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最后一步,疾控中心主任为5岁及以上儿童签署辉瑞疫苗

2021-11-03 09:42   美国新闻网   - 

在美国疾病控制与预防中心于周二晚上正式向5至11岁的儿童推荐辉瑞疫苗后,又有2800万美国人能够接种新冠肺炎疫苗。

“在科学的引领下,我们在国家抗击导致新冠肺炎病毒的斗争中又向前迈出了重要的一步。我们知道数百万父母渴望让他们的孩子接种疫苗,通过这个决定,我们现在已经建议大约2800万儿童接种新冠肺炎疫苗,”疾控中心主任罗谢尔·瓦伦斯基在一份声明中说。

一个为疾病控制和预防中心提供建议的独立专家委员会周二一致投票,建议为5-11岁的儿童接种辉瑞疫苗,在授权过程中勾选了最后一个框,瓦伦斯基周二晚上的最终建议结束了这一过程。

注射可以立即进行,但预计要到11月8日才会进入高潮,届时白宫表示辉瑞的儿科疫苗将更容易获得全国各地。

预计下周将有约1500万剂疫苗出货。其中大部分,约1000万,将在儿科医生办公室、儿童医院、社区中心和大规模疫苗接种点提供。大约500万剂药物将流向药店。

乔·拜登总统在一份声明中说:“这将使父母结束数月来对孩子的焦虑担忧,并减少孩子将病毒传播给他人的程度。这是我们国家在战胜病毒的斗争中向前迈出的重要一步。”

许多父母急于保护他们的孩子夏季三角洲激增导致儿童病例和住院人数增加。虽然这种变种并不是更致命,但它更容易传播,而且因为孩子们没有接种疫苗,这种变种在学校和营地里迅速传播。

辉瑞临床试验的最新数据发现,针对5-11岁儿童的疫苗对症状性疾病的有效性接近91%。

对于儿童来说,疫苗的剂量会更小,只有三分之一。

PHOTO: Charles Muro,13, celebrates being inoculated by Nurse Karen Pagliaro in Hartford, Connecticut, May 13, 2021.

约瑟夫·普雷齐奥索/法新社,通过盖蒂图像,文件

13岁的查尔斯·穆罗在康涅狄格州哈特福德庆祝护士卡伦·帕利亚罗接种疫苗

该疫苗似乎也是安全的。该公司表示,临床试验中没有一名儿童出现被称为心肌炎的罕见心脏炎症副作用,这种副作用与基因疫苗相关的病例非常罕见,主要发生在年轻男性中。

美国疾控中心心肌炎专家、亚特兰大儿童保健中心儿科心脏病专家马特·奥斯特博士在周二的会议上明确表示,他认为疫苗对5-11岁儿童的益处超过了疫苗相关心肌炎的潜在风险。

奥斯特告诉委员会:“底线是,无论你的年龄或性别如何,获得COVID对心脏的风险都比获得这种疫苗高得多。

与此同时,疾控中心的莎拉·奥利弗博士说,不接种疫苗的风险远远大于在一些青少年身上看到的罕见且大多温和的疫苗副作用。

奥利弗使用一个基于迄今为止整个大流行中病例的模型估计,每一百万次儿科疫苗接种,就可以预防超过18,500例COVID病例和80例住院。如果病例恢复到delta变量期间的峰值水平,超过58,200例COVID病例和超过220例住院治疗是可以避免的。

奥利弗说:“也有可能预防传播,对更安全地重返校园和社会交往更有信心。“有效疫苗的广泛使用将减轻5至11岁儿童的COVID公共卫生负担。”

其他疾控中心委员会成员同意。

美国疾控中心委员会成员、德雷克塞尔大学儿科教授萨拉·朗博士说:“我认为数据支持我们又多了一种可以挽救儿童生命的疫苗,我们应该非常有信心最大限度地使用这种疫苗。

授权过程始于上周,当时食品药品监督管理局的一个专家小组审查了所有的有效性和安全性数据,然后几乎一致投票批准了该疫苗。周五,该疫苗获得了美国食品和药物管理局代理局长珍妮特·伍德库克的授权,这使得疫苗接种过程可以在注射前移交给疾控中心进行最后的步骤。

父母是否会为孩子接种疫苗仍然是个问题。十月投票,凯泽家庭基金会发现,大约三分之一有5-11岁孩子的父母愿意马上给孩子接种疫苗,而另外三分之一的父母希望“拭目以待。”这些数据表明,自7月份以来,小学生家长对疫苗的接受度略有上升,但自9月份以来一直保持稳定。

伍德库克周五告诉记者,她希望家长们能尽快看到好处。

她说:“我们当然希望,随着人们看到儿童接种疫苗并得到保护,能够毫无顾虑地参与活动,越来越多的人将为他们的孩子接种疫苗。

她还强调了预防儿童COVID诊断相关疾病的紧迫性。

“作为父母,如果我有这个年龄段的孩子,我现在就会让他们接种疫苗。伍德库克说:“我不想冒这样的风险,他们会成为发展成长时间COVID的人之一,他们会发展成多系统炎症综合征,或者因为病毒而不得不住院。

In final step, CDC director signs off on Pfizer vaccine for kids 5 and up

Another 28 million Americans are able to get vaccinated against COVID-19 after the CDC officially recommended the Pfizer shot for 5- to 11-year-olds on Tuesday night.

"Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine," CDC Director Rochelle Walensky said in a statement.

A committee of independent experts advising the Centers for Disease Control and Prevention voted unanimously on Tuesday to recommend the Pfizer vaccine for children 5-11, checking off one of the last boxes in the authorization process, and Walensky's final recommendation Tuesday night capped off the process.

Shots can be administered immediately, but are not expected to kick into high-gear until Nov. 8, when the White House says Pfizer’s pediatric vaccines will bemore widely accessibleacross the nation.

About 15 million doses are expected to ship out over the next week. The majority, about 10 million, will be available at pediatrician's offices, children’s hospitals, community centers and mass vaccination sites. About 5 million doses will go to pharmacies.

In a statement, President Joe Biden said: "It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus."

Manyparents are anxious to protect their childrenafter the delta surge over the summer led to increased cases and hospitalizations among kids. Though the variant is not more deadlier, it is more transmissible -- and because kids are unvaccinated, the variant rocketed through schools and camps.

The most recent data from Pfizer's clinical trials found that the vaccine for children ages 5-11 was nearly 91% effective against symptomatic illness.

For kids, the vaccine will be given at a smaller, one-third dose.

The vaccine also appears safe. The company says none of the children in clinical trials experienced a rare heart inflammation side effect known as myocarditis, which has been associated with the mRNA vaccines in very rare cases, mostly among young men.

The CDC's expert on myocarditis, Dr. Matt Oster, a pediatric cardiologist at Children’s Healthcare of Atlanta, said unequivocally at Tuesday's meeting that he believes the benefits of the vaccine for 5-11 year-olds outweighs the potential risks of vaccine-related myocarditis.

"The bottom line is getting COVID I think is much riskier to the heart than getting this vaccine, no matter what age or sex you have," Oster told the committee.

Meanwhile, the risks of not getting vaccinated loom far larger than the rare and mostly mild vaccine side effects seen in some adolescents, CDC's Dr. Sarah Oliver said.

For every million pediatric vaccinations, more than 18,500 COVID cases and 80 hospitalizations could be prevented, Oliver estimated, using a model based on cases throughout the pandemic so far. If cases returned to the peak seen during the delta variant, over 58,200 COVID cases and over 220 hospitalizations could be prevented.

"There could also be possible prevention of transmission and a greater confidence in a safer return to school and social interactions," Oliver said. "Wide use of an effective vaccine would reduce the public health burden of COVID in children five through 11 years of age."

Other CDC committee members agreed.

"I think the data supports that we have one more vaccine that saves lives of children and that we should be very confident to employ it to the maximum," said Dr. Sarah Long, a member of the CDC's committee and professor of pediatrics at Drexel University.

The authorization process began last week, when a panel of experts at the Food and Drug Administration reviewed all of the efficacy and safety data and then voted nearly unanimously to authorize the vaccine. On Friday, the vaccine was authorized by FDA acting commissioner Janet Woodcock, which allowed the process to move over to the CDC for the final steps before shots could be administered.

Whether parents will embrace the vaccine for their kids is still a question. In an Octoberpoll, the Kaiser Family Foundation found that about a third of parents with kids ages 5-11 were willing to vaccinate their kids right away, while another third wanted to "wait and see." The figures represented a slight uptick in vaccine acceptance among parents of elementary-school-aged kids since July, but they have stayed steady since September.

Woodcock told reporters on Friday that she hoped parents would quickly see the benefits.

"We certainly hope that as people see children getting vaccinated and being protected, being able to participate in activities without concern, that more and more people will get their kids vaccinated," she said.

And she emphasized the urgency of preventing the conditions that can come with COVID diagnoses in kids.

"As a parent, if I had young children this age group I would get them vaccinated now. I would not want to take the risk that they would be one of the ones who would develop long COVID, who would develop multi-system inflammatory syndrome or have to be hospitalized from from the virus," Woodcock said.

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