Lancet Publishes Covaxin Phase 2 Trial Results, Finds It Safe
The interim results of Covaxin’s Phase 3 trials, announced last week, are yet to be peer reviewed.
On 8 March, The Lancet published the results of Phase 2 trials of India’s first homegrown COVID-19 vaccine, Covaxin, declaring it to be "safe, immunogenic with no serious side effects", reported NDTV.
The Lancet has also clarified that the efficacy of the vaccine cannot be determined until the results of Phase 3 are reviewed.
“The results reported in this study do not permit efficacy assessments. The evaluation of safety outcomes requires extensive phase 3 clinical trials.”The Lancet
According to the report, the most common adverse event in Phase 2 trials was pain at the injection site, followed by headache, fatigue, and fever.
It also says, “no severe or life-threatening (i.e., grade 4 and 5) solicited adverse events were reported.”
The report goes on to say that the results of Phase 2, when compared to that of Phase 1, were especially substantial.
Covaxin, developed by Bharat Biotech, became India’s first COVID vaccine to be given approval for emergency use, back in January.
The vaccine has since been marred with controversy as the move was made before it had cleared all three phases of clinical trials.
(With inputs from NDTV.)
(This story was first published in FIT and has been republished with permission.)
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