美国FDA:5至11岁接种辉瑞疫苗好处大于风险




美国FDA:5至11岁接种辉瑞疫苗好处大于风险

文 / 陈慧璋

10/23/2021

(法新社)

(早报讯)美国食品与药物管理局(FDA)的科学家周五(22日)表示,让5岁至11岁儿童接种辉瑞-BioNTech冠病疫苗的好处,明显大于其感染罕见心肌炎的风险。

路透社报道,美国辉瑞公司与其德国合作伙伴BioNTech公司说,一项针对5岁至11岁儿童进行的临床实验显示,接种这款冠病疫苗的儿童所产生的中和抗体效力达到90.7%。

如果美国FDA给予辉瑞-BioNTech疫苗用于5至11岁儿童的紧急使用授权,它将是第一款获准用于这个年龄组儿童的冠病疫苗,5岁至11岁儿童将可在11月初开始接种疫苗。

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辉瑞向FDA申请疫苗在5至11岁的儿童中紧急使用

文 / 林煇智

10/07/2021

辉瑞公司已经要求美国食品药物管理局批准辉瑞疫苗在5至11岁的儿童中紧急使用。(法新社)

(早报讯)辉瑞公司和BioNTech公司周四(7日)表示,他们已经要求美国食品药物管理局批准辉瑞疫苗在5至11岁的儿童中紧急使用。

路透社报道,美国食品和药物管理局已将10月26日定为外部顾问开会讨论辉瑞公司申请的日期。这意味,孩子们有可能在不久之后开始接受疫苗。

由于全国范围内的学校已经开学,快速授权可以帮助缓解今年秋季可能出现的病例激增。在这之际,美国儿科学会的数据显示,冠病在儿童中的感染率飙升,在9月初达到了大流行的最高点。



两家公司在9月20日说,这种疫苗已经被授权用于12至15岁的儿童,并被完全批准用于16岁及以上的青年。在一项有2268名参与者的临床试验中,这种疫苗已经被证明能在目标年龄组中产生强烈的免疫反应。

据报道,辉瑞疫苗在该公司申请授权后约一个月就被授权用于12-15岁的儿童。

虽然孩子们对严重的冠病不太敏感,但他们可以将病毒传播给其他人,包括更容易患严重疾病的弱势人群。

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Schools grapple with thousands in isolation or quarantine as delta variant rages

Many schools that planned to forgo virtual and hybrid learning this year, in favor of in-person classes, are revisiting those plans as outbreaks require students to quarantine.

By Daniella Silva

9/05/2021

A classroom sits empty at Rogers International School as students from that class quarantine at home Oct. 21, 2020, in Stamford, Conn. John Moore / Getty Images file

Schools that have opened their doors to students amid the spread of the highly contagious delta variant of the coronavirus already are grappling with how to best continue teaching students when hundreds and sometimes thousands of them are in quarantine.

As cases of Covid-19 started to wane over the spring and the early summer, many schools planned to forgo virtual and hybrid learning this year, in favor of in-person classes. But the lag in vaccination rates and the rapid spread of the delta variant have led districts to revisit those plans, with varying results.

Some schools have sent students home with packets of self-guided work to submit at the end of each day or when on-campus classes resume. Others have temporarily switched to virtual learning. And in some cases, schools have canceled classes altogether while campuses are closed or kids are in quarantine.


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In Mississippi, officials last month said more than 20,000 students were in quarantine from exposure to the coronavirus after the first week of school.

The high quarantine numbers among students and staff members led at least 29 schools to “go virtual for a short time in order to interrupt transmission,” the state’s epidemiologist said.

Similarly, the Connally Independent School District in Texas, which opened to students Aug. 18, closed its schools for in-person classes Tuesday after two teachers died last week of Covid. The five schools in the suburban Waco district hastily switched to remote learning and are scheduled to reopen for in-person learning after Labor Day.

“If this pandemic has taught us one thing, it is the ability to change directions quickly,” Connally Elementary School Principal Eric Cantu wrote in a note to parents on the district’s website. “Going from Face to Face learning to remote learning is an example of this.”



More than 300 miles east, however, in Iraan, Texas, learning was put on hold for two weeks when schools closed because of a Covid outbreak in August, about a week into the school year.

Iraan-Sheffield Independent School District Superintendent Tracy Canter said in the letter to the school district’s community Aug. 16 that neither virtual nor remote learning would take place during the closure, but that teachers would be available by email.

She said schools would still meet the minimum 75,600 minutes of instructional time required by law, in part by turning two early-release days into full days of school.

“We know that this is difficult for everyone involved and we thank you for your support and patience during this unprecedented time,” Canter said in the letter.

School districts are confronting the dilemma of how to keep the school year going as the number of parents who want their children to go to in-person school drops.



Only 43 percent of public school parents and guardians said they wanted their children in a classroom full time this year after the Centers for Disease Control and Prevention on July 27 updated its health guidance to recognize the threat of the delta variant.

That was down from 58 percent of parents and guardians who said they wanted in-person instruction before July 27, according to a survey funded by the CDC through the Atlanta-based nonprofit CDC Foundation. It polled 1,448 public school parents and guardians July 23-Aug. 8.

Just more than half of the nation’s largest 100 school districts are planning to make a remote learning option available to all students, according to the University of Washington’s Center on Reinventing Public Education, while 92 will offer some type of remote instruction.

In Florida’s Hillsborough County Public Schools, thousands of students have been quarantined since the start of the school year in August.



Teachers are putting lessons and instructional material online for kids in quarantine and sending out electronic devices or providing physical copies of work based on student need, Jennifer Sparano, the district’s Covid coordinator, said.

She said work is done independently, with check-ins from teachers, but the district is looking into hiring teachers and support staff to be available online during the day to give children live access to a teacher if their own ones are not available because they are teaching in a classroom.

There were more than 7,380 reported Covid cases and nearly 9,270 students and staff in isolation or quarantine, as of Friday, according to a district dashboard. Last Friday, there were more than 5,270 reported Covid cases and nearly 12,000 students and staff in isolation or quarantine, according to the dashboard. The total district population is more than 240,000.

A symptom-free student could still be out of school for five to seven days, under the district’s quarantine procedures, though Sparano said said many students don’t typically miss five full days of school.



In Metro Nashville Public Schools in Tennessee, from Aug. 9 to Aug. 15, there were 95 staff who were isolated or quarantined, with 52 confirmed cases and 980 students were isolated or quarantined, with 207 confirmed cases. From Aug. 16 to Aug. 22, there were 143 staff isolated or quarantined, with 67 confirmed cases and 2,879 students isolated or quarantined, with 395 confirmed cases, according to Sean Braisted, the district’s executive officer of communications and community engagement.

Isolated or quarantined students can access their course information and assignments online and the district offers remote learning assistance to students, he said in an email. Parents must also verify a student participated in all instructional activities, he said.

In the Northeast, where many schools don’t reopen until after Labor Day, school districts are announcing return plans that include planning for continuing education in quarantine.

New York City, which houses the nation’s largest school system and where all public school teachers and staff must get vaccinated, is planning to try to limit the number of students who have to quarantine.



In elementary schools, a classroom will be required to quarantine for 10 calendar days in the event of a positive test in that class and students will continue to receive instruction while they quarantine. But in middle and high schools, students who are at least 12 years old, vaccinated and not showing symptoms will be allowed to continue to attend school in-person. Students who are at least 12 years old, vaccinated and showing symptoms will have to quarantine for 10 calendar days and will have access to remote learning while quarantining. Unvaccinated students will have to quarantine for 10 calendar days, continue learning remotely, and will be allowed to return with a negative result after the seventh day.

The city’s strategy is designed to avoid the disruption of major school closures, which would be necessary only in case of widespread transmission in the school, the New York City Department of Education said in a health and safety guide.

“Our commitment to parents is to minimize disruption this year, keep as much continuity as possible and make sure all those health and safety measures are in place,” New York City Mayor Bill de Blasio said.

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