这两种疫苗都得到了食品和药物管理局的紧急使用授权,但是一些组织仍然对疫苗的安全性有疑问。

通过科琳Stinchcombe
2021年1月4日,
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美国正式拥有两种COVID-19疫苗批准紧急使用美国食品和药物管理局:辉瑞的疫苗被批准用于16岁以下的人群,而Moderna的疫苗被批准用于18岁以上的人群。目前,这两种疫苗主要用于美国疾病控制与预防中心的疫苗接种第一轮优先级组,其中包括卫生保健工作者以及在长期护理设施工作和居住的人。

这是科学界的一项里程碑式成就,为了抗击COVID-19大流行,在不到一年的时间里,有两种疫苗通过了疫苗开发和批准程序。但是,尽管许多人广泛赞扬了这些疫苗及其背后的科学家通过疫苗试验进行的严格测试,一些人仍然对疫苗在特定群体中的安全性存在疑问。以下是你需要知道的。

我们怎么知道疫苗是安全的?

首先,也是最重要的美国疾病控制与预防中心维护美国有一个疫苗安全系统,确保所有疫苗都尽可能安全。这就是为什么FDA能够授予辉瑞和Moderna的COVID-19疫苗紧急使用授权(EUAs),此前来自制造商和大型临床试验的数据表明,这些疫苗的潜在好处超过了感染COVID-19的已知和潜在危害。

当涉及到疫苗临床试验的安全性测试时,也就是决定疫苗在试验参与者中使用是否安全,以及疫苗是否有效时,研究人员会在整个试验过程中跟踪疫苗参与者的健康状况,Megan Ranney,医学博士,公共卫生硕士布朗大学(Brown University)布朗生命周期数字健康中心(Brown- lifespan Center for Digital Health)主任、急诊医生告诉我们健康.任何时候他们生病,住院,甚至死亡,专家们都会调查它是否与疫苗有任何可能的联系。辉瑞和Moderna的COVID-19疫苗等试验也有独立的监督委员会,这些委员会由与研究没有关联的人组成。“他们唯一的工作就是确保药物是安全的,”她说。

同样重要的是,“安全”并不意味着“零副作用”。兰尼博士解释说,当疫苗不会引起严重的不良反应时,它就被认为是安全的。兰尼博士说:“一种‘不安全’疫苗会造成永久性或严重的伤害,这种伤害会改变一个人的生命历程。”这些事情包括改变生育能力,引起神经问题,或引起新的感染。因此,关于冠状病毒疫苗可能伴随的轻微副作用——疲劳、头痛、手臂疼痛——这些都是避免COVID-19更严重症状和风险的小代价,因此不必担心医生,兰尼博士说。

此外,mRNA疫苗可能比传统疫苗更安全。他们不含常见过敏原这可能会让更多过去不得不放弃接种疫苗的人获得疫苗。(辉瑞疫苗然而,据ABC新闻.)

那么,这种疫苗是为谁批准的?哪些群体还需要更多信息?

根据辉瑞公司的具体数据,该疫苗在被认为对年龄、性别、种族和民族的16岁及以上人群均有效后,被批准用于紧急用途。同样,来自Moderna的数据显示,疫苗在18岁及以上的人群中也有效——大约37%的参与者来自种族或少数民族美国国立卫生研究院

但这些人口统计数据非常广泛,两种疫苗的临床试验排除了一些特定群体,包括孕妇或哺乳人群和儿童——尽管这并不一定是一种罕见的做法。“孕妇和儿童被认为是弱势群体。在你被允许用它们进行新药试验之前,你必须有相当好的证据证明某些东西有效,”兰尼博士说。

但是,现在证明这种疫苗安全性的证据更加有力,试验也正在开始,如果还没有开始的话。兰尼医生说:“还会有更多的儿童试验。”据报道,Moderna将开始在3000名12至17岁的儿童中测试疫苗纽约时报一半人注射疫苗,另一半人注射安慰剂。辉瑞公司已经开始着手这项工作:早在10月份,12岁的儿童就开始接受疫苗试验。该机构表示,预计将于2021年初开始对年幼儿童进行测试,但尚不清楚疫苗是否会在秋季学期之前广泛应用于儿童美联社

即使孕妇和哺乳期的人没有被专门招募来参加临床试验,这并不意味着他们完全不参与试验。“一般来说,疫苗不是故意在孕妇身上进行测试的,这些数据通常是随着时间的推移而积累起来的,因为孕妇偶然接种疫苗或他们选择接种疫苗。”奥托杨医学博士,医学教授传染性疾病加州大学洛杉矶分校大卫·格芬医学院的教授告诉我们健康.的美国妇产科医师学会(ACOG)很快就支持了这一观点,即一旦母乳喂养和怀孕的人可以获得疫苗,他们都应该有选择接种的权利。

兰尼博士说,另一个没有专门对疫苗进行测试的人群是免疫缺陷人群或使用免疫抑制剂的人群,但这是出于对有效测试疫苗的担忧,而不是对安全性的担忧。她解释说:“你担心它们无法产生良好的免疫反应,所以在它们身上测试疫苗的效果会比你预期的要小。”然而,一些免疫功能低下的人群也被纳入了研究范围——辉瑞公司在他们的试验中纳入了120名艾滋病毒感染者;据报道,Moderna包括176名艾滋病毒感染者POZ.据报道,这些组织没有安全隐患。最终,是否需要疫苗取决于那些免疫系统受损的人和他们的医生。

然而,有严重过敏反应史的人——尽管此前已被纳入临床试验——在接种疫苗时应谨慎使用。根据美国疾病控制与预防中心的说法,那些对COVID-19疫苗中的任何成分都有严重过敏反应的人都被敦促不要接种疫苗,他们是美国疾病控制与预防中心发布这一建议的唯一人群。任何类型的人有严重的过敏反应过去,与疫苗无关,仍然被要求获得疫苗,但有了适当的安全措施(现场监控由医疗专业谁有权访问紧急药物如肾上腺素或抗组胺药)。这些建议是在一个少量过敏反应疫苗推出后有报道吗在英国专家们正在试图确定是什么导致了这些变化。病人接受了治疗,一切正常。“现在没有理由仅仅因为你有过敏史就避免接种疫苗,”兰尼博士说,尽管向你的医生提出之前对疫苗的反应是值得的。

兰尼博士说,总的来说,目前没有理由相信任何一种COVID-19疫苗都是不安全的,会造成严重伤害,对绝大多数人来说,包括任何被排除在临床试验之外的群体。相反,研究人员和科学家还没有收集到足够的数据来以某种方式发表一个全面的声明。如果你对是否或何时应该接种COVID-19疫苗有任何疑问,最好咨询你的医生,并提出任何可能的担忧。

截至发稿时,这篇报道中的信息是准确的。然而,随着围绕COVID-19的形势继续发展,一些数据可能自发布以来发生了变化。在《健康》杂志努力使我们的故事尽可能最新的同时,我们也鼓励读者通过使用疾病预防控制中心以及当地的公共卫生部门作为资源。

要想让我们的头条新闻进入你的收件箱,请注册健康生活通讯

The virus that causes COVID-19 is called SARS-CoV-2, short for severe acute respiratory syndrome coronavirus 2. It is a type of coronavirus similar to the one that causes SARS, or severe acute respiratory syndrome.

" }, { "answer_choices": [ { "answer_title": "Fever or chills", "correct_answer": false, "answer_id": "A1", "answer_value": 0, "$vf_selected_count": { "value": 1786, "lastModified": "2021-08-24T07:45:28.000Z" } }, { "answer_title": "Fever dreams", "correct_answer": true, "answer_id": "A2", "answer_value": 1, "$vf_selected_count": { "value": 91063, "lastModified": "2021-08-24T13:22:21.000Z" } }, { "answer_title": "Diarrhea or loose stools", "correct_answer": false, "answer_id": "A3", "answer_value": 0, "$vf_selected_count": { "value": 16928, "lastModified": "2021-08-24T11:42:17.000Z" } }, { "answer_title": "Breathing difficulties or shortness of breath", "correct_answer": false, "answer_id": "A4", "answer_value": 0, "$vf_selected_count": { "value": 2381, "lastModified": "2021-08-24T02:06:47.000Z" } } ], "answer_type": "text", "question_title": "This is not a possible symptom of COVID-19:", "question_id": "Q2", "answer_description": "

You might have wild dreams when you're ill—fever can do that. But bizarre or emotionally intense fever dreams are not recognized as a symptom of COVID-19.

" }, { "answer_choices": [ { "answer_title": "Wear a mask", "correct_answer": false, "answer_id": "A1", "answer_value": 0, "$vf_selected_count": { "value": 7042, "lastModified": "2021-08-24T03:42:05.000Z" } }, { "answer_title": "Wash your hands", "correct_answer": false, "answer_id": "A2", "answer_value": 0, "$vf_selected_count": { "value": 42290, "lastModified": "2021-08-24T00:22:13.000Z" } }, { "answer_title": "Maintain social distance from others", "correct_answer": false, "answer_id": "A3", "answer_value": 0, "$vf_selected_count": { "value": 6367, "lastModified": "2021-08-24T12:54:54.000Z" } }, { "answer_title": "Wipe down groceries packaged in cardboard or plastic wrap with bleach", "correct_answer": true, "answer_id": "A4", "answer_value": 1, "$vf_selected_count": { "value": 56460, "lastModified": "2021-08-24T13:22:21.000Z" } } ], "answer_type": "text", "question_title": "To slow the spread of COVID-19, don't do this:", "question_id": "Q3", "answer_description": "

CDC specifically warns against using disinfecting products on food or food packaging. You don't want to accidentally taint your food. Plus, the risk of COVID-19 from handling or consuming food is thought to be low. Use disinfectants like bleach to wipe down tables, countertops, and faucets

" }, { "answer_choices": [ { "answer_title": "A multi-layer medical procedure mask (aka a surgical mask or disposable face mask)", "correct_answer": false, "answer_id": "A1", "answer_value": 0, "$vf_selected_count": { "value": 9016, "lastModified": "2021-08-24T12:25:55.000Z" } }, { "answer_title": "A mask with a vent or valve", "correct_answer": true, "answer_id": "A2", "answer_value": 1, "$vf_selected_count": { "value": 80159, "lastModified": "2021-08-24T13:22:21.000Z" } }, { "answer_title": "A cloth mask made of two or more breathable, washable layers", "correct_answer": false, "answer_id": "A3", "answer_value": 0, "$vf_selected_count": { "value": 17671, "lastModified": "2021-08-24T12:54:54.000Z" } }, { "answer_title": "A cloth mask over a surgical mask", "correct_answer": false, "answer_id": "A4", "answer_value": 0, "$vf_selected_count": { "value": 5312, "lastModified": "2021-08-24T12:57:02.000Z" } } ], "answer_type": "text", "question_title": "Which masking option is least effective for stopping the spread of COVID-19?", "question_id": "Q4", "answer_description": "

If your mask has a vent or valve, respiratory particles may escape and reach other people. Opt instead for a well-fitting mask with multiple layers, or wear a cloth mask over a disposable mask to secure the underlying mask to your face.

" }, { "answer_choices": [ { "answer_title": "Anal swab testing", "correct_answer": true, "answer_id": "A1", "answer_value": 1, "$vf_selected_count": { "value": 95492, "lastModified": "2021-08-24T13:22:21.000Z" } }, { "answer_title": "Nasal swab testing", "correct_answer": false, "answer_id": "A2", "answer_value": 0, "$vf_selected_count": { "value": 11435, "lastModified": "2021-08-24T10:17:37.000Z" } }, { "answer_title": "Saliva testing", "correct_answer": false, "answer_id": "A3", "answer_value": 0, "$vf_selected_count": { "value": 3094, "lastModified": "2021-08-24T12:54:54.000Z" } }, { "answer_title": "Throat swab testing", "correct_answer": false, "answer_id": "A4", "answer_value": 0, "$vf_selected_count": { "value": 2137, "lastModified": "2021-08-24T11:00:26.000Z" } } ], "answer_type": "text", "question_title": "Which COVID-19 screening method is not routinely in use in the US?", "question_id": "Q5", "answer_description": "

Most diagnostic tests rely on mucus collected from your nose or throat, and some use saliva that you spit into a test tube. While China is using anal swab testing, that method hasn't caught on in the US.

" }, { "answer_choices": [ { "answer_title": "2 to 12 hours", "correct_answer": false, "answer_id": "A1", "answer_value": 0, "$vf_selected_count": { "value": 5087, "lastModified": "2021-08-24T12:29:16.000Z" } }, { "answer_title": "3 days", "correct_answer": false, "answer_id": "A2", "answer_value": 0, "$vf_selected_count": { "value": 24224, "lastModified": "2021-08-24T13:22:21.000Z" } }, { "answer_title": "14 days", "correct_answer": true, "answer_id": "A3", "answer_value": 1, "$vf_selected_count": { "value": 82041, "lastModified": "2021-08-24T13:12:40.000Z" } }, { "answer_title": "30 days", "correct_answer": false, "answer_id": "A4", "answer_value": 0, "$vf_selected_count": { "value": 807, "lastModified": "2021-08-23T19:53:13.000Z" } } ], "answer_type": "text", "question_title": "How long is the incubation period—the amount time from when you are infected with the novel coronavirus to when you exhibit symptoms?", "question_id": "Q6", "answer_description": "

The incubation is thought to be 14 days, with a median of 4 to 5 days. (But keep in mind that some people never develop symptoms).

" }, { "answer_choices": [ { "answer_title": "A variant", "correct_answer": true, "answer_id": "A1", "answer_value": 1, "$vf_selected_count": { "value": 73854, "lastModified": "2021-08-24T13:22:21.000Z" } }, { "answer_title": "A high viral load", "correct_answer": false, "answer_id": "A2", "answer_value": 0, "$vf_selected_count": { "value": 9463, "lastModified": "2021-08-24T10:59:39.000Z" } }, { "answer_title": "A vaccine", "correct_answer": false, "answer_id": "A3", "answer_value": 0, "$vf_selected_count": { "value": 11353, "lastModified": "2021-08-24T02:06:47.000Z" } }, { "answer_title": "Another virus, like influenza", "correct_answer": false, "answer_id": "A4", "answer_value": 0, "$vf_selected_count": { "value": 17489, "lastModified": "2021-08-23T04:48:13.000Z" } } ], "answer_type": "text", "question_title": "A mutated version of the virus that causes COVID-19 is called:", "question_id": "Q7", "answer_description": "

Variants of the virus that causes COVID-19 have been identified in the US and around the world. Scientists are studying these variants to learn how they spread and whether current vaccines will protect against them.

" }, { "answer_choices": [ { "answer_title": "Researchers have coined the term \"coronaphobia\" to describe the fear of contracting COVID-19", "correct_answer": false, "answer_id": "A1", "answer_value": 0, "$vf_selected_count": { "value": 8995, "lastModified": "2021-08-24T13:22:21.000Z" } }, { "answer_title": "The virus that causes COVID-19 can sometimes spread through tiny airborne particles", "correct_answer": false, "answer_id": "A2", "answer_value": 0, "$vf_selected_count": { "value": 14468, "lastModified": "2021-08-24T12:43:28.000Z" } }, { "answer_title": "The term \"long-haulers\" refers to people who experience long-term coronavirus symptoms", "correct_answer": false, "answer_id": "A3", "answer_value": 0, "$vf_selected_count": { "value": 5903, "lastModified": "2021-08-24T03:42:05.000Z" } }, { "answer_title": "COVID-19 is just like having the seasonal flu", "correct_answer": true, "answer_id": "A4", "answer_value": 1, "$vf_selected_count": { "value": 82794, "lastModified": "2021-08-24T13:14:03.000Z" } } ], "answer_type": "text", "question_title": "Which of the following statements is false?", "question_id": "Q8", "answer_description": "

Early on, some people speculated that the novel coronavirus would behave like the seasonal flu. Now we know COVID-19 is much more contagious and spreads more rapidly than influenza.

" }, { "answer_choices": [ { "answer_title": "Women who want to become pregnant some day", "correct_answer": false, "answer_id": "A1", "answer_value": 0, "$vf_selected_count": { "value": 10963, "lastModified": "2021-08-24T01:47:11.000Z" } }, { "answer_title": "Anyone who has had a severe allergic reaction (anaphylaxis) to any vaccine ingredient", "correct_answer": true, "answer_id": "A2", "answer_value": 1, "$vf_selected_count": { "value": 59986, "lastModified": "2021-08-24T13:22:21.000Z" } }, { "answer_title": "People who have recovered from COVID-19", "correct_answer": false, "answer_id": "A3", "answer_value": 0, "$vf_selected_count": { "value": 9749, "lastModified": "2021-08-24T00:01:19.000Z" } }, { "answer_title": "People with underlying medical conditions", "correct_answer": false, "answer_id": "A4", "answer_value": 0, "$vf_selected_count": { "value": 31461, "lastModified": "2021-08-24T10:08:25.000Z" } } ], "answer_type": "text", "question_title": "Who should not get a COVID-19 vaccine?", "question_id": "Q9", "answer_description": "

CDC does not recommend COVID vaccination if you've had a severe allergic reaction to any COVID vaccine ingredient. Contact your doctor if you have questions about whether it's safe for you to be vaccinated.

" }, { "answer_choices": [ { "answer_title": "You can't get COVID-19 from a COVID-19 shot", "correct_answer": false, "answer_id": "A1", "answer_value": 0, "$vf_selected_count": { "value": 17436, "lastModified": "2021-08-24T12:43:28.000Z" } }, { "answer_title": "Side effects are generally mild and short-lived", "correct_answer": false, "answer_id": "A2", "answer_value": 0, "$vf_selected_count": { "value": 6917, "lastModified": "2021-08-24T09:26:56.000Z" } }, { "answer_title": "It can take a few weeks after getting vaccinated for your body to build immunity to the virus", "correct_answer": false, "answer_id": "A3", "answer_value": 0, "$vf_selected_count": { "value": 4179, "lastModified": "2021-08-24T02:09:23.000Z" } }, { "answer_title": "None of the above", "correct_answer": true, "answer_id": "A4", "answer_value": 1, "$vf_selected_count": { "value": 83627, "lastModified": "2021-08-24T13:22:21.000Z" } } ], "answer_type": "text", "question_title": "Which of the following statements about COVID-19 are false?", "question_id": "Q10", "answer_description": "

Vaccination is safe, effective, and an important tool for beating the pandemic.

" } ], "description": "

News about the novel coronavirus is breaking nearly 24-7, which makes it challenging at best to keep up with the latest scientific evidence, especially when you're bombarded by false or misleading claims on social media. So how much do you really know about COVID-19? Take our quiz to gauge how knowledgeable you are.

", "gate": "none", "intro_page": true, "uuid": "c5d20a0c-6b54-4691-ac5b-7362b5c9e58c", "brand": "health", "headline": "Quiz: How Much Do You Know About Coronavirus?", "results": [ { "result_starting_range": 0, "button": { "_type": "button", "title": "Start Learning More", "src": "https://x.specialoffers.meredith.com/ats/show.aspx?cr=588&fm=201®source=20571" }, "result_ending_range": 3, "result_description": "

Time to bone up on the basic facts about COVID-19. Check out our COVID-19 condition center and subscribe to our daily Healthy Living newsletter and never miss an update.

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More on COVID-19:

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Is the Coronavirus Worse Than the Flu? Here's How the Two Illnesses Compare

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Living Through a Pandemic: A Guide to Surviving the New Normal

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Coronavirus 101: Symptoms, Transmission, Severity and More

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While Health is trying to keep our content as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDCWHO, and their local public health department as resources.

", "result_title": "Not Much." }, { "result_starting_range": 4, "button": { "_type": "button", "title": "Learn Some More", "src": "https://x.specialoffers.meredith.com/ats/show.aspx?cr=588&fm=201®source=20571" }, "result_ending_range": 6, "result_description": "

Not bad, but there’s much more to know about this illness. Subscribe to our daily Healthy Living newsletter and never miss an update.

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More on COVID-19:

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Is the Coronavirus Worse Than the Flu? Here’s How the Two Illnesses Compare

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Living Through a Pandemic: A Guide to Surviving the New Normal

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Coronavirus 101: Symptoms, Transmission, Severity and More

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While Health is trying to keep our content as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDCWHO, and their local public health department as resources.

", "result_title": "You Know Some Things About Some Things." }, { "result_starting_range": 7, "button": { "_type": "button", "title": "Stay Updated with Newsletters", "src": "https://x.specialoffers.meredith.com/ats/show.aspx?cr=588&fm=201®source=20571" }, "result_ending_range": 8, "result_description": "

Terrific. Keep reading about COIVD-19 on Health.com and stay safe!

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More on COVID-19:

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Is the Coronavirus Worse Than the Flu? Here’s How the Two Illnesses Compare

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Living Through a Pandemic: A Guide to Surviving the New Normal

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Coronavirus 101: Symptoms, Transmission, Severity and More

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While Health is trying to keep our content as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDCWHO, and their local public health department as resources.

", "result_title": "You Are Certified to Debate on Social Media." }, { "result_starting_range": 9, "button": { "_type": "button", "title": "Sign Up for Newsletters", "src": "https://x.specialoffers.meredith.com/ats/show.aspx?cr=588&fm=201®source=20571" }, "result_ending_range": 10, "result_description": "

You are definitely in the know! Keep coming back to Health.com for the latest information.

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More on COVID-19:

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Is the Coronavirus Worse Than the Flu? Here’s How the Two Illnesses Compare

\n

Living Through a Pandemic: A Guide to Surviving the New Normal

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Coronavirus 101: Symptoms, Transmission, Severity and More

\n

While Health is trying to keep our content as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDCWHO, and their local public health department as resources.

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