BENGALURU:
An expert panel of India’s drug regulator has recommended relaxing norms for the use of a government-backed coronavirus vaccine after it was found to be highly effective in a late-stage trial, the regulator said on its website on Thursday.
“After detailed deliberation, the committee recommended for omission of the condition of the use of the vaccine in clinical trial mode,” the Central Drugs Standard Control Organization said. “However, the vaccine should be continued to be used under restricted use in emergency situation condition.”
Bharat Biotech’s vaccine showed an 81% efficacy in preventing symptomatic COVID-19 in an interim analysis of a late-stage trial in India, it said last week.
Covaxin is also the first vaccine to have come out with Phase 3 data locally. The vaccine based on whole-inactivated virus also has higher chances to be effective against mutations, experts say. Apart from its efficacy and safety, Covaxin also has other advantages. For instance, it is stable at 2-8 degree Celsius – which is normal refrigerator temperature. It also comes in a ‘ready to use’ liquid formulation that allows distribution using the existing cold chain and supply machinery.
Both Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield, developed by Oxford University and AstraZeneca, were given emergency use authorisation for restricted use in January.