Something Is Amiss in Gitmo and Crackpot Nations — on episode 79

The U.S. Department of Health and Human Services
provided funding to Baxter and our partner, DynPort
Vaccine Company, for the continued development
of our cell-cultured seasonal and pandemic influenza
candidate vaccines. We have initiated Phase III clinical
trials for both vaccines, and continue to sign advance-
purchase and stockpile agreements with governments
around the world for avian flu (H5N1) vaccine in the
event of a pandemic.

“ The threat of a pandemic is very real. And with cases of H5N1 avian influenza
now beginning to appear in new geographic areas, governments are taking notice.
Baxter’s use of vero-cell technology is a welcome advance in the development of
influenza vaccine for both seasonal and pandemic influenza.” John Oxford (left),
professor of virology at St. Bart’s and The London School of Medicine

tHe tHreat of a Pandemic
In 1918, an influenza pandemic killed as many as 100 million people
worldwide. Most health experts predict it is only a matter of time before
another pandemic strikes. While it’s unknown what flu strain will cause the
next pandemic, many suspect it could be the H5N1 avian flu virus that has
killed millions of birds and more than 300 people, mostly in Asia, over the
last several years. Experts fear the virus could begin to spread among the
human population, making the development of a vaccine a global priority.
In 2007, Baxter initiated a Phase III clinical trial of its candidate H5N1 vaccine.
Phase I/II results had shown the vaccine to be highly immunogenic at low
doses and capable of inducing substantial levels of cross immunity against
widely divergent H5N1 strains. The vaccine is manufactured using Baxter’s
proprietary vero-cell technology, which produces pandemic vaccine more
quickly than traditional egg-based production methods.
Baxter is contracting with the U.S. government for development of cell
culture-based seasonal and pandemic influenza vaccines. The contract
funds development of seasonal influenza vaccine through U.S. Food and
Drug Administration licensure, and the development of the pandemic
vaccine candidate through Phase II clinical trials in adults and pediatric
Phase I trials. DynPort Vaccine Company, the prime contractor for this
effort, is providing overall management of the clinical trials. Baxter, as
subcontractor, is developing the candidate vaccines, and will manufacture
the vaccines and own all clinical data and licenses.
Baxter also is working with governments worldwide on pandemic prepared-
ness. In 2007, Baxter entered into an agreement with the United Kingdom
giving the country the option to purchase pandemic influenza vaccine in
the event of a pandemic. Baxter has similar advance-purchase agreements
with other countries. The company also has delivered several million doses
of H5N1 vaccine to countries worldwide as part of stockpile agreements,
and is providing a multiyear donation of its pandemic influenza vaccine to
the World Health Organization’s stockpile program to increase access in
developing countries.In addition, Baxter is working with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), in partnership with Fisher BioServices Inc., and with the U.S. Department of Health and Human Services in partnership with DVC LLC, a Computer Sciences Corporation Company, to develop vero-cell based H5N1 pandemic and seasonal influenza candidate vaccines. Both collaborations are the result of U.S. Government contract awards. Baxter and its partners will be providing the vero-cell based candidate vaccines to the agencies for further clinical testing in the United States, which is expected to begin later in 2006 and 2007. Baxter is currently in discussions with several other governments regarding its candidate pandemic vaccine, and has been awarded a contract to supply two million doses of cell-culture based candidate H5N1 vaccine to the U.K. government.

Phase 3 Clinical Studies

LifeGen.de – Editorial: Baxter’s H5N1 as global flu pandemic threat

http://cryptogon.com/?p=2136

cosmos_avian_flu.jpg 1698×1638 pixels

BAXTER GETS CONTRACT FROM U.K. NHS FOR H5N1 FLU VACCINE. – Free Online Library

CSC DynPort Vaccine Company LLC

CSC: Consulting, Systems Integration and Outsourcing

Baxter, DynPort Receive HHS Flu Vax Funds
Posted on November 28, 2007 @ 08:22 am
DynPort Vaccine Co. and Baxter International have received a $201.2 million contract modification from the U.S. Department of Health and Human Services (HHS) for the development of Baxter’s cell-cultured seasonal and pandemic influenza candidate vaccines.

The contract funds development of the seasonal influenza vaccine through FDA licensure, and the pandemic vaccine candidate through Phase II clinical trials in adults and pediatric Phase I clinical trials. DVC, the prime contractor for this effort, is providing overall management of the clinical trials. Baxter is developing the candidate vaccines, and will manufacture the vaccines and own all clinical data and licenses.

The clinical portion of a Phase I/II clinical trial to test the safety and immunogenicity of Baxter’s cell-culture-derived split virus seasonal influenza vaccine candidate in Europe was recently completed. Preliminary data announced in July 2007 indicate that the vaccine induced strong antibody responses and good tolerability in all study populations. DVC and Baxter vaccinated the first volunteers of a Phase III trial in healthy adults using the seasonal vaccine candidate in the U.S. on Nov. 26, and plan to enroll patients in a Phase I clinical trial for a pandemic influenza clade 2 strain vaccine candidate in 2008. This trial will also be conducted in the U.S.

"The progress made on the pandemic and seasonal influenza programs in such a short time reflects the priority and importance of this development program for both companies," said Dr. Robert V. House, president and chief scientific officer of DVC. "By combining Baxter’s technology with DVC’s biologics life-cycle and contract management expertise, the team has made great progress in advancing these two influenza vaccine candidates."