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Covaxin Led to Tolerable Safety Results and Better Immune Responses, Says Lancet | India News

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NEW DELHI: Even as controversy sparks over the safety of India’s first indigenous Covid-19 vaccine, Covaxin, after it was granted Emergency Use Authorization (EUA), even as efficacy trials are underway phase III, the renowned medical journal Lancet said that the vaccine, codenamed BBV152, led to tolerable safety results and improved immune responses.
The Lancet, which has published the Covaxin Phase 1 results in its latest issue, said that the vaccine was well tolerated in all dose groups with no serious vaccine-related adverse events and that humoral and cell-mediated responses were observed in Algel’s receivers. -IMDG-based vaccines.
He said the only reported serious adverse event was not causally associated with the vaccine.
The research article said that the most common adverse event was pain at the injection site, followed by headache, fatigue and fever. “The overall incidence of requested local and systemic adverse events in this study was 14-21% in all vaccine-treated groups, which is markedly lower than the rates for other candidates for the SARS vaccine platform. CoV-2 “.
“24 (6%) of 375 participants reported up to 44 unsolicited adverse events … All adverse events were mild or moderate and were more frequent after the first dose than the second. No significant differences were observed between those vaccinated and control groups “.
Between July 13 and July 30, 2020, 897 people between the ages of 18 and 55 were screened and 375 were enrolled for the phase 1 human trials of Covaxin. Among the enrolled participants, 100 were randomly assigned to each of the three vaccine groups and 75 were randomly assigned to the control group (Algel only).
Covaxin is a full virion inactivated Covid-19 vaccine that has been developed with Bharat Biotech in conjunction with the Indian Council of Medical Research-Pune National Institute of Virology (ICMR-NIV).

Times of India

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