存在血栓风险，美FDA限制强生疫苗使用 | 双语精选

在新冠疫情的大背景下，疫苗已经成为抗击疫情不可或缺的一部分。然而就在前不久，美国食品药品监督管理局（FDA）在经过评估后，决定限制强生公司旗下杨森新冠疫苗的使用。究竟是怎么一回事呢？我们一起看文章。

FDA limits Johnson & Johnson's COVID vaccine to some people due to blood clot risk

因存在血栓风险，美FDA限制部分人群使用强生新冠疫苗

The U.S. Food and Drug Administration is limiting the use of Johnson & Johnson's Janssen COVID-19 vaccine as a last resort for adults who cannot accept a shot from another manufacturer.

美国食品药品监督管理局（FDA）正在限制强生公司旗下杨森新冠疫苗的使用，对于不能接种其他制药公司新冠疫苗的成人而言，注射强生新冠疫苗是最后的选择。

Though the potential benefits of the vaccine outweigh the risks, the FDA said Thursday that it is restricting the use of the Janssen vaccine. It will be limited to individuals 18 and older and medically ineligible for another approved vaccine and to those who only have access to the J&J vaccine and want one, according to an FDA news release.

FDA周四表示，尽管接种杨森新冠疫苗的潜在好处超过了风险，但其仍然在限制该疫苗的使用。根据FDA的一份新闻稿，将限制两类人群接种强生疫苗：18岁及以上且在医学上不适用于其他已获批新冠疫苗的个人以及那些只能接种到强生疫苗并且也有意愿接种该疫苗的人群。

Researchers with the FDA and Centers for Disease Control and Prevention found that the vaccine resulted in 60 confirmed cases of thrombosis with thrombocytopenia syndrome. This leads to rare but potentially life-threatening blood clots, the FDA said, one to two weeks after receiving the shot. And with multiple vaccines available, the FDA decided to bench the J&J vaccine, only to be used when other options are unavailable.

FDA和美国疾病控制和预防中心的研究人员发现，该疫苗导致了60例血栓性血小板减少综合征（TTS）的确诊病例。FDA表示，在注射疫苗后的一到两周内会引起罕见但可能危及生命的血栓。而鉴于有多种疫苗可供选择，FDA决定叫停强生公司的新冠疫苗，只在没有其他选择的情况下投入使用。

"Today's action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We've been closely monitoring the Janssen COVID-19 vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

“今天的行动证明了我们安全监测系统的健全，以及我们致力于通过科学和数据来指导决策。我们一直在密切监测杨森新冠疫苗及其接种后发生TTS的情况，同时利用我们安全监测系统获取的最新信息来修订紧急使用授权（EUA）。”美国食品药品监督管理局生物制品评估和研究中心主任彼得·马克斯（Peter Marks）说。

"The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information."

“FDA将继续监测杨森新冠疫苗和其他所有疫苗的安全性。和新冠疫情暴发以来一样，将会对新的安全信息进行彻底评估。” 

More than 18.7 million doses of the J&J vaccine have been administered in the U.S. since it was first approved for emergency use, the Centers for Disease Control and Prevention reported. Of which, a total of 60 cases of TTS have been confirmed, including nine deaths.

美国疾病控制和预防中心的报告表示，自从强生疫苗首次获批用于应急使用以来，全美已注射超过1870万剂强生疫苗。其中，共确诊60例TTS病例，包括9例死亡病例。

In the release, the FDA said, "The factors that put an individual at risk for TTS following administration of Janssen COVID-19 Vaccine remain unknown."

FDA在新闻稿中说：“导致个体在注射杨森新冠疫苗后面临TTS风险的因素仍然未知。”

The Janssen vaccine rollout was first paused last spring after six cases of the rare blood clots were reported. The pause was lifted days later and a warning was issued to healthcare providers to be on the lookout for patients with blood clots in combination with low blood platelets.

去年春天，在报告了6例罕见的血栓病例后，杨森新冠疫苗首次暂停推广。几天后，暂停令被取消，卫生保健机构收到提醒，要求他们注意患有血栓同时伴随血小板低的患者。

译者：签约笔译班学员 Elle

审校：Jennifer

英文来源：NPR

*对应译文采用DeepL机翻+文章编辑撰写由译介翻译团队完成，仅供参考，不当之处欢迎大家在评论区讨论！转载请注明来源！

▲ 如需人工翻译服务，请联系微信号kevinssf ！

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