疫情
全世界
今天全球确诊人数已经1亿5499 万了，死亡人数已经324万。
今日新增确诊 77.6万人，新增死亡 1.3万人，这是每日新增人数的曲线变化：
美国
美国CDC官方报道， 今日新增病例3.2万，新增死亡404。确诊人数已达3226万，死亡人数57.4万。
加州今天新增确诊1349例，死亡新增2例。
Alameda今天新增确诊 1204例 ，死亡人数新增 19 例。
疫苗：
Dublin是1713 例，新增23例。
今日话题
辉瑞疫苗临床实验文件分析
辉瑞疫苗的临床实验文件我已经拿到好几天了，应该分享过其中的一小段。
不过今天小明出了个视频，专门分析这份文件中的一个关于接触传染上报流程的章节，他详细分析了其中的句子，这些都是些让人细思极恐的。由于视频里的字体不是很清晰，我也想知道有没有那么可怕，所以也就把这个文件拿出来再看一下那个章节。
我把相关原文贴在这里，不再翻译，免得让不靠谱的翻译影响了大家的判断。
说到Exposure During Pregnancy，文件里是这么定义的：
【An EDP occurs if:
- A female participant is found to be pregnant while receiving or after discontinuing study intervention.
- A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception.
- A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure. Below are examples of environmental exposure during pregnancy:
- A female family member or healthcare provider reports that she is pregnant after having been exposed to the study intervention by inhalation or skin contact.
- A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception. 】
确实跟小明中文描述一样，刻意强调了呼吸和皮肤接触两种暴露方式，难道真的如小明猜测的那样，疫苗进入体内能催发产生可以通过皮肤或者呼吸传染给别人的东西？这不仅让我想起最近在一些群里看到的实例，一些没接种疫苗的女性抱怨接触了接种过疫苗的人之后她们的生理期会出现超大的血块，跟以往很有些不同。
可是这些人接触的应该都是这次主动去打疫苗的一般小白鼠，应该不属于官方登记在册的参与临床实验的实验对象，所以不知道她们该如何上报这种情况。
上报呢，也是需要24小时之内上报：
【The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s awareness, irrespective of whether an SAE has occurred. The initial information submitted should include the anticipated date of delivery (see below for information related to termination of pregnancy).
• If EDP occurs in a participant or a participant’s partner, the investigator must report this information to Pfizer Safety on the Vaccine SAE Report Form and an EDP Supplemental Form, regardless of whether an SAE has occurred. Details of the pregnancy will be collected after the start of study intervention and until 6 months after the last dose of study intervention.
• If EDP occurs in the setting of environmental exposure, the investigator must report information to Pfizer Safety using the Vaccine SAE Report Form and EDP Supplemental Form. Since the exposure information does not pertain to the participant enrolled in the study, the information is not recorded on a CRF; however, a copy of the completed Vaccine SAE Report Form is maintained in the investigator site file.】
关于后续跟进，文件里是这么说的：
【Follow-up is conducted to obtain general information on the pregnancy and its outcome for all EDP reports with an unknown outcome. The investigator will follow the pregnancy until completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural integrity of the neonate can be assessed at the time of birth. In the event of a termination, the reason(s) for termination should be specified and, if clinically possible, the structural integrity of the terminated fetus should be assessed by gross visual inspection (unless preprocedure test findings are conclusive for a congenital anomaly and the findings are reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly), the investigator should follow the procedures for reporting SAEs. Additional information about pregnancy outcomes that are reported to Pfizer Safety as SAEs follows:
• Spontaneous abortion including miscarriage and missed abortion;
• Neonatal deaths that occur within 1 month of birth should be reported, without regard to causality, as SAEs. In addition, infant deaths after 1 month should be reported as SAEs when the investigator assesses the infant death as related or possibly related to exposure to the study intervention.
Additional information regarding the EDP may be requested by the sponsor. Further follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on preterm infants to identify developmental delays). In the case of paternal exposure, the investigator will provide the participant with the Pregnant Partner Release of Information Form to deliver to his partner. The investigator must document in the source documents that the participant was given the Pregnant Partner Release of Information Form to provide to his partner.】
跟小明的理解也差不多。我就有疑问了，如果是这种暴露引起的副作用，难道就不算是疫苗引起的异常情况了？那么这些“吸二手烟”的受害者就无法得到一个公正了？不过想想，EUA让辉瑞公司免责了，那些吸一手烟的都无法控告它，更别说吸二手烟的人了。
【 the structural integrity of the neonate】里的neonate不认识，导致我理解不了指的是啥的结构完整性，一查字典，哦，新生儿。难道说有可能的严重后果是导致新生儿畸形？缺胳膊少腿？倒是真的看到过新生儿不正常的案例。那个案例没找到链接，不过倒是有提造成流产等现象的。
其实我觉得最让人心惊的是这一段，第70页的8.3.7节，对预料之中的病症不会上报：
【Potential COVID-19 illnesses and their sequelae that are consistent with the clinical endpoint definition should not be recorded as AEs. These data will be captured as efficacy assessment data only on the relevant pages of the CRF, as these are expected endpoints. Potential COVID-19 illnesses and their sequelae will not be reported according to the standard process for expedited reporting of SAEs, even though the event may meet the definition of an SAE. These events will be recorded on the COVID-19 illness pages in the participant’s CRF within 1 day. 】
而它的endpoint是这么定义的：
我没怎么看明白，第一期临床实验里endpoint一栏，写着AE和SAE，难道这些不正常反应都算正常现象？不用上报？
今天太晚了，还有一段关于母乳喂养的暴露问题的，明天接着研究。
今天看到大学的通知，说今年秋季入学时要求全校师生都打疫苗，这真的是没一点儿自由了。我得研究一下如何让孩子避过去。
百花齐放论盖茨夫妇
今天好多人分析盖茨夫妇的离婚，有些分析很有意思：
其实，我相信梅琳达是个狠人，曾经有人扒过这对夫妇的料，只能扒到她父亲，而且她父亲是个很神秘的人物，网络上除了说是阿波罗航天计划的工程师外，几乎没有什么其他明显的材料，但那人深挖下去，还是挖到很多官方登记材料里提到了梅琳达的老爹，应该掌控着不少家公司呢。她母亲就没挖出来，只说是个家庭妇女，更别说再上一辈的事迹了。
有很多人分析过盖茨夫妇的肢体语言，都得出过结论，俩人尤其是梅琳达对周围的人（也即访谈节目里出现的其他人）都是很蔑视的态度，有一种高高在上的优越感。
我前两天刚看了有关CIA的Paper Clip项目的节目，会不会航天计划的工程师是从战败的德国弄来的？偷名换姓开始了在美国的新生活？遇上CIA，一切皆可造假哈。
明天有大事发生？
今天代表川普总统打选举舞弊官司的Jenna Ellis今天发了个推文：
【BIG ANNOUNCEMENT coming tomorrow morning on the effort for election integrity in America!
Did you really think we weren’t working on this?】
明天一大早有大的关于美国选举完整性的声明。你以为我们啥都没做吗？
言下之意，现在到了收官时刻了。
坐等明天的大瓜。
今日分享
记得刚开始看猪妹的节目时，觉得她的节目有点儿玄幻，都不知道哪里来的资料，看得人一愣一愣的。不过最近看到听到的东西多了，就不觉得她说的有多玄幻了。
虽然最近看她的节目，还是能看到一些不知哪儿来的材料，但越来越多的东西是已经从不同渠道看到过的。希望她说的另外一些东西也真的在发生哈，就像CIA的Looking Glass项目发现的那样，各个时间线要在汇聚一起了，不论你接受不接受，很多事情的真相和谣言都要展示在大家面前了。
打赏作者
码字不易，谢谢鼓励。一杯茶水钱，胜似千千万。