Posted: Fri Dec 19, 2008 9:58 pm Post subject: European agency endorses Baxter's bird flu vaccine
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.
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.
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. _________________ ------------------------------------------------------
--gs . Send me estimates of H5N1-deaths for the next 5 years (expectation value) !
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