Straight off the HHS website:
HHS 2009 H1N1 Vaccine Development Activities
Fact Sheet
Overview
The newly emergent 2009 H1N1 influenza virus is a novel virus with
pandemic potential. Consistent with the National Strategy for Pandemic
Influenza, HHS is committing funds for the production of pilot lots for
clinical studies, as well as a bulk supply of antigen and adjuvant for
use in a potential vaccine for the 2009 H1N1 which will become a part
of the national stockpile of pre-pandemic influenza vaccines.
A vaccine is made from a virus or bacteria (referred to as an
antigen), which causes the human body’s immune system to develop
antibodies against a specific virus or bacteria so the body can
recognize and fight the virus or bacteria. Adjuvants may be added to a
vaccine to help generate a stronger immune response so less vaccine is
needed for the body to recognize and fight a virus or bacteria.
Vaccine Development
When the 2009 H1N1 strain was isolated and identified as a novel
influenza virus, work began to prepare a virus reference strain. This
is a standard practice when new influenza strains are discovered, where
a clinical sample of the virus is mixed with another influenza virus
that grows in eggs to develop a new virus that has some of the
properties of the novel virus and the ability to grow in eggs. This
work is necessary in order to create an influenza vaccine using
conventional methods.
Once a virus reference strain is ready, it will be made
available to influenza vaccine manufacturers in order to create a
master virus seed, which prepares a virus to be used in making the
vaccine.
HHS Contracting Activities
Since 2004, HHS has
contracted with manufacturers that currently hold U.S. licenses for flu
vaccine as part of the National Strategy for Pandemic Influenza. In May
2009, HHS issued new orders on these contracts to produce a bulk supply
of vaccine antigen and adjuvant and to produce pilot (also called
investigational) lots of a 2009 H1N1 vaccine. Most will be stored in
bulk, and a small amount will be prepared as vaccine for use in
clinical studies to evaluate vaccine safety and the dosage required for
a protective effect. This research will include studies with adjuvant
to determine its safety and the effect it would have on the immune
system’s response.
Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: May 22, 2009
|
Manufacturer
|
Bulk
Vaccine Antigen
|
Oil-In-Water
Bulk Adjuvant
|
|
Novartis
|
$150
million
|
$139
million
|
|
GlaxoSmithKline
|
$ 38
million
|
$144
million
|
|
Sanofi Pasteur
|
$191
million
|
|
|
CSL Biotherapies
|
$180
million
|
|
|
MedImmune
|
$ 90
million
|
|
|
Total
|
$649 million
|
$283 million
|
Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: July 9, 2009
|
Manufacturer
|
Bulk Vaccine Antigen
|
Bulk
Virus Concentrate/FFF
|
Oil-In-Water Bulk Adjuvant
|
|
Sanofi Pasteur
|
$61,425,000
|
0
|
0
|
|
GSK
|
$0
|
0
|
$71,400,000
|
|
Novartis
|
$346,334,450
|
0
|
$343,810,470
|
|
CSL
|
$0
|
0
|
0
|
|
MedImmune
|
$0
|
$61,008,000
|
0
|
|
Total
|
$407,759,450
|
$61,008,000
|
$415,210,470 |
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