On Friday, India’s drug regulatory committee called on Hyerderbad-based vaccine maker Bharat Biotech to submit efficacy data for ongoing phase 3 trials of its Covid-19 vaccine candidate “Covaxin “.
The Central Drug Control Organization (CDSO) committee of thematic experts said in a statement: “The company should present data on the efficacy and safety of the ongoing Phase III clinical trial in adults together with age subgroup analysis “.
In the statement, the expert committee noted that Bharat Biotech had “submitted its proposal for conducting the phase III clinical trial of the whole crown virus antivariate vaccine (BBV152) in the group of age ≥ 5 years to ≤ 18 years together with the clinical trial protocol. “
In addition, SEC also added, “The design of the trial should be reviewed in phase II / III. Sample size and other consequent changes should be made to the protocol, accordingly.”
After making the necessary modifications, Bharat Biotech is also requested to submit a revised clinical trial protocol for committee review.
Meanwhile, the Indian government authorized the emergency use of two Covid-19 vaccines developed by AstraZeneca and Oxford University and by Bharat Biotech last month as it began its mega vaccination test against Covid-19. Covid-19 as of January 16, 2021.
Covaxin is one of only two Covid-19 vaccines approved for emergency use in India, although efficacy data for its final phase trial have not yet been released.
In a previous report, Bharat Biotech expects the results of an ongoing trial involving 25,800 participants in India in March alone, although the country’s drug regulator has considered 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 Covaxin vaccine.
“The company is delighted to partner with Brazil in its battle against Covid-19 and help its virus vaccination program. It has signed an agreement for the delivery of COVAXIN during Q2 (April to June ) and Q3 (July to September) (of) 2021, ”the company said in a statement.