HHS Takes Additional Steps Toward Development of Vaccine for the Novel Influenza A (H1N1)

HHS Secretary Kathleen Sebelius announced today that the department will
take important steps necessary to prepare for potential commercial-scale
production of a candidate vaccine for the novel Influenza A (H1N1). The
Secretary is directing approximately $1 billion in existing funds that
will be used for clinical studies that will take place over the summer
and for commercial-scale production of two potential vaccine ingredients
for the pre-pandemic influenza stockpile.

"Preparation and planning are critical to keep Americans safe in the
face of a potential pandemic," Secretary Sebelius said. "Our goal
throughout this new H1N1 outbreak has been to stay one step ahead of the
virus. An important part of this effort has been our work to develop a
potential vaccine because vaccines can help prevent and control
influenza virus outbreaks. The actions we are taking today will help us
be prepared if a vaccine is needed."

The funds will be used to place new orders on existing contracts with
companies that hold U.S. licenses for flu vaccines. With these orders,
they will produce a bulk supply of vaccine antigen and adjuvant. Antigen
is the active ingredient in a vaccine that causes the human body's
immune system to develop antibodies that help fight an invading virus.
Depending on the results of clinical studies, adjuvants could be added
to a vaccine to improve the immune system's response and potentially
reduce the amount of antigen necessary for the body to recognize and
fight a virus.

Having both antigen and adjuvant on hand provides maximum flexibility in
a future immunization program, if a program is recommended. For example,
if needed these ingredients could be used in vaccine to help protect
health providers and other members of the critical workforce, as
recommended by the National Strategy for Pandemic Influenza.

With these funds manufacturers will also prepare pilot lots of potential
vaccine for use in clinical studies to determine the proper dose for a
vaccine, determine if adjuvants are appropriate and ensure a vaccine is
safe and effective. The U.S. government will share as much information
as possible from the results of these clinical studies with the World
Health Organization and the global community so that other countries can
benefit from the U.S. efforts to determine dosage, safety and
effectiveness.

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