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Covaxin leads to tolerable safety outcomes, enhanced immune responses: Lancet

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eMediNexus    23 January 2021

Covaxin was associated with tolerable safety outcomes and led to enhanced immune responses, reported the Lancet.

The data point to impressive safety and immunogenicity profile. All adverse events were mild and moderate and were more frequently reported following the first dose. From July 13 to 30, 2020, 827 participants were screened, and 375 were enroled. Of the participants that were enroled, 100 each were randomly assigned to three vaccine groups, and 75 constituted the control group. Following both doses, solicited local and systemic adverse reactions were observed in 17 participants in the 3 μg with Algel-IMDG group, 21 in the 6 μg with Algel-IMDG group, 14 in the 6 μg, and 10 in the Algel-only group.The Lancet stated that the most common solicited adverse events included pain at the injection site, headache, fatigue, fever and nausea or vomiting. All of the solicited adverse events were mild or moderate and were more frequently seen after the first dose. There was one serious adverse event of viral pneumonitis in the 6 μg with Algel group, which was not related to the vaccine… (ET Healthworld, January 22, 2021)

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