Insights from 26 Years in Immunization Walter A. Orenstein Associate Director Emory Vaccine Center May 2004

Critical Lessons The ultimate goal is disease prevention Science and program must be intimately linked The program must be data driven with quantitative goals Partnerships with a wide variety of public and private sector groups are needed

11/22/2019 Comparison of 20th Century Annual Morbidity and Current Morbidity, Vaccine-Preventable Diseases 20th Century Annual Morbidity† Percent Decrease Disease 2003* Diphtheria Measles Mumps Pertussis Polio (paralytic) Rubella Congenital Rubella Syndrome Tetanus H. influenzae, type b and unknown (<5 yrs) 175,885 503,282 152,209 147,271 16,316 47,745 823 1,314 20,000‡ 1 42 197 8,483 7 14 213 99.99% 99.87% 94.24% 100% 98.93% 98.94% Updated, 9/19/03 † Source: CDC. MMWR 1999. 48: 242-264 * Source: MMWR January 9, 2004. 52, No 53(provisional data) ‡ Data are estimated. Numbers in yellow indicate record lows

Reported Measles Cases, by Age Group, U.S. 1973-1977 11/22/2019 Reported Measles Cases, by Age Group, U.S. 1973-1977

Measles in 6 States Strictly Enforcing School Laws vs. Other States* 11/22/2019 Measles in 6 States Strictly Enforcing School Laws vs. Other States* Measles incidence† 1975-76 1977 1978‡ 6 states 47.0 40.6 2.7 Other states 50.4 90.3 35.2 * MMWR 1978; 27:303-4 † per 100,000 < 18 years ‡ 1st 31 weeks

Measles Elimination Strategy A single dose in the second year of life Catch-up with a single dose for older unvaccinated children Arguments against a second dose 1st dose highly effective > 95% High cost for minimal impact Only 2-5% of revaccinees derived benefit Hopes that reaching high coverage with one dose would terminate transmission

Measles Outbreaks, United States, 1985-1986 Outbreak Classification (Age) Preschool (n=40) School (n=101) Median (Range) Median (Range) Number of cases Preventable cases (%) Patients’ characteristics (%) <16 mos of age Vaccinated at >12 mos Vaccinated at 12-14 mos 13 45 32 14 (5-945) (0-100) (0-80) (0-42) (0-40) 25 27 2 60 20 (5-363) (0-81) (0-29) (0-100) N Engl J Med 1989; 320: 75-81

Characteristics of Counties Reporting Measles Every Year Between 1980 and 1989† Total counties = 3137 Total, in all 10 years, with measles cases = 17 (0.5%) Higher median population Higher median population density Higher proportion minority populations Cases predominantly in unvaccinated preschoolers Cases in counties reporting measles less frequently predominantly school-aged † JAMA 1992; 267: 1936-41

Polio Cases by Four-Week Period Brazil, 1975-1984* Routine Coverage† 500 450 21% 51% 400 350 300 National Vaccination Days Polio Cases 250 200 150 100 50 DNE-SNABS, MS, and, PAHO †Rev Inf Dis 1984;S400-S403 Year

Polio Eradication Strategy Routine immunization National immunization days Careful surveillance Mop-up campaigns

Polio Eradication 1988 - 2003 1988 2003 779 cases* 6 countries *As of February 4, 2004

Influenza Vaccine Effectiveness Determinants age and immune status vaccine match Effectiveness by age and status < 65 years, healthy 70-90% influenza 65 years, community 30-70% influenza 65 years, nursing home 30-40% influenza 50-60% hospital 80% death From Nancy Cox e-mail, 3/13/04

Differences Between Influenza and Other Vaccine Preventable Diseases Year to year variation in viruses with differences in Virulence Transmissibility Host susceptibility Year to year variation in vaccine effectiveness

Estimated Annual Influenza-Associated Deaths and Influenza Coverage for Persons Aged >65 Years† †Deaths taken from JAMA 2003; 289: 179-186 Coverage taken from U.S. Immunization Survey 1969-85 National Health Interview Survey (NHIS) 1989-2002 Influenza: 1997-2000 preliminary NHIS data based on Jan. - June interviews only. Deaths are in underlying respiratory and circulatory category

Possible Explanations for Increasing Deaths and Coverage Aging population Sicker population More H3 N2 outbreaks in the 1990’s Lower efficacy in elderly Non-influenza related deaths

Japan Influenza† 1962 – mass vaccination of school children 1977 – vaccination obligatory Mid 1970’s to late 80’s – coverage 50-85% 1984 – law to opt out 1994 – program ended † N Eng J Med 2001; 344: 889-896

Excess Deaths Attributed to Pneumonia and Influenza Over a 50 Year Period in Japan and the United States Bars are vaccine doses/1,000 popluation N Engl J Med 2001; 344: 889-96

Concerns Raised about Japanese Data† Aging (>65 years) Japanese population – 10% 1985 – 16% 1998 Exaggerated influenza season – 6 months Lack of age-specific data 10 fold increase in nursing homes, convalescent facilities, etc. † N Engl J Med 2001; 344: 1946-1948

Age Specific Rates of Respiratory Illness in Tecumseh and Adrian, Michigan, During the Influenza Period Bull WHO 1969; 41: 537-542 85.8% of students vaccinated against H2 Hong Kong in Tecumseh

Issues That Will Need to be Addressed Would universal vaccination of children and young adults be effective in protecting high risk adults? What are the benefits to the children and how do they compare to risks? What would be the cost-effectiveness? What is the feasibility – how can it be done?

Lesson 1 Vaccination of children < 2 years of life is critically important for a number of vaccine-preventable diseases However, for some diseases, not sufficient Must determine optimal vaccination strategy based on surveillance of disease

Critical Scientific Disciplines Epidemiologic science Vaccine science (how vaccines work, effectiveness, reasons for failure) Vaccine safety science Health services research Behavioral science Economics Communications

Perceived Problems with Under-immunization: 1980s Parents were the problem Undervaccinated children did not have providers

Potential Impact of Vaccinating at all Visits* *CDC MMWR 1994; 43(39):709-718

Relationship of Maternal Beliefs at Time of Birth and Immunization Status at 7 Months† Percent up-to-date P value Disease Serious Not Susceptibility Likely Unlikely Vaccine benefit A lot Little or no 28 32 30 29 23 34 >0.1 >0.1 >0.1 <0.05 † JAMA 1994; 272:1105-1110

Physician-Estimated vs Measured Performance of 45 Practices 11/22/2019 Physician-Estimated vs Measured Performance of 45 Practices Watt J, Smith N et al. Presented at Pediatric Academic Societies, 1998 2

Selected Contributions of Health Services Research AFIX – Assessment, Feedback, Incentives, eXchange of information Reminder/recall Linkage with WIC

Insights from Communication Research In case of pneumococcal vaccination: There’s relatively low awareness of recommendation And relatively high concern about “pneumonia” In the case of influenza vaccination: Very high awareness of influenza vaccination recommendation (e.g., 90% in Harvard survey, 2003) Relatively high adoption or planned adoption of recommendation by those 65 and older (e.g., 82% in Roper/NFID survey, 10/2003) Many who don’t get vaccinated have deeply held beliefs and/or are very skeptical about the value and effectiveness of influenza vaccine (e.g., Harvard, Roper/NFID survey, and Healthstyles surveys, 2003)

Research-based Communications

“What Gets Measured Gets Done” Roger Bernier

Measurement of Immunization Coverage Preschool children Daycare attendees School attendees Adolescents High risk populations

Goals of the Immunization Program Healthy People 2010 goals Need interim targets State and local ownership Real time information – registries ideally suited but use generally disappointing to date

Estimated Vaccination Coverage with the 4:3:1:3:3 Estimated Vaccination Coverage with the 4:3:1:3:3* Series, by Coverage Level and State National Coverage = 78% 69 75 84 VT 84 78 NJ CT MA NH RI DC DE MD 87 89 91 81 80 72 73 83 79 81 83 79 70 81 82 74 78 83 81 76 78 77 77 63 78 69 81 76 78 86 80 75 66 71 68 83 78 79 80 90-100% 75 68 72 79 80-89% 78 70-79% 60-69% *4+DTP, 3+Polio, 1MCV, 3+Hib, 3+HepB Source: National Immunization Survey, 2002 Children in the Q3/2002-Q2/2003 NIS Survey were born between August 1999 and November 2001

Critical Partners for Immunization Federal, State and local governments Manufacturers Scientists Provider community Political, business, and community leaders Minority groups Volunteers Educators And more

The Immunization Task Children Size Infants ~4 million 1 year olds School enterers 11-12 year olds ~16 million Influenza ~80 million

Vaccines for Children Program – a Successful Public-private Partnership† Total VFC sites 42, 313 Public sector sites 11,396 Private sector sites 30,917 † As of 2002

Some National Coalitions for Immunization National Partnership for Immunization Immunization Action Coalition National Network for Immunization Information

Key Lessons for Immunization Program Disease surveillance critical for program success – guides development of strategies Program must be well grounded in science Program must be data driven with measurable short term and long term goals Success requires establishing and maintaining strong partnerships between a variety of public and private sector groups

EXTRA SLIDES

Physician-Estimated vs Measured Performance of 45 Practices Watt J, Smith N et al. Presented at Pediatric Academic Societies, 1998