Ocugen's Partner COVID-19 Vaccine Covaxin Shows Encouraging Action In Children Below 18 Years
Ocugen's Partner COVID-19 Vaccine Covaxin Shows Encouraging Action In Children Below 18 Years
$Ocugen(OCGN.US)$ announced the publication of positive pediatric Phase 2/3 study results in children aged 2–18 years for COVID-19 vaccine, Covaxin (BBV152), in The Lancet Infectious Diseases.
Covaxin is developed and manufactured by Ocugen's India-based partner Bharat Biotech International Limited.
It is under clinical investigation by Ocugen in the U.S. for use in adults aged 18 years and older.
Related: FDA Removes Clinical Hold On Ocugen's COVID Vaccine Trial.
The low reactogenicity can potentially make Covaxin more acceptable in pediatric populations than the more reactogenic mRNA vaccines.
Bharat Biotech's pediatric Phase 2/3 study showed no serious adverse events, deaths, or withdrawals due to an adverse event, including no cases of Guillain-Barré syndrome, thromboembolic events, myocarditis, pericarditis, or other adverse events of particular interest being observed to date.
Data comes from 526 children. Local reactions mainly consisted of mild injection site pain.
Geometric mean titers of microneutralization antibodies at day 56 were similar to titers in vaccinated adults.
Price Action: OCGN shares are up 4.63% at $2.26 during the market session on the last check Tuesday.
$Ocugen(OCGN.US)$ 宣布在《柳叶刀传染病》杂志上发表新冠肺炎疫苗Covaxin(BBV152)在2-18岁儿童中的儿科2/3期阳性研究结果。
Covaxin是由Ocugen的印度合作伙伴Bharat Biotech International Limited开发和制造的。
它正在由美国Ocugen公司进行临床研究,用于18岁及以上的成年人。
相关: FDA取消Ocugen的COVID疫苗试验的临床搁置.
与更具反应性的mRNA疫苗相比,低反应性可能会使Covaxin更容易被儿科人群接受。
Bharat Biotech的儿科2/3期研究显示,到目前为止,没有观察到严重的不良事件、死亡或因不良事件导致的停药,包括格林-巴利综合征、血栓栓子事件、心肌炎、心包炎或其他特别感兴趣的不良事件。
数据来自526名儿童。局部反应主要表现为注射部位轻度疼痛。
在第56天,微量中和抗体的几何平均滴度与接种疫苗的成人相似。
价格行动:周二尾盘,OCGN股价上涨4.63%,至2.26美元。
译文内容由第三方软件翻译。