Expert Committee Pushes Bharat Biotech For Efficacy Data Analysis In Trial III

India’s drug regulatory committee has now asked Bharat Biotech to share the efficacy report towards the Phase III trial of Covaxin, reports have confirmed. A formal statement by the Central Drugs Standard Control Organization (CDSO)’s Subject Expert Committee says that “The firm should submit Efficacy and Safety Data of the ongoing Phase III clinical trial in adults along with the age subgroup analysis.”

While the success rate for India through its homegrown vaccine has been good, there is a general scare over the mutation of the virus traveling through carriers across Europe and the UK. 

Subject Expert Committee (SEC) has stated that Bharat Biotech has in fact, also submitted a proposal to conduct a Phase III clinical trial of Whole Virion, Inactivated Corona Virus Vaccine (BBV152) in the age group of ≥ 5years to ≤18 years along with the clinical trial protocol. For, this, SEC has asked for them to ensure that the design of the trial is revised to a Phase II/III. Further, the firm is expected to make alterations to the sample size and other consequential changes must be made to the protocol accordingly. 

After the desired modifications, Bharat Biotech would then need to submit a revised clinical trial protocol for review of the committee. Ironically, a previous report, it was stated that Bharat Biotech only expected results from the ongoing trial involving 25,800 participants in India by March. However, the country’s drug regulator has called the vaccine safe and effective amid criticism from some doctors and health experts.

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.

Undertaking one of the world’s biggest immunization drives at hand, India has now given approval for the use of two Covid-19 vaccines developed by AstraZeneca and Oxford University and by Bharat Biotech.