关于莫德纳新冠病毒疫苗(mRNA-1273)你需要知道的事

原文链接:The Moderna COVID-19 (mRNA-1273) vaccine: what you need to know

The WHO Strategic Advisory Group of Experts (SAGE) on Immunization has issued Interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19 in people aged 18 years and older.

Here is what you need to know.

世界卫生组织专家战略建议小组(简称 SAGE)在疫苗(大会?周?)上指出目前建议使用莫德纳代号 mRNA-1273 的新冠疫苗的人群是18岁及以上。

Who should be vaccinated first?

As with all COVID-19 vaccines, health workers at high risk of exposure and older people should be prioritized for vaccination.

As more vaccine becomes available, additional priority groups should be vaccinated, with attention to people disproportionately affected by COVID-19 or who face health inequities.

哪些人应该优先接种该疫苗?

对于所有疫苗而言,有高暴露风险的医护人员和老年人应该优先接种。

一旦疫苗数量充足,其他主要人群,包括不同程度受到新冠(COVID-19)影响或者面临健康不平等问题的人口应该得到接种。

Who else can take the vaccine?

The vaccine is safe and effective in people with known medical conditions associated with increased risk of severe disease, such as hypertension, diabetes, asthma, pulmonary, liver or kidney disease, as well as chronic infections that are stable and controlled.

Although further studies are required for immunocompromised persons, people in this category who are part of a group recommended for vaccination may be vaccinated after receiving information and counselling.

Persons living with HIV are at higher risk of severe COVID-19 disease. Known HIV-positive vaccine recipients should be provided with information and counselling.

Vaccination can be offered to people who have had COVID-19 in the past. But individuals may wish to defer their own COVID-19 vaccination for up to six months from the time of SARS-CoV-2 infection.

The vaccine can be offered to a breastfeeding woman who is part of a group recommended for vaccination (e.g. health workers); discontinuing breastfeeding after vaccination is currently not recommended.

其他哪些人可以接种该疫苗呢?

就目前已知的医疗状况下是安全有效的。对于有高严重疾病风险的人而言,例如高血压,糖尿病,哮喘,肺、肝、肾疾病以及有慢性感染的人都是稳定且可控的。

尽管对免疫功能低下的人需要进一步的研究,但在接受信息和咨询后,可以建议对这一类别的人群进行疫苗接种。

艾滋病人有较高的风险出现新冠(COVID-19)重症。已知的艾滋阳性疫苗接受者提供相关信息和咨询。

已经感染过新冠的人群也可以接种新冠(COVID-19)疫苗。但是应该至少推迟到感染新冠(SARS-CoV-2)六个月以后再接种。

哺乳期的妇女也属于推荐接种人群,可以提供疫苗接种;但是正在终止哺乳的妇女暂时不推荐接种。

Who should not take the vaccine?

While pregnancy puts women at a higher risk of severe COVID-19, the use of this vaccine in pregnant women is currently not recommended, unless they are at risk of high exposure (e.g. health workers).

Individuals with a history of severe allergic reaction to any component of the vaccine should not take this or any other mRNA vaccine.

While vaccination is recommended for older persons due to the high risk of severe COVID-19 and death, very frail older persons with an anticipated life expectancy of less than 3 months should be individually assessed.

The vaccine should not be administered to persons younger than 18 years of age pending the results of further studies.

哪些人不应该接种该疫苗?

由于妊娠使得妇女有较高风险出现新冠(COVID-19)重症,目前不建议妊娠期妇女接种,除非她们有高暴露风险(例如医护工作者)。

有过任何疫苗严重过敏反应史的人不应该使用该疫苗以及任何 mRNA 疫苗。

而老年人由于有新冠(COVID-19)重症甚至死亡的风险,推荐进行接种。预计剩余时间不足3个月的、非常虚弱的老年人应当单独评估。

该疫苗在没有更多报告结果前不应使用在年龄低于18周岁的人身上。

SAGE recommends the use of the Moderna mRNA-1273 vaccine at a schedule of two doses (100 µg, 0.5 ml each) 28 days apart. If necessary, the interval between the doses may be extended to 42 days.

Compliance with the full schedule is recommended and the same product should be used for both doses.

推荐计量是多少?

专家战略建议小组建议间隔28天使用两剂(每次100微克,0.5毫升)的莫德纳 mRNA-1273 疫苗作为一个疗程。如果有必要的话,两次注射的间隔可以延长到42天。

建议接受完整疗程的注射,并且两次注射使用相同的产品。

Is it safe?

While this vaccine has yet to be approved by WHO for an Emergency Use Listing, it has undergone review by the European Medical Agency (EMA) and consequently meets WHO’s criteria for SAGE consideration.

The EMA has thoroughly assessed the data on the quality, safety and efficacy of the Moderna COVID-19 vaccine and authorized its use across the European Union.

SAGE recommends that all vaccinees be observed for at least 15 minutes after vaccination. Those who experience an immediate severe allergic reaction to the first dose should not receive additional doses.

Longer-term safety assessment involves continued follow up of clinical trial participants, as well as specific studies and continued surveillance of secondary effects or adverse events of those being vaccinated in the roll out.

The Global Advisory Committee on Vaccine Safety, a group of experts that provides independent and authoritative guidance to the WHO on the topic of safe vaccine use, receives and assesses reports of suspected safety events of potentially international impact.

该疫苗安全吗?

虽然该疫苗还没有被世卫组织批准加入紧急情况使用清单,但是该疫苗已经接受了欧洲药品管理局(European Medical Agency, EMA)的审核,所以达到了世卫组织专家战略建议小组评估标准。

欧洲药品管理局仔细评估了莫德纳新冠(COVID-19)疫苗的质量、安全和疗效数据并授权它在欧盟国家内使用。

欧洲药品管理局建议所有接种疫苗的人在接种后接受15分钟的医学观察。第一针立即出现严重过敏反应的接种者不应该再接种后续一针疫苗。

更长时间的安全评估需要持续跟进临床实验参与者,包括特定研究以及持续关注其副作用或者发布之后的不良事件。

全球疫苗安全顾问委员会是由一群专家组成的专家组,就关于疫苗使用向世卫组织提供独立且权威的指导意见,并接收和评估有关潜在国际影响的可疑安全事件的报告。

How efficacious is the vaccine?

The Moderna vaccine has been shown to have an efficacy of approximately 92 per cent in protecting against COVID-19, starting 14 days after the first dose.

该疫苗效果如何?

实验显示该莫德纳疫苗在第一针接种后14天内对新冠病毒(COVID-19)的抵御有效率达到了大约百分之九十二。

Does it work against new variants?

Based on the evidence so far, the new variants of SARS-CoV-2, including the B.1.1.7 and the 501Y.V2, do not alter the effectiveness of the Moderna mRNA vaccine. The monitoring, collection and analysis of data on new variants and their impact on the effectiveness of COVID-19 diagnostics, treatments and vaccines continues.

该疫苗对新的病毒变种有效吗?

基于目前掌握的证据,莫德纳 mRNA 疫苗对新冠病毒(SARS-CoV-2)的新型变种包括 B.1.1.7 以及 501Y.V2 的效力没有变化。对于新的病毒变种和它们是否会对新冠病毒(COVID-19)的诊断、治疗和评估方式的有效性产生影响的监控、数据收集和分析仍在进行中。

Does it prevent infection and transmission?

We do not know whether the vaccine will prevent infection and protect against onward transmission. Immunity persists for several months, but the full duration is not yet known. These important questions are being studied.

In the meantime, we must maintain public health measures that work: masking, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds, and ensuring good ventilation.

该疫苗能避免感染和传播吗?

我们不知道该疫苗是否能避免感染以及阻断病毒继续传播。免疫会持续数月,但是完整的持续时间尚不明确。这个重要问题正在研究之中。

同时,我们必须维持有效的安全措施:戴口罩,保持距离,勤洗手,注意呼吸和咳嗽时的卫生,避免聚集,确保通风良好。

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