Impact of the Routine 2-Dose Varicella Vaccination Program and New Directions in Varicella Surveillance Stephanie R. Bialek, MD MPH National Immunization Conference September 29, 2014 National Center for Immunization & Respiratory Diseases Division of Viral Diseases, Epidemiology Branch, Herpes Virus Team

Outline  ACIP recommendations for use of varicella vaccine  Progress with implementation of the varicella vaccination program  Impact of the 2-dose varicella vaccination program  Surveillance for varicella

U.S. Varicella Vaccination Program ACIP Recommendations  1995: Routine 1-dose vaccination of children  1-dose policy for children 12 – 18 months  2-dose vaccination of susceptibles >13 years (4 – 8 weeks apart)

 2006: Routine 2- dose vaccination of children  1st dose: 12 – 15 months  2nd dose: 4 – 6 years  Catch-up vaccination (2nd dose if previously received 1 dose) and vaccination of all eligible persons without evidence of immunity

MMWR 2007;56(RR-4):1-39 available at www.cdc.gov

Rationale for Change to a 2-Dose Varicella Vaccine Policy Incomplete protection after 1 dose  1-dose vaccine effectiveness ~80-85%

Breakthrough varicella cases are contagious Ongoing transmission with outbreaks in school populations with high 1-dose coverage Improved vaccine efficacy with 2 doses  98% against varicella of any severity  100% against severe disease

Varicella in Vaccinated Persons (Breakthrough Varicella) 



 

~15-20% of 1-dose vaccinated persons develop breakthrough varicella if exposed to VZV Varicella in vaccinated persons usually milder with fewer lesions and shorter duration of rash 25-30% breakthrough cases not mild 1-dose vaccinees are half as contagious as unvaccinated persons, contagiousness dependent on number of lesions

MMWR 2007 Varicella Recommendations, Arvin 1996, Seward JAMA 2004, Chaves JID 2008

VARICELLA VACCINE PROGRAM IMPLEMENTATION

One-dose Varicella Vaccination Coverage, Children 19-35 months National Immunization Survey, 1997-2013 100 90

81 76

80 Coverage (%)

85

91 90 90 91 90 91 88 88 89 90

68

70 58

60 50

43

40 30

26

20 10 0 Year

*www.cdc.gov/vaccines/stats-surv/default.htm#nis

7

2-Dose Varicella Vaccination Coverage among 7 year olds, 6 Immunization Information System (IIS) Sentinel Sites, United States, 2006–2012

Lopez et al, MMWR February 28, 2014 / 63(08);174-177

Varicella vaccine school entry requirements, by number of doses required — United States, September 2012

Lopez et al, MMWR February 28, 2014 / 63(08);174-177

Estimated Vaccination Coverage Among 13-17 year olds, NIS-Teen, U.S. 2013 Age (years)

Overall

13 %

14 %

15 %

16 %

17 %

%

History of varicella disease

16

20

25

31

37

25

Among teens without history of varicella: >2 doses

83

80

79

77

72

76

Hx of varicella or 2 doses

86

84

84

84

82

84

MMWR July 25, 2014 / 63(29);625-33

VARICELLA VACCINE PROGRAM IMPACT

Varicella Incidence: 2 Sentinel Surveillance Sites 2000-2010

Bialek et al, Pediatrics 2013

Reduction in Age-specific Varicella Incidence – 2 Sentinel Surveillance Sites, 2006-2010 Age (years)

Antelope Valley, CA West Philadelphia, PA Percent Change Percent Change

1-4

-54

-73

5-9

-88

-79

10-14

-75

-91

15-19

-29

-25

20+

-50

-17

Bialek et al, Pediatrics 2013

Varicella Outbreak Characteristics Sentinel Surveillance - Antelope Valley, CA 1995-2010 Characteristic

1995-1998

1999-2002

2003-2006

2007-2010

236

52

47

12

No. of cases median (range)

15 (5-124)

11 (5-56)

9 (5-45)

9 (5-11)

Duration outbreak

45 (7-198)

39 (1-149)

30 (3-90)

43 (5-52)

Age case patients, median (range)

6 (0-59)

7 (0-49)

9 (0-43)

11 (0-41)

2%

22%

59%

65%

Number of outbreaks

Percent cases vaccinated

Bialek et al, Pediatrics 2013

Severe Varicella Disease in the 2-dose Era • Varicella-related hospitalizations – Declined >40% during 2006-2010 compared with 2002–2005 in active surveillance sites – Most varicella hospitalizations occur among healthy individuals; as many as half may be preventable through vaccination

• Varicella mortality (CDC preliminary unpublished data) – 70% lower among persons <20 years of age in the 2-dose era compared to the 1-dose era based on national vital statistics data – No varicella deaths were reported among persons <20 years in 2010-2011 versus an annual average of 2 deaths in the 1-dose era and 48 deaths in the pre-vaccine era

Bialek et al, Pediatrics 2013; Agopian Vaccine 2014

Evolution of Varicella Surveillance

• National surveillance not adequate to monitor varicella vaccination program when initially implemented – Active surveillance for varicella established in 1995 – With declines in varicella, active surveillance sites became insufficient to monitor varicella and project ended in 2010

• Evaluation of state passive surveillance data reported to CDC in 2010 indicated that these data are now robust enough for monitoring trends in varicella

Incidence of varicella in states meeting criteria for adequate and consistent reporting* and number of states reporting — United States, 2000–2010

• Adequate and consistent reporting defined as reporting at least one varicella case per 100,000 population (considered adequate) for ≥3 consecutive years (considered consistent) to the National Notifiable Diseases Surveillance System. • 31 states met these criteria in 2010: AL, AK, AR, CO, CT, DC, DE, FL, HI, IL, KS, LA, ME, MA, MI, MS, MN, NH, NM, ND, OH, PA, SC, SD, TX, UT, VT, VA, WV, WI, and WY.

Din et al, MMWR Aug 17, 2012 / 61(32);609-612

CSTE Survey of Varicella Surveillance Practices, 2012 • All 50 states and DC responded • 44 jurisdictions mandated varicella reporting – 63% increase from 2004

• 37 jurisdictions conduct statewide case-based reporting • Most jurisdictions conducting case-based surveillance collect varicella-specific information on cases – 84% collect data on disease severity – 92% on hospitalization – 95% on vaccination status

• Only 43% are able to send those data to CDC via HL7 messaging Lopez et al MMWR Sep 12, 2014 / 63(36);785-788

Conclusions from 20 Years of Experience with Routine Use of Varicella Vaccine in the United States  As a result of the vaccination program, more than 3.5 million varicella cases, 9,000 hospitalizations and 100 deaths are prevented annually in the United States  Good safety profile; confirmed serious adverse events rare  Improvements with varicella surveillance practices have allowed transition to use of national data for monitoring varicella epidemiology

 Further work to increase completeness of reporting and transmission of varicella-specific data to CDC will help with monitoring the impact of the vaccination program

THANK YOU

For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: [email protected] Web: www.cdc.gov 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 Immunization and Respiratory Diseases Division of Viral Diseases, Epidemiology Branch, Herpes Virus Team

Is risk for HZ increasing in the US? Yes, but …..

No evidence that this increase is related to the varicella vaccination program  Increased risk predates program  Increased risk in countries without varicella vaccination program  Increase seen in unvaccinated cohorts across all ages  An increase in some unrecognized risk factor for HZ is responsible?

21

Varicella Disease  Etiology: Varicella-zoster virus (VZV)  Humans only reservoir of infection • Primary infection: Varicella (chickenpox) • Reactivation: Herpes zoster (shingles)

 Incubation period 14-16 days (range 10-21 days)  Febrile vesicular rash, itchy, crops, 250-500 skin lesions  Generally mild in childhood

 Severe cases occur • Complications: skin and soft tissue infection, sepsis, pneumonia, neurologic, hemorrhagic • More common at extremes of age (newborns, adults) and in immunocompromised persons

 Highly infectious childhood disease with household 22 secondary attack rates >80%

Varicella Disease Epidemiology in the US – Pre-vaccine Era  Annual Burden  Cases: ~4 million (approximate to birth cohort)  Hospitalizations: ~11,000-13,500  Deaths: ~100-150  Congenital varicella syndrome: ~44 (1-2% risk for pregnancies affected 0-20 weeks)

 Greatest disease burden in children  > 90% of cases, 70% hospitalizations, 50% deaths

23

Varicella Vaccines  Contain live, attenuated virus, developed in Japan  U.S. vaccines  Varicella vaccine (VARIVAX) licensed 1995 for persons age >1 year on the basis of efficacy, safety  MMRV vaccine (ProQuad) licensed 2005 for children age 1 – 12 years on the basis of non inferior immunogenicity • Higher potency than single antigen vaccine (~12-14 X)

 Require freezer storage

24

Varicella Vaccine Effectiveness and Safety  1-dose vaccine effectiveness*:  85%  >95%

varicella of any severity severe disease

 Vaccine safety**:  Excellent safety profile with >55 million vaccine doses distributed  Rash, fever, and injection-site reactions accounted for 2/3 of all reports  Vaccine Adverse Event Reporting System  Rate of severe adverse events***: 2.6/100,000 doses distributed

 Similar safety profile with >140 million doses (unpublished data) *Seward et al JID 2008; **Chaves et al. JID 2008 *** Rash, hepatitis, pneumonia, herpes zoster, meningitis, encephalitis; 1 vaccine 25 strain VZV death in a person with significant medical history suggestive of immunocompromise

8

West Philadelphia, PA 100

8

100

7

7 80

6 5

60

80

6 5

60

4

Year

Overall incidence

2005

2004

0 2003

0 2002

2005

2004

2003

2002

2001

2000

1999

1998

0 1997

0

2001

1

20

1 2000

20

2

1999

2

40

3

1998

40

3

1997

4

One dose vaccination coverage

Antelope Valley, CA Cases per 1000 population

26

One-dose Varicella Vaccination Program Impact – Varicella Active Surveillance Project (VASP) Sites, 1995-2005

Year

One dose vaccination coverage

26

Reduction in Age-specific Incidence Rates – VASP Sites, 1995-2005 27

Age (years)

Antelope Valley, CA (%)

West Philadelphia, PA (%)

<1

84

77

1-4

95

89

5-9

92

95

10-14

64

98

15-19

86

78

20+

82

67

Total

90

93

27 27

Varicella Hospitalization Rates* by Year and Age Group – US, 1988–2006 ACIP Recommendation

Rate per 100,000 population

6

2000-2006: 71% decline from 1988-1995

(1 dose) 5

By 2006: declines of 99% for 0-4 years 94% for 5-9 years 95% for 10-19 years 65% for 20+

4 3 2 1 0

Year 0 to 4 yrs

5 to 9 yrs

10 to 19 yrs

*Data from the National Hospital Discharge Survey Lopez A et al. Pediatrics, 2011

20 to 49 yrs

50+ yrs

28

Varicella-related* Mortality Rates, by Year, US, 1990–2007 Rate per 1 million population

0.6

0.5

ACIP Recommendation (1 dose)

0.4

0.3

2005-2007 88% decline from 1990-1994

0.2

0.1

0 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Year Marin et al. Pediatrics, 2011 *Varicella as the underlying cause of death, data from the National Vital Statistics System

29

Varicella Deaths* among Children and Adolescents < 20 Years, US, 1990-2007

70

60

Average 48 deaths/year 61

53

46 40 43 43

50 40

30 24

30

15 13

20

8

10

Average 2 deaths/year 2 2 1 4 1 3 1

0 1990

1992

1994

1996

1998

2000

2002

2004

2006

*Varicella as the underlying cause of death, data from the National Vital Statistics System

30

decline in <50 yo for 2005-06 compared with prevaccine (1990-94) =93%

Decline in Reported Varicella Deaths <50 Years of Age, US, 1990-2006

120

average=85

No. of Deaths

100 80

93% decline in deaths in 2005-2006 compared to pre-vaccine era 1990-1994

60 40

average=8

20 0

YEAR National Center for Health Statistics

31 31

Reduction in Varicella Health Care Costs  Total estimated direct medical expenditures for varicella hospitalizations and ambulatory visits  1994-1995  2002  74% decline

Zhou et al, JAMA, 2005

$85 million $22 million

32

Two-dose varicella vaccination coverage among children aged 6 years, 2012 IIS data and 2012–13 kindergarten survey

Sentinel site

2-dose varicella vaccination coverage, 2012 IIS data %

2-dose varicella vaccination coverage, 2012–13 kindergarten school year survey %

Sites requiring 2 doses of varicella vaccine for school entry* Michigan

92.2

92.9

Minnesota

80.3

95.9

North Dakota

92.9

88.5

Wisconsin

93.1

91.1

Sites requiring 1 dose of varicella vaccine for school entry* New York City

89.1



Oregon

80.9



Average % for all six sites

88.1



* The differences in 2-dose varicella vaccination coverage among sites requiring 2 doses and sites requiring 1 dose were not statistically significant (p=0.5).

Lopez et al, MMWR February 28, 2014 / 63(08);174-177

Varicella vaccine and herpes zoster (HZ)  Effect in community will depend on effect in vaccinated and unvaccinated cohorts  In vaccinated healthy and immunocompromised children  Varicella vaccine also prevents herpes zoster • VE

68% - 100%

 Declines in HZ incidence in vaccinated cohorts described US, Canada

 In persons with history of varicella  Models predicted increases based on assumptions about role of and duration of external boosting from exposure to children with varicella  Real world data? 34

Varicella Public Health Burden  Direct medical costs  Physician visits, hospitalizations, deaths

 Outbreak related costs  Schools, other closed settings especially involving adults (hospitals, ships, prisons etc.)

 Healthcare associated costs  Exposures and illness in healthcare settings

 Societal costs  Days of school and/or work missed for case and caretaker  Medications, other

Varicella Vaccination Program Topics for the Future  Monitoring the effect of two doses of varicella vaccine in children  Evaluation of immunity in the vaccine era  Duration of vaccine-induced immunity (correlates of protection?)

 Diagnosis of highly modified varicella in vaccinated persons: clinical and laboratory  Monitoring and interpreting trends in herpes zoster  In vaccinated persons –will lower risk be maintained over time?  In total population, will herpes zoster epidemiology change without external boosting from varicella exposures?

C1 - Bialek.pdf

received 1 dose) and vaccination of all eligible. persons without evidence of immunity. MMWR 2007;56(RR-4):1-39 available at www.cdc.gov. Page 3 of 32 ...

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