The Effectiveness of Interim CDC Guidelines in Restricting

Background § § § 2/2000 PCV-7 first licensed 6/2000 ACIP endorses vaccine 9/2000 State

Background 7/2001 First problems with availability of vaccine § 9/2001 First CDC interim recommendations

Recommendations for PCV-7 Use During Vaccine Shortage Age at 1 st vaccination 6 months

Recommendations for PCV-7 Use During Vaccine Shortage Age at 1 st vaccination 7 -11

Recommendations For PCV-7 Use During Vaccine Shortage Age at 1 st vaccination 12 -23

Background 2/2002 Moderate shortage schedule letter to DHS Clinics § 5/2002 Severe shortage schedule

Objective § To determine the effectiveness of the CDC Interim guidelines on PCV-7, in

Methods Analysis of monthly usage data for PCV -7 in LACDHS clinics, for the

Age Group Summary Statistics Baseline Protocol 1 Protocol 2 <1 <2 2 -5 Max

www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Percentage of Doses < 12 Months of Age Groups P Value Baseline To Protocol

Percentage of Doses To Children 1 to < 2 Yrs of Age Groups P

Percentage of Doses To Children 2 to 5 Yrs of Age Groups P Value

Discussion § The results support the conclusion that promulgation of interim CDC guidelines for

Discussion § Prior suggestions that interim guidelines are not always effective in changing practice

Discussion Variation in Public and Private Supply of Pneumococcal Conjugate Vaccine During a Shortage

Discussion § Special considerations regarding our clinics: 1) relationships built on years of monitoring,

Recommendations Interim guidelines should be straightforward, easy to understand, and easy to apply §

Other Contributors to the Abstract Shanda Cordova § David Gambill, MSc. § Jon Lamori,

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The Effectiveness of Interim CDC Guidelines in Restricting Use of PCV-7 In Public Health Community Clinics During the Nationwide Shortage A. Nelson El Amin MD, MPH Medical Director Los Angeles County Immunization Program www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Background § § § 2/2000 PCV-7 first licensed 6/2000 ACIP endorses vaccine 9/2000 State of Ca IZ makes vaccine available to local health departments 9/2000 DHS LAC clinics prepared for PCV-7 6/2001 excellent use of PCV-7 in DHS clinics www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Background 7/2001 First problems with availability of vaccine § 9/2001 First CDC interim recommendations on vaccine usage § 12/21/01 ACIP develops revised interim guidelines § www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Recommendations for PCV-7 Use During Vaccine Shortage Age at 1 st vaccination 6 months Standard Schedule High-Risk Children Shortage Schedules Low to Moderate Risk Children Moderate Shortage Severe Shortage 4 doses 3 doses 2 doses (2, 4, 6, & 12 -15 mos. ) (2, 4, & 6 mos. ; defer 4 th dose) (2 doses 2 months apart in 1 st 6 months of life; defer 3 rd & 4 th doses) www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Recommendations for PCV-7 Use During Vaccine Shortage Age at 1 st vaccination 7 -11 months Standard Schedule High-Risk Children Shortage Schedules Low to Moderate Risk Children Moderate Shortage Severe Shortage 3 doses 2 doses (2 doses 2 months apart & at 12 -15 mos. ) (2 doses 2 mos. apart; defer 3 rd dose) www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Recommendations For PCV-7 Use During Vaccine Shortage Age at 1 st vaccination 12 -23 months Standard Schedule High-Risk Children Shortage Schedules Low to Moderate Risk Children Moderate Shortage Severe Shortage 2 doses 1 dose (2 doses 2 mos. apart) (defer 2 nd dose) Defer 2 doses 24 -59 months (2 doses 2 mos. apart) www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Background 2/2002 Moderate shortage schedule letter to DHS Clinics § 5/2002 Severe shortage schedule letter to DHS Clinics § www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Objective § To determine the effectiveness of the CDC Interim guidelines on PCV-7, in restricting vaccine usage to high risk groups www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Methods Analysis of monthly usage data for PCV -7 in LACDHS clinics, for the period April 2001 through August 2002 § Analysis for statistical significance using non-parametric tests: Kruskal-Wallis and Dunn § www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Age Group Summary Statistics Baseline Protocol 1 Protocol 2 <1 <2 2 -5 Max 4, 422 6, 754 3, 417 Min 3, 473 5, 312 2, 025 Median 4, 005 6, 103 2, 753 Max 3, 992 5, 963 1, 079 Min 3, 266 4, 655 495 Median 3, 518 5, 051 627 Max 4, 144 5, 775 578 Min 632 732 16 Median 2, 083 2, 563 171 www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Percentage of Doses < 12 Months of Age Groups P Value Baseline To Protocol 1 <0. 0001 Baseline To Protocol 2 <0. 0001 Protocol 1 To Protocol 2 0. 0056 www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Percentage of Doses To Children 1 to < 2 Yrs of Age Groups P Value Baseline To Protocol 1 0. 0003 Baseline To Protocol 2 <0. 0001 Protocol 1 To Protocol 2 0. 0153 www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Percentage of Doses To Children 2 to 5 Yrs of Age Groups P Value Baseline To Protocol 1 0. 0007 Baseline To Protocol 2 <0. 0001 Protocol 1 To Protocol 2 0. 2645 www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Discussion § The results support the conclusion that promulgation of interim CDC guidelines for vaccines in short supply can result in better prioritization of the limited vaccine to medically high risk groups www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Discussion § Prior suggestions that interim guidelines are not always effective in changing practice patterns as quickly as desired www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Discussion Variation in Public and Private Supply of Pneumococcal Conjugate Vaccine During a Shortage (JAMA 2003; 289: 575 -578) § Impact of Vaccine shortage on Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine Coverage Rates Among Children Aged 24 Months – Puerto Rico, 2002 (MMWR 2002; 51/no. 30: 667 -668) § www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Discussion § Special considerations regarding our clinics: 1) relationships built on years of monitoring, correspondences, and educational activities with clinic staff; 2) DHS Immunization Program staff regularly deliver and retrieve vaccines from the clinics www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Recommendations Interim guidelines should be straightforward, easy to understand, and easy to apply § Interim guidelines should not require provider discretion regarding implementation of certain sections. § www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM

Other Contributors to the Abstract Shanda Cordova § David Gambill, MSc. § Jon Lamori, MA § www. lapublichealth. org/ip/ County of Los Angeles Department of Health Services IMMUNIZATION PROGRAM