Covaxin, manufactured by Hyderabad-based Bharat Biotech International Limited, has been declared “safe, immunogenic with no serious side effects” by Lancet, which has released its Phase 2 results. Lancet also said that effectiveness cannot be determined by phase 2 trials. “We report the interim results of the phase 2 trial on the immunogenicity and safety of BBV152, with the first dose administered on day 0 and the second dose on day 28”, states the published report Monday.
Covaxine induced high neutralizing antibody responses that remained high in all participants 3 months after the second vaccination in the phase 1 trial, he said. “In the phase 2 trial, BBV152 showed better results in reactogenicity and safety, and improved humoral and cell-mediated immune responses compared to the phase 1 trial. 6 μg with the Algel formulation -IMDG was selected for the Phase 3 efficacy trial, ”he said.
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“BBV152 (developed using a well-established manufacturing platform) was safe, immunogenic (persistent for 3 months) and can be stored at 2-8 ° C, which is compatible with the chain’s requirements. cold vaccination from most countries. Follow-up studies to assess efficacy and immune responses in the elderly and people with co-morbidities are ongoing, ”he added.
The Lancet study recruited a small number of participants aged 12 to 18 and 55 to 65. “Follow-up studies are needed to establish immunogenicity in children and in people aged 65 and older,” he said, noting that the study population lacked ethnic, racial and gender diversity. gender, “further emphasizing the importance of evaluating BBV152 in other populations.”
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The Lancet report states that the results reported in the Phase 2 outcome study do not allow an assessment of efficacy and that “the evaluation of the safety outcomes requires extensive phase 3 clinical trials”. “We were not able to assess other immune responses (ie, binding antibodies and cell-mediated responses) in the convalescent serum samples due to the low quantity. , no additional data on participant age or disease severity in symptomatic individuals were Comparisons between phase 1 and 2 trials were not made in a randomized set of participants, and no adjustment on the basic parameters has not been carried out. The conclusions should be considered as post-hoc analyzes, “he said.
Bharat Biotech announced earlier this month that preliminary results show Covaxin has 81% efficacy in a Phase 3 clinical trial amid months of speculation on rest. “Today is an important step in the discovery of vaccines, for science and our fight against coronavirus disease. With today’s results from our Phase 3 clinical trials, we have now reported data on our Covid-19 vaccine from Phase 1, 2 and 3 trials involving approximately 27,000 participants. Covaxin demonstrates a trend of high clinical efficacy against Covid-19, but also significant immunogenicity against rapidly emerging variants, ”said Krishna Ella, President and CEO of Bharat Biotech.
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Prime Minister Narendra Modi opted to receive a dose of the local vaccine on March 1, when the second phase of the country’s vaccination campaign began.
India has registered 15,388 new cases of coronavirus disease in the past 24 hours, bringing its total to 11,244,786, the Union Health and Family Ministry said on Tuesday. There were 77 new deaths during the same period, bringing the death toll to 1,57,930, according to the health ministry.