According to an interim review of its phase 3 trial published in The Lancet on Friday, two doses of Covaxin, India's indigenous COVID-19 vaccine, provide 77.8 percent protection against symptomatic disease and pose no major safety concerns.
The World Health Organization (WHO) recently granted emergency use authorisation to Covaxin, an inactivated whole virus vaccine created by Hyderabad-based Bharat Biotech, for adults aged 18 and up. The outcomes of the phase 3 trial show that Covaxin elicits a strong antibody response, with no serious vaccine-related adverse events or deaths among the trial participants, according to the study's authors.
They explained that the majority of the side effects, such as headache, weariness, fever, and soreness at the injection site, were modest and occurred within seven days of vaccination. The vaccine is given in two doses, 28 days apart, and can be stored and transported at temperatures ranging from 2 to 8 degrees Celsius. The researchers "reported 24 positive instances among 8,471 vaccine recipients and 106 positive cases among 8,502 placebo recipients, suggesting overall vaccine efficacy of 77.8 percent," according to the authors. They also cautioned that the findings are preliminary, and that more research with a bigger sample size is needed to determine efficacy in preventing severe disease and hospitalisation.
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