India’s drug regulatory committee said on Friday that it had asked Hyerderbad-based vaccine maker Bharat Biotech to provide data on the effectiveness of ongoing phase 3 testing of its Covid-19 candidate vaccine ‘Covaxin’.
The Central Drugs Standard Control Organization (CDSO) Subject Experts Committee said in a statement: “The company must submit the efficacy and safety data from the ongoing Phase III clinical trial in adults, along with age subgroup analysis. “.
In the statement, the expert committee noted that Bharat Biotech “presented its proposal for the Phase III clinical trial of the Whole Virion Inactivated Corona Virus (BBV152) in the age range ≥ 5 years to ≤18 years, together with the clinical trial protocol. “
In addition, the SEC also added: “The assay design should be revised for Phase II / III. The sample size and other consequential changes must be made to the protocol, accordingly.”
After the necessary modifications, Bharat Biotech is also requested to send the revised clinical trial protocol for analysis 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 started its mega vaccination campaign Covid-19 on January 16, 2021.
Covaxin is one of two Covid-19 vaccines approved for emergency use in India, although the efficacy data from its final-stage study has not yet been published.
In a previous report, Bharat Biotech expects results from an ongoing trial involving 25,800 participants in India only until March, although the country’s drug regulator 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 to supply 20 million doses of the Covaxin vaccine.
“The company is pleased to partner with Brazil in its battle against Covid-19 and assist its immunization program against the virus. It signed an agreement for delivery of COVAXIN during the second quarter (April to June) and third quarter (July to September)) 2021, “the company said in a statement.