The Indian Medicines Regulatory Committee said on Friday it had asked Hyerderbad-based vaccine manufacturer Bharat Biotech to submit efficacy data from the ongoing Phase 3 trials of its Covid-19 vaccine candidate ‘Covaxin’.
The Expert Committee of the Central Drugs Standard Control Organization (CDSO) said in a statement: “Firm must submit efficacy and safety data from the ongoing phase III clinical trial in adults, together with the age subgroup analysis,”
In the statement, the expert committee noted that Bharat Biotech ‘submitted its proposal for conducting Phase III clinical trial of Whole Virion, Inactivated Corona Virus Vaccine (BBV152) in the age group ≥ 5 years to ≤ 18 years, together with the clinical trial protocol. “
Furthermore, the SEC also added: “The design of the trial should be reviewed after Phase II / III. The size of the sample and other consequent changes should be made to the protocol accordingly.”
Bharat Biotech is also requested to submit the revised clinical trial protocol for review by the committee.
Meanwhile, the Indian government has approved the emergency use of two Covid-19 vaccines developed by AstraZeneca and Oxford University and Bharat Biotech last month, when it launched its mega Covid-19 vaccination ride from 16 January 2021.
Covaxin is one of the two Covid-19 vaccines approved for emergency use in India, although the efficacy data of the late-stage trial have not yet been published.
In an earlier report, Bharat Biotech expects the results of an ongoing trial with 25,800 participants in India to be expected only by March, although the country’s drug regulator called the vaccine safe and effective amid criticism from some doctors and health experts.
Meanwhile, Bharat Biotech today confirmed that the company has signed an agreement with Brazil for the supply of 20 million doses of Covaxin vaccine.
“The company welcomes a partnership with Brazil in its fight against Covid-19 and the immunization program to help the virus. The company has signed an agreement for the delivery of COVAXIN during the second quarter (April to June) and the third quarter (July to September) (from) 2021, ”the company said in a statement.