Moderna to test vaccine on infants


A nurse draws a Moderna coronavirus disease (COVID-19) vaccine, in Los Angeles, California, US, March 12, 2021. [Photo/Agencies]

Moderna announced Tuesday that it will test its COVID-19 vaccine in children as young as 6 months, the first US vaccine maker to test on infants.

The clinical trial, named the KidCOVE, intends to enroll approximately 6,750 healthy children ages 6 months to 11 years in the US and Canada, the biotech company said.

The volunteer study will assess the safety and efficacy of Moderna's two-dose regimen, given 28 days apart. In a separate study, Moderna is testing its vaccine in 3,000 children ages 12 to 17 years and may have results for that age group this summer.

While only 216 children under age 17 have died of COVID-19, according to the latest Centers for Disease Control and Prevention data, children still can transmit the virus it to adults.

"We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population," said Stéphane Bancel, CEO of Moderna.

Moderna said that the first age group to start in the trial will be children ages 6 to 11, followed by children ages 2 to 6 and then children 6 months to 2 years of age.

The trial is the latest effort to widen the mass-vaccination campaign beyond adults. Most COVID-19 vaccines authorized in the US so far are protecting adults, who are at higher risk of severe disease caused by the coronavirus than children. Moderna's and Johnson & Johnson's vaccines are authorized for use in adults 18 and older, while the vaccine from Pfizer and BioNTech SE are for people 16 and older.

Moderna's trial comes as US schools start to reopen, and children are returning to classrooms under the guidelines of keeping 6 feet apart — or less — to avoid infections.

Dr Rochelle Walensky, CDC director, said the agency is now exploring whether children can be seated closer together than was previously recommended. The 6-feet spacing guideline is among the biggest challenges schools have faced in reopening, she said.

States including Illinois and Massachusetts are allowing 3 feet of distance, and others including Oregon are considering it.

The CDC suggested the 6-feet spacing limit in school guidelines issued last month, and concluded that schools can safely operate during the pandemic with masks, distancing and other precautions.

Other organizations have issued more relaxed guidelines. The American Academy of Pediatrics says to space desks "3 feet apart and ideally 6 feet apart". The World Health Organization urges 1 meter (3.28 feet).

Dan Domenech, executive director of AASA, a national school superintendents group, said he expects to see more states and schools move to the 3-feet rule in coming weeks. With the larger guideline, he said, most schools have the space to bring only half of their students in at a time. Moving to 3 feet could allow about 75 percent at a time, he said.

"There are districts that have been doing 3 feet for quite some time without experiencing any greater amount of infection," he said.

Meanwhile, encouraged by the rollout of COVID-19 vaccines, Americans are flying again.

More than 1.3 million people traveled through Transportation Security Administration checkpoints at airports both Friday and Sunday, according to data released by the government agency, setting a new high since the pandemic outbreak devastated travel a year ago.

"The fact that TSA checkpoint numbers continue to climb 5 percent every week underscores the optimism that travelers are feeling across the board," Scott Keyes, founder and chief flight expert at travel website Scott's Cheap Flights told MarketWatch. "With vaccinations accelerating and all adults eligible for the shot by May 1, their world will soon be all our world."

Southwest Airlines CEO Gary Kelly said during a Washington Post webcast that his airline could break even by June, "where you have had much of the population vaccinated".

President Joe Biden signed a $1.9 trillion pandemic relief bill on March 11, which includes $14 billion for airlines and an additional $9 billion for airports and other operations. The bill also sets aside $1 billion for aviation contractors and $8 billion for airports to help them operate normally, limit the spread of the virus, and pay workers and service their debts.

The stimulus package will protect airline jobs through Sep 30, as airlines must not furlough workers through then as a condition for receiving the aid. American Airlines and United Airlines told 27,000 employees that the warnings about furloughs received earlier are no longer valid.

Leading airline and business groups have asked the Biden administration to develop temporary credentials that would let travelers show they have been tested and vaccinated for COVID-19, but the White House said Monday the federal government shouldn't be involved in verifying that people have been vaccinated.

"It's not the role of the government to hold that data and to do that," Andy Slavitt, White House senior adviser for COVID-19 response, said in a news briefing.

While Americans need a way to reliably demonstrate that they've been vaccinated, the government shouldn't be the one issuing such a certification, he said.

"It should be private. The data should be secure. Access to it should be free. It should be available both digitally and in paper and in multiple languages. And it should be open source," Slavitt said.

"It is crucial to establish uniform guidance" and "the US must be a leader in this development," more than two dozen groups said in a letter last week to White House coronavirus-response coordinator Jeff Zients. However, the groups said that vaccination shouldn't be a requirement for domestic or international travel.

Various groups and countries are working on developing so-called vaccine passports aimed at allowing more travel. The US groups include the main US and international airline trade organizations, airline labor unions and the US Chamber of Commerce. The World Health Organization and the United Nations' aviation arm are working on the type of information to include in a credential.

Agencies contributed to this story.

2021年3月12日,美国加利福尼亚州洛杉机,一名护士正在注射一种新型冠状病毒(新冠肺炎)疫苗。[图片/机构]莫德纳公司周二宣布,将在6个月大的儿童身上测试其新冠肺炎疫苗,这是第一家在婴儿身上进行测试的美国疫苗制造商。这家生物技术公司表示,这项名为基德科夫的临床试验计划在美国和加拿大招募大约6750名6个月至11岁的健康儿童。这项志愿者研究将评估莫德纳两剂疗法的安全性和有效性,间隔28天。在另一项研究中,莫德纳正在3000名12至17岁的儿童中测试其疫苗,今年夏天可能会有该年龄组的结果。根据疾病控制和预防中心的最新数据,虽然只有216名17岁以下的儿童死于新冠肺炎,但儿童仍然可以将病毒传染给成年人。莫德纳首席执行官斯特凡·班塞尔(Sté phane Bancel)表示:“我们对18岁及以上成年人的第三阶段COVE-1273基因研究的初步分析感到鼓舞,这项儿科研究将帮助我们评估我们的新冠肺炎候选疫苗在这一重要的年轻人群中的潜在安全性和免疫原性。”。莫德纳说,第一个开始试验的年龄组将是6至11岁的儿童,其次是2至6岁的儿童,然后是6个月至2岁的儿童。这项试验是将大规模疫苗接种运动扩大到成年人以外的最新努力。迄今为止,美国批准的大多数新冠肺炎疫苗都是为了保护成年人,他们比儿童更容易患冠状病毒引起的严重疾病。莫德纳和强生的疫苗授权用于18岁及以上的成年人,而辉瑞和生物技术公司的疫苗适用于16岁及以上的人。莫德纳的审判正值美国学校开始重新开放,孩子们在保持6英尺(或更小)间距以避免感染的指导下回到教室。疾病预防控制中心主任罗谢尔·瓦伦斯基博士说,该机构正在探索儿童是否可以比以前建议的坐得更近。她说,6英尺的间距是学校在重新开放时面临的最大挑战之一。包括伊利诺伊州和马萨诸塞州在内的州允许3英尺的距离,包括俄勒冈州在内的其他州也在考虑。疾控中心在上月发布的学校指南中建议了6英尺的间距限制,并得出结论,在大流行期间,学校可以安全地使用口罩、距离和其他预防措施。其他组织发布了更宽松的指导方针。美国儿科学会表示,将桌子间隔“3英尺,最好是6英尺”。世界卫生组织敦促1米(3.28英尺)。国家学校监督组织AASA的执行董事丹·多梅内克说,他预计在未来几周内会有更多的州和学校开始实行3英尺的规定。他说,根据更大的指导方针,大多数学校一次只能招收一半的学生。他说,移动到3英尺可以一次允许大约75%。他说:“有些地区在相当长的一段时间内已经长到了3英尺,却没有受到更大的感染。”。与此同时,受新冠肺炎疫苗推广的鼓舞,美国人又开始飞行了。根据政府机构公布的数据,周五和周日,超过130万人通过机场的运输安全局检查站,创下一年前大流行疫情摧毁旅游业以来的新高。旅游网站斯科特廉价航班的创始人兼首席飞行专家斯科特·凯斯(Scott Keyes)对市场观察(MarketWatch)表示:“美国运输安全管理局(TSA)检查站的人数每周继续攀升5%,这一事实突显出游客普遍感到乐观。”“随着疫苗接种的加速,到5月1日,所有成年人都有资格接种疫苗,他们的世界将很快变成我们的世界。”

西南航空公司首席执行官加里·凯利在《华盛顿邮报》的网络直播中说,他的航空公司可能会在6月份达到收支平衡,“在那里,你已经让很多人接种了疫苗”。乔·拜登总统于3月11日签署了一项1.9万亿美元的大流行救济法案,其中包括140亿美元用于航空公司,另外90亿美元用于机场和其他运营。该法案还为航空承包商预留了10亿美元,为机场预留了80亿美元,以帮助它们正常运营,限制病毒传播,支付工人工资并偿还债务。刺激计划将在9月30日前保护航空公司的工作岗位,因为航空公司不得将员工休假作为接受援助的条件。美国航空公司和联合航空公司告诉27000名员工,之前收到的关于休假的警告不再有效。主要的航空公司和商业团体已经要求拜登政府制定临时证书,让旅行者证明他们已经为新冠肺炎进行了测试和疫苗接种,但白宫周一表示,联邦政府不应该参与核实人们是否接种了疫苗。白宫新冠肺炎回应高级顾问安迪·斯拉维特在一次新闻发布会上说:“政府的职责不是保存数据并做到这一点。”。他说,虽然美国人需要一种方法来可靠地证明他们已经接种了疫苗,但政府不应该颁发这样的证书。“应该是私人的。数据应该是安全的。应该是免费的。它应该有数字版、纸质版和多种语言版本。而且应该是开源的,”斯拉维特说。二十多个团体在上周给白宫冠状病毒反应协调员杰夫·齐恩斯的一封信中说,“建立统一的指导方针至关重要”,“美国必须在这一发展中发挥领导作用”。然而,这些团体表示,疫苗接种不应成为国内或国际旅行的要求。各种团体和国家正在开发所谓的疫苗护照,旨在允许更多的旅行。美国团体包括主要的美国和国际航空公司贸易组织、航空公司工会和美国商会。世界卫生组织和联合国航空部门正在研究证书中包含的信息类型。机构促成了这个故事。

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