Baxter: Product contained live bird flu virus

RedWeasel, RN · Aug 30, 2009

That is just, wow.

oramar · Aug 30, 2009

Hasn't Baxter been in the news before? Not in a good way either.

indigo girl · Aug 30, 2009

http://www.reuters.com/article/healthNews/idUSTRE57P5BF20090826

Baxter is not one of the five companies providing the swine flu vaccine for the US, just in case anyone thinks that it is.

Five companies are making swine flu vaccine for the U.S. market -- AstraZeneca's MedImmune unit, CSL Ltd, GlaxoSmithKline Plc, Novartis AG and Sanofi-Aventis SA.

indigo girl · Aug 30, 2009

https://allnurses.com/pandemic-flu-forum/pandemic-awareness-preparation-361932-page6.html - Post #54

We learned about Baxter's error back in Feb 2009. I am glad that they are not producing any swine flu vax for the US market.

An almost unbelievable story of how a major vaccine manufacturer somehow contaminated a seasonal flu vaccine (H3N2) with the H5N1 bird flu virus. They don't admit to using live virus but, with dead ferrets as a result it could only have been live virus that killed them. The 30 or so employees unwittingly exposed were covered with the inevitable Tamiflu blanket and have tested negative.
Baxter still is refusing to divulge details on just how this happened. I just don't have a warm and cozy feeling about them anymore...
https://allnurses.com/pandemic-flu-forum/world-news-curr...ml#post3448097
http://chealth.canoe.ca/channel_heal...hannel_id=1020
Accidental release of a mixture of live H5N1 and H3N2 viruses - if that indeed happened - could have resulted in dire consequences. Nicoll said officials still aren't 100 per cent sure the mixture contained live H5N1 viruses. But given that ferrets exposed to the mixture died, it likely did.
H5N1 doesn't easily infect people, but H3N2 viruses do. They are one of two types of influenza A viruses that infect people each flu season.
If someone exposed to the mixture had been co-infected with H5N1 and H3N2, the person could have served as an incubator for a hybrid virus able to transmit easily to and among people. That mixing process, called reassortment, is one of two ways pandemic viruses are created.
Research published last summer by scientists at the U.S. Centers for Disease Control found that in the laboratory, H5N1 and H3N2 viruses mated readily. While less virulent than H5N1, a number of the offspring viruses appeared to retain at least a portion of the killing power of their dangerous parent.

ozoneranger · Aug 30, 2009

Don't be so sure about that

"Who Gets What?

Baxter International (NYSE:BAX) could be getting an estimated $245 million in sales from France, and the U.K. has ordered up to 90 million doses of an H1N1 vaccine through a Baxter/Glaxo partnership. Though no price has been set yet, a cost of $10 per dose of flu vaccine seems to (roughly) be the going rate. So, it wouldn't be off base to say Glaxo and Baxter could be splitting up to $900 million."

"GlaxoSmithKline (NYSE:GSK), aside from the deal with Baxter and the U.K. government, will also be receiving $71.4 million from the U.S. government for bulk oil and water adjuvant.

http://stocks.investopedia.com/stock-analysis/2009/Swine-Flu-Vaccine-Quantity-Over-Quality-BAX-GSK-NVS-SNY-AZN-SVA0720.aspx

Lets take a look at the companies who are producing the vaccine.

Sanofi Pasteur

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm075964.htm

That's just an example.

You can look up any manufacturer for anything from GMP violations, to criminal investigations.

http://www.accessdata.fda.gov/scripts/warningletters/wlSearchResult.cfm?office=Office%20of%20Enforcement

It's pretty interesting reading.

indigo girl · Aug 30, 2009

Those links do not support any evidence that Baxter is providing swine flu vaccine to the US.

ozoneranger · Aug 31, 2009

Those links do not support any evidence that Baxter is providing swine flu vaccine to the US.

Look again, these companies buy stocks of viruses & adjuncts from each other, they "partner" to combine resources, this happens on a daily basis.

I have a close friend who co-authored portions of the GMP act which currently defines the conditions required by the FDA to produce biological agents in the US.

He also wrote the first ISO 9000 software used to track raw materials in a final product.

During his tenure with the FDA, he frequently criticized the lax attitude toward vaccine manufacturers shipping materials back & forth, because in many cases, the original lot # weren't cross referenced properly, making the tracking of raw materials impossible.

Should supply's of any raw material become scarce, manufacturers will buy whatever they need from each other. In the end, the vaccine sold here could contain agents from just about anywhere.

oramar · Aug 31, 2009

Look again, these companies buy stocks of viruses & adjuncts from each other, they "partner" to combine resources, this happens on a daily basis.
I have a close friend who co-authored portions of the GMP act which currently defines the conditions required by the FDA to produce biological agents in the US.
He also wrote the first ISO 9000 software used to track raw materials in a final product.
During his tenure with the FDA, he frequently criticized the lax attitude toward vaccine manufacturers shipping materials back & forth, because in many cases, the original lot # weren't cross referenced properly, making the tracking of raw materials impossible.
Should supply's of any raw material become scarce, manufacturers will buy whatever they need from each other. In the end, the vaccine sold here could contain agents from just about anywhere.

I sometimes post things that people tell me here also and I realize people may or may not believe me. I wouldn't be surprised if there are problems in areas that you describe, sounds probable. There have been documented issue with vaccines in the past and there was a flu vaccine shortage not to long ago. However, your saying that a friend on the inside said this or that does not qualify as evidence. I will keep my eyes and ears open for evidence of this sort of thing in the future. The links you gave are on topics that were posted and discussed around these boards earlier this year, there is nothing new there. It is not the first time I am seeing these things. Hearsay and rumors can come in handy at times because they raise level of suspicion and put me one on the alert for actual data but I want you to be aware that I see no proof.

ozoneranger · Aug 31, 2009

The Baxter/Glaxo partnership coupled with Baxters Vero cell production technology has made it possible to complete production of its first commercial batches of H1N1 vaccine 12 weeks after receiving the virus strain. (we aren't given the source of the strain).

The company believes the speed of this turnaround represents an innovation in vaccine production and is a validation of its proprietary technology.

Baxter is now in discussing distribution plans with health authorities and is also ensuring that the company is in accordance with requirements needed to support marketing approval.

Clinical trials to evaluate the safety of the mock-up vaccine in adults, the elderly and children will begin this month.

Baxter is set to fill the production gap with it's new ability to produce the vaccine in 12 weeks.

When other suppliers run out, who do you think will fill that gap?

As for the vaccine shortage of 2004

http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=1682

Not all vaccines are created equally. If you Check VAERS you will discover that some manufacturers have higher adverse event rates (for the same product) than their counterparts.

I'll try to rouse the good Dr. he's retired now & should be getting bored with fishing by now. If anyone has the scoop on this situation, it's him.

indigo girl · Aug 31, 2009

The Baxter/Glaxo partnership coupled with Baxters Vero cell production technology has made it possible to complete production of its first commercial batches of H1N1 vaccine 12 weeks after receiving the virus strain. (we aren't given the source of the strain).

These cell based technologies are not approved for use in the US as per this report to the White House.

http://www.whitehouse.gov/assets/documents/PCAST_H1N1_Report.pdf

From Page 60:

Cell-based vaccines, in which viruses are grown in cultured cells rather than eggs. This method obviates the need for large quantities of embryonated eggs and potentially permits increased levels of production beyond those currently achievable. The method, however, does not substantially shorten the timeline between identification of the virus strains to be included in the vaccine and the vaccine's availability. This approach is currently being used by several companies to produce candidate 2009-H1N1 vaccines, but such cell-based vaccines have not yet achieved licensure in the United States.

ozoneranger · Aug 31, 2009

When the supply runs low, how long do you think it will take the FDA to approve this technology?