update FDA不建议普通成年人广泛注射第三针,但是建议65以上和高危人士注射第三针 === Scientific advisers to the US Food and Drug Administration have voted overwhelmingly not to recommend approving Pfizer’s application to offer a third shot of its Covid-19 vaccine, dealing a serious blow to the Biden administration’s plans to launch a wide-ranging booster programme. Members of the regulator’s vaccine advisory committee voted 16-2 on Friday against endorsing a booster of the BioNTech/Pfizer vaccine for everyone aged 16 or older.
WASHINGTON -- An influential federal advisory panel has soundly rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans. The vote Friday, 61-3, was a blow to the Biden administration's effort to shore up people's protection against the virus amid the highly contagious delta variant. Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses.
Scientific advisers to the US Food and Drug Administration have voted overwhelmingly not to recommend approving Pfizer’s application to offer a third shot of its Covid-19 vaccine, dealing a serious blow to the Biden administration’s plans to launch a wide-ranging booster programme. Members of the regulator’s vaccine advisory committee voted 16-2 on Friday against endorsing a booster of the BioNTech/Pfizer vaccine for everyone aged 16 or older. bigjohn123456 发表于 2021-09-17 15:47
Scientific advisers to the US Food and Drug Administration have voted overwhelmingly not to recommend approving Pfizer’s application to offer a third shot of its Covid-19 vaccine, dealing a serious blow to the Biden administration’s plans to launch a wide-ranging booster programme. Members of the regulator’s vaccine advisory committee voted 16-2 on Friday against endorsing a booster of the BioNTech/Pfizer vaccine for everyone aged 16 or older. bigjohn123456 发表于 2021-09-17 15:47
Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens, and complained about the lack of data about the safety and long term efficacy of a booster dose. the VRBPAC voted 16-2 to not recommend the booster for approval. The FDA has rewritten the question it is asking its advisers. Although the Pfizer vaccine has full approval, the committee will be asked to vote on an emergency use authorization or EUA for a booster. They are being asked to vote on whether boosters should get emergency use authorization for a booster dose six months after full vaccination in people 65 and older and those at high risk of severe Covid-19.
Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens, and complained about the lack of data about the safety and long term efficacy of a booster dose. the VRBPAC voted 16-2 to not recommend the booster for approval. The FDA has rewritten the question it is asking its advisers. Although the Pfizer vaccine has full approval, the committee will be asked to vote on an emergency use authorization or EUA for a booster. They are being asked to vote on whether boosters should get emergency use authorization for a booster dose six months after full vaccination in people 65 and older and those at high risk of severe Covid-19. vitd120 发表于 2021-09-17 16:31
主要原因是数据不足。为了凸显疫苗的作用,CDC没有统计美国的打了疫苗后被突破的比例,只有被突破后重症和死亡的统计。既然据政府的统计重症的95%以上都是没打疫苗的,数据不能支持有打第三针的必要。 政府也是两难,统计突破的比例又会显得疫苗不管用。 The second question is a little harder to answer. Is immunity waning? Are fully vaccinated people becoming, with each day, more likely to become infected? Again, data from Israel indicated that the longer out people were from their first round of immunizations, the more likely they were to suffer breakthrough infections. But there is much less data about this from the United States. That's in no small part because the US Centers for Disease Control and Prevention has not been tracking all breakthrough cases — only those serious enough to put people into the hospital or to kill them. One question VRBPAC will be asking is how much data there is indicating that immunity is starting to drop off among Americans who were among the first to be vaccinated.
update FDA不建议普通成年人广泛注射第三针,但是建议65以上和高危人士注射第三针 === Scientific advisers to the US Food and Drug Administration have voted overwhelmingly not to recommend approving Pfizer’s application to offer a third shot of its Covid-19 vaccine, dealing a serious blow to the Biden administration’s plans to launch a wide-ranging booster programme. Members of the regulator’s vaccine advisory committee voted 16-2 on Friday against endorsing a booster of the BioNTech/Pfizer vaccine for everyone aged 16 or older. bigjohn123456 发表于 2021-09-17 15:47
Pfizer has reported a 92% increase in revenue to $19bn in the second quarter (Q2) of 2021, compared to $9.86bn in the Q2 last year. Revenue: $14.6bn in Q1 2021, Reported net income also grew 45% to $4.9bn for the three months ended 4 April 2021
===
Scientific advisers to the US Food and Drug Administration have voted overwhelmingly not to recommend approving Pfizer’s application to offer a third shot of its Covid-19 vaccine, dealing a serious blow to the Biden administration’s plans to launch a wide-ranging booster programme.
Members of the regulator’s vaccine advisory committee voted 16-2 on Friday against endorsing a booster of the BioNTech/Pfizer vaccine for everyone aged 16 or older.
The vote Friday, 61-3, was a blow to the Biden administration's effort to shore up people's protection against the virus amid the highly contagious delta variant.
Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses.
很好,一直坚决反对第三针,FDA算做了件好事。
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https://www.youtube.com/embed/rsEGC38rhII
真想不到,美国人这么有独立思考能力。
第三针如果能对付delta还可以
是这个道理,这波明显普及两针加戴好口罩就够用了,如果再来一波更厉害的时候再evaluate。
科学家们已经后悔投biden了
我打完辉瑞,以前好掉的湿疹又出来了
等疫苗副作用发作的时候,你就不用来发帖了。
有病得治。
我的黑名单又多了一位。哈哈。
谁说不是呢,莫名其妙。
FDA这批人不用管WHO怎么说,我理解没有批准是因为辉瑞给的数据太少了。
作为一直支持疫苗派,我支持专家坚持原则。
好像现在这个投票只是针对给大众打第三针的,等下还要继续讨论是不是建议给老年人打第三针,那个另外再投票
怎么可能不管WHO,特别是民主党政府。WHO已经明说了反对西方国家打booster,除非全世界国家都有疫苗可打。这不美国政府正在加紧大量采购疫苗准备捐给穷国。好换来WHO支持西方国家打booster
https://www.washingtonpost.com/health/2021/09/17/biden-pfizer-vaccine-global/
即使批了我也坚决不打第三针了,16-2 已经给了我想要的答案。
FDA这些人不是官僚,也只是建议,不是批准的人
16:3不同意的原因,不是因为这个疫苗不安全,而是因为数据不充分。我觉得辉瑞操之过急了
the VRBPAC voted 16-2 to not recommend the booster for approval.
The FDA has rewritten the question it is asking its advisers. Although the Pfizer vaccine has full approval, the committee will be asked to vote on an emergency use authorization or EUA for a booster.
They are being asked to vote on whether boosters should get emergency use authorization for a booster dose six months after full vaccination in people 65 and older and those at high risk of severe Covid-19.
现在这样一搞,以后还有多少人会相信第三针?即使以后批了, 估计愿意打的人也很少。
是 把那些一针没打的打了再说 木桶原理
好消息啊。看第三针的数据,一共测了那么点人,老人也不多,有一个老人还死了。不批准是对的。
上次那个关于pfizer SEC filing的帖子,我有空时查了一下pfizer的press release,他们forecast covid疫苗能赚的income是revenue的20%,但是还需要allocate一些admin cost等等。那个帖子找不到了,就没有回。
肯定是能赚钱的吧,income那么多怎么会没有profit呢
老人的什么时候投票?
是赚钱的,但你要仔细看看他们产品线,疫苗当然并不是最赚钱的,主要靠走量。之前没有仔细关心他家的financials,其实很多可以看。但是没有宣传的这么多就是,他们也没有澄清,还是focus提高产品质量吧。其实他们想赚钱很简单,拓宽国际市场就行了,我觉得加一倍去国际上卖也能卖的出去。
是呀!如果有一半人不打,剩下的人就算疫苗100%有用也没法防止病毒流行。
我还是觉得很赚的,因为走的量也大, 还卖其他国家
你跟viagra对比一下,2019年才0.5billion. 所有的revenue 加起来2019年$51.8 billion
我也不准备打第三针,但担心批了,拜登又要强制第三针了,虽然在不准强制州,但他要来个不打三针不准做飞机什么的,还是挺麻烦的
这个湿疹的问题确实有,但是生命和湿疹之中,我选择生命啊
Fda 就是不管who 的,完全不相干的两个组织。今天会上讨论根本没考虑这个。
我打了pfizer,卵巢failure,把我快气死了。吃了好多重要和针灸, 过了四个月才来例假。
不信的怎么说都不会信。我觉得今天这样挺好的 ,FDA专家组就是要有自己的独立性。也给白宫和CDC出了个好踢,看看他们是不是真的尊重科学。
不过话说回来,如果这个会在川皇在任的时候开,估计这回了川皇已经在发推骂人了。
已经通过了,全票通过
🙏
等下次release的时候我看看,他们没第三针了,肯定要revise guidance。
如果拜登真的尊重科学,他就不会在FDA决定之前大肆推销第三针了,还真以为他有多好,阿富汗,疫苗, 非法移民,哪件事他搞好了,他的支持率已经跌到四十几,老百姓眼睛是雪亮的。
这只是专家委员会的建议,FDA可以听,也可以不听。虽然大多数时候都听。
改了,多谢建议
拜登的民调最低约等于川普的最高
即使FDA强行批准,又有多大用处?大家又不是傻瓜,看见16比2的结果,有几个人会去冒险?
别着急,这才刚开始,拜登还有的时间作出更愚蠢的决定,还会把民主党一起拖下水
是。非常同意。
看看香港打了疫苗怎样:
——————————————————————————————
港府的科学委员会及专家顾问团建议,香港12至17岁青少年只需接种一剂BNT疫苗,主 因是香港出现心肌炎机率比美国高。疫苗可预防疾病科学委员会主席刘宇隆表示,有关 决定是平衡疫苗好处及风险。
刘宇隆今在电台节目表示,6月时曾审视其他国家,包括美国,认为发生心肌炎的概率 不太高,在高风险群组,每2万至3万人才有1例,但香港疫苗接种计划于6月中开放予12 至17岁的青少年打针的3个月内,发现12至17岁群组接种后,出现心肌炎及心包炎的机 率偏高,每几千名接种青年,即有1例,机率比美国高。不过他强调,个案的症状较轻 微,一般住院5至6天就可痊癒,儿童医院已成立特别门诊跟进个案。
刘宇隆又指,8成出现心肌炎的个案均在接种第二剂疫苗后发生,所以只打一剂可大幅 减低风险。不过,他强调,接种安排应留有弹性,若青年需要到外国升学,便可接种第 二剂。他补充,若政府考虑恢復面授课安排,亦可视只接种一剂疫苗的学生为完成接种。
对于青年接种mRNA疫苗后出现心肌炎的原因,刘宇隆说,有很多不同解说,其中一个较 合理的说法是现行剂量对青少年来说偏高。至于个案中以男生占8成、女生占2成的现象 ,暂时无法解释。
刘宇隆透露,科学委员会曾讨论延长接种两剂疫苗之间的时间,或将一剂的剂量分两次 打,但由于涉及更改药厂指示,要交由政府及其他委员会审视。
由于两个专家委员建议青少年只需打一剂BNT,卫生署表示,今日起,若12至17岁青少 年已预约接种第二剂BNT疫苗,可于网路上取消预约。如果有特别需要而选择继续接种 第二剂疫苗,并按预约到达社区疫苗接种中心,在场医护人员将会向他们及其监护人讲 解有关的建议和相关风险,以便他们作出合适决定。
Covid又不是埃博拉,别吓自己
旧金山的一个传染病专家甘地医生,疫情期间常接受本地5台采访的,一直反对给普通人群打booster ,从5月这个话题出现开始就明确反对。 补充一下,她是相信疫苗效果,相信b t cell记忆,即使抗体随时间下降,在人体接触新冠病毒时,会产生有效抗体的。 我的理解是,即使有breakthrough, 对免疫系统正常,注射过疫苗的人,问题也不大,不值得打加强针。靠自身的记忆,接触病毒后激发免疫反应迅速产生新抗体就可以了。 她说抗体逐渐下降是自然的也是必要的,不然感染一下产生抗体,抗体都不减退,日积月累感染不同病毒产生的抗体都累积在那里,血液就太粘了。
有科学原因吗?
看来对生育系统的副作用也不少,年轻人真要小心。
还是有区别的。如果批准了,有的公司和医院就可以要求员工都打第三针了。
就是担心肌炎,现在都在犹豫给不给儿子打这个疫苗
是的,这是承认了疫苗的风险和副作用,要大于免疫力下降导致的covid风险,否则16岁接着打就是了,干嘛要否了
总算现在官方也开始讨论risk benefit了,risk可不是不存在的
觉得随时间推移,疫苗会慢慢淡化了,事实还是会越来越明显,报以巨大希望的疫苗是个失望 估计美国将来可能是至少3针的30%,至少2针的60%,至少1针的80%,0针的20%
的确,第三针先放一边,鼓励大众把第一第二针打了先
+1
+1
大多数FDA的reviewer都是懂science,尊重数据的。就是政府喜欢胡说八道一切为政治服务,把疫苗office的老大都气得走人了
觉得有点混淆视听哈 请看辉瑞今年疫苗的收入再说。 伟哥已经是过气的产品,收入不多很正常
自始至终持反对意见的医生多了去了,只不过官方一直打压媒体一直smear,直到最近口风才变。
75% of U.S. adults have taken at least one dose of COVID-19 vaccine - CDC September 7, 2021 https://www.reuters.com/world/us/75-us-adults-have-taken-least-one-dose-covid-19-vaccine-cdc-2021-09-07/
Pfizer has reported a 92% increase in revenue to $19bn in the second quarter (Q2) of 2021, compared to $9.86bn in the Q2 last year.
Revenue: $14.6bn in Q1 2021, Reported net income also grew 45% to $4.9bn for the three months ended 4 April 2021
第一,75%只不过打了一针不是fully vaccinated,而且只是在成人中,不是所有population的比例。Bloomberg 根据现在的打疫苗速度预测,达到全民75%还需四个月
第二,疫情和去年109%没疫苗时一样吗?无论死亡人数还是感染数,都是比去年大大减少,还是在社会开放,有一个更厉害的Delta毒株的情况下
第三,美国各州疫苗率及其不均。那些疫苗率低下的红州,不是贡献每日case和死亡的大户吗?疫苗率高的州,比如麻省,78%的疫苗率,现在检测阳性率才2%-3%。相比之下,地广人稀的密西西比州,疫苗率50%不到,检测阳性率要16.5%
特效药? 人民的希望? 希望越高失望越大。
很多药在开发和试验阶段呢
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
就跟一胎还没生就逼着人生三胎似的