New Omicron-targeting COVID-19 boosters are approved. Here's what you need to know.

新奥密克戎加强剂已经批准使用。这些是你要知道的。

Rebecca Corey and Laura Ramirez-Feldman
Fri, September 2, 2022 at 7:05 AM·8 min read
The Centers for Disease Control and Prevention approved new COVID-19 boosters by Pfizer and Moderna on Thursday, following authorization by the Food and Drug Administration on Wednesday. The new vaccines should start to arrive at clinics within days. Here's what you need to know before getting boosted.

美国疾病控制和预防中心(Centers for Disease Control and Prevention)周四批准了辉瑞(Pfizer)和Moderna的新型COVID-19加强剂，此前美国食品和药物管理局(fda)周三批准了这种加强剂。新疫苗将在几天内送到诊所。以下是你在接种前需要知道的事情。


How is this booster different from other COVID-19 vaccines?

这种加强剂与其他COVID-19疫苗有何不同?

The new booster is what’s known as a bivalent vaccine, meaning it offers protection from more than one virus or subtype of a virus. So far the available boosters and primary vaccines have been monovalent, targeting the original strain of SARS-CoV-2. But Pfizer's and Moderna’s new bivalent boosters target both the original strain and the BA.4 and BA.5 Omicron subvariants, which the FDA says are responsible for most cases in the U.S. and are expected to circulate this fall and winter.

新的加强剂是所谓的二价疫苗，这意味着它可以保护免受一种以上病毒或一种病毒亚型的感染。到目前为止，现有的加强剂和主要疫苗都是一价的，针对的是SARS-CoV-2的原始毒株。但辉瑞和摩德纳的新型二价助推剂针对的是原始菌株和BA.4和BA.5奥密克戎亚变体，FDA表示，这是美国大多数病例的罪魁祸首，预计将在今年秋冬流行。

The bivalent boosters will replace the monovalent boosters that have been used in the U.S., but Pfizer's and Moderna’s monovalent formulations will continue to be used as primary vaccines.

二价加强剂将取代在美国使用的一价加强剂，但辉瑞和摩德纳的单价配方将继续用作主要疫苗。
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While this is the first time a bivalent vaccine has been used in the U.S. to fight COVID-19, the employment of bivalent vaccines is nothing new. Dr. Wafaa El-Sadr, a professor of epidemiology and medicine at Columbia University, told Yahoo News that the polio vaccine, for example, was developed to protect against multiple subtypes of the poliovirus, and that this technique “is a good way of keeping up with the coronavirus as it evolves over time.”

虽然这是美国首次二价疫苗被用于抗击COVID-19，但使用二价疫苗并不是什么新鲜事。哥伦比亚大学流行病学和医学教授瓦法·萨德尔博士告诉雅虎新闻，例如，脊髓灰质炎疫苗是为了预防多种亚型脊髓灰质炎病毒而开发的，这种技术“当新冠病毒不断演化，这是一种跟进的好方法”。

Who can get the booster dose?

哪些人可以接种加强剂?

The Pfizer booster is approved in children and adults ages 12 and older, and the Moderna booster is approved in adults ages 18 and older.

辉瑞加强剂被批准用于12岁及以上的儿童和成人，摩德纳加强剂被批准用于18岁及以上的成人。

Some have argued that a fall vaccination campaign should focus on reaching the most vulnerable populations, including older and immunocompromised Americans. But during a press conference on Wednesday, the FDA pointed to risks associated with "long COVID" as one reason the new boosters should be available more broadly, saying that a third dose of vaccine can probably reduce the chance of getting long COVID by more than half.

一些人认为，秋季疫苗接种运动应该把重点放在最脆弱的人群上，包括老年人和免疫功能低下的美国人。但在周三的新闻发布会上，FDA指出，与“LONG COVID”相关的风险是新加强剂应该更全面的提供的原因之一，称第三剂疫苗可能将会使感染LONG COVID的机会减少一半以上。

Younger children may be eligible to start receiving the new booster “in the coming weeks,” according to a statement by the CDC, though primary vaccination rates among this group remain low. As of Aug. 24, 37% of children ages 5 to 11 had received one dose of a COVID-19 vaccine, and only 7% of children ages 6 months to 4 years had received a dose, according to the CDC.

根据美国疾病控制与预防中心的一份声明，年龄较小的儿童可能在“未来几周”开始接受新的疫苗接种，尽管这一群体的首次疫苗接种率仍然很低。根据美国疾病控制与预防中心的数据，截至8月24日，5至11岁的儿童中有37%接种了一剂COVID-19疫苗，6个月至4岁的儿童中只有7%接种了一剂。

When should you get vaccinated?

什么时候接种疫苗?

Individuals will need to wait at least two months after receiving their primary vaccination or at least two months after their most recent booster dose before they can get the new bivalent booster.

个人需要在接受首次疫苗接种后至少等待两个月，或在接受最近的加强剂接种后至少等待两个月，才能接种新的二价加强剂。

In a statement on Thursday, CDC Director Rochelle Walensky said, “If you are eligible, there is no bad time to get your COVID-19 booster.”

在周四的一份声明中，美国疾病控制与预防中心主任罗谢尔·瓦伦斯基说:“如果你有符合条件，任何时候都可以接种COVID-19疫苗。”

El-Sadr advised Americans to get ahead of a possible spike in cases as temperatures drop and people begin congregating indoors.

萨德尔建议，随着气温下降，人们开始聚集在室内，美国人要提前预防病例激增。

“I think it’s also important to keep in mind that the time to get a booster is not in the middle of the surge,” El-Sadr said. “We recommend that people take the next booster dose before the anticipated surge, meaning taking these booster doses early in the fall before we encounter a potential surge of COVID-19 this winter.”

萨德尔说:“我认为，同样重要的是要记住，接种加强剂的时机不是在（案例）激增的时候。”“我们建议人们在预期的激增之前接种下一次加强剂，这意味着在今年冬天我们遇到COVID-19的潜在激增之前，在秋天早些时候接种这些加强剂。”

What does the data say?

数据说明了什么?

U.S. regulators have said that they are confident in the data supporting the authorization of both Pfizer's and Moderna’s bivalent boosters.

美国监管机构表示，他们对批准有数据支持的辉瑞和摩德纳的二价加强剂有信心。

“We have worked closely with the vaccine manufacturers to ensure the development of these upxed boosters was done safely and efficiently,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement released on Wednesday by the agency.

FDA生物制品评估和研究中心主任彼得·马克斯博士在该机构周三发布的一份声明中说:“我们与疫苗制造商密切合作，以确保这些升级版的增强剂的开发是安全有效的。”

The FDA said the decision to grant emergency-use authorization for the Omicron boosters at this time was based on “the totality of available evidence,” including the extensive safety and effectiveness data of the current mRNA-based COVID-19 vaccines, which have now been administered to billions of people worldwide.

美国食品药品监督管理局表示，目前批准紧急使用奥密克戎加强剂的决定是基于“现在可获得的全部证据”，包括目前基于mrna的COVID-19疫苗的广泛安全性和有效性数据，这些疫苗目前已在全球数十亿人身上使用。

The agency also uated data from human studies of bivalent booster vaccines developed by Pfizer and Moderna targeting Omicron BA.1, an earlier version of the virus that is no longer circulating in the U.S. These formulations, however, are “similar to each of the vaccines being authorized,” the FDA said, and give the agency confidence that the approved shots will also be as safe and effective.

FDA还评估了辉瑞和摩德纳针对奥密克戎ba1(一种较早的病毒，已在美国不再流行)开发的二价增强疫苗的人体研究数据。无论如何，FDA表示，这些剂型“与每一种正在批准的疫苗相似”，并给代理商信心，批准的疫苗也将同样是安全有效的。

In these studies, both Pfizer's and Moderna’s bivalent vaccines targeting Omicron BA.1 were found to generate a significant amount of antibodies in humans compared with the companies’ current booster shots, which target only the ancestral strain of the coronavirus. The BA.1 booster shots were recently approved for use in the U.K.

在这些研究中，发现辉瑞和摩德纳针对奥密克戎ba1的二价疫苗与两家公司目前仅针对冠状病毒祖先毒株的加强疫苗相比，在人类中产生了大量的抗体。ba1加强针最近在英国被批准使用。

A concern that has been raised about the authorization of these boosters aimed at Omicron subvariants BA.4 and BA.5 is that there are currently no human studies available showing their effectiveness. Instead, the FDA assessed the shots using data from research on mice.

针对Omicron亚型BA.4和BA.5的这些加强剂的授权引起的一个担忧是，目前没有可用的人体研究显示它们的有效性。作为替代，FDA使用小鼠研究的数据对疫苗进行了评估。

El-Sadr said this approach is not unusual and pointed out that we rely on mice data to upxe the annual influenza vaccine.

El-Sadr说这种方法并不罕见，并指出我们依靠小鼠数据来更新每年的流感疫苗。

“Every year, essentially, we conduct the studies and look for the immune response for the vaccine within animals,” El-Sadr said of the flu vaccine. “So it’s not unheard of, and it’s actually been the norm, that as you build over time new types of vaccines, you are measuring their effectiveness by comparing the amount of antibodies that are produced in various animal models,” she added.

El-Sadr在谈到流感疫苗时说:“基本上，每年我们都会进行研究，寻找疫苗在动物体内的免疫反应。”她补充说:“所以这并不是不寻常的，实际上这是常态，你建立流行的新疫苗类型，你通过比较各种动物模型产生的抗体数量来衡量它们的有效性。”
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Dr. Monica Gandhi, an infectious disease doctor and professor of medicine at the University of California, San Francisco, recognized the importance of the animal data and said she was looking forward to these shots becoming available. However, she said that since this is the first time the mRNA-based COVID-19 vaccines have been upxed, she would have liked to see some human data before the shots were made available to the public.

加州大学旧金山分校(University of California, San Francisco)的传染病医生兼医学教授莫妮卡·甘地(Monica Gandhi)认识到动物数据的重要性，并表示她期待着这些疫苗的问世。然而，她说，由于这是第一次升级基于mrna的COVID-19疫苗，她希望在疫苗向公众开放之前看到一些人体数据。

“Being the first time, I think it would be really helpful for the public health trust to have a little more human data,” Gandhi said. “It may not need to be, you know, a full-scale trial and a big trial, but really just even showing [that] antibody responses increase in humans; even that, I think would give the public more trust that we've done a little more vetting of this upxed vaccine,” she added.

甘地说:“这是第一次，我认为这将对公共卫生信托机构获得更多的人体数据非常有帮助。”“你知道，这可能不需要进行全面的试验和大规模的试验，但实际上只是表明抗体反应在人体中增加;即使这样，我认为也会给公众更多的信任，让他们相信我们对这种更新的疫苗做了更多的审查，”她补充说。

Both Pfizer and Moderna plan to run human trials for their bivalent boosters. Those studies are expected to start this month, and results should be available later this year, the companies have said.

辉瑞和摩德纳都计划对它们的二价加强剂进行人体试验。这些公司表示，这些研究预计将于本月开始，结果将于今年晚些时候公布。

Will people take it?

人们会接受吗?

Vaccination rates in the U.S. have been lagging behind other developed countries. Only 33% of the U.S. population is currently boosted and two-thirds are fully vaccinated. So now that this new booster is available, will people take it?

美国的疫苗接种率一直落后于其他发达国家。目前只有33%的美国人最近接种了疫苗，三分之二的人完全接种了疫苗。现在这种新的加强剂已经上市，人们会接受吗?

During Wednesday’s press conference, FDA Commissioner Robert Califf tried to spur confidence in the bivalent booster by using himself as an example.

在周三的新闻发布会上，FDA专员罗伯特·卡利夫试图以自己为例来促进人们对二价加强剂的信心。

“I’ll also tell you I’m turning 71 next month, [and] I will be at the front of the line at the pharmacy getting my vaccination. I’m very confident about this,” Califf said.

“我还会告诉你，我下个月就要71岁了，我会在药房排队接种疫苗。我对此非常有信心，” 卡利夫说。

With breakthrough cases common even among fully vaccinated and boosted Americans, Marks said the FDA is hoping this new vaccine will not only guard against hospitalization and death, but also offer protection from symptomatic disease the way the first crop of vaccines did in late 2020 and early 2021.

随着突破病例在完全接种疫苗和病情好转的美国人中也很常见，马克斯表示，FDA希望这种新疫苗不仅能防止住院和死亡，还能像2020年底和2021年初的第一批疫苗那样，保护人们免受症状性疾病的影响。

“We don’t know for a fact yet whether we will get to that same level, but that is the goal,” Marks said. “The hope here is not to have to give lots of vaccines each year. It’s hopefully to have this be the vaccine that hopefully holds us for as much of this or for the entire season, if it can,” he added.

“我们还不知道我们是否会达到同样的效果，但这就是目标，”马克斯说。“现在的希望是不用每年打很多疫苗。如果可能的话，希望这种疫苗能让我们撑过整个季节（冬季）。”他补充说。

El-Sadr emphasized that even if breakthrough cases continue to occur, people should still seek vaccinations because they offer protection from some of the worst outcomes of COVID-19.

萨德尔强调，即使突破性病例继续发生，人们仍然应该接种疫苗，因为它们可以保护人们免受COVID-19的一些最糟糕后果。

“I think the most important thing to keep in mind is that these booster doses save lives,” she said. “I appreciate the disappointment that people have had in terms of getting infected even though they’ve done everything right. But nonetheless, let’s keep in mind what’s most important. These vaccines can keep us out of the hospital and keep us well.”

她说:“我认为最重要的是要记住，这些加强剂可以拯救生命。”“我理解人们在被感染方面的失望，尽管他们做了所有正确的事情。但不管怎样，让我们记住什么是最重要的。这些疫苗可以让我们远离医院，让我们保持健康。”