Vaccine-Derived Poliovirus Infections Minnesota, 2005

Jim Alexander & Jane SewardNational Vaccine Advisory Committee

Washington, DCFebruary 8, 2006

VDPV Investigations: USA & Canada

VDPV Investigations (1)

Wisconsin:– Investigated 2 communities– Community A (grandparents):

• 13 stool specimens – all negative• 6 serum specimens – 4 triple PV(+), 2 mixed

– Community B:• 4 stool specimens – all negative

– Vaccinations offered – mixed response

VDPV Investigations (2)

Michigan:– Identified Amish communities – “thumb” area– Families refused to give clinical specimens– Only 2 families initiated vaccination

Missouri:– Identify Amish communities – NW Missouri– Bride & groom visited family & returned to Canada– Families refused to give clinical specimens– Little/no response to vaccination

Iowa: – Vaccine coverage assessments – Amish

VDPV Investigations (3)

Canada:– Investigated Amish community – SW Ontario

• October wedding & MN community contact

– 159 people in 24 families– 41 persons: stool and/or throat swab

• All 36 stools & 5 unique throat swabs = PV (-)• 2 stools = Coxsackie A2 (+)

– >17 persons received 1 dose IPV• Additional doses being offered

– Post-wedding disease & infection surveillance

VDPV Investigations (4)

CDC, National Immunization Program:– Coordination with states & Canada (CSTE)

– Communication with other federal & international agencies – e.g. FDA, PAHO & WHO Geneva

– Notification of state immunization partners, clinicians, & public – MMWR, press releases, e-mail alerts

– Immunization Safety Office & MN collaboration: vaccine acceptance study

FDA, Office of Blood Research:– Helped obtain PV1 high-titered IGIV

Conclusions

VDPV: No known spread beyond central MN Amish community

Well-coordinated response -- state, federal, other

Sufficient supply of IPV for response– No need to access a stockpile

Community acceptance of investigation = mixed– Good relationship with local HD >> better response

– No paralytic disease >> lower sense of risk & response

– Media attention >> disturbed privacy & adversely affected cooperation

Lessons Learned

Current surveillance strategy = not optimal– Surveillance for paralytic poliomyelitis, not AFP

– Poliovirus infections not notifiable

Optimal control strategy = multifactorial– Sensitive surveillance & rapid response

– Better understanding of perceptions of disease risk & vaccination benefit among under-vaccinated groups

– Balance between public/media right to know & community’s right to privacy

Global Issues

Increased recognition of risks of OPV use – Recent cVDPV outbreaks: Indonesia, Madagascar

– Vaccine-Associated Paralytic Polio (VAPP) cases

• USA: 1st documented imported VAPP case – 2005

Evolving WHO strategies for polio eradication:– Use of mOPV for final eradication efforts

– Risk considerations in developing stockpile & outbreak response post-eradication: mOPV, IPV, antiviral drug

WHO policies, strategies & products will influence US polio outbreak response & stockpile

U.S. Polio Vaccine Stockpile: IPV

Recommended: 8 million doses

Current status: ~3.5 million doses– Financing/accounting barriers to 8M dose goal

Future directions:– Continue efforts to develop uncombined IPV stockpile

through Pediatric Vaccine Stockpile

– Consider other options for IPV stockpile?

U.S. Polio Vaccine Stockpile: Global Collaboration

NVAC/ACIP Recommendation:– U.S. & partners: finance, create & maintain global PVS

– Guaranteed & immediate U.S. access

Global developments (since 2004):– Funding mechanism (IFFM) established for global PVS

– Stockpile size:

• Initial: 750 million doses – each serotype (PV1, PV2, PV3)

• No doses stockpiled yet

– Mechanisms for access being developed

U.S. Polio Vaccine Stockpile: OPV

NVAC/ACIP Recommendation: – 8 million doses; mOPV, if available

Global Developments (since 2004):– Rapid progress in production, licensure & use of mOPV

• Sanofi-Pasteur: mOPV1 licensure (France & Egypt)

• GSK: mOPV1 licensure (Belgium, Pakistan & Egypt)

– Use of mOPV1 in eradication efforts – Egypt & India

Current status:– Work with WHO to select mOPV products– Develop IND for each product (serotype & company)– Explored EUA option – not applicable

Acknowledgements

Minnesota HD & Lab– Harry Hull– Kris Ehresmann– Gary Wax– Kathy Harriman– Norman Crouch– John Besser– Susan Fuller

FDA– Jonathan Goldsmith– Dorothy Scott

Other Health Depts– Jeff Davis (WI)– Dan Hofspenberger (WI)– Bao Ping Zhu (MO)– Harvey Marx (MO)– Joel Blostein (MI)

Canada– Susan Squires– Salwa Bishay– Bryna Warshawsky

Additional Slides

Minnesota Investigation: Summary

IC Amish infant infected with VDPV

Virus circulated within infant’s community– Infant probably infected in community

– No clinical disease from these infections

No known spread outside community– No hospital transmission

– No spread to other Amish communities – MN

Source of virus = unknown– Origin: OPV recipient in country outside US & Canada

– Proximal (likely): IC person (virus = iVDPV)