National Immunization

1

• National Immunization
• Program (NIP)/Advisory Committee on Immunization
• Practices (ACIP) Report
• Stephen L. Cochi, MD, MPH
• Acting Director, National Immunization
  ProgramCenters for Disease Control and
  Prevention
• National Vaccine Advisory Committee
• October 6, 2004

2
Upcoming ACIP MeetingOctober 27-28, 2004

• Major Issues
• Influenza vaccine supply/coverage/ effectiveness
• Health-care worker influenza vaccination
  (HICPAC-ACIP document)
• Recommendations for use of meningococcal
  conjugate vaccine

3
Upcoming ACIP MeetingOctober 27-28, 2004
(Continued)

• Review of hepatitis B vaccine use/
  recommendations
• Varicella epidemiology/program goals/2-dose data
• Proposed evidence-based format for ACIP
  recommendations
• Update on cardiac adverse events following
  smallpox vaccination

4
Pediatric Vaccine Stockpiles

• Goal six month supply for universally
  recommended vaccines for children
• Target quantities currently based on birth cohort
• Funding available through VFC Program
• To be completed by FY 2007

5
Current Stockpile Status(1) Doses Delivered
Vs. Target
Additional Required For Completion, Not Purchased
Purchased Delivered
Number of Doses in Millions
0
0(2)
33
79
100
7
45
33(2)
0
Stockpile Delivered
Note (1) Status based on recently modified
targets by SWAT Team, 9/9/2004 (2) Target
adjusted to reflect market demand Source NIP data
6
Factors Complicating Stockpiles

• Changing market share
• Combination vaccines (e.g., DTaP-HepB-IPV)
• Overlapping combinations (e.g., DTaP-HepB-IPV
  and DTaP-Hib-IPV)
• Revenue recognition issues currently present a
  roadblock to progress

7
Vaccine StockpilesRevenue Recognition

• The Committee requests that the Secretary of
  Health and Human Services, after consultation
  with the Securities and Exchange Commission and
  other appropriate agencies, submit a report and
  recommendations within 90 days to the Committee. 
  The report should include what administrative
  actions are being taken, solutions proposed, or
  identify what legislative clarification may be
  necessary to resolve this problem.

Source From Senate Labor-HHS Appropriations
Subcommittee Report, September 2004
8
Risks of Polio After Eradication'
After interruption of wild poliovirus, continued
use of OPV will compromise the goal of a
polio-free world. Expert Consultation
on Vaccine-derived Polioviruses (VDPVs), Sept
2003, Geneva
based on current understanding
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Proposed Policy Decision

• Cessation of OPV for routine immunization
• Consensus of September 2003 meeting
• Risks gt benefits in absence of wild poliovirus
• Expectation of countries and stakeholders
• High opportunity financial costs of continued
  OPV.

Timing must occur while population immunity
surveillance sensitivity (for cVPDV emergence)
are high.
Source David Heymanns Polio Eradication
Presentation to AACPE, 9/21/04
10
Conditionalities for OPV Cessation

• Appropriate containment of all polioviruses.
• Global surveillance notification capacity.
• mOPV stockpile response mechanism.
• Coordinated cessation of OPV.
• Post OPV vaccination policy in place.

Source David Heymanns Polio Eradication
Presentation to AACPE, 9/21/04