China-Made Swine Flu Vaccine Protects After One Shot (Update1)

[nurse2009]

china-made swine flu vaccine protects after one shot (update1)

by simeon bennett

aug. 18 (bloomberg) -- swine flu vaccine made in china by sinovac biotech co. is safe and protects people against the pandemic virus after a single shot, according to its developer.

studies showed the inoculation met "international criteria for vaccines" and caused no severe adverse reactions in any of the 1,614 volunteers who received it, sinovac said in an e- mailed statement today. it didn't give details about the efficacy of differing doses or vaccination methods used.

the results are the first reported anywhere in the world on a vaccine to fight the new h1n1 strain that's sparked the first influenza pandemic in 41 years, said beijing-based sinovac, which was created in 2001 to make immunizations for hepatitis. the company is compiling data on the flu shot as soon as possible before seeking regulatory approval for it in china.

read the story at http://www.bloomberg.com/apps/news?pid=20601202&sid=adt9iv5l1dow

[tokidoki7, ASN, RN]

It seems like I would be damned if I got the Chinese vaccine and damned if I didn't get it. I'd rather take my chances with the swine flu.

[Diaper, RN]

I don't have much trust in any products coming out of China.

I'm sorry, but most of the products that you buy in the US, are from China.

[lamazeteacher]

I was going to say the same thing when I saw the first post. Honestly. Baby formula, pet food, etc. And we're supposed to trust their labs?

Again, we need to monitor closely, the production of anything coming from China!

[lamazeteacher]

It seems like I would be damned if I got the Chinese vaccine and damned if I didn't get it. I'd rather take my chances with the swine flu.

Is your reply based on knowledge of microbiological facts, or gut reaction?

[elkpark]

I'm sorry, but most of the products that you buy in the US, are from China.

Some of us check labels/packaging before we buy. I only buy any product from China if I really need it and truly have no other option (inc. paying more for a similar item made somewhere else).

[misswoosie]

China has been doing dodgy, unregistered clinical trials on humans for years-it is a common fact.

They joined the WHO clinical trials registry in 2007, but many trials remain unregistered.

They also have their own Chinese clinical trial register launched in 2005 and since 2006 someresearchers have been regisrtering their trials with the US register clinicaltrials.gov

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2636409

When I visited the chinese clinical trials website in English

http://www.chictr.org/Site/English/Index.htm[/url

there was no useful information available and links were not working.

I did find the chinese vaccine studies listed on clinicaltrials.gov.This must be the follow on from the trial whos results are out

http://clinicaltrials.gov/ct2/show/NCT00956111?term=H1N1+cHINA&rank=1

Note the exclusion criteria and upper age cut off.

It was dose ranging(5-30micrograms)

Adjuvanted and non adjuvanted.

There is another study listed,again phase 4 ,but the dose was 45micrograms.

I cannot find any phase 2 or 3 studies.

I wonder where the data has been published?

There are no links to publications on clinicaltrials.gov and when I go to the Sinovac (drug company)website the info is pretty much aimed at investors!

http://www.sinovac.com/Investors/2009/8/ymiswndps5.htm"]http://www.sinovac.com/Investors/2009/8/ymiswndps5.htm

They have launched the vaccination programme in China, but don't know what dose they are using or whether adju or non adju

:thnkg:

[Wishinonastar, BSN]

It is not a matter of knowledge, they have lots of brilliant scientists in China. It is a matter of process quality. Trust me, I am in QI and in my grad program I did a lot of research on China and their QI processes. Not good, not good at all. Not to be confused at all with Japan, they are leaders in the quality field. I'd take a Japanese vaccine.

[dcampbell]

What makes you think you will have a choice as to where the vaccine you receive comes from? Will you be able to check the packaging yourself? It could have an american label on it but was made in China, like many other products here. If the U.S. government feels pressured to have more vaccines than it currently is planned to have than why wouldn't they get some from China? (Without bothering to let the U.S. people know or have a choice).

I am not even thoroughly convinced the U.S. made vaccines will be studied enough (especially for children) before it will be released on the public. There just doesn't seem to be enough time.

[CrunchRN, ADN, RN]

I'm sorry, but most of the products that you buy in the US, are from China.

True enough, but i am making more of an effort to avoid there products if there is any way it will be used internally! And for anything if I have a reasonable choice not from China at near the same cost I take that.

[TheHomelessRN]

Not that I prefer China made vaccines but take a look at the track record of Baxter International:

In December, a Baxter facility in Austria sent a human flu vaccine contaminated with the deadly H5N1 live avian flu virus to 18 countries, including the Czech Republic, where testing showed it killed the ferrets inoculated . Czech newspapers questioned whether Baxter was involved in a deliberate attempt to start a pandemic.

"Bird flu mix-up could have spelled disaster", NewScientist 6 March 2009, http://www.newscientist.com/article/mg20126983.40

[CrunchRN, ADN, RN]

Worse and worser?

[Diaper, RN]

Not that I prefer China made vaccines but take a look at the track record of Baxter International:

In December, a Baxter facility in Austria sent a human flu vaccine contaminated with the deadly H5N1 live avian flu virus to 18 countries, including the Czech Republic, where testing showed it killed the ferrets inoculated . Czech newspapers questioned whether Baxter was involved in a deliberate attempt to start a pandemic.

"Bird flu mix-up could have spelled disaster", NewScientist 6 March 2009, http://www.newscientist.com/article/mg20126983.40

I can't view the link, would you send us the link again please? Thanks.