加州暂时喊停33万支疫苗，moderna又出现强过敏反应

https://www.latimes.com/science/story/2021-01-15/mandatory-covid-19-vaccine-workplace
The fact that the Food and Drug Administration sanctioned the vaccinesthrough an emergency use authorization procedure instead of its usual approval process may also make a mandate trickier.
Vaccines for diseases such as polio, measles and whooping cough have been around for decades, and their track records inspire confidence that they’re safe and effective. The same can’t be said of the COVID-19 vaccine — at least, not yet. 
Fear is a powerful motivator, and the belief that the COVID-19 shots were developed too quickly and haven’t been through enough safety testing “leads to people coming up with more inventive ways to legally challenge a requirement to get a vaccine,” Grossenbacher said.
Even in cases in which a vaccine mandate can be legally enforced, there may be ethical reasons not to, said Ruth Faden, founder of the Johns Hopkins Berman Institute of Bioethics.
For example, a long history of unequal care and outright abuse from medical and public health professionals has given Black, brown and Native communities good reason to be suspicious of a vaccination campaign, Faden said. She calls it “justified distrust.”
Indeed, a survey by the Public Policy Institute of California found that 69% of Black adults in the state would definitely or probably skip the vaccine, along with 43% of Latinos. (By contrast, 35% of white respondents and 30% of Asian Americans shared that view.) 
At the same time, others may have social, cultural or political reasons for not wanting to get vaccinated. For example, the Kaiser Family Foundation poll found that across the country, 42% of Republicans are vaccine hesitant, compared with 12% of Democrats and 31% of people who described themselves as independents.
“Do we want to distinguish between people who we think have a good reason to not want to be vaccinated and those who don’t?” Faden said. “That’s an ethical conundrum and a political nightmare.”
Another factor to consider is that although the two vaccines authorized so far are at least 94% effective in reducing the risk of developing COVID-19, whether they also reduce the risk of transmitting the coronavirus to others has not yet been tested. In some scenarios, that lack of evidence may weaken the ethical imperative for requiring it. 
After all, if a vaccinated teacher can still infect his students, and a vaccinated restaurant worker can spread the virus to her customers, does that diminish the rationale for requiring them to get the shot?
“You have to have a good reason to give people about why it is ethically right for them to subject themselves to a vaccine they don’t want to get,” Ogbogu said.
Data on how effective the vaccines are at stopping the spread of the virus should be coming in the next few months, Faden said. Until then, employers might encourage their workers to get vaccinated but stop short of requiring it, she said.
Ogbogu added that workers who have managed to avoid an infection so far — such as intensive care unit nurses who have been fastidious in using personal protective equipment and following other safety measures — may rightly feel they don’t need a vaccine to keep themselves and others safe. In that case, he said, there is little ethical reason to mandate a vaccine they don’t trust.
CleverBeaver 发表于 2021-01-19 04:13

好消息啊。这么多人主动放弃，别人就有机会了。

那么多来来去去的。 发一些正经和可靠一点的信息好吗？为何没人发加州卫生部直接发给医疗人员的信？
https://www.cdph.ca.gov/Programs/OPA/Pages/NR21-021.aspx
”This week, a higher-than-usual number of adverse events were reported with a specific lot of Moderna vaccine (Moderna Lot 041L20A) administered at one community vaccination clinic. Fewer than ten individuals required medical attention over the span of 24 hours. Follow up investigation of outcomes of these individuals is underway, and more information will be forthcoming.
All appeared to be experiencing a possible severe allergic reaction during the standard observation period – a type of adverse event that the CDC reports some people have experienced when receiving a COVID-19 vaccine. The vaccine site switched to another lot of Moderna vaccine after closing for a few hours.
More than 330,000 doses from this lot have been distributed in the state, and we have not been notified of any other cluster or individual events related to this lot.
The manufacturer, CDC and FDA are promptly reviewing the lot and related medical information. No additional clusters have been reported. Their investigation continues, and we expect to learn more this week. Out of an extreme abundance of caution and also recognizing the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory and pause administration of vaccines from Moderna Lot 041L20A until the investigation is complete.
There are not immediate replacement doses during the pause in addition to pending orders scheduled for shipment in the next few days. We expect to provide an update this week as we learn more.
Providers of COVID-19 vaccine should continue their routine precautions to recognize and manage allergic reactions and potential adverse events.”
让我抓头皮的是：同一个lot, 一共33万针，送到近300个地方去打，全部的反应都只出现在一个clinic而其他地方一个都没有。。。 如果这个lot 有问题，应该所以注射地方都有反应啊？ 这怎么让我觉得要不就是送往这个clinic的路程或者储存罐过程中出了问题，要么clinic里面有人故意做了坏事？ 希望不又是一个anti-vaxxer医疗人员在搞破坏。

那么多来来去去的。 发一些正经和可靠一点的信息好吗？为何没人发加州卫生部直接发给医疗人员的信？
https://www.cdph.ca.gov/Programs/OPA/Pages/NR21-021.aspx
”This week, a higher-than-usual number of adverse events were reported with a specific lot of Moderna vaccine (Moderna Lot 041L20A) administered at one community vaccination clinic. Fewer than ten individuals required medical attention over the span of 24 hours. Follow up investigation of outcomes of these individuals is underway, and more information will be forthcoming.
All appeared to be experiencing a possible severe allergic reaction during the standard observation period – a type of adverse event that the CDC reports some people have experienced when receiving a COVID-19 vaccine. The vaccine site switched to another lot of Moderna vaccine after closing for a few hours.
More than 330,000 doses from this lot have been distributed in the state, and we have not been notified of any other cluster or individual events related to this lot.
The manufacturer, CDC and FDA are promptly reviewing the lot and related medical information. No additional clusters have been reported. Their investigation continues, and we expect to learn more this week. Out of an extreme abundance of caution and also recognizing the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory and pause administration of vaccines from Moderna Lot 041L20A until the investigation is complete.
There are not immediate replacement doses during the pause in addition to pending orders scheduled for shipment in the next few days. We expect to provide an update this week as we learn more.
Providers of COVID-19 vaccine should continue their routine precautions to recognize and manage allergic reactions and potential adverse events.”
让我抓头皮的是：同一个lot, 一共33万针，送到近300个地方去打，全部的反应都只出现在一个clinic而其他地方一个都没有。。。 如果这个lot 有问题，应该所以注射地方都有反应啊？ 这怎么让我觉得要不就是送往这个clinic的路程或者储存罐过程中出了问题，要么clinic里面有人故意做了坏事？ 希望不又是一个anti-vaxxer医疗人员在搞破坏。
drugdealer 发表于 2021-01-19 08:13

这也是我看到新闻的第一反应。如果是某个批次出问题，为什么只有这一个诊所chua chua chua地爆过敏反应？这个调查应该优先检查诊所里剩下的疫苗的情况。

这年头 说句不反智的 质疑下疫苗试验设计 说说疫苗副作用就是五毛 我也是很无语的


miss6161 发表于 2021-01-18 18:54

请问下你是专业人士吗？做疫苗clinical trial 这块的吗？很想请教下专业人士一些问题

不给小孩打 做什么clinic trail 自欺欺人何必呢
miss6161 发表于 2021-01-18 20:50

呃。。看来不是专业人士呢 Btw Clinical trial, not trail

这也是我看到新闻的第一反应。如果是某个批次出问题，为什么只有这一个诊所chua chua chua地爆过敏反应？这个调查应该优先检查诊所里剩下的疫苗的情况。
coalpilerd 发表于 2021-01-19 09:42

集中在一个地方出现这种情况确实很可疑，完全不像随机事件

在华人上 不能说辉瑞和moderna疫苗不好 不然你就是五毛！
miss6161 发表于 2021-01-18 17:59

还好FBI抓了一批闹事的川粉，消停点了。
华人上的一帮专门咬人的，要是也全送进去，华人恶风也就消停了。
我观察这些咬人帮一共也就百十头吧，多数都是挺川的，少量反共反华的和极个别台湾绿。

excuse me？何必自欺欺人呢 clinical trail难道不是为了接下来大批孩子接种服务的？不然trail了玩吗？
miss6161 发表于 2021-01-18 22:03

啥意思？你说是不该研制给小孩子的疫苗呢，还是说给小孩子研制的疫苗不用trial？
现在全世界的娃生下来都一堆疫苗打上，你的意思是那些疫苗都是没经过儿童trial的，还是说你活在一个娃都一个疫苗不打的旮旯？

自从faa和波音站一起以后 我就不信fda了 fda也是被华尔街绑架了 moderna被用来拉股票
miss6161 发表于 2021-01-18 18:52

FDA肯定不是完美的，像70年代批准过的抑制孕吐的药最后发现可能导致胎儿畸形。然后赶紧喊停。所以现在很多新药的要求都很高，基本一个新药从discovery到FDA批准要5-10年。现在新药的开发pipeline， 从毒理到三期临床试验这个framework，纸面政策中国都是copy欧美的。总体来讲，FDA还是以看数据为准。当然有时候短期之内必须做出决定，像现在疫苗的这个情况，只好take risk加快速度审批也是有的。 但比中国zf或者FDA实在是强太多。CFDA大规模造假，腐败，不看数据乱批准药都是出现过很多次的 不光CFDA，整个中国数据又有多少是透明和trustable的呢。

回复 108楼aeolous的帖子
搞错了，那是欧洲批准的药，美国FDA不批，后来欧洲出事了，FDA从此声名大振！你搞反了。
美国医药公司很多到最后一刻不批准的，FDA真的在捍卫世界人民的健康，如果不夸张的说。

打完了 胳膊酸了两天 其他没啥

回复 108楼aeolous的帖子
搞错了，那是欧洲批准的药，美国FDA不批，后来欧洲出事了，FDA从此声名大振！你搞反了。
美国医药公司很多到最后一刻不批准的，FDA真的在捍卫世界人民的健康，如果不夸张的说。
blueridgefall 发表于 2021-01-19 13:18

现在的好像倒过来了 fda先批 欧洲再跟进

谁暂停疫苗是那就是妥妥的5毛，应该滚去中国，这个逻辑没错吧?

FDA肯定不是完美的，像70年代批准过的抑制孕吐的药最后发现可能导致胎儿畸形。然后赶紧喊停。所以现在很多新药的要求都很高，基本一个新药从discovery到FDA批准要5-10年。现在新药的开发pipeline， 从毒理到三期临床试验这个framework，纸面政策中国都是copy欧美的。总体来讲，FDA还是以看数据为准。当然有时候短期之内必须做出决定，像现在疫苗的这个情况，只好take risk加快速度审批也是有的。 但比中国zf或者FDA实在是强太多。CFDA大规模造假，腐败，不看数据乱批准药都是出现过很多次的 不光CFDA，整个中国数据又有多少是透明和trustable的呢。
aeolous 发表于 2021-01-19 12:49

反应停欧洲上市，美国FDA阻止上市。
40年代。