# Presentation: 301348

## Vaccine-Derived Poliovirus Infections Minnesota, 2005

- Jim Alexander & Jane Seward
- National Vaccine Advisory Committee
- Washington, DC
- February 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)