【讨论】猪流感疫苗：打还是不打？

[sage]

俺村的疫苗下周一开始。目前可以优先打的人有：

• 6个月－65岁有病史的
• 孕妇
• 健康的6个月－5岁儿童
• 医务工作者
• 护理6个月以下新生儿或者免疫系统有问题者

孕妇还可以选择不含辅助剂的猪流感疫苗，会在11月中旬出来。

[sage]

加拿大今年的猪流感疫苗是加了辅助剂的，只用了普通不加辅助剂1／4的抗原。副作用就是在注射的地方容易发红，对人体倒是似乎并没有太大影响。

我们姑娘们的PD说会尽量推迟打这个针的时间，先观望一段。

[sage]

作者: redboy2000

辅助即是什么？为什么加辅助记的反而抗原少很多？

辅助剂就是一种增强疫苗效果的东西，通常都在抗原缺少的情况下使用。
美国的猪流感疫苗没有加，但主要还是为的是加快疫苗批准速度。
今年加拿大的猪流感疫苗是添加了辅助剂的，而且是制药商(GlaxalSmithKline)自己的一种辅助剂，叫AS03。据说很安全，在欧洲已经使用了十几年了。不添加辅助剂的疫苗十一月中才会出来，是专门给孕妇使用的。

看看下面的文章：sample size太小了，而且还有很多未知数。我打算再等等。

September 14, 2009

Helen Branswell, Medical Reporter, THE CANADIAN PRESS

TORONTO - A shot of swine flu vaccine that is about a third of the size of a standard dose is protective when boosted with an additive called an adjuvant, Canada's pandemic vaccine manufacturer said Monday.

The ability to use one dose - and a small one at that - should both speed up the time it takes to fill an individual country's order and stretch limited global supplies of pandemic vaccine, experts have said.

Results of a clinical trial conducted in Europe by GlaxoSmithKline showed that 98 per cent of adults who received a single shot containing 5.25 micrograms of vaccine and the company's AS03 adjuvant had a spike in antibody levels thought to signal protection.

While a number of other companies have already shown that one shot of pandemic vaccine will likely protect most people, this is the smallest dose size that has been shown to be protective. Other companies have demonstrated that 15 micrograms of vaccine without adjuvant or 7.5 micrograms with adjuvant will probably protect against the new virus.

However, this trial does not answer the question of whether the dose GSK hopes to sell to Canada will work.

The company plans to sell a formulation containing 3.75 micrograms of antigen (vaccine) plus adjuvant. A statement from GSK said the formulation tested was "comparable to the expected final formulation of the adjuvanted vaccine."

An influenza expert said that may be true, but the company still needs to generate data showing that the smaller dose will work as well.

"The truth of the matter is if you have good immunogenicity with a 5.25 mcg dose, then, yeah, probably 3.75 mcg is going to be not bad. But it's clearly better to have data with the real dose," said Dr. Allison McGeer, an influenza expert at Toronto's Mount Sinai Hospital.

"The best data is obviously immunogenicity data that is as close as you can get to the actual vaccine that's being produced."

The Public Health Agency of Canada said these results and others released last week are promising but are not the final answer on dosing requirements.

"These preliminary results to date show that the vaccines help to protect people from the H1N1 strain. We will need additional data before making any final decisions about safety and effectiveness," Jirina Vlk, a spokeswoman for the agency, said in an email.

Though evidence is mounting that one shot of vaccine will protect adults against the novel H1N1 virus, Vlk said the public health agency is still hedging its bets. "Prudence dictates that we continue planning for a two-dose regime until we have more conclusive information on which to take a decision."

GSK did not explain in its release why it tested 5.25 mcg of vaccine with adjuvant and 21 mcg without. Neither dose size is among those routinely chosen for testing. Generally speaking clinical trials look at doses that are some fraction or multiple of 15 mcg, the amount of antigen per strain contained in a seasonal flu shot.

But the company said in an email that the clinical trial was started before standardized reagents - tests used to determine the concentration of vaccine - were available from the World Health Organization. Rather than wait for the standardized reagents, the company used alternative tests that appear to have led to higher-than-intended doses.

"Based on GSK's experience with its adjuvants systems, we do not anticipate that there will be any significant difference in the immune response elicited by the final formulation," GSK said in the email.

The GSK release also did not reveal whether there were any side-effects seen or how frequently they were reported. Studies done by other vaccine manufacturers have reported a side-effect profile for swine flu vaccine that is similar to what is seen with seasonal flu shots, mainly sore arms.

The release did say, though, that the findings have been shared with regulatory authorities and additional studies will be done in Europe, Canada and the United States.

"This trial provides encouraging data on the potential use of a single dose of our pandemic vaccine," said Jean Stephenne, president GlaxoSmithKline Biologicals.

"Our next step is to complete this trial, as well as 15 other studies in our clinical development programme for the vaccine."

The trial took place in Germany and involved 130 healthy volunteers 18 to 60 years old. GSK has two flu vaccine manufacturing facilities - one in Dresden, Germany and the other in St-Foy, Que. The latter will supply Canada's pandemic vaccine.

The company said 98 per cent of volunteers who got the small dose with adjuvant had antibody levels that exceeded what regulatory agencies consider is protective when tested three weeks after the shot was administered. Among those who got the larger dose of unadjuvanted vaccine, 95 per cent reached the same threshold.

Last week Novartis, Sanofi Pasteur and CSL Limited announced that their vaccines were protective with a single dose. And studies done by the U.S. National Institute of Allergy and Infectious Diseases showed that antibody levels reached the predicted protective threshold within eight to 10 days after one shot, which is very quick for vaccine.

Source: http://www.whistlerquestion.com/arti...template=cpArt

[sage]

作者: bmx

Very Sad: Cheerleader Gets A Flu Shot & Now She Can Only Walk Backwards ... ("http://video.google.ca/videosearch?source=ig&hl=en&rlz=1R2SKPB_enCA349&...

太奇怪了，跑着没事，甚至讲话都正常。
可怜呀。

[sage]

作者: 美麗無罪

我之前就是在youtube看到这个美国女子的问题，就更令我对这个新疫苗有质疑了

我今天还在收音机里听说普通流感疫苗会引发MS？
真是什么怪事都有，谣言都满天飞了。

[sage]

我家俩大人肯定会打，Emma嘛，再等等。
就是现在打针要排大队呀。俺村今天一开张5个注射点竟然爆满，提前关门了。

[sage]

作者: 快乐妈妈

我家打了几年疫苗都没啥反映，昨天和掌柜的说了，好像大家都在观望，今年我们就再等等。掌柜的说了，管别人干嘛，好东西自己享受就行了，有的人连政府规定的都不打呢。我们决定去打了。

打完后上来知会一声。
我们村现在就是想打也要排大队。

[sage]

作者: 红樱桃，绿芭蕉

到底都是大城市的人啊。
我这乡下，方圆5里没人的地儿，我如今都没机会亲密接触一下得过swine flu的人，连耳朵都没听说过谁swine了。
我LG公司有police，说是要是一个办公室有人swine了，整个办公室都可以放假1周。
我这日日夜夜的盼着呢。

你们是高危群体，住偏远地方的都可以提前打。

[sage]

作者: ForeverYoung

刚给89约了儿科医生，下周四打疫苗。

俺村还没散疫苗给医生呢，说货源不够。

[sage]

作者: ForeverYoung

幼儿不是优先吗？儿科医生应该先配才对。我其实也是犹豫的不得了，815说打了好，孩子太小，都在daycare，风险大，那就打吧。

http://www.chinasmile.net/forums/sho...d.php?t=432522

刚收到朋友发来的，觉得不错。我也决定给Emma打了。

[sage]

作者: 十之八九

昨天去OB那里，她让我去医院打疫苗，因为医院就在隔壁，我也想看看生产的环境，就过去了，在医院生产病房那一层，有专门接待的人给孕妇打针，还只给孕妇打，我刚走过去，她就问我名字，然后给了一个表和说明，我想OB说要打就打了算了，填了表，顺便看看说明，结果发现要打的是adjuvant的，我刚在这个星期上产前...

你什么时候有老二的？
目前只有孕妇才有选择打添加佐剂或者不加佐剂的针。
新孕妇和月份大的危险更高，建议大于20周孕期的现在就打加了佐剂的。佐剂里其实就是些深海鱼油，维生素E什么的。破伤风和乙肝疫苗里都加佐剂的。
这里面有详细介绍：http://www.phac-aspc.gc.ca/alert-ale...ssesse-eng.php

[sage]

作者: 十之八九

我大概有30多周了吧，一周周过得太快了，老记不清。那么说带辅助剂的还更好？

不是更好，是因为你属于高危人群，跟疫苗的副作用相比，好处大于坏处，所以建议你现在就打。没有佐剂的疫苗要11月底才会出来。

[sage]

作者: 我在温哥华

wiki呀，我二宝4个多月啦，全家除了他都优先打。不过，咱都是在哺乳的妈，该不该unadjuvant的呢？是不是该和孕妇一个待遇安全些呢？adjuvant的对二宝有什么负作用没有？下周三就打了，有点儿犹豫。

我们温哥华对这个H1N1不是很“热”，家庭医生那里挺好约的。

我这些天都在学习，觉得adjuvant vaccine跟unadjuvant vaccine没有太大区别。里面就是些深海鱼油(squalene oil)，维生素E还有微量汞什么的。你吃一小罐沙丁鱼的含汞量都比这个高。

如果不是因为俺村要排大队，我自己肯定早打了。我犹豫的是该不该给老大打。

[sage]

建议大家都看看这个presentation。是我一个搞传染病研究的朋友发来的。她以前在国内是妇科医生。

http://docs.google.com/fileview?id=0...YzRkMDMw&hl=en

[sage]

作者: anuokiki

no, they changed. Only once

俺村的小朋友都要打两次针，一次一半剂量，中间必须相隔21天。

[sage]

作者: dangbl

浮云ｍｍ知道这里的疫苗是加拿大生产的还是从中国进口的吗

美国有些州的疫苗是从中国进口的

这是GlaxalSmithKline在魁北克城附近的Ste-Foy厂生产的。

[sage]

作者: 米呵呵

那份presentation里面，普通人感染的概率是9-12%，而家里有小孩的人概率是42%
为什么呢？我不明白。

我脚的是因为小朋友不洗手，还爱用手乱抓东西，感染机会高很多。
的确如此，我们家老二才2个多月就被姐姐传染上感冒了。当时姐姐在上daycare之前可从来没病过。

[sage]

这些症状我都有，但估计普通流感也是这症状。
总之，打不打是个人选择。

[sage]

作者: 哈哈豆

有没有jm知道最新的指示啊，到底要几针呀。要是必须打两针，我们的回国计划又要推迟了。

如果要回国，是不是还是应该打呀？我想。

5岁以下需要打两针，中间相隔21天。

[sage]

作者: 游戏专用.

谁知道，刚过5岁生日的小孩，打一针，还是二针？谢谢！

5岁打一针。