BackIndia asks Bharat Biotech to submit efficacy data of Covaxin's ongoing Phase 3 trials
Bharat Biotech is also asked to submit revised clinical trial protocol for review of the committee.The expert committee says Bharat Biotech presented proposal to conduct phase III clinical trial of Covaxin in people aged between 5 & 18
PremiumIndia's drug regulator committee on Friday said that it has asked Hyerderbad-based vaccine manufacturer Bharat Biotech to submit efficacy data of the ongoing phase 3 trials of its Covid-19 vaccine candidate 'Covaxin.'
The Central Drugs Standard Control Organization (CDSO)'s Subject Expert Committee said in a statement, "Firm should submit Efficacy and Safety data of 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 for conduct of phase III clinical trial of Whole Virion, Inactivated Corona Virus Vaccine (BBV152) in the age group of ≥ 5years to ≤18 years along with clinical trial protocol."
Furthermore, SEC also added, "The design of trial should be revised to Phase II/III. Sample size and other consequential changes should be made to the protocol, accordingly."
Post the necessary modifications, Bharat Biotech is also asked to submit revised clinical trial protocol for review of the committee.
Meanwhile, the Indian government authorised the emergency use of two Covid-19 vaccines developed by AstraZeneca and Oxford University and by Bharat Biotech last month as it started its mega Covid-19 vaccination drive from 16 January, 2021.
Covaxin is one of the two Covid-19 vaccines approved for emergency use in India, though efficacy data from its late-stage trial is yet to be published.
In an earlier report, Bharat Biotech expects results from an ongoing trial involving 25,800 participants in India only by March, though the country's drug regulator has 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 is delighted to partner with Brazil in its battle against Covid-19 and aid its immunization program against the virus. It has signed an agreement for delivery of COVAXIN during Q2 (April to June) and Q3 (July to September) (of) 2021," the company said in a statement.
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