16, 2021.
Covaxin is one of two Covid-19 vaccines approved for emergency use in India, although efficacy data from its advanced stage trial has yet to be released.
In a previous report, Bharat Biotech is awaiting the results of an ongoing trial involving 25,800 participants in India alone by March, although the country’s pharmaceutical regulator has called the vaccine safe and effective amid criticism from some doctors and health experts.
Meanwhile, Bharat Biotech confirmed today that the company has signed an agreement with Brazil for the supply of 20 million doses of the Covaxin vaccine.
“The company is delighted to partner with Brazil in its battle against Covid-19 and to assist its vaccination program against the virus. It has signed an agreement for the delivery of COVAXIN during the second quarter (April to June ) and third quarter) 2021, ”the company said in a statement.
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