22 October 2008
Smallpox Countermeasures Declaration under the U.S. Public
Readiness and Preparedness (PREP) Act
The US Department of Health and Human Services (HHS) posted
a notice in the US Federal Register on October 17th by the HHS Secretary
Michael O. Leavitt of a “Public
Readiness and Emergency Preparedness Act (PREP) Act Declaration Regarding
Smallpox Countermeasures.” See: http://www.hhs.gov/disasters/discussion/planners/prepact/index.html
Appendix I to this document includes the following six (6)
specific U.S. government contracts as one part of this PREP Act declaration:
|
|
|
|
“Covered Countermeasure” |
Manufacturer |
|
|
|
|
MVA (Modified Vaccinia Ankara) |
Bavarian Nordic |
|
WetVax |
Aventis Pasteur |
|
VIG (Vaccinia Immune Globulin) |
Cangene |
|
ACAM 2000 (Vaccine) |
Acambis |
|
ACAM 2000 warm-base |
Acambis |
|
Cidofovir (antiviral) |
Gilead |
|
|
|
The Federal Register notice of this Smallpox Countermeasure
PREP Act Declaration by HHS Secretary Leavitt can be found in Volume 73, Number
202, pages 61869-61871. The ”smallpox countermeasures” could include vaccines,
antiviral or other drugs, diagnostics or devices to identify, prevent, or treat
smallpox or orthopoxviruses or adverse events from such countermeasures that
are licensed, approved or authorized for emergency use under specific Federal
documents as listed in the full Federal Register notice at: http://edocket.access.gpo.gov/2008/E8-24734.htm
“The PREP Act authorizes the Secretary of the Department of
Health and Human Services (“Secretary”) to issue a declaration (“PREP Act
Declaration”) that provides immunity from tort liability (except for willful
misconduct) for claims of loss caused, arising out of, relating to, or
resulting from administration or use of countermeasures to diseases, threats
and conditions determined by the Secretary to constitute a present, or credible
risk of a future public health emergency to entities and individuals involved
in the development, manufacture, testing, distribution, administration, and use
of such countermeasures.”
Similar PREP Act Declarations were made for anthrax
countermeasures on October 1, 2008, as well as on October 17, 2008 for Botulism
countermeasures, pandemic influenza antivirals, and acute radiation syndrome
countermeasures.
Daniel R. Lucey, MD, MPH
EROne Institutes, Department of Emergency Medicine
Washington Hospital Center
Adjunct Professor of Microbiology and Immunology
Georgetown University Medical Center
Washington, D.C.
Website for this posting: www.BePast.org
Email:DRL23@Georgetonw.edu