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                为何12岁以下的儿童,最后打新冠疫苗?

                为何12岁以下的儿童,最后打新冠疫苗?

                Sy Mukherjee 2021年08月26日
                有几个因素正在推迟为幼儿接种新冠疫苗,但目前可能是时候了。

                现在,辉瑞(Pfizer)的新冠疫苗已经获得了美国食品与药品管理局(Food and Drug Administration)的全面批准,成为美国目前唯一一种可供12岁至15岁青少年接种的紧急授权疫苗。看着孩子们成群结队地回到学校,家长们可能会有所疑问:年纪更小的孩子什么时候才有资格接种新冠疫苗?为什么这个过程要花这么长的时间?即使大多数的儿童不太可能因为新冠病毒而患上重病,但是,在过去几个月中,因为新冠肺炎而住院的儿童人数一直在上升。此外,儿童群体还是德尔塔变种毒株传播的“沃土”:儿童可能携带病毒,并将其传给未接种疫苗的朋友、家人和邻居,以及那些随着时间的推移,体内疫苗的免疫反应减弱、对德尔塔等变体病毒的免疫力低下的人。

                “我们知道,随着德尔塔变种毒株的传播,它的传染性是什么样的。有越来越多的儿童和青少年受到了感染,当然,因为越来越多的儿童和青少年受到感染,所以越来越多的人患重病并住院。此外,这些儿童和青少年有可能在他们的家庭和社区传播这种疾病。”美国卫生与公众服务部(Department of Health and Human Services)的助理部长雷切尔?莱文在最近一次的美国食品与药品管理局圆桌会议上讨论青少年疫苗接种问题时说。

                于是问题来了:为什么要推迟新冠疫苗的批准?如果辉瑞的疫苗已经被证实对12岁及以上的群体安全有效,那么给仅小1岁的11岁儿童接种疫苗,真的会有很大的不同吗?

                这个问题的答案,在于儿童临床试验的特殊设计,以及父母、研究志愿者、研究人员和监管机构必须思考的后续问题,其中就包括向希望参加新冠疫苗试验的年幼儿童的父母提供关于风险和试验设计的一些“知情同意”材料。此外,儿童的生理特性比较独特,而且变化非常迅速,这就要求制药商做出调整,例如减少部分年龄组的疫苗剂量——因为5岁儿童所需要的疫苗剂量可能远远低于青少年和成年人所需要的剂量。

                关于新冠疫苗对儿童的潜在健康影响,还有其他一些重要问题需要回答。“拿新冠疫苗来说,我们需要确保其不被其他常规的儿童疫苗所触发的人体免疫反应所干扰,反之亦然。”西达塞奈(Cedars-Sinai)的儿科传染病部学术主任摩西?阿尔迪蒂在接受采访时说,“这需要一些时间来评估。”

                在新冠肺炎这样的全球性疫情之下,公共卫生需求非常紧迫,此类试验的时间可能会缩短。毕竟传统的新疫苗开发可能需要10年以上的时间,但新冠疫苗在不到一年的时间里就问世了。对儿童医疗团体来说,这可能会导致紧急和谨慎这两个观念之间的微妙平衡。比如,美国儿科学会(American Academy of Pediatrics)对美国食品与药品管理局批准辉瑞公司的新冠疫苗表示欢迎,但与此同时,考虑到现有的未知因素,该学会敦促不要在标准以外给12岁以下的儿童使用疫苗。此外,美国儿科学会几个月来一直在游说美国食品与药品管理局尽其所能批准辉瑞和Moderna的针对12岁以下儿童的新冠疫苗。

                美国儿科学会的会长李?萨维奥?比尔斯在8月5日致美国食品与药品管理局的代理局长珍妮特?伍德考克的信中写道:“我们了解到,美国食品与药品管理局最近与辉瑞和Moderna合作,将5岁至11岁儿童参与新冠疫苗临床试验的人数增加了一倍。我们认为,德尔塔变种毒株的增加改变了儿童疫苗授权的‘风险-效益分析’。美国食品与药品管理局应该根据其已经获得的初始登记同期组群的数据,尽快批准这些疫苗,以用于5岁至11岁的儿童,同时继续跟踪这批在疫苗上市后,接种群体扩大之后的同期组群的安全性数据——这一方法并不会减慢这一年龄组对其迫切需要的疫苗的批准时间。”

                简单来说,该组织认为,辉瑞和Moderna正在进行的儿童临床试验,说明尽早为更多的儿童接种新冠疫苗是明智的;此外,还应该密切关注安全性和有效性数据,以便及时做出调整。

                今年3月,辉瑞和BioNTech公司在1/2/3期的连续研究中开始给6个月到11岁的儿童注射新冠疫苗。“占全球人口很大一部分的儿童,将在我们持续抗击新冠病毒的斗争中发挥关键作用。我们的1/2/3期研究将在美国、芬兰、波兰以及西班牙的90多个临床试验地点,招募大约4500名6个月至11岁的儿童。”辉瑞表示,“一旦可接受的安全情形建立,6个月以下的儿童随后也或将接受评估。”辉瑞预计,其将在9月初开始提交这些研究的数据,并启动针对5岁至11岁儿童的疫苗监管程序。新冠疫苗对这一群体的影响需要比对成年人更长时间的监测(需要随访4个月至6个月的安全性数据,而对成年人则是2个月),但有不具名的报告称,监管机构可能会在深冬之前批准针对5岁及以上儿童的新冠疫苗。

                在提交这些数据、安全检查完成之后,最终将由美国疾病控制中心(Centers for Disease Control)负责制定疫苗接种计划,并就疫苗在不同年龄段的适用性和剂量提出建议。

                因此,尽管新冠疫苗授权的年龄界线似乎十分武断,而且减缓了免疫进程,但是也应当注意到,长期存在的监管要求和当下美国最年轻人群特别需要的谨慎性,对疫苗批准时间线带来的影响。总之,在接下来的几个月里,预计会有越来越多的儿童能够打上新冠疫苗。(财富中文网)

                编译:杨二一

                现在,辉瑞(Pfizer)的新冠疫苗已经获得了美国食品与药品管理局(Food and Drug Administration)的全面批准,成为美国目前唯一一种可供12岁至15岁青少年接种的紧急授权疫苗。看着孩子们成群结队地回到学校,家长们可能会有所疑问:年纪更小的孩子什么时候才有资格接种新冠疫苗?为什么这个过程要花这么长的时间?即使大多数的儿童不太可能因为新冠病毒而患上重病,但是,在过去几个月中,因为新冠肺炎而住院的儿童人数一直在上升。此外,儿童群体还是德尔塔变种毒株传播的“沃土”:儿童可能携带病毒,并将其传给未接种疫苗的朋友、家人和邻居,以及那些随着时间的推移,体内疫苗的免疫反应减弱、对德尔塔等变体病毒的免疫力低下的人。

                “我们知道,随着德尔塔变种毒株的传播,它的传染性是什么样的。有越来越多的儿童和青少年受到了感染,当然,因为越来越多的儿童和青少年受到感染,所以越来越多的人患重病并住院。此外,这些儿童和青少年有可能在他们的家庭和社区传播这种疾病。”美国卫生与公众服务部(Department of Health and Human Services)的助理部长雷切尔?莱文在最近一次的美国食品与药品管理局圆桌会议上讨论青少年疫苗接种问题时说。

                于是问题来了:为什么要推迟新冠疫苗的批准?如果辉瑞的疫苗已经被证实对12岁及以上的群体安全有效,那么给仅小1岁的11岁儿童接种疫苗,真的会有很大的不同吗?

                这个问题的答案,在于儿童临床试验的特殊设计,以及父母、研究志愿者、研究人员和监管机构必须思考的后续问题,其中就包括向希望参加新冠疫苗试验的年幼儿童的父母提供关于风险和试验设计的一些“知情同意”材料。此外,儿童的生理特性比较独特,而且变化非常迅速,这就要求制药商做出调整,例如减少部分年龄组的疫苗剂量——因为5岁儿童所需要的疫苗剂量可能远远低于青少年和成年人所需要的剂量。

                关于新冠疫苗对儿童的潜在健康影响,还有其他一些重要问题需要回答。“拿新冠疫苗来说,我们需要确保其不被其他常规的儿童疫苗所触发的人体免疫反应所干扰,反之亦然。”西达塞奈(Cedars-Sinai)的儿科传染病部学术主任摩西?阿尔迪蒂在接受采访时说,“这需要一些时间来评估。”

                在新冠肺炎这样的全球性疫情之下,公共卫生需求非常紧迫,此类试验的时间可能会缩短。毕竟传统的新疫苗开发可能需要10年以上的时间,但新冠疫苗在不到一年的时间里就问世了。对儿童医疗团体来说,这可能会导致紧急和谨慎这两个观念之间的微妙平衡。比如,美国儿科学会(American Academy of Pediatrics)对美国食品与药品管理局批准辉瑞公司的新冠疫苗表示欢迎,但与此同时,考虑到现有的未知因素,该学会敦促不要在标准以外给12岁以下的儿童使用疫苗。此外,美国儿科学会几个月来一直在游说美国食品与药品管理局尽其所能批准辉瑞和Moderna的针对12岁以下儿童的新冠疫苗。

                美国儿科学会的会长李?萨维奥?比尔斯在8月5日致美国食品与药品管理局的代理局长珍妮特?伍德考克的信中写道:“我们了解到,美国食品与药品管理局最近与辉瑞和Moderna合作,将5岁至11岁儿童参与新冠疫苗临床试验的人数增加了一倍。我们认为,德尔塔变种毒株的增加改变了儿童疫苗授权的‘风险-效益分析’。美国食品与药品管理局应该根据其已经获得的初始登记同期组群的数据,尽快批准这些疫苗,以用于5岁至11岁的儿童,同时继续跟踪这批在疫苗上市后,接种群体扩大之后的同期组群的安全性数据——这一方法并不会减慢这一年龄组对其迫切需要的疫苗的批准时间。”

                简单来说,该组织认为,辉瑞和Moderna正在进行的儿童临床试验,说明尽早为更多的儿童接种新冠疫苗是明智的;此外,还应该密切关注安全性和有效性数据,以便及时做出调整。

                今年3月,辉瑞和BioNTech公司在1/2/3期的连续研究中开始给6个月到11岁的儿童注射新冠疫苗。“占全球人口很大一部分的儿童,将在我们持续抗击新冠病毒的斗争中发挥关键作用。我们的1/2/3期研究将在美国、芬兰、波兰以及西班牙的90多个临床试验地点,招募大约4500名6个月至11岁的儿童。”辉瑞表示,“一旦可接受的安全情形建立,6个月以下的儿童随后也或将接受评估。”辉瑞预计,其将在9月初开始提交这些研究的数据,并启动针对5岁至11岁儿童的疫苗监管程序。新冠疫苗对这一群体的影响需要比对成年人更长时间的监测(需要随访4个月至6个月的安全性数据,而对成年人则是2个月),但有不具名的报告称,监管机构可能会在深冬之前批准针对5岁及以上儿童的新冠疫苗。

                在提交这些数据、安全检查完成之后,最终将由美国疾病控制中心(Centers for Disease Control)负责制定疫苗接种计划,并就疫苗在不同年龄段的适用性和剂量提出建议。

                因此,尽管新冠疫苗授权的年龄界线似乎十分武断,而且减缓了免疫进程,但是也应当注意到,长期存在的监管要求和当下美国最年轻人群特别需要的谨慎性,对疫苗批准时间线带来的影响。总之,在接下来的几个月里,预计会有越来越多的儿童能够打上新冠疫苗。(财富中文网)

                编译:杨二一

                Now that Pfizer's COVID-19 vaccine has received full Food and Drug Administration (FDA) approval for those age 16 and older and is the only coronavirus jab in the U.S. available to teens who are 12 to 15 years old under emergency authorization, parents watching their children flock back to school may be wondering when younger kids will qualify for a shot—and why the process is taking so long. Even if most children are unlikely to get seriously ill from COVID-19, the number of kids hospitalized for COVID-19 has been on the rise in the past few months. Plus, children appear to be fertile ground for the Delta variant's spread: They could still carry the virus and pass it on to friends, family, and neighbors who may be unvaccinated, or individuals whose immune response from a vaccine has weakened over time or is less effective against variants like Delta.

                “We know that with the spread of the Delta variant, how contagious it is, more children and more adolescents are getting infected, and certainly because more are getting infected, more are becoming significantly ill and becoming hospitalized,” as Department of Health and Human Services assistant secretary for health Rachel L. Levine said during a recent FDA roundtable discussing youth vaccination. “In addition, these children and adolescents are potentially spreading this disease in their homes and their communities.”

                So why the delay? If Pfizer's vaccine is already deemed safe and effective for Americans 12 and over, would inoculating an 11-year-old really be all that different?

                The answer is rooted in the special design of children's clinical trials and the ensuing considerations that parents, study volunteers, researchers, and regulators must balance. That may include delivering the proper "informed consent" on risks and trial design to parents of younger children who want to enroll in COVID vaccine trials. Furthermore, the unique and rapidly changing biology of kids necessitates that drugmakers make adjustments, such as reduced dosing for different age groups since the appropriate amount of vaccine for a 5-year-old might be much lower than what is needed for a teenager or an adult.

                There are also other important health questions that need answering when it comes to a vaccine's potential effects on a child. "With the COVID-19 vaccine, for example, we need to make sure it doesn't interfere with immunity generated by routine childhood vaccinations—and that standard vaccination protocols are not interfering with the COVID-19 vaccine," said Moshe Arditi, academic director of the division of pediatric infectious diseases at Cedars-Sinai in an interview. "And that's going to take some time to assess."

                In the case of a pandemic like COVID-19, the timeline for such trials may be compressed given the urgent public health need. (After all, traditional new vaccine development can take upwards of a decade, but coronavirus jabs were made available to the public in less than a year.) That can lead to a delicate balancing act between urgency and caution for children's medical groups. For instance, the American Academy of Pediatrics (AAP) hailed the FDA's Pfizer vaccine approval while urging against off-label use of the jab in children younger than 12 given the existing unknowns. Simultaneously, the AAP has lobbied the FDA for months to do everything it can to authorize Pfizer’s and Moderna’s vaccines for kids under the age of 12.

                "We understand that the FDA has recently worked with Pfizer and Moderna to double the number of children ages 5–11 years included in clinical trials of their COVID-19 vaccines," wrote AAP president Lee Savio Beers in an Aug. 5 letter to acting FDA Commissioner Janet Woodcock. "In our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children. The FDA should strongly consider authorizing these vaccines for children ages 5–11 years based on data from the initial enrolled cohort, which are already available, while continuing to follow safety data from the expanded cohort in the post-market setting. This approach would not slow down the time to authorization of these critically needed vaccines in the 5–11-year age group."

                Put plainly, the group believes it's prudent to move sooner rather than later on getting COVID jabs to more kids given Pfizer's and Moderna's ongoing and continuous clinical trials in children, and to keep tabs on the safety and effectiveness numbers going forward if adjustments need to be made.

                Pfizer and BioNTech began dosing children as young as six months and up to 11 years of age in a continuous Phase 1/2/3 study in March. "Younger children, who make up a significant portion of the total global population, will play a critical role in our continued fight against COVID-19. The Phase 1/2/3 study will enroll approximately 4,500 children 6 months to 11 years old in the United States, Finland, Poland, and Spain at more than 90 clinical trial sites," according to the company. "Children younger than 6 months of age may subsequently be evaluated, once an acceptable safety profile has been established." Pfizer is expected to begin submitting data from these studies by early September and launching the regulatory process for kids ages 5 to 11. The vaccines' effect on this group would have to be monitored for longer than it is for adults (four to six months of follow-up safety data versus two months for adults), but there have been anonymous reports that regulators could authorize COVID vaccines for those age 5 and over by midwinter.

                After this data submission and ongoing safety checkups, the Centers for Disease Control (CDC) would ultimately be responsible for setting up a vaccine schedule and recommendations for a vaccine’s appropriateness across ages and in what doses.

                So while it may seem like the age lines for COVID vaccine authorizations are arbitrary and slowing down the immunization campaign, longstanding regulatory guidelines and the need for special caution in America's youngest have influenced the current timeline. In the coming months, expect more and more kids to qualify for a jab.

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