India's Covaxin vaccine drawing global attention: ICMR
India's vaccine against Coronavirus has drawn global attention concerning its safety and immunogenicity, the Indian Council of Medical Research has informed.
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FollowIndia's vaccine against Coronavirus has drawn global attention concerning its safety and immunogenicity, the Indian Council of Medical Research has informed.
Announcing the results of phase 2 of the human clinical trials with BBV152 or Covaxin -- manufactured by Bharat Biotech -- collaborator ICMR had exhibited the potential to provide durable humoral immunity and cell-mediated immunity.
"Data generated from within India underlines the impressive safety and immunogenicity profile of Covaxin, which sparked Lancet's interest in publishing them," the ICMR said.
The most common adverse event was pain at the injection site, followed by headache, fatigue, and fever. No severe or life-threatening solicited adverse events were reported.
After any dose, the combined incidence rate of local and systemic adverse events in this study is noticeably lower than the rates for other SARS-CoV-2 vaccine platform candidates.
The Phase 2 trial was conducted across nine sites in nine states in India.
The encouraging Phase 1 and Phase 2 Covaxin trial results have paved the way for Phase 3 clinical trials in India, which is currently underway at 22 sites.
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