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信使RNA治疗剂开发商Moderna宣布RSV疫苗将会推迟上市

Moderna says FDA delayed RSV vaccine approval to end of May

CNBC | 2024-05-10 | 翻译由动脉网AI生成,点击反馈

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In this articleMRNAFollow your favorite stocksCREATE FREE ACCOUNTNikos Pekiaridis | Lightrocket | Getty ImagesModerna on Friday said the Food and Drug Administration has delayed the approval of its vaccine for respiratory syncytial virus to the end of May due to 'administrative constraints' at the agency.The FDA was expected to make a decision on the RSV shot on Sunday.

在这篇文章中,Mrnafollow your favorite stocksCREATE FREE ACCOUNTNikos Pekiaridis | Lightrocket | Getty ImagesModerna周五表示,由于该机构的“行政限制”,食品和药物管理局已将其呼吸道合胞病毒疫苗的批准推迟到5月底。预计FDA将于周日对RSV注射做出决定。

The agency has not informed Moderna of any issues related to the vaccine's safety, efficacy or quality that would prevent its approval, the biotech company said in a release.Investors are watching the upcoming approval closely as Moderna tries to rebound from the rapid decline of its Covid business last year.

该生物技术公司在一份新闻稿中表示,该机构尚未向Moderna通报任何与疫苗安全性、有效性或质量有关的问题,这些问题将妨碍其获得批准。投资者正在密切关注即将到来的批准,Moderna正试图从去年快速下滑的新型冠状病毒业务中反弹。

If cleared, the RSV shot would become the company's second product to launch in the U.S. after its once-blockbuster Covid vaccine. It would also be the third RSV vaccine to enter the market after shots from Pfizer and GSK rolled out last year.Moderna said its RSV vaccine is still on track to be reviewed by an advisory panel to the Centers for Disease Control and Prevention during a meeting on June 26 and 27.

如果获得批准,RSV疫苗将成为该公司继其一度轰动一时的新型冠状病毒疫苗之后在美国推出的第二款产品。这也是继辉瑞(Pfizer)和葛兰素史克(GSK)去年推出疫苗后第三种进入市场的RSV疫苗。摩德纳表示,其RSV疫苗仍在接受疾病控制和预防中心咨询小组6月26日和27日会议的审查。

That panel will vote on recommendations for the shot's use and intended population, which is necessary before it enters the market.Moderna has been testing the shot in older adults, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 seniors every year and results in 60,000 to 120,000 hospitalizations, according to CDC data.'Moderna is very grateful to the FDA for their continued efforts and diligence,' said Dr.

该小组将对该疫苗的使用和预期人群的建议进行投票,这在其进入市场之前是必要的。Moderna一直在老年人身上测试这种疫苗,老年人更容易感染严重的呼吸道合胞病毒。根据疾病预防控制中心的数据,这种病毒每年导致6000至10000名老年人死亡,并导致60000至120000人住院莫德纳博士说,她非常感谢FDA的持续努力和勤奋。

Stephen Hoge, president of Moderna, said in a release. 'We look forward to helping the agency complete the review of our application, and to the June [advisory] meeting.' The approval would demonstrate the versatility of Moderna's messenger RNA platfo.

摩德纳总裁斯蒂芬·霍格(StephenHoge)在一份新闻稿中说我们期待着帮助该机构完成对我们申请的审查,并期待6月份的[咨询]会议。”该批准将证明Moderna信使RNA平台的多功能性。

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