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副作用、剂量、价格,关于辉瑞疫苗你想知道的一切

DAVID Z. MORRIS
2020-12-11

像新冠这样的高传染性疾病仍需要非常高的免疫力来打破人群中的“传播链”。

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今天,辉瑞和BioNTech共同开发的新冠疫苗在美国进入了审批环节的关键阶段。周四晚,由病毒学家和其他医学专家组成的疫苗和相关生物制品咨询委员会(VRBPAC)建议,美国食药监管局(FDA)应对该疫苗颁发紧急使用授权,以便尽快将疫苗分发给美国患者接种。 预计FDA也将遵循该建议,那样的话,疫苗可能会在几天内就开始流通。

以下是我们对辉瑞疫苗的了解,包括它的效力,能覆盖多大的范围,谁将首先获得接种机会,可能花费多少,以及是否会结束这场疫情。

疫苗的效果如何?

与大多数疫苗相比,辉瑞疫苗非常有效。FDA证实了辉瑞公司的发现,即该疫苗在预防人们感染新冠病毒方面的有效性高达95%。这样的保护作用比美国人每个秋天都要排队接种的流感疫苗要好得多——流感疫苗最多只能产生60%的有效性。

FDA最近也证实,这种效力也包括能预防危重病例,而不仅仅是轻度或中度感染。

而同样值得一提的是,尽管该疫苗在不同年龄,性别和种族的人群中均显示出相似的效果,但在辉瑞公司的试验对象中,白种人的占比严重失调(达80%),因此数据可能不完整。

同时,辉瑞的第一轮试验没有包括16岁以下的接种者,因而目前尚不清楚,该疫苗何时能获准在儿童中接种。

疫苗会产生哪些副作用?

广泛来看,根据英国成千上万的受试者和更多已接种人群的反应,这种疫苗的副作用极小。出现的副作用可能包括持续一天左右的疲劳、痛感或类似流感的症状。据报道,有四例接种者出现贝尔麻痹症状——一种通常是暂时性、且无生命危险的面部肌肉麻痹,但FDA表示,这种发病率与在普通人群中的概率是一致的。

疫苗会引起过敏反应吗?

然而,两名有严重过敏史的英国卫生工作者在接种疫苗后,确实出现了严重反应。英国卫生部建议对有过相似病史的患者谨慎对待,同时要调查出现这种风险的严重性。

获批后,将能提供多少剂量的疫苗?

首批疫苗的剂量很少。目前,据辉瑞公司和美国相关部门官员预测,到2020年底,将有4000万剂辉瑞疫苗在美国流通。这足以使完成接种流程所需的两剂疫苗覆盖2000万人口、占美国人口的6%。到2021年,将再提供另外8000万剂,足以满足4000万美国人的需求。但由于特朗普政府拒绝签订额外供应的协议,因此预计到2021年7月才能有更多剂量提供。

但是,这并不像听起来那样令人担忧,因为疫苗大军中的其他成员——尤其是Moderna的疫苗后备军——也已经步入批准流程,且紧随辉瑞之后。

谁有资格率先接种疫苗?

由于最初供应的剂量很少,美国疾控中心(CDC)建议,应让医务人员和那些需要长期护理的居民优先接种。但具体分配由每个州自行处理。CDC也已在编排各州的疫苗接种计划。

接种疫苗要花费多少钱?

美国政府已按每剂39美元的费用,向辉瑞和BioNTech支付了前1亿剂疫苗所需的金额,因而据预计,美国人自己只需支付很少的费用就能接种疫苗。美国政府还将强制要求,各类医保和私人保险要向患者提供接种疫苗所需的费用。甚至,没有保险的患者也能以低廉的费用或免费接种疫苗:已有一项为注射疫苗提供补贴的特殊基金会设立了。

何为“紧急使用授权”?

顾问委员会提出今天的建议之后,FDA预计将为辉瑞疫苗发布紧急使用授权。重要的是,这是疫苗获得全面批准之前就可以投入使用的放行信号,而不是正式批准。辉瑞将继续进行更多的试验,走完流程,以获得全面批准。

FDA评估哪些信息?

FDA已经确认了其对辉瑞和BioNTech的试验结果的信心,今天顾问委员会对紧急批准的投票结果也未持严重怀疑态度——该委员会审查了(或将确定)关于疫苗基本安全性和有效性的调查结果。

委员会今天还讨论了紧急授权将产生的次要影响,包括紧急授权获批后随机试验如何继续进行等问题。但这些似乎不太可能成为紧急授权发布的阻碍。

疫苗中含有什么成分?

与目前大多数疫苗不同的是,辉瑞公司的疫苗不包含来自病毒的物质。相反,它含有人工合成的信使RNA——这是一种模仿新冠病毒生物学原理的“基因小抄”,训练你身体的免疫反应以对抗病毒。信使RNA被包裹在由脂质或脂肪组成的外壳中,以便传递。

为什么注射辉瑞疫苗需要打两剂?

注射辉瑞疫苗需要打两剂,其中间隔三周:这主要是为了提高疫苗的效力。FDA公布的数据显示,只注射一剂疫苗在一定程度上是有效的,但要建立完全的免疫力,则需要两剂疫苗。

疫苗在多长时间内有效?

由于疫苗试验进行还没多久,所以这一点还不清楚。世界卫生组织期望,疫苗至少在六个月内有效。专家们对《新科学家》杂志表示,有必要每一年都进行一次强化疫苗注射。

接种疫苗后还能传播新冠病毒吗?

辉瑞疫苗的试验衡量了其安全性和在预防个体症状方面的有效性。然而,试验并没有确定接受疫苗接种的人是否仍然可以携带新冠病毒且不表现出症状。多伦多大学的免疫学教授马里奥•奥斯特洛夫斯基向加拿大CTV新闻表示,只有在大多数人接种疫苗后,感染率仍然居高不下的情况出现时,我们才能搞清楚这一点。这也就意味着,即使在数千万美国人接种疫苗后,戴口罩和保持社交距离仍将是常态。

疫苗能终结疫情吗?

最终,而不是立即。即使辉瑞疫苗中止了新冠的发病和传播,像新冠这样的高传染性疾病仍需要非常高的免疫力来打破人群中的“传播链”。对于同样具有高度传染性的麻疹,这个阈值为94%。在美国,通过接种疫苗和感染人群相结合,明年的大部分时间可能都得继续投入到抗疫的努力中,才能最终实现免疫。而在这之前,疫情不会真正结束。(财富中文网)

编译:陈聪聪,杨二一

今天,辉瑞和BioNTech共同开发的新冠疫苗在美国进入了审批环节的关键阶段。周四晚,由病毒学家和其他医学专家组成的疫苗和相关生物制品咨询委员会(VRBPAC)建议,美国食药监管局(FDA)应对该疫苗颁发紧急使用授权,以便尽快将疫苗分发给美国患者接种。 预计FDA也将遵循该建议,那样的话,疫苗可能会在几天内就开始流通。

以下是我们对辉瑞疫苗的了解,包括它的效力,能覆盖多大的范围,谁将首先获得接种机会,可能花费多少,以及是否会结束这场疫情。

疫苗的效果如何?

与大多数疫苗相比,辉瑞疫苗非常有效。FDA证实了辉瑞公司的发现,即该疫苗在预防人们感染新冠病毒方面的有效性高达95%。这样的保护作用比美国人每个秋天都要排队接种的流感疫苗要好得多——流感疫苗最多只能产生60%的有效性。

FDA最近也证实,这种效力也包括能预防危重病例,而不仅仅是轻度或中度感染。

而同样值得一提的是,尽管该疫苗在不同年龄,性别和种族的人群中均显示出相似的效果,但在辉瑞公司的试验对象中,白种人的占比严重失调(达80%),因此数据可能不完整。

同时,辉瑞的第一轮试验没有包括16岁以下的接种者,因而目前尚不清楚,该疫苗何时能获准在儿童中接种。

疫苗会产生哪些副作用?

广泛来看,根据英国成千上万的受试者和更多已接种人群的反应,这种疫苗的副作用极小。出现的副作用可能包括持续一天左右的疲劳、痛感或类似流感的症状。据报道,有四例接种者出现贝尔麻痹症状——一种通常是暂时性、且无生命危险的面部肌肉麻痹,但FDA表示,这种发病率与在普通人群中的概率是一致的。

疫苗会引起过敏反应吗?

然而,两名有严重过敏史的英国卫生工作者在接种疫苗后,确实出现了严重反应。英国卫生部建议对有过相似病史的患者谨慎对待,同时要调查出现这种风险的严重性。

获批后,将能提供多少剂量的疫苗?

首批疫苗的剂量很少。目前,据辉瑞公司和美国相关部门官员预测,到2020年底,将有4000万剂辉瑞疫苗在美国流通。这足以使完成接种流程所需的两剂疫苗覆盖2000万人口、占美国人口的6%。到2021年,将再提供另外8000万剂,足以满足4000万美国人的需求。但由于特朗普政府拒绝签订额外供应的协议,因此预计到2021年7月才能有更多剂量提供。

但是,这并不像听起来那样令人担忧,因为疫苗大军中的其他成员——尤其是Moderna的疫苗后备军——也已经步入批准流程,且紧随辉瑞之后。

谁有资格率先接种疫苗?

由于最初供应的剂量很少,美国疾控中心(CDC)建议,应让医务人员和那些需要长期护理的居民优先接种。但具体分配由每个州自行处理。CDC也已在编排各州的疫苗接种计划。

接种疫苗要花费多少钱?

美国政府已按每剂39美元的费用,向辉瑞和BioNTech支付了前1亿剂疫苗所需的金额,因而据预计,美国人自己只需支付很少的费用就能接种疫苗。美国政府还将强制要求,各类医保和私人保险要向患者提供接种疫苗所需的费用。甚至,没有保险的患者也能以低廉的费用或免费接种疫苗:已有一项为注射疫苗提供补贴的特殊基金会设立了。

何为“紧急使用授权”?

顾问委员会提出今天的建议之后,FDA预计将为辉瑞疫苗发布紧急使用授权。重要的是,这是疫苗获得全面批准之前就可以投入使用的放行信号,而不是正式批准。辉瑞将继续进行更多的试验,走完流程,以获得全面批准。

FDA评估哪些信息?

FDA已经确认了其对辉瑞和BioNTech的试验结果的信心,今天顾问委员会对紧急批准的投票结果也未持严重怀疑态度——该委员会审查了(或将确定)关于疫苗基本安全性和有效性的调查结果。

委员会今天还讨论了紧急授权将产生的次要影响,包括紧急授权获批后随机试验如何继续进行等问题。但这些似乎不太可能成为紧急授权发布的阻碍。

疫苗中含有什么成分?

与目前大多数疫苗不同的是,辉瑞公司的疫苗不包含来自病毒的物质。相反,它含有人工合成的信使RNA——这是一种模仿新冠病毒生物学原理的“基因小抄”,训练你身体的免疫反应以对抗病毒。信使RNA被包裹在由脂质或脂肪组成的外壳中,以便传递。

为什么注射辉瑞疫苗需要打两剂?

注射辉瑞疫苗需要打两剂,其中间隔三周:这主要是为了提高疫苗的效力。FDA公布的数据显示,只注射一剂疫苗在一定程度上是有效的,但要建立完全的免疫力,则需要两剂疫苗。

疫苗在多长时间内有效?

由于疫苗试验进行还没多久,所以这一点还不清楚。世界卫生组织期望,疫苗至少在六个月内有效。专家们对《新科学家》杂志表示,有必要每一年都进行一次强化疫苗注射。

接种疫苗后还能传播新冠病毒吗?

辉瑞疫苗的试验衡量了其安全性和在预防个体症状方面的有效性。然而,试验并没有确定接受疫苗接种的人是否仍然可以携带新冠病毒且不表现出症状。多伦多大学的免疫学教授马里奥•奥斯特洛夫斯基向加拿大CTV新闻表示,只有在大多数人接种疫苗后,感染率仍然居高不下的情况出现时,我们才能搞清楚这一点。这也就意味着,即使在数千万美国人接种疫苗后,戴口罩和保持社交距离仍将是常态。

疫苗能终结疫情吗?

最终,而不是立即。即使辉瑞疫苗中止了新冠的发病和传播,像新冠这样的高传染性疾病仍需要非常高的免疫力来打破人群中的“传播链”。对于同样具有高度传染性的麻疹,这个阈值为94%。在美国,通过接种疫苗和感染人群相结合,明年的大部分时间可能都得继续投入到抗疫的努力中,才能最终实现免疫。而在这之前,疫情不会真正结束。(财富中文网)

编译:陈聪聪,杨二一

Today marked a crucial stage in the U.S. approval process of the coronavirus vaccine developed by Pfizer and BioNTech. On Thursday evening, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of virologists and other medical experts, recommended that the Food and Drug Administration issue an Emergency Use Authorization to allow the vaccine to be administered to patients in the United States. The FDA is expected to follow that recommendation, at which point the vaccine could begin rolling out within a matter of days.

Here is what we know about the Pfizer vaccine, including how effective it is, how widely available it will be, who will have access to it first, how much it may cost—and whether it will end the pandemic.

How effective is the vaccine?

Compared with most vaccines, the Pfizer coronavirus vaccine is extremely effective. The FDA has affirmed Pfizer’s finding that its vaccine is 95% effective in protecting recipients from becoming infected with COVID-19. That’s much better than the flu vaccines Americans line up to get in a typical fall, which are at most 60% effective.

It was also recently confirmed by the FDA that this effectiveness includes preventing severe cases, not just mild or moderate infections.

Just as important, the vaccine shows similar effectiveness across age, gender, and racial groups, although Pfizer’s trial subjects were disproportionately (80%) white, so that data may be incomplete.

The first round of trials did not include recipients under 16 years of age, and the timeline of vaccine approval for children is currently unclear.

What are the side effects of the vaccine?

Broadly, the vaccine has minimal side effects, based on tens of thousands of trial recipients and thousands more already receiving the vaccine in the U.K. Side effects can include fatigue, aches, or flu-like symptoms lasting about a day. There were four reported cases of recipients suffering Bell’s palsy, an often temporary and non–life threatening paralysis of facial muscles, but the FDA has said those occurrences were consistent with the rate in the general population.

Could the vaccine trigger an allergic reaction?

However, two British health workers with a history of severe allergies did have serious reactions after receiving the vaccine. British health authorities are advising caution for patients with similar histories while they investigate how serious the risks might be.

How many doses of the vaccine will be available after it is approved?

Initially, very few. Pfizer and U.S. officials currently project that 40 million doses of the vaccine will reach the United States by the end of 2020. That’s enough to give the two-dose vaccine to 20 million people, or 6% of the U.S. population. Another 80 million doses, enough for 40 million Americans, will be available in 2021. But because the Trump administration declined to lock in additional supply, no doses beyond that are expected to be available until July 2021.

However, this may not be as scary as it sounds, because other vaccine candidates—particularly Moderna’s—are close behind Pfizer’s in the approval pipeline.

Who will be eligible to receive the vaccine first?

With so few doses initially available, the Centers for Disease Control recommends prioritizing medical staff and the residents of long-term-care facilities. But distribution is being handled separately by each state. The CDC has compiled each state’s vaccine game plan here.

How much will the vaccine cost?

The U.S. government has paid Pfizer and BioNTech $39 per dose for the first 100 million doses, and Americans are expected to pay very little out of pocket to be vaccinated. Medicaid, Medicare, and most forms of private insurance will be required by government mandate to cover vaccine costs for patients. Even uninsured patients should be able to get vaccinated at low or no cost: A special fund has been set up to reimburse providers for those shots.

What’s an Emergency Use Authorization?

After the advisory committee makes its recommendation today, the FDA is expected to issue an Emergency Use Authorization, or EUA, for the Pfizer vaccine. Crucially, this is not a form of FDA approval, but a go-ahead to use the vaccine before it obtains full approval. Pfizer will have to continue the process for full approval, including conducting more trials.

What is the FDA evaluating?

The FDA has already affirmed its faith in Pfizer and BioNTech’s trial results, and the outcome of today’s advisory committee vote for emergency approval is not seriously in doubt. The committee has reviewed (and will likely affirm) findings about the vaccine’s basic safety and effectiveness.

The committee today also discussed secondary implications of the emergency authorization, including questions of how to continue randomized trials after the emergency authorization is approved. But these appear unlikely to be a barrier to the EUA.

What is in the vaccine?

Unlike most current vaccines, the Pfizer vaccine does not contain material from the virus it’s designed to block. Instead, it contains synthesized messenger RNA, or mRNA, a kind of genetic cheat sheet that mimics COVID-19’s biology just enough to train your body’s immune response to fight it. That mRNA is encased in a shell made of lipids, or fats, for delivery.

Why does the Pfizer vaccine require two doses?

Pfizer’s vaccines require two doses, three weeks apart. This is primarily to increase its effectiveness. The FDA has released data showing the vaccine is somewhat effective after one dose, but both doses are needed to build up full immunity.

How long is the vaccine effective?

This is still unknown because the vaccine trials were so recent. The World Health Organization hopes the vaccine is effective for at least six months. Experts speaking to New Scientist expect annual booster shots to be necessary.

Can you still transmit COVID after being vaccinated?

Trials for the Pfizer vaccine measured its safety and its effectiveness in preventing symptoms in individuals. It did not determine whether immunized people could still carry the coronavirus without showing symptoms. Mario Ostrowski, an immunology professor at the University of Toronto, told Canada’s CTV News that we will only find out if vaccinated people can be asymptomatic transmitters if infection rates remain high after a majority of the population is vaccinated. That means that masks and social distancing will remain the norm even after the vaccine has reached tens of millions of Americans.

Will the vaccine end the pandemic?

Eventually—but not immediately. Even if the Pfizer vaccine halts transmission as well as symptoms, highly infectious diseases like COVID-19 require very high levels of immunity to break the “chain of transmission” that can keep an infectious disease circulating in a population. For measles, which is also highly infectious, that threshold is 94%. It seems likely it will take most of next year to get to that level of COVID immunity in the U.S., through a combination of vaccinations and those already infected. Until that happens, the pandemic won’t really be over.

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