New England Journal Of Medicine Publishes Study Investigating Safety And Efficacy Of Baxter's Cell-Based Pandemic, Avian Flu

Vaccine 12/07/2009 21:10

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Ophthalmology About CELVAPAN

Urology CELVAPAN is manufactured in a cell culture-based system in Bohumil, Czech

Republic, at one of the largest cell culture vaccine production facilities in the world.
Other Navigation Links Vero cell technology uses a well-established cell line originally derived from African
green monkey kidneys in 1962. A continuous cell line has been derived from these
About Us cells so that an unlimited supply of cells is available without the requirement of
generating additional cells from animals.
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Baxter's candidate avian flu vaccine is derived from the H5N1 strain
A/Vietnam/1203/2004. Its antigen composition and structure are identical to the
actual virus circulating in nature without the need to enhance an immune response
by including adjuvants, additives that may cause side effects. In this Phase I/II
study, CELVAPAN induced an immune response that is similar to the body's

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New England Journal Of Medicine Publishes Study Investigating Safety And Efficacy Of Baxter's Cell-Based Pandemic, Avian Flu Vaccine 12/07/2009 21:10

Accessibility defense against a natural virus infection. Earlier this year CELVAPAN was
accepted for licensure review by the Committee for Medicinal Products for Human Ads by Google
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Use within the European Medicines Agency, making it the first cell culture-based
Article Submission pandemic influenza vaccine to be reviewed by the regulatory authority. The U.S.
National Institute of Allergy and Infectious Diseases (NIAID), part of the National Today's Featured Health Videos
Links Institutes of Health, is also conducting a trial with Baxter's CELVAPAN in the
Contact Us United States. Prolotherapy -
Age of Injuries
Phase I/II Clinical Trial Results
Clinical Trials Prolotherapy is
The randomized Phase I/II study enrolled 284 subjects in Austria and Singapore helping doctors
Go! heal the body
(ages 18-45) and met its immunogenicity and safety endpoints. The study mainly
investigated the ability of the vaccine to induce substantial levels of cross-immunity through
against divergent H5N1 strains. treatments in the
tendons and
The trial tested four different antigen concentrations ranging from 3.75 micrograms ligaments. The
body is actually helping to heal itself.
to 30 micrograms; 7.5 micrograms and 15 micrograms formulations were studied
with and without adjuvant (additive). Statistically, the non-adjuvanted formulations
induced the highest rates of subjects with a titer (antibody concentration in the more videos are available in our health videos
blood) more than 1:20 after the first (40.5 percent and 39.5 percent for 7.5 section.
micrograms and 15 micrograms) and second (76.2 percent and 70.7 percent for
7.5 micrograms and 15 micrograms) vaccinations, demonstrating this vaccine
generates a robust immune response. Most Popular Categories

Regarding seroconversion (development of antibodies) or the percent of subjects

demonstrating a more than four-fold increase in titer after immunization, the
highest responses were again seen with the 7.5 micrograms and 15 micrograms
nutrition cancer
non-adjuvanted formulations, with 69.0 percent and 68.3 percent seroconversion, cardiovascular diabetes hiv
respectively.
obesity pediatrics neurology
High levels of cross-reactivity were demonstrated against the A/Hong Kong strain dermatology urology pregnancy
with the 7.5 micrograms and 15 micrograms non-adjuvanted formulations (76.2
percent and 78.0 percent, respectively, with neutralizing titer more than 1:20). The psychology medicare infectious
responses against the clade 2 strain were somewhat lower (45.2 percent and 36.6 diseases alcohol breast cancer
percent with NT titers greater than or equal to 1:20 for the 7.5 micrograms and 15 women's health asthma
micrograms non-adjuvanted formulations, respectively). This demonstrates the
ability of the vaccine to induce cross-reactive immune responses against divergent gastrointestinal alzheimer's stem cell
H5N1 strains. research prostate bones pain sexual
health smoking eye health sleep sports
Ads by Google The most common side effects were injection site reactions, headaches and medicine multiple sclerosis health insurance
Bird Flu fatigue, and the most common local reaction was pain at the injection site. medical devices hypertension dentistry
H5N1 Virus biology genetics depression it arthritis autism
H5N1 Vaccine Baxter's Pre-Pandemic Planning Efforts pharma industry fertility abortion liver disease
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Pandemic
Baxter works closely with governments worldwide on pandemic preparation. The
company has delivered several million doses of CELVAPAN to various
governments around the world. In 2006, Baxter entered into a pandemic
preparedness contract with the Austrian Ministry of Health to supply 16 million
doses of pandemic influenza vaccine in the event a pandemic is declared. The
company also delivered a stockpile of two million doses of CELVAPAN to the U.K.
Department of Health as part of an agreement announced in February 2006. To
improve access to treatment in developing countries, Baxter also supports the
World Health Organization's pandemic planning programs through participation in a
planned international stockpile program.

Baxter is also working with the NIAID in partnership with Fisher BioServices Inc.,
and with the U.S. Department of Health and Human Services in partnership with
DynPort Vaccine Company LLC (DVC LLC), a Computer Science Corporation
Company, to further develop Vero cell culture-based candidate pandemic and
seasonal influenza vaccines. Baxter is working with the U.S. Department of Health
and Human Services, in partnership with DVC LLC, on a seasonal Phase III
clinical trial that is currently underway in the United States and also plans to initiate
a pandemic Phase I trial later this year in the United States with an H5N1 reverse
genetic reassorted (RG) Indonesia strain vaccine. Baxter is also working with the
NIAID in partnership with Fisher BioServices Inc. on a Phase I trial in the United
States using the H5N1 Vietnam strain.

About Pandemic Flu

A pandemic is a global disease outbreak of a virus for which there is little or no

immunity in the human population, causing serious illness and spreading easily
person-to-person worldwide. Most cases of avian flu infection in humans have
resulted from direct or close contact with infected poultry (e.g., domesticated
chicken, ducks, and turkeys) or surfaces possibly contaminated from feces of
infected birds. Avian influenza infection follows an unusually aggressive clinical
course, with rapid deterioration and high fatality. Primary viral pneumonia and
multi-organ failure have been common among people who have become ill with
avian influenza.

About Baxter

Baxter International Inc., through its subsidiaries, assists healthcare professionals

and their patients with treatment of complex medical conditions, including
hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma
and other indications. The company applies its expertise in medical devices,
pharmaceuticals and biotechnology to make a meaningful difference in patients'
lives.

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New England Journal Of Medicine Publishes Study Investigating Safety And Efficacy Of Baxter's Cell-Based Pandemic, Avian Flu Vaccine 12/07/2009 21:10

This release includes forward-looking statements concerning the company's

vaccine products, including with respect to clinical trials, licensures, and the
advantages of the vaccine products. The statements are based on assumptions
about many important factors, including the following, which could cause actual
results to differ materially from those in the forward-looking statements: satisfaction
of regulatory and other requirements for timely commencement of additional clinical
trials; additional clinical results demonstrating the safety and efficacy of the
products; market acceptance of vaccines developed with Vero cell technology
relative to egg-based or other alternatives; continued public commitment to
addressing avian flu and other pandemic threats including additional experience
producing such vaccines at a large scale; and other risks identified in the
company's most recent filing on Form 10-Q and other SEC filings, all of which are
available on the company's web site. The company does not undertake to update
its forward-looking statements.

http://www.baxter.com

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