同盟的健康由于担心新冠肺炎变异效力，当局已经暂停在八个州分发礼来公司单克隆抗体鸡尾酒。
新冠肺炎治疗将停止在亚利桑那州，加利福尼亚州，佛罗里达州伊利诺伊州、印第安纳州、马萨诸塞州、俄勒冈州和华盛顿州，由于这些州的变异体数量增加，美国卫生和公众服务部以及负责准备和响应的助理部长“另行通知”在本周的公告中宣布。
在亚利桑那州、加利福尼亚州、佛罗里达州、印第安纳州、俄勒冈州和华盛顿州，P.1变体(首先在巴西发现)和B.1.351变体(首先在南非发现)的“组合频率”现在超过10%;声明称，在伊利诺伊州和马萨诸塞州，P1变异体“以超过10%的频率持续升高”。
詹姆士·布莱克/图标体育线通过美联社
制药巨头礼来公司和公司总部在新冠肺炎大流行期间，马克
这种中断与鸡尾酒的安全性无关，在鸡尾酒中，药物bamlanivimab和etesevimab一起给药，而是担心它对这些变异株无效。公告称，暂停不会影响该国其他地区的分发。
这种治疗在2月份获得了食品药品监督管理局的紧急使用授权。像这样的单克隆抗体治疗是为了在新冠肺炎感染的早期阶段用于非住院患者，这些患者有发展为严重疾病的高风险，以帮助他们远离医院。必须在诊断后几天内给药。
目前，美国食品和药物管理局建议这些州的医疗保健提供者使用授权的雷根龙单克隆鸡尾酒来治疗新冠肺炎患者。
塞尔吉奥·弗洛雷斯/盖蒂图像，文件
2020年7月7日，德克萨斯州奥斯汀的COVID19测试中心进行了冠状病毒测试。
迄今为止的临床试验数据显示，Regeneron鸡尾酒对目前的主要变体的疗效略高于礼来，礼来在其实验室研究中显示，除了B.1.1.7或英国变体之外，所有变体的疗效都有所下降。
在给美国广播公司新闻的一份声明中，礼来公司表示，它“继续监测新冠肺炎的环境，评估我们的抗体疗法对各种现有和新出现的突变和变异的中和作用”，并将继续与所有政府和监管机构合作，确保他们的治疗流向“适当的患者”。
雷根龙告诉美国广播公司新闻，其鸡尾酒对包括印度在内的令人担忧的变体“仍然看起来不错”，并将在新变体出现时继续对其进行测试。
出于对变体有效性的担忧，礼来公司的单克隆抗体治疗bamlanivimab于3月份停止，首先在西方三个州停止，然后在全国范围内停止。接下来的一个月，礼来公司要求美国食品和药物管理局取消该疗法的EUA——这一要求在同一天得到了满足——这样该公司就可以更加专注于鸡尾酒疗法。
尽管礼来公司的抗体治疗受到了变异体的影响，研究迄今为止显示新冠肺炎疫苗对他们有效。所有三种授权疫苗都被证明能有效对抗英国变异体最主要的COVID菌株在美国
Distribution of Eli Lilly COVID-19 therapy paused in 8 states over variant concerns
Federalhealthauthorities have paused distribution of Eli Lilly's monoclonal antibody cocktail in eight states over COVID-19 variant efficacy concerns.
The COVID-19 treatment will halt distribution in Arizona, California,Florida, Illinois, Indiana, Massachusetts, Oregon and Washington "until further notice" due to variants' elevation in those states, the U.S. Department of Health and Human Services and Assistant Secretary for Preparedness and Responseannounced in a bulletin this week.
The "combined frequency" of the P.1 variant (first identified in Brazil) and the B.1.351 variant (first identified in South Africa) now exceeds 10% in Arizona, California, Florida, Indiana, Oregon and Washington; in Illinois and Massachusetts, the P.1 variant has been "persistently elevated at a frequency exceeding 10%," the announcement said.
The stoppage is not related to the safety of the cocktail -- in which the drugs bamlanivimab and etesevimab are administered together -- but rather concerns that it is not as effective against these variant strains. The pause will not impact distribution in other parts of the country, according to the bulletin.
The treatment was issued an emergency use authorization from the Food and Drug Administration in February. Monoclonal antibody treatments like these are meant to be used in the early stages of COVID-19 infection for non-hospitalized patients who are at high risk of progressing to severe illness, to help keep them out of the hospital. It must be administered within days of diagnosis.
For now, the FDA recommends health care providers in these states use the authorized Regeneron monoclonal cocktail for COVID-19 patients instead.
Clinical trial data so far has shown that Regeneron's cocktail is slightly more effective against current major variants than Lilly's, which in its own laboratory studies showed some diminishing efficacy among all variants except the B.1.1.7, or U.K. variant.
In a statement to ABC News, Lilly said it "continually monitors the COVID-19 environment, assessing the neutralization of our antibody therapies against a wide array of existing and emerging mutations and variants," and that it will continue to work with all government and regulating bodies to ensure their treatments go to the "appropriate patients."
Regeneron told ABC News its cocktail is "still looking good" against variants of concern, including those in India, and that it will continue testing against new variants as they emerge.
Lilly's solo monoclonal antibody treatment, bamlanivimab, was halted in March -- first in three Western states and then nationwide -- out of concerns over effectiveness against variants. The following month, Lilly asked the FDA to revoke the treatment's EUA -- a request that was fulfilled the same day -- so that the company could focus more on its cocktail treatment.
Though Lilly’s antibody treatment has been impacted by variants,researchso farhas shown that COVID-19 vaccines are effective against them. All three authorized vaccines have proven to work effectively against the U.K. variant, which is themost dominant COVID strainin the U.S.
