Experience with Quadrivalent Meningococcal Conjugate Vaccines (MenACWY) in Adolescent Vaccine Programs in the United States and Canada

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1 Experience with Quadrivalent Meningococcal Conjugate Vaccines (MenACWY) in Adolescent Vaccine Programs in the United States and Canada Jessica MacNeil, MPH Epidemiologist Centers for Disease Control and Prevention (CDC) March 19, 2012 National Center for Immunization & Respiratory Diseases Meningitis and Vaccine Preventable Diseases Branch

2 Presentation Goals Understand the epidemiology and burden of meningococcal disease in the US and Canada Understand US adolescent meningococcal vaccination recommendations and use of MenACWY in Canada Describe the impact of routine adolescent meningococcal vaccination on US disease burden

3 EPIDEMIOLOGY AND BURDEN OF MENINGOCOCCAL DISEASE

4 Rate per 100,000 Meningococcal Disease Incidence, United States, Current incidence: US*: 0.3 cases/100,000 population Canada**: 1 case/100,000 population Year * NNDSS data, ABCs data estimated to U.S. population **

5 Rate per 100,000 Incidence Declines Observed in All Serogroups, United States, B C Y W MenACWY 0 Year ABCs cases from estimated to the U.S. population with 18% correction for under reporting

6 Incidence of Meningococcal Disease by Serogroup, Canada, MenC Update on the Invasive Meningococcal Disease and Meningococcal Vaccine Conjugate Recommendations (accessed March 13, 2012)

7 A Comparison of the Epidemiology Similarities: Rates of serogroup B are highest in children <5 years 60-70% of disease caused by serogroup B Serogroups C and Y more common in adolescents and adults Differences: Serogroup Y emerged in the US in the late 1990 s Associated with bacteremic pneumonias in older adults Serogroup distribution and rates vary slightly

8 MENINGOCOCCAL VACCINES AND RECOMMENDATIONS

9 Meningococcal Vaccines in Canada Vaccine MenC (3 available vaccines; first licensed in 2002) MenACWY (Menactra licensed 2007; Menveo licensed 2010) Suggested Uses One dose in second year of life (12 months) For infants at increased risk, a dose at two, four, and 12 months of age Adolescent booster Adolescent booster After age two in groups at increased risk Vaccination programs differ by province. As of December 2010 all provinces and territories had implemented publicly funded, universal MenC vaccination programs for young children. (accessed February 27, 2012)

10 Summary of US Meningococcal Vaccine Recommendations Group Primary Series* Booster Dose* Adolescents aged years Persons aged 2-55 years at high-risk** 1 dose, preferably at age years HIV-infected adolescents: 2 doses, 8 to 12 weeks apart 2 doses, 8 to 12 weeks apart 1 dose for microbiologists and travelers Age 16 years if primary dose at age years During ages of primary dose at age years No booster needed if primary dose on or after age 16 years Age 2-6 years: 3 years Age 7 years: 5 years Persons aged 9-23 months at high-risk** 2 doses, 8 to 12 weeks apart *Two licensed MenACWY vaccines: Menactra in 2005 and Menveo in 2010 **High-risk includes persistent complement deficiency, functional or anatomic asplenia, or prolonged increased risk of exposure

11 Differing Vaccination Strategies Canada s meningococcal vaccine program focuses on young children and uses primarily MenC MenACWY can be used as a booster dose in adolescents High-risk individuals after age 2 years The US meningococcal vaccine program is an adolescent program using MenACWY Adolescent booster dose added in 2011 MenACWY also used for high-risk individuals 9 months-55 years

12 US ADOLESCENT VACCINE PROGRAM AND IMPACT ON DISEASE BURDEN

13 2005 US Meningococcal Vaccination Recommendations Goal: Protect adolescents through peak in disease seen in year-olds Assumptions: Vaccine would protect most adolescents for 10 years Vaccination at years of age preferred High coverage prior to increased period of risk Adolescent vaccination platform

14 Rate per 100,000 Rates of Meningococcal Disease (C and Y) by Age, Serogroup C Serogroup Y Period of risk Age (years) *Active Bacterial Core surveillance (ABCs), estimated to the US population

15 Percent Coverage Coverage of 1-dose MenACWY among year-olds, NIS-Teen, * Age (years) National Immunization Survey Teen In 2010, MenACWY coverage varied from 26-90% by state

16 Rates of Serogroup C,Y,W135 Meningococcal Disease* Year Rate per 100,000 (95% confidence intervals) year-olds 20 year-olds 2004 and (0.15, 0.35) 0.16 (0.13, 0.20) 2006 and (0.18, 0.40) 0.22 (0.18, 0.26) 2008 and (0.08, 0.24) 0.21 ( ) *Active Bacterial Core surveillance, estimated to the U.S. population

17 Average Annual Number of Cases of C,Y,W135 Meningococcal Disease Age Group Percent Change yrs % yrs % yrs % Total (11-22 yrs) % *Active Bacterial Core surveillance, estimated to the US population

18 Meningococcal Disease Among Persons Previously Vaccinated Reports of over 40 cases of meningococcal disease among persons who received MenACWY Case-fatality ratio of vaccinated cases high (20%) Increasing number of vaccinated cases occurring 2-5 years after vaccination

19 Preliminary Menactra VE Estimates, Case-Control Study, Duration of Protection* Cases (n=147)* VE (95% CI) Vaccinated <1 year 79% (46, 92%) Vaccinated 1-2 years 73% (32, 89%) Vaccinated 3 years 43% (-1, 68%) *Analysis results based on paperwork received by December 31, Controls for smoking status and underlying condition status PRELIMINARY RESULTS, SUBJECT TO CHANGE. PLEASE DO NOT DISTRIBUTE

20 % >= 1:128 SBA-BR Seroresponse 1:128 Post-Vaccination, Serogroup C MenACWY (Menactra) MPSV Age-matched naive n= 440, 441 n= 71, 72, 84 n= 108, 207, mo 3 years 5 years Time post-vaccination *Data courtesy of sanofi pasteur, 3 year follow-up of MTA02 (11-18 year-olds), 5 year follow-up of (2-10 year-olds)

21 SBA-BR GMT (log scale) SBA-BR Pre- and Post-Booster: Serogroup C MenACWY (Menactra) MPSV4 Naïve n= 440, 441 n= 108, 207, 107 n= 55, 56 1 month 5 years, pre-vac 5 years, post-vac *Data courtesy of sanofi pasteur, 5 year follow-up of (11-18 year-olds at dose 1)

22 hsba Seroresponse 1:8 Post-Vaccination, Serogroup C Age group (yrs) at vaccination 11 through 18 years Years post vaccination Serogroup C SBA Vaccine No. of vaccine recipients in study 2 % hsba 1:8 Menveo % Menactra % Recipients with protective antibody levels *Data courtesy of Novartis

23 Rationale: 2011 Booster Dose Recommendations Optimize protection through late adolescence Expectation that antibody decline will not be as rapid after the booster dose Increase potential for herd immunity

24 MenACWY Impact on Disease Burden, United States Measuring vaccine impact is challenging because of low disease burden Incidence declined from 0.41 to 0.27/100,000 during Vaccination coverage varies by state (2010: 26-90% in y.o.) Correlation between increasing vaccine coverage and decreasing disease incidence seen in year olds No correlation between adolescent vaccine coverage and disease incidence in <5 year olds and 25 year olds States with more rapid uptake of MenACWY have achieved greater declines in meningococcal disease incidence in adolescents

25 Future Strategies: Do We Need an Infant Meningococcal Program in the United States? Impact of adolescent program not fully realized Disease rates continue to decline in infants in the absence of vaccination Epidemiology in infants makes disease prevention difficult in this age group High proportion of serogroup B disease Highest rates of disease prior to 6 months of life

26 Number of Cases Estimated Annual Number of Cases of Meningococcal Disease, United States: Age 0-21 years Serogroups A,C,Y,W-135 Serogroup B 0 < Age (Years) *Active Bacterial Core surveillance, estimated to the US population

27 Thank you! For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone, CDC-INFO ( )/TTY: Web: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Immunizations and Respiratory Diseases Meningitis and Vaccine Preventable Diseases Branch