Moderna的新新冠疫苗获FDA批准用于老年人和高风险人群-动脉网

Moderna's New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals

benzinga 等信源发布 2025-06-02 08:35

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The U.S. Food and Drug Administration (FDA) on Saturday approved

美国食品和药物管理局 (FDA) 于周六批准了

Moderna, Inc.’s

莫德纳公司

MRNA

信使核糖核酸

mNexspike (mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease

mNexspike（mRNA-1283）是一种针对COVID-19的新疫苗，适用于所有65岁及以上的成年人以及12至64岁且具有至少一种或多种由疾病控制中心定义的潜在风险因素的人群。

Control and Prevention (CDC)

控制与预防（CDC）

。

“The FDA approval of our third product, mNEXSPIKE…,” said

“我们的第三款产品mNEXSPIKE获得FDA批准，”表示

Stéphane Bancel

斯特凡纳·班塞尔

, Chief

，酋长

Executive Officer of Moderna

Moderna首席执行官

。

The FDA’s approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 trial, which enrolled approximately 11,400 participants aged 12 years and older.

FDA对mNEXSPIKE的批准是基于一项随机、观察者盲法、活性对照的3期试验结果，该试验招募了约11,400名12岁及以上的参与者。

Also Read:

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The primary efficacy objective was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNexspike compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna’s original COVID-19 vaccine.

主要疗效目标是证明与对照疫苗mRNA-1273（Spikevax，Moderna最初的COVID-19疫苗）相比，从接种mNexspike 14天后开始，其对COVID-19的疫苗疗效不劣于对照疫苗。

Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273.

参与者分别接受了10微克剂量的mRNA-1283或50微克剂量的mRNA-1273。

mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.

mRNA-1283 在 12 岁及以上人群中显示出比 mRNA-1273 高 9.3% 的相对疫苗效力 (rVE)，而在描述性亚组分析中，65 岁及以上成人的 rVE 高出 13.5%。

In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions.

在三期试验中，mRNA-1283 的安全性与 mRNA-1273 相似，局部反应更少，系统性反应相当。

The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.

最常见的副作用是注射部位疼痛、疲劳、头痛和肌肉痛。

Moderna expects to have mNexspike available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the company’s approved respiratory syncytial virus (RSV) vaccine.

Moderna 预计将在 2025-2026 年呼吸道病毒季节之前，为美国符合条件的人群提供 mNexspike，同时提供的还有 Spikevax 和该公司获批的呼吸道合胞病毒（RSV）疫苗 mRESVIA。

William Blair

威廉·布莱尔

writes, “Approval of mRNA-1283 is an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.’s negative public opinion on mRNA COVID-19 vaccines, and we continue to see autonomy and data-driven decisions at the FDA.”

写道：“mRNA-1283的获批对Moderna来说是一个渐进的胜利，尤其是考虑到美国卫生与公众服务部部长小罗伯特·F·肯尼迪对mRNA新冠疫苗的负面公众舆论，我们继续看到FDA的自主性和数据驱动决策。”

“We do not see approval of mRNA-1283 as a massive boost to Moderna’s COVID-19 vaccine sales, which we believe are primarily driven by sentiment surrounding the vaccination market in general, but this is a critical step in the regulatory path for the combo flu/COVID vaccine product, mRNA-1083, which uses mRNA-1283 as the COVID-19 component of its formulation,” analyst Myles Minter writes..

“我们认为，mRNA-1283的获批并不会大幅推动Moderna新冠疫苗的销售，其销售主要受整体疫苗市场情绪驱动，但这对于组合流感/新冠疫苗产品mRNA-1083的监管路径来说是关键一步，该疫苗配方中的新冠成分使用了mRNA-1283，”分析师迈尔斯·明特写道。

Analyst Minter says Moderna is still facing challenges from new government policies, including

分析师明特表示，Moderna 仍面临来自新政府政策的挑战，包括

losing about $700 million

损失了大约 7 亿美元

in funding from the Department of Health and Human Services for its bird flu vaccine project.

美国卫生与公众服务部为其禽流感疫苗项目提供资金。

In addition, William Blair writes that the company’s goal to break even by 2028 is overly optimistic since it would need to more than double its revenue—based on cash costs—to reach that target.

此外，威廉·布莱尔写道，公司到2028年实现收支平衡的目标过于乐观，因为根据现金成本计算，要达到这一目标，公司的收入需要增加一倍以上。

In May, the FDA approved

今年五月，FDA批准了

Novavax, Inc.’s

诺瓦瓦克斯医药公司

NVAX

诺瓦瓦克斯医药

Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g.

Nuvaxovid 用于主动免疫，以预防由严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）引起的 2019 冠状病毒病（COVID-19），适用于 65 岁及以上的成年人以及 12 至 64 岁之间至少患有一种基础疾病、存在高风险导致 COVID-19 重症后果的个体（例如

asthma, cancer, .

哮喘，癌症，。

diabetes, obesity, smoking)

糖尿病、肥胖、吸烟）

。

Achievement of the U.S. license approval has triggered a $175 million milestone payment from

美国许可证批准的达成已触发了一笔1.75亿美元的里程碑付款

Sanofi SA

赛诺菲公司

SNY

索尼