The Indian Drug Regulatory Committee said on Friday that it had asked Hyerderbad vaccine manufacturer Bharat Biotech to provide efficacy data for the ongoing phase 3 studies of its candidate for Covid-19 “Covaxin” vaccine.
The subject matter expert committee of the Central Drug Control Organization (CDSO) 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 the analysis of the age subgroup.”
In the statement, the expert committee noted that Bharat Biotech “submitted its proposal for the phase III clinical trial of the whole coronary virus vaccine, virion (BBV152) in the age group ≥ 5 years to ≤ 18 years, together with clinical trial protocol. “
Furthermore, the SEC also added that the design of the process should be reviewed in phase II / III. The sample size and other amendments should be made accordingly to the Protocol accordingly.
After the necessary changes, Bharat Biotech is also requested to submit the revised protocol of the clinical trial for review by the committee.
Meanwhile, the Indian government has authorized the emergency use of two Covid-19 vaccines developed by AstraZeneca and Oxford University and Bharat Biotech last month, as it began its mega Covid-19 vaccination journey on January 16, 2021.
Covaxin is one of two Covid-19 vaccines approved for emergency use in India, although efficacy data from its late-stage study are not yet published.
In a previous report, Bharat Biotech expects the results of an ongoing trial that involved 25,800 participants in India alone until March, although the country’s drug regulator called the vaccine safe and effective amid criticism from doctors and experts. in health.
Meanwhile, Bharat Biotech confirmed today that the company has signed an agreement with Brazil to supply 20 million doses of Covaxin vaccine.
“The company is pleased to partner with Brazil in the fight against Covid-19 and to help with its immunization program against the virus. It has signed an agreement for the delivery of COVAXIN between Q2 (April-June) and Q3 (July-September) ( from) 2021 “, the company said in a statement.