The Indian Medicines Commission said Friday it has 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 Central Drugs Standard Control Organization (CDSO) Subject Expert Committee said in a statement, “The company must submit efficacy and safety data from the ongoing Phase III clinical trial in adults, along with the age subgroup analysis.”
In the statement, the expert committee noted that Bharat Biotech “had presented its proposal to conduct a phase III clinical trial with Whole Virion, Inactivated Corona Virus Vaccine (BBV152) in the age group ≥ 5 years to ≤ 18 years, together with a clinical trial protocol. “
In addition, SEC also added, “The trial design should be revised to phase II / III. Sample size and other resulting changes should be made to the protocol accordingly.”
After the necessary changes, Bharat Biotech is also asked to submit a revised clinical trial protocol 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 last month by Bharat Biotech, when it began its mega-vaccination program against Covid-19 from January 16, 2021 .
Covaxin is one of two Covid-19 vaccines approved for emergency use in India, although efficacy data from the later study has yet to be published.
In a previous report, Bharat Biotech expects results from an ongoing study involving 25,800 participants in India as late as March, although the country’s drug regulator has called the vaccine safe and effective under 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 pleased to partner with Brazil in the fight against Covid-19 and to support its virus immunization program. It has signed an agreement to supply COVAXIN during the second quarter (April to June) and the third. quarter (July to September) (of) 2021, ” the company said in a statement.