panflu Stats

[Mixin]

By Bruce Japsen | Tribune staff reporter
3:55 PM CST, December 18, 2008

Baxter this afternoon said the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a "positive opinion" for Baxter's Celvapan, a vaccine against H5N1 strains of avian influenza, also known as bird flu. The committee's endorsement is generally a precursor to approval by the European Union.

Baxter uses a cell-based technology that can produce vaccines quicker and in large quantities. The method could enable Baxter to produce dosages faster in the event of a flu pandemic, the company has said.

http://www.chicagotribune.com/business/chi-biz-baxter-bird-flu-vaccine-dec18,0,567144.story

[gs]

In addition to its culture method, the vaccine also makes no use of adjuvants,

In Europe, the United Kingdom and Austria signed contracts to stockpile Baxter's vaccine and that made of other companies.

Baxter is also in final stage clinical trials for a vaccine to prevent seasonal influenza that uses the company's cell-based technology, which could help boost production and prevent flu vaccine shortages that have arisen in recent years.

http://www.chicagotribune.com/business/chi-biz-baxter-bird-flu-vaccine-dec18,0,567144.story

Baxter expects final stage results of cell based seasonal PreFluCel flu-vax in Apr-Jun 2009.

In late 2004, Baxter had to suspend a final-stage human study of its seasonal flu vaccine
because it was causing fevers in some patients.



see also the recent trial in Germany
http://www.dradio.de/dlf/sendungen/forschak/886370/
(in German)
Baxter H5N1-vaccine tested in 100 volunteers in Cologne, Phase 3

204 google-hits for Celvapan


http://pandemicinformationnews.blogspot.com/

full text of Juni/2008 article in NEJM:
http://content.nejm.org/cgi/content/full/358/24/2573
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--gs . Send me estimates of H5N1-deaths for the next 5 years (expectation value) !

[gs]

http://www.praguepost.com/articles/2008/06/25/baxter-develops-bird-flu-vaccine.php
June 25.2008

In addition to its culture method, the vaccine also makes no use of adjuvants

“If you speak to experts within the WHO or within the ministries of health of various countries,
there’s a lot of concern in this direction, and that’s why some countries have already decided
to buy the vaccine directly from us or buy manufacturing capacity for them in the case of a
pandemic,” Ehrlich said.

### and, does Ehrlich confirm this concern ? Or could the Baxter production capacity be scaled up
### suitably in case of a severe pandemic with restricted biosafety,increased efforts and
### increased prices for the vaccine ?

The United Kingdom has already been one such country to purchase the vaccine, and Ehrlich said the Czech government has been in talks with Baxter as well.

The vaccine’s production time, is cut nearly in half with the cell-culture method,
from 22–28 weeks using eggs to 12 weeks with cell cultures.

The process using hen’s eggs also has a different effect on the immune system because of how it is manufactured. The virus in the hen’s egg is treated with bleach and delivers a “disrupted” version of the virus.

### so, could we take viruses from dead people in a pandemic, treat them with bleach
### and inhale them so to build up immunity ?

Baxter’s next step has been a phase III study with 550 subjects, the data from which has not been fully analyzed yet. The results of all three studies are being process edfor an application for licensure from the European Medicines Agency, which Ehrlich expects to be approved this fall.
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--gs . Send me estimates of H5N1-deaths for the next 5 years (expectation value) !