“Researchers haven’t found any serious safety issues, the companies said. The vaccine appeared to be well tolerated following a review of data from 8,000 study subjects, the companies said. A severe side effect was fatigue, reported by 3.8% of the subjects, the companies said. Also, 2% of subjects reported headaches.” https://apple.news/AvKQN6ueqS0uVocxc1Q_KWg 只能说这4%的志愿者被放大了
回复 1楼nehz的帖子 Pfize:3.8% of participants experienced fatigue By Reuters Staff NEW YORK (Reuters) - Pfizer Inc on Tuesday updated its analysis of the safety profile of its COVID-19 vaccine seen during its large, late-stage trial, saying that 3.8% of participants experienced fatigue after receiving a second dose of the shot. It said the updated analysis was based on 8,000 trial participants. Pfizer said in a previous analysis that 3.7% of 6,000 volunteers had experienced fatigue. Pfizer also added that there was a second adverse event with a frequency of at least 2% in the trial. The U.S. drugmaker said 2% of participants experienced headaches after the second shot.
Pfizer 的详细数据: To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination. 今天中国灭活疫苗发表的一期数据 In the phase 1 trial, the overall incidence of adverse reactions was seven (29%) of 24 participants in the 3 μg group, nine (38%) of 24 in the 6 μg group, and two (8%) of 24 in the placebo group in the days 0 and 14 vaccination cohort; and three (13%) of 24 in the 3 μg group, four (17%) of 24 in the 6 μg group, and three (13%) of 23 in the placebo group in the days 0 and 28 vaccination cohort, with no significant difference seen among the three groups for both vaccination schedules (figure 2; appendix 2 pp 5–6). The most common symptom was injection-site pain, which was reported by four (17%) participants in the 3 μg group, five (21%) in the 6 μg, and one (4%) in the placebo group in the days 0 and 14 vaccination cohort and three (13%) in the 3 μg group, three (13%) in the 6 μg group, and three (13%) in the placebo group in the days 0 and 28 vaccination cohort. Most adverse reactions were mild (grade 1) in severity and participants recovered within 48 h. Only one case of acute hypersensitivity with manifestation of urticaria 48 h after the first dose of study drug was reported in the 6 μg group (one [4%] of 24) in the days 0 and 14 vaccination cohort, which was graded as severe and considered to be possibly related to vaccination. The participant was given chlorphenamine and dexamethasone and recovered within 3 days, and no similar reaction was observed after the second dose of vaccine. No vaccine-related serious adverse events were noted within 28 days of vaccination (figure 2; appendix 2 pp 4–5).
下面两篇新闻里的participants都描述了相同的反应,first dose后有一天的low fever,not big deal, 2nd dose后high fever,大部分都推荐second dose后卧床休息一天。我不是学生物的,不知道生物实验placebo组是不是会给同样反应的药物。
如果下面这些描述不是个例,那Pfizer和moderna股票我觉得还得掉一掉。
https://www.google.com/amp/s/www.cnbc.com/amp/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.html
https://www.google.com/amp/s/www.wfaa.com/amp/article/news/health/coronavirus/here-are-the-side-effects-you-might-feel-from-a-covid-vaccine/287-f938e648-4ae8-4ed4-bf71-7ecb2a674b3f
🔥 最新回帖
每个人都有自己选择的权力,你不打是你的自由,别人也有选择打的权力,同样受尊重。没有牺牲自己勇做人肉小白鼠的志愿者们,医药水平还停留在中世纪,我们应该致敬这些人。
Last time I checked mRNA-based vaccines against MERS were also in moderna’s pipeline
not sure what happened to them
因为做疫苗不赚钱呀,你以为呢? 还什么“mRNA疫苗发明几十年了” -- 这么不严谨的表述又是哪个中文媒体给灌输的?
🛋️ 沙发板凳
而且没看文章说的吗,就算有反应,it’s worth it!
再说了,每个人对疫苗都会有不同的反应,就连普通流感疫苗都会有人打了发烧,有人打了一点没反应。打不打是每个人自己的选择,没有必要特意跑上来唱衰。流感疫苗都有好多人选择不打。
https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.html
层主为什么会有这个希望? 很难理解。
不是打架啊,是说打疫苗,这么好的疫苗当然要以身作则
是啊,我也这么想的,国内的疫苗,大家不也说让领导们先打吗?就跟做河豚的厨师,要自己先尝一口以示无毒,才好让食客们开吃一样。
免疫系统产生干扰素的时候会有一些像流感一样的症状,不是特别大的事情。Pfizer和Moderna都能产生远远高于自然感染的免疫反应,当然会有一些副作用。这点副作用和新冠病毒的危害性比起来是不值一提的,别忘了即使是年轻人的无症状感染,都会有很多人有心肌损害。
PS:这就是为什么到现在还没有一个药厂敢做12岁以下小孩的疫苗实验,Pfizer直到最近才开始招12-18岁的志愿者。
这位大姐,你看看报道的时间,疫苗结果还没出来的时候好吗,人家说的worth it是对未知疫苗献身做实验是worth it,不是已知疫苗有效,然后疫苗side effects可以忽略不计的worth it。
我怎么就唱衰了,我只是就事论事,这个论坛只允许单方向讨论吗?一点辩证思考都容不得了吗?那你不如回中国去。
我也肯定打,外面那么多人无症状感染,自己不打疫苗就恢复正常生活,那是置自己身于险地。
关于mRNA疫苗技术和历史,WSJ这两天有篇不错的科普文章。 https://www.wsj.com/articles/moderna-and-pfizer-are-reinventing-vaccines-starting-with-covid-11605638892
不愿意读英文的下面有翻译版: https://legendowl.com/2020/11/17/moderna-and-pfizer-are-reinventing-vaccines-starting-with-covid/
那篇心肌损伤的文章你没读懂。无症状根本不会去查心肌损伤好嘛?
楼主家没孩子吗?小孩打了各种疫苗,都有可能发烧的,都是正常反应。
我儿子从小打感冒疫苗就有反应,小时候要发烧两天。今年有进步,只低烧一上午就好了。
确实是,搞研发得,其实压力大得狠,特别是这种,剑在弦上,多少眼睛盯着,不容易。我觉得从研发到高层肯定都会谨慎对待,但是确实时间比较仓促,有的东西他们即使想做也没有时间做,这个也不是他们想控制也控制得了的。
今年我们家flu shot都有发烧,往年不记得了。
这次mRNA技术的疫苗是不含病毒的,不是传统的减毒/灭毒疫苗,所以更安全。
mRNA最大的问题是没有前例。 疫苗原本就是对安全性要求最高的,现在用一个没有时间检验的新技术,而且临床试验观察期明显不够,还要大面积接种,这实在是不让人放心。
一个大型药企里做survey,要第一时间打的人比例相当低
Yeah
昨天就跌掉一半
这个也很有可能是对的
所以才吓人
这个疫苗就是用来圈钱的。药厂高管和建制派的政客。大家小心吧。别那么容易被洗脑。
完全这么说可能不妥当,但是目前的结果有点早
看上去两边的志愿者虽然都是应该接触病毒而不是关在家里的,但是实际感染率很低,哪怕是对照组,那估计是采用了某个防止感染的措施,比如口罩,那我们其实呼吁多戴口罩,也是会比现在好很多了
今天确实mrna的股价又跌了
隔壁小道消息说placebo是反应很小的 treatment是要在床上躺一两天的
那就不双盲了
就怕有长远的副作用短时间没发现。会等一段时间再打。不过估计普通人能打上还得过一段时间。
总体我还是对疫苗持positive的态度。不相信政客但是相信广大药厂科技人员和医务人员的职业操守。
这个疫苗的重点, 并不是小的发烧局部红肿之类的反应吧, 重点难道不是mRNA?目前世界上还没有过mRNA用于临床,所以现在还没人敢大胆说mRNA 疫苗是安全的吧?
Pfize:3.8% of participants experienced fatigue
By Reuters Staff
NEW YORK (Reuters) - Pfizer Inc on Tuesday updated its analysis of the safety profile of its COVID-19 vaccine seen during its large, late-stage trial, saying that 3.8% of participants experienced fatigue after receiving a second dose of the shot.
It said the updated analysis was based on 8,000 trial participants. Pfizer said in a previous analysis that 3.7% of 6,000 volunteers had experienced fatigue.
Pfizer also added that there was a second adverse event with a frequency of at least 2% in the trial. The U.S. drugmaker said 2% of participants experienced headaches after the second shot.
像医院一样,不打疫苗的人需要强制带口罩。总会有一些人因为健康原因不能打,这样对自己对社会都比较负责
今天中国灭活疫苗发表的一期数据 In the phase 1 trial, the overall incidence of adverse reactions was seven (29%) of 24 participants in the 3 μg group, nine (38%) of 24 in the 6 μg group, and two (8%) of 24 in the placebo group in the days 0 and 14 vaccination cohort; and three (13%) of 24 in the 3 μg group, four (17%) of 24 in the 6 μg group, and three (13%) of 23 in the placebo group in the days 0 and 28 vaccination cohort, with no significant difference seen among the three groups for both vaccination schedules (figure 2; appendix 2 pp 5–6). The most common symptom was injection-site pain, which was reported by four (17%) participants in the 3 μg group, five (21%) in the 6 μg, and one (4%) in the placebo group in the days 0 and 14 vaccination cohort and three (13%) in the 3 μg group, three (13%) in the 6 μg group, and three (13%) in the placebo group in the days 0 and 28 vaccination cohort. Most adverse reactions were mild (grade 1) in severity and participants recovered within 48 h. Only one case of acute hypersensitivity with manifestation of urticaria 48 h after the first dose of study drug was reported in the 6 μg group (one [4%] of 24) in the days 0 and 14 vaccination cohort, which was graded as severe and considered to be possibly related to vaccination. The participant was given chlorphenamine and dexamethasone and recovered within 3 days, and no similar reaction was observed after the second dose of vaccine. No vaccine-related serious adverse events were noted within 28 days of vaccination (figure 2; appendix 2 pp 4–5).
这两个RNA疫苗也都是无一例严重不良反应啊。 发烧头疼乏力都不算严重不良反应啊。
方舟子 @fangshimin · 6m 我昨晚的节目才说按目前的感染速度预计辉瑞疫苗和莫德纳疫苗临床试验这个月底能有足够感染人数结束试验,一觉醒来发现辉瑞疫苗试验已有170人感染,试验结束了。其中疫苗组8人感染,对照组162人感染,疫苗保护效力95%。美国政府给了辉瑞公司19.5亿美元买下1亿剂疫苗,美国人将免费接种。明年大规模接种
我也是不在意这些不良反应,身体有些不舒服忍忍就过去了。就是RNA疫苗以前没做过,虽然理论上无害,都会被降解掉,但人体这么复杂,不知道是不是会有科学家们没想到或者没发现的long term 副反应。有懂行的说一说吗?
只能两害取其轻了。实在害怕的人可以继续呆在家里。这个世界很多事情就是要take risk的,就像开车坐飞机都有风险,但是不用车不坐飞机人生会少了很多乐趣。
Moderna最早进一期临床的mRNA疫苗是2017 年, 至少这几年在最早的志愿者身上没发现严重副反应。
看到这么多川粉反对我就放心了
两万多志愿者(不全在美国)两个礼拜感染了快一百不包括无症状 不算低了
这是一个reasonable concern,楼主说的都是屁大点的事儿。长期不良反应的确是个问题,特别是如果新冠病毒清除不了,就有可能年年打,这样长期使用疫苗有没有可能引起癌症一类的病变,这些确实是一些问题。但目前看来,先解决新冠的传染,打一次风险还是值得的,以后还是要看长期追踪的研究结果。
No. 产生不产生抗体与有没有感觉到的反应没有必然联系
我每年flu都不打,因为我觉得打了没用,得了流感也没那么可怕。
但是这个疫苗我肯定打。
mrna疫苗相当于把个敌人头的照片给你,然后你的身体根据照片制造了很多敌人的头。你的免疫系统把这些人头消灭的同时,也记住了这个长相。以后真的敌人进来,免疫系统一看他们的头就会记起来,就会第一时间揍他们。
这里有一个用自己的身体制造敌人头的过程,至于会制造多少敌人头不是能控制得了的。你的免疫系统如果反应慢了,那就会有很多敌人头被制造出来,那消灭起来就会花费更多功夫,免疫反应就会更大,身体就会表现出更强烈的”症状“。但头就只是头,照片本来就只照了个头,你的身体没有半点机会把完整的敌人造出来,只有个头没有身体没有器官不会有攻击性。所以哪怕造了很多头也不会对你有什么伤害。
灭活疫苗相当于预先把很多敌人杀死,把成千上万的尸体给你。然后你的免疫系统在处理这些尸体的同时,记住了这个样子,以后敌人进来一看和尸体很像就去攻击他们。但问题在于尸体就是尸体,死了之后样子也有点不一样了,你的免疫系统对其没那么高的兴趣,处理起来懒懒散散的,所以一般最后的免疫反应都比较弱。下次真敌人进来,只处理过尸体的免疫系统可能还是没法很好地认出他们。
mrna疫苗还有一大好处就是只需要给你一点照片,你的身体就可以根据照片造出很多人头。照片造起来分发起来,理论上比批量生产敌人尸体容易多了。所以虽然现在大家缺乏批量生产mrna疫苗的经验,但是从原理上来说这是一种很适合scale up的疫苗。
我不明白,对一个新出来的疫苗有些问题,有些顾虑,怎么就是唱衰了?
这个论坛里有讨论房子,股票,教育,甚至一口锅都有人说好说不好。怎么到了疫苗就只能说好了?
吓人,既然是自己制造敌人,难免混了自己的信息进去,然后自己消灭敌人也记住了自己是自己的敌人。妥妥引发自体免疫疾病。
国内领导们打进口疫苗 老百姓打国产的 呵呵
That is a possibility
最普通的流感疫苗,一样有人打了会低烧
人家里有老人小孩啊。你家就你一个的话,你当然不在乎。
每个RNA病毒都是用人体自己的材料复制啊。疫苗是一段不能自己复制的mRNA,表达出病毒身上的一个蛋白的一部分然后就降解了;病毒是一段能无限复制不断突变的RNA,源源不断的在你的体内用你的细胞表达出一大堆异体蛋白,然后这个细胞死掉让病毒跑出来进入新的细胞,这个过程会引起一系列损害和免疫反应。无法理解为什么有人宁愿感染病毒都不想打疫苗。。。