COVAXIN shows high safety, immunogenicity during phase 1 clinical trial: Lancet journal
Jan 22, 2021
By Priyanka Sharma
New Delhi [India], January 22 : In a remarkable finding, India's indigenous Covid-19 vaccine--COVAXIN developed by the Bharat Biotech and Indian Council of Medical Research (ICMR) has shown high safety and immunogenicity during the phase 1 clinical trial, according to the findings of the clinical trial published in renowned Lancet Infectious Diseases Journal on Friday.
"We report the interim findings from the phase 1 clinical trial of BBV152 (Covaxin), a whole-virion inactivated SARS-CoV-2 vaccine. The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events. Both humoral and cell-mediated responses were observed in the recipients of the Algel-IMDG-based vaccines," said the findings.
Between July 13-30, 2020, 827 participants were screened, of whom 375 were enrolled. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only).
"After both doses, solicited local and systemic adverse reactions were reported by 17 participants in the 3 ug with Algel-IMDG group, 21 in the 6 ug with Algel-IMDG group, 14 in the 6 ug with Algel group, and ten in the Algel-only group," read the research paper.
"The most common solicited adverse events were injection site pain (17 of 375 participants), headache (13), fatigue (11), fever (nine), and nausea or vomiting (seven [2%]). All solicited adverse events were mild (43 of 62) or moderate (19 [31%]) and were more frequent after the first dose," it said.
