TM OPV Stockpiling in the United States Trudy V. Murphy, M.D. National Immunization Program Centers...
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Transcript of TM OPV Stockpiling in the United States Trudy V. Murphy, M.D. National Immunization Program Centers...
![Page 1: TM OPV Stockpiling in the United States Trudy V. Murphy, M.D. National Immunization Program Centers for Disease Control and Prevention February 5, 2003.](https://reader036.fdocuments.us/reader036/viewer/2022072110/56649f2a5503460f94c44294/html5/thumbnails/1.jpg)
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OPV Stockpiling in the United States
Trudy V. Murphy, M.D.National Immunization ProgramCenters for Disease Control and
Prevention
February 5, 2003
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Is the US at Risk of an Outbreak of Poliomyelitis?
• US has high vaccination coverage –1995 -1999 National Immunization
Survey, parents of 1.9% - 3.1% of children reported child had no poliovirus vaccine by 19-35 months of age
• Western Hemisphere certified free of indigenous wild poliovirus in 1994
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Outbreaks of Poliomyelitis in Countries with High Vaccine
Coverage
• Pockets of under-vaccination -Religious communities
-Vaccine objectors
-Refugees, immigrants
Patriarca P. JID 1997;175;S165
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Potential Sources of Neurovirulent Polioviruses
• Eradication of polioviruses incomplete
–Endemic areas
–Vaccine-derived strains
–Laboratory containment
• The U.S. remains at risk of an outbreak of poliomyelitis
Patriarca P. JID 1997;175;S165
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Emergency Response to an Outbreak of Poliomyelitis in U.S.
• Inactivated (IPV) and live attenuated oral (OPV) poliovirus vaccines induce similar levels of individual protection after three doses
• IPV and OPV differ in their risks and effectiveness when used to control an outbreak of poliomyelitis
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OPV Vaccine of Choice in Outbreak Settings
• Public health goal is to eradicate outbreak strain
• Extensive experience using mass campaigns demonstrates OPV interrupts transmission polioviruses
• Interferes with or reduces replication of outbreak strain at mucosal level
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OPV Halts Circulation of Poliovirus
• OPV used in Albania, 1996: –80% population vaccinated in
mass campaign–90% decrease in cases within 2
weeks –No case poliomyelitis after
second mass campaignPrevots R. CID 1998;26:419
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IPV and Outbreaks of Poliomyelitis
• No example of successful control of an outbreak using IPV
• Countries that use all-IPV for routine vaccination, used OPV for control of outbreaks (Netherlands, Finland)
Hovi T, Lancet 1986;1:1427; Oostvogel PM. Lancet 1994;344:665
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Challenges of Response to an Outbreak of Poliomyelitis
• Vaccine acceptance among objectors may not be optimal regardless of type
• Risk of VAPP after OPV is established, but less than the risk of poliomyelitis in an outbreak
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Challenges of Response to an Outbreak of Poliomyelitis
• IPV is vaccine of choice for
–immediate vaccination
–the immunodeficient and their contacts
–adults (usually)
–persons refusing OPV
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U.S. Uses IPV for Routine Poliovirus Vaccination
• In January 2000, the ACIP recommended IPV for routine vaccination against poliomyelitis to avoid the rare but established risk of vaccine associated paralytic poliomyelitis (VAPP)
• OPV no longer is manufactured in U.S.
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Options for Obtaining OPV
• Administer remaining U.S. licensed, expired OPV as investigational new drug (IND), given adequate potency, sufficient supply
• Establish stockpile of non-U.S. OPV• Administer under IND• Administer as U.S. licensed product
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Desirable Characteristics of OPV Product for U.S. Stockpile
• Trivalent OPV • Extensive (global) use, meets U.S. or
WHO standards for safety, potency • ~ 4,000,000 doses; available on
staggered timeline• Rotation with OPV in active market to
avoid replacing expired vaccine
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Status of U.S. OPV Stockpile
• Interim stockpile of licensed, expired Wyeth-Lederle OPV (IND)
• First solicitation for non-U.S. made OPV
• Planned second solicitation for non-U.S. made OPV
• Hurdles to establish U.S. OPV stockpile
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Potential Interim Stockpile Wyeth-Lederle OPV (Expired)
• ~800,000 doses, expired Nov. 2002• Potency test ~quarterly; Sept. 2002• CDC application for IND incomplete• Manufacturer requests no release of
OPV unless Government approves request for indemnification (Public Law 85-804) and contract reflects approval by Secretary of HHS
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First Solicitation for StockpileNon-U.S. Made OPV
• Initiated June 1999; preference for product licensed in U.S.
• One respondent• Product required IND• Lacked desirable characteristics• Liability issues unresolved • Negotiations ended February 2002
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Second Solicitation for StockpileNon-U.S. Made OPV
• CDC intends to issue in near future
• 4,000,000 doses, trivalent OPV
• IND use (U.S. license preferred)
• One year; option 9 additional years
• Liability issues remain
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OPV under IND Covered byNational Childhood Vaccine Injury Act
• OPV listed in Vaccine Injury Table
• Vaccine taxed on use
• No distinction made between investigational and approved vaccines for purposes of injury compensation
• Final determination resides with court
August 2001
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Hurdles to Establish OPV Stockpile for Emergency Use in the U.S.
• Manufacturer interest–Future demand for OPV uncertain–Requirements to obtain IND (U.S.
license) perceived as onerous, expensive
–Assurance of full indemnification• CDC to hold IND
–Protocol, IRB
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Conclusion
• All groups recommend OPV to control an outbreak of poliomyelitis; use of OPV is supported by experience and scientific evidence
• A stockpile of OPV meeting FDA requirements for use is the foundation for preparedness in the event of an outbreak of poliomyelitis in the U.S.