National Immunization Program (NIP)/Advisory

Committee on ImmunizationPractices (ACIP) Report

Stephen L. Cochi, MD, MPHStephen L. Cochi, MD, MPH

Acting Director, National Immunization ProgramActing Director, National Immunization ProgramCenters for Disease Control and PreventionCenters for Disease Control and Prevention

National Vaccine Advisory CommitteeNational Vaccine Advisory CommitteeOctober 6, 2004October 6, 2004

Upcoming ACIP MeetingUpcoming ACIP MeetingOctober 27-28, 2004October 27-28, 2004

Major Issues:Influenza vaccine supply/coverage/

effectivenessHealth-care worker influenza

vaccination (HICPAC-ACIP document)

Recommendations for use of meningococcal conjugate vaccine

Upcoming ACIP MeetingUpcoming ACIP MeetingOctober 27-28, 2004 (Continued)October 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

Pediatric Vaccine Pediatric Vaccine StockpilesStockpiles

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

Num

ber o

f Dos

es in

Mill

ions

Note: (1) Status based on recently modified targets by SWAT Team, 9/9/2004 (2) Target adjusted to reflect market demand

Source: NIP data

0123456789

10

DTaP DTAPHBIP EIPV HEPA HEPB HiB MMR PCV7 VAR 0% 0%(2) 33% 79%100%7%45% 33%(2) 0% % Stockpile Delivered

Purchased & Delivered

Additional Required For Completion, Not Purchased

Current Stockpile Status(1) : Current Stockpile Status(1) : Doses Delivered Vs. TargetDoses Delivered Vs. Target

Factors Complicating Factors Complicating StockpilesStockpiles

Changing market shareCombination 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

Vaccine StockpilesVaccine StockpilesRevenue RecognitionRevenue 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

Risks of Polio After Eradication'Risks of Polio After Eradication'

*based on current understanding

Risk Frequency to date

Annual burden

Evolution over time

VAPP 2-4/million birth cohort 250-500 stable

iVDPV 19 identified(since 1963) <1 decreases

cVDPV 1* per year 10 increases

IPV sites 1 accident (1990s) <1 decreases

Lab accident 1 investigation NK decreases

Deliberate 0 NK unknown

After interruption of wild poliovirus,continued use of OPV will compromisethe goal of a polio-free world.

Expert Consultation on Vaccine-derivedPolioviruses (VDPVs), Sept 2003, Geneva

Proposed Policy DecisionProposed Policy DecisionCessation of OPV for routine immunization• Consensus of September 2003 meeting• Risks > 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 Heymann’s Polio Eradication Presentation to AACPE, 9/21/04

Conditionalities for Conditionalities for OPV CessationOPV 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 Heymann’s Polio Eradication Presentation to AACPE, 9/21/04