Pfizer Gets FDA OK to Test Adolescents in COVID-19 Vaccine Trial


2020-10-15 01:33:04 BioSpace


To date, all the major clinical trials of vaccines against COVID-19 have been in adults. Typically, Phase I safety trials were in healthy volunteers ages 18 to 55. Phase II and Phase III trials expanded that to include people older than 55 as well as individuals with various health issues. Children are not typically included in any of these trials. Pfizer announced that they received approval from the U.S. Food and Drug Administration (FDA) to enroll children as young as 12 years of age in its COVID-19 vaccine trial. The goal is to determine the safety and efficacy of the vaccine in adolescents. “I think this is a really big deal,” said LJ Tan, chief strategy officer of the Immunization Action Coalition. “Without clinical trials actually done in children, the only way to actually extend the use of the COVID-19 vaccine into children would be to rely on the adult data,” which is not ideal. Earlier in the month, Sara Goza, president of the American Academy of Pediatricians, sent a letter to Alex Azar, secretary of the Health and Human Services, and Stephen Hahn, commissioner of the FDA, writing, “Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns.” Goza noted that more than half a million children have been infected with COVID-19 this year and “more than two-thirds of the children who died were Black and Latinx children.” She went on to say that it is unethical “to allow children to take on great burdens during this pandemic but not have the opportunity to benefit from a vaccine, or to delay that benefit for an extended period of time, because they have not been included in vaccine trials.” In an update on its COVID-19 vaccine, Pfizer published that about 43% of overall and 29% of U.S. participants in its trial have diverse backgrounds: in the U.S., 5% are Asian, 10% Black, 13% Hispanic/Latinx, 0.8% Native American and 47% are between the ages of 56 and 85. To date, the Phase II/III trial has enrolled 37,864 people and of them, 31,062 have received their second vaccination. It has 120 sites in four countries, with 39 in the U.S. The Pfizer vaccine was developed by Germany’s BioNTech, and is an mRNA vaccine. No mRNA vaccines have been approved before. Moderna, another leader in the vaccine race, also uses this technology. The vaccine contains a strip of mRNA that codes for the spike protein of the SARS-CoV-2 virus that causes COVID-19. It is encapsulated in a nanolipid particle—essentially a tiny fat molecule—and when injected, tells the body to generate the spike protein, which trains the immune system to recognize the virus. The Pfizer-BioNTech vaccine requires two doses about 28 days apart. Pfizer and BioNTech recently increased their Phase III trial from 30,000 to 45,000 to address the difficulty of enrolling a more diverse patient population. Pfizer and BioNTech have begun a rolling submission of their vaccine candidate to the European Medicines Agency (EMA). The rolling submission allows regulators to evaluate data as it becomes available, which can decrease the time it takes to decide on an approval once the final submission is made. Each cycle of the EMA’s rolling review typically takes two weeks and the duration of the review of the final application will depend on how much data was evaluated during the rolling process. Currently, the Pfizer-BioNTech product appears to be the leader, with possible actionable data available by the end of this month with an emergency use authorization (EUA) request to the FDA potentially in November. In addition, the Pfizer-BioNTech vaccine, dubbed BNT162, appears to have fewer side effects than some of the competing vaccines, such as the one being developed by Moderna and the vaccine being developed by the University of Oxford and AstraZeneca. Ugur Sahin, BioNTech’s chief executive officer and co-founder, told CNN in mid-September, “We don’t see frequent fever. So only a minor proportion of participants in this trial have fever. We see also much lower symptoms like headaches or like feeling tired. And the symptoms that are observed with such vaccines are temporary, they are usually observed for one or two days and then are gone.”
迄今为止,所有针对COVID-19疫苗的主要临床试验都是在成人身上进行的。通常,I期安全性试验是在18至55岁的健康志愿者中进行的。第二期和第三期试验将其扩大到包括55岁以上的人以及有各种健康问题的人。儿童通常不包括在任何这些试验中。 辉瑞公司宣布,他们获得了美国食品和药物管理局(FDA)的批准,允许年仅12岁的儿童参加其COVID-19疫苗试验。目的是确定该疫苗在青少年中的安全性和有效性。 免疫行动联盟的首席战略官LJ Tan说:“我认为这确实是一件大事。”“如果没有真正在儿童身上进行的临床试验,将COVID-19疫苗真正推广到儿童身上的唯一方法就是依赖成人数据,”这并不理想。 本月早些时候,美国儿科医生学会主席萨拉·戈扎给卫生与公众服务部部长亚历克斯·阿扎尔和FDA专员斯蒂芬·哈恩发了一封信,信中写道:“必须将儿童纳入疫苗试验,以最好地了解任何潜在的独特免疫反应和/或独特的安全担忧。” 戈扎指出,今年已有50多万儿童感染了COVID-19病毒,“三分之二以上的死亡儿童是黑人和拉丁裔儿童”。她接着说,“让儿童在这场大流行期间承担巨大负担,却没有机会从疫苗中受益,或者因为他们没有被纳入疫苗试验而延长受益时间,这是不道德的。” 辉瑞在其COVID-19疫苗的最新资料中公布,参与试验的美国人中约有43%的人和29%的人具有不同的背景:在美国,5%是亚洲人,10%是黑人,13%是西班牙裔/拉丁裔,0.8%是美国原住民,47%的人年龄在56岁至85岁之间。 到目前为止,第二/第三阶段试验已经登记了37,864人,其中31,062人接受了第二次疫苗接种。它在四个国家有120个站点,其中39个在美国。 辉瑞疫苗由德国BioNTech公司研发,是一种mRNA疫苗。此前还没有mRNA疫苗获批。疫苗竞赛中的另一个领先者Moderna也使用了这种技术。这种疫苗含有一条mRNA,编码引起Covid-19的新型冠状病毒病毒的尖峰蛋白。它被封装在一个纳米脂质体中--本质上是一种微小的脂肪分子--当注射时,它告诉身体产生刺蛋白,该蛋白训练免疫系统识别病毒。辉瑞生物技术公司的疫苗需要间隔28天接种两次。 辉瑞和BioNTech最近将他们的III期试验从30,000人增加到45,000人,以解决招收更多样化患者群体的困难。辉瑞和BioNTech已经开始向欧洲药品局(EMA)滚动提交他们的候选疫苗。滚动提交允许监管机构在数据可用时对其进行评估,这可以减少最终提交后做出批准决定所需的时间。EMA的滚动审查的每个周期通常需要两周,最终申请的审查持续时间将取决于在滚动过程中评估了多少数据。 目前,辉瑞生物技术公司的产品似乎是领先者,本月底可能会有可采取行动的数据,11月可能会向FDA提出紧急使用授权(EUA)请求。 此外,辉瑞生物技术公司的BNT162疫苗的副作用似乎比一些竞争疫苗要少,比如Moderna公司正在研发的疫苗,牛津大学和阿斯利康公司正在研发的疫苗。 Biontech的首席执行官兼联合创始人Ugur Sahin在9月中旬告诉CNN,“我们没有看到经常发烧。所以在这项试验中只有一小部分参与者发烧。我们看到的症状也要低得多,比如头痛或感觉疲倦。而且用这种疫苗观察到的症状是暂时的,通常观察一两天,然后就消失了。“