Page 52 - Bioterrorism

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The FLUAD-H5N1 drug being tested was approved for market in the European Union on May 2,
2007 before it was tested on the homeless in Poland and proved to be lethal.

This vaccine is for “government use in case of pandemic caused by Avian Influenza virus“ also
for US government use.

”Novartis has also received contract from US DHHS to further develop MF59C.1 adjuvant
technology to potentially extend vaccine supplies in case of Influenza pandemic outbreak“

”Represents "mock-up vaccine", filed as normal step for eventual accelerated approval of final
vaccine once a pandemic has been declared; Initial preparations were made with viral strain H5N3
(1999) and H9N2 (2004); File submitted for approbation in 2006 was based on clinical trials
conducted with various strains of Avian Influenza virus, but more specifically with reverse
genetic-engineered strain H5N1 A/Vietnam/1194/2004, with adjuvant MF59C.1;

Vaccine will eventually contain pandemic Avian Influenza strain designated by WHO at the time
of pandemic, along with adjuvant MF59. “

http://www.antiviralintelistrat.com/1/Database?prod=1737

Perhaps this lethal drug got a licence because the primary outcome listed for the study was
“adverse events rate” after two doses. That is to say, its success was measured in terms of its
capacity to cause injury and damage. That is why the drug no doubt got the licence because it
proved to be very damaging indeed and so met the primary outcome desired by Novartis
according to the official documents of the trial.

http://clinicaltrials.gov/ct2/show/NCT00434733

Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in
Adult and Elderly Subjects
This study has been completed.
First Received: February 12, 2007 Last Updated: April 23, 2008 History of Changes

Novartis
Sponsors and Collaborators:
Novartis Vaccines

Information provided by: Novartis

ClinicalTrials.gov Identifier: NCT00434733

Purpose

This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of
FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each
administered 3 weeks apart.

Condition Intervention Phase