The Indian Council of Medical Research took to Twitter on Thursday night sharing details about the ongoing clinical trials for the COVID-19 vaccine it is developing with Bharat Biotech. Their vaccine candidate, COVAXIN is still undergoing human tests, and according to early trial data has shown promising results.
"Indian vaccine against COVID-19 draws global attention," the ICMR tweeted. In an attached infographic it added that the data generated from within India "underlines impressive safety and immunogenicity profile of COVAXIN and had "sparked Lancet's interest in publishing them". It also explained that based on "encouraging" Phase 1 and Phase 2 trial results, third phase clinical trials were now underway at 22 sites.
According to the Phase 2 trial data made available, the whole-virion inactivated SARS-CoV-2 vaccine candidate (named BBV152) had performed well in the "controlled, randomised, double-blind trial". According to the researchers, 921 participants were screened between September 7 and September 13 this year. Of these, 380 participants were "randomised to the safety and immunogenicity population". The trial had been conducted across nine sites in nine states.
"In the phase 1 trial, BBV152 produced high levels of neutralising antibodies that remained elevated in all participants three months after the second vaccination. In the phase 2 trial, BBV152 led to tolerable safety outcomes and enhanced humoral and cell-mediated immune responses. The safety profile of BBV152 is noticeably lower than the rates for other SARS-CoV-2 vaccine platform candidates," the paper explains.
"No neutralising antibody differences were observed between sexes and across age groups", and the vaccine was well tolerated by all dose groups with no serious adverse events. "No severe or life threatening (Grade 4 and 5) solicited adverse events were reported," the paper adds.
However, it explained that the results did not yet permit efficacy assessments.
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