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强生新冠肺炎疫苗:需要知道的是

2021-03-01 11:03   美国新闻网   - 

疾病控制和预防中心推荐强生一次注射新冠肺炎(新型冠状病毒肺炎)周日,18岁及18岁以上人群使用的疫苗,这是第三种新冠肺炎疫苗向公众提供前最后一步监管措施。

在一次紧急会议上,疾病预防控制中心的免疫实践咨询委员会(ACIP)审查了疫苗试验数据,并投票推荐了该疫苗。投票后来由疾控中心主任罗谢尔·p·瓦伦斯基博士正式确定。

瓦伦斯基在一份新闻稿中说,新疫苗将为“公众、司法管辖区和疫苗提供商提供更多的选择和灵活性。”

疾控中心没有考虑是否建议某些人接种一针疫苗,而不是辉瑞和莫德纳现有的两针疫苗,而是强调了用任何可用的选择接种疫苗的重要性。

“接种第一种疫苗将有助于保护我们所有人免受新冠肺炎病毒的侵害,”瓦伦斯基说。

FILE PHOTO: Vials labelled

dado Ruvic/路透社

文件照片:在这张摄于2021年2月9日的照片中,标有“新冠肺炎冠状病毒疫苗”的小瓶和注射器出...

随着一种新的疫苗被添加到国家的武器库中,下面是你应该知道的关于强生新冠肺炎疫苗的情况。

强生疫苗是如何工作的

强生疫苗是一种病毒载体疫苗。它是由一种导致普通感冒的灭活腺病毒制成的,并含有一段指示身体制造新冠肺炎尖峰蛋白的DNA。

这反过来会引发免疫系统的反应,如果你将来暴露在真正的病毒面前,给你提供保护。

基因指令的使用使强生疫苗与辉瑞-生物泰克和莫德纳疫苗相似,但不完全相同,后者含有指导人体制造新冠肺炎尖峰蛋白的基因。

你不能从任何授权的疫苗中获得新冠肺炎或感冒,因为它们不含活病毒。

如何好强生疫苗起作用了

在临床试验中,接种疫苗后28天,强生疫苗在预防严重/危重疾病方面的有效性为85%,在预防症状疾病方面的有效性为66%。重要的是,它100%有效地防止了新冠肺炎的住院和死亡。

辉瑞-生物技术公司和现代疫苗在预防症状性疾病方面的有效性分别为95%和94.1%,但它们在新的、更具传染性的变体出现之前进行了测试。强生疫苗针对新的相关变异体进行了测试,仍然表现良好。

FILE PHOTO: A Johnson & Johnson worker prepares a syringe during the Phase 3 ENSEMBLE trial of its Janssen coronavirus disease (COVID-19) vaccine candidate in an undated photograph.

强生公司/通过路透社

档案照片:在一张未注明日期的照片中,一名强生公司员工在让桑冠状病毒病(新冠肺炎)候选疫...

事实上,专家警告不要比较疫苗的相对有效性,因为它们的测试方式不同。

诺思韦尔健康中心科恩儿童医疗中心儿科传染病主任、前ACIP成员劳里·鲁宾博士说:“(强生)疫苗不能与辉瑞或莫德纳疫苗相提并论,事实上,它们不能相互比较。”。“这些研究是在不同的时期进行的,我们有不同的新冠肺炎病毒变异体在传播,所以这并不是在拿苹果和苹果做比较。”

美国食品和药物管理局对任何新冠肺炎疫苗的授权和批准标准是在预防症状性疾病方面至少有50%的疗效,这意味着强生疫苗远远超过了这个阈值。

流感疫苗的平均水平是大约50%有效“根据鲁宾的说法,所有年龄段的人。

“所以,有些人可能会说这是一个失败,但你每年拯救成千上万的生命,”他说。

疫苗有多安全

强生临床试验中报告的最常见的副作用是任何疫苗通常都会出现的副作用,包括注射部位疼痛、发烧和疲劳,通常持续24至48小时。

鲁宾说:“从向美国食品和药物管理局申请紧急使用授权的数据来看,这种疫苗看起来是安全的。”。“我们必须将令人讨厌的疫苗接种后手臂酸痛、发烧和肌肉疼痛与严重不良事件的定义区分开来。”

试验期间没有严重的不良反应报告,但该公司正在调查后来报告的两例可能的过敏反应。

剂量和储存是如何工作的

强生疫苗是一剂,可以在正常冰箱温度下储存。莫德纳和辉瑞-生物技术公司的疫苗是两种剂量,需要更严格的温度调节。

瓦伦斯基称新疫苗是“我们工具箱中的另一个重要工具”。

根据准备好的评论,瓦伦斯基说:“作为一剂疫苗,人们不必为了保护第二剂疫苗而返回。”。“此外,这种疫苗不需要保存在冰箱中,可以在冷藏温度下储存,因此易于运输和储存,并随着供应的增加,在大多数社区环境和移动站点扩大了可用性。”

FILE PHOTO: A lab worker holds a vial of Johnson & Johnson's Janssen coronavirus disease (COVID-19) vaccine candidate in an undated photograph.

强生公司/通过路透社

档案照片:在一张未注明日期的照片中,一名实验室工作人员拿着一小瓶强生让桑冠状病毒病

为什么最好的疫苗是你能得到的任何一种

强生疫苗是安全和高效的,类似于其他已经授权的新冠肺炎疫苗。公众可能无法选择接种哪种疫苗,因为这取决于分发地点。专家强调,最重要的是,当新冠肺炎疫苗对人们可用时,他们会接种。

鲁宾说:“新冠肺炎是一种潜在的致命疾病,它有时甚至会导致以前健康的20岁和30岁的人死亡。”。

鲁宾说:“所有的疫苗都可以预防严重和致命的疾病,它们在很大程度上可以防止感染疾病。”“这是时间问题。先拿能拿的。”

Johnson & Johnson COVID-19 vaccine: Here's what to know

The Centers for Disease Control and Prevention recommended the Johnson & Johnson one-shotCOVID-19vaccine for use in people 18 years of age and older Sunday -- the last regulatory step needed before a third COVID-19 vaccine could be made available to the public.

In an emergency meeting, the CDC's Advisory Committee on Immunization Practices (ACIP) reviewed the vaccine trial data and voted to recommend the vaccine. The vote was later formalized by CDC Director Dr. Rochelle P. Walensky.

In a press release, Walensky said the new vaccine would offer "more options and flexibility for the public, jurisdictions and vaccine providers."

The CDC did not weigh in on whether it would recommend certain people get the one-shot vaccine over existing two-shot vaccines from Pfizer and Moderna, instead emphasizing the importance of getting vaccinated with any available option.

"Getting vaccinated with the first vaccine available to you will help protect all of us from COVID-19," Walensky said.

With a new vaccine added to the nation’s arsenal, here’s what you should know about the Johnson & Johnson COVID-19 vaccine.

How the Johnson & Johnson vaccine works

The Johnson & Johnson vaccine is a viral vector vaccine. It is made from an inactivated adenovirus, the virus that causes the common cold, and contains a piece of DNA that instructs the body to make the COVID-19 spike protein.

This in turn triggers an immune system response, giving you protection should you ever be exposed to the real virus in the future.

The use of genetic instructions makes the Johnson & Johnson vaccine similar -- but not exactly the same -- to the Pfizer-BioNTech and Moderna vaccines, which contain mRNA that instructs the body to make the COVID-19 spike protein.

You cannot get COVID-19 or a cold from any of the authorized vaccines, because they do not contain live virus.

Howwellthe Johnson & Johnson vaccine works

In clinical trials, the Johnson & Johnson vaccine was 85% effective in preventing severe/critical illness and 66% effective in preventing symptomatic illness 28 days after vaccination. Importantly, it was 100% effective in preventing hospitalization and death from COVID-19.

The Pfizer-BioNTech and Moderna vaccines are 95% and 94.1% effective in preventing symptomatic illness, respectively, but they were tested before the new, more contagious variants emerged. The Johnson & Johnson vaccine was tested against the new concerning variants and still performed well.

In fact, experts caution against comparing the relative effectiveness of vaccines because of differences in the way they were tested.

The “[Johnson & Johnson] vaccine was not compared to the Pfizer or Moderna vaccine, which in fact, were not compared to each other,” said Dr. Lorry Rubin, director of pediatric infectious diseases at Northwell Health's Cohen Children’s Medical Center and a former ACIP member. “These studies were done at a somewhat different time period, and we have different variants of the COVID-19 virus circulating, so it’s not really comparing apples to apples.”

The FDA’s standard for authorization and approval of any COVID-19 vaccine is at least 50% efficacy in preventing symptomatic disease, meaning the Johnson & Johnson vaccine far exceeds this threshold.

The flu vaccine, on average, is "about 50% effective" across all age groups, according to Rubin.

“So, some people might say that’s a failure, but you are saving tens of thousands of lives each year," he said.

How safe the vaccine is

The most common side effects reported in the Johnson & Johnson clinical trials were the side effects that typically occur with any vaccine, including pain at the injection site, fever and fatigue, which typically lasts 24 to 48 hours.

“From the data available in the application to the FDA for the emergency use authorization, the vaccine looks to be safe," Rubin said. "We have to differentiate the annoying post-vaccine sore arms, fever, and muscle aches from the definition of SAEs, severe adverse events."

No severe adverse reactions were reported during the trial, but the company is investigating two possible cases of anaphylaxis that were later reported.

How dosing and storage works

The Johnson & Johnson vaccine is one dose and can be stored at normal refrigerator temperatures. The Moderna and Pfizer-BioNTech vaccines are two doses and require more stringent temperature regulation.

Walensky called the new vaccine another "important tool in our toolbox."

"As a one-dose vaccine, people do not have to return for a second dose to be protected," Walensky said, according to prepared remarks. "In addition, this vaccine does not need to be kept in a freezer and can be stored at refrigerated temperatures -- so it is easy to transport and store and allows for expanded availability in most community settings and mobile sites, as supply scales up.”

Why the best vaccine to get is any one you can get

The Johnson & Johnson vaccine is safe and highly efficacious, similar to the other COVID-19 vaccines that have already been authorized. Members of the public might not have a choice of which vaccine they get, because it depends on the distribution site. The most important thing, experts stress, is that people get any of the COVID-19 vaccines when it becomes available to them.

“COVID-19 is a potentially fatal disease, and it sometimes even causes death in previously healthy 20- and 30-year-olds,” Rubin said.

“All the vaccines protect against serious and fatal disease, and they protect to a large extent from getting sick at all from the infection," Rubin said. "It’s a time thing. Get whichever one you can get first.”

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