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Rotavirus Vaccination in the United States
Umesh D. Parashar For the Viral Gastroenteritis Team Centers for Disease Control and Prevention Atlanta, GA
TM
Viral Gastroenteritis Unit, CDC
Daniel Payne
Jackie Tate
Umesh Parashar
Ben Lopman
Margaret Cortese
Manish Patel
Jon Gentsch Baoming Jiang
Vaccine Implementation
• Feb 2006 -- RotaTeq recommended
• June 2008 -- Rotarix recommended
3
National Laboratory Surveillance
• Network of 67 laboratories
reporting since 2000
• Weekly reporting:
– # stool specimens tested for
rotavirus by EIA
– # positive tests
4 Tate et al. Pediatrics 2009 and unpublished CDC data
Vaccine introduction
Tate et al. Pediatrics 2009 and unpublished CDC data
60%-80% reduction in rotavirus +ve
Pre-Vaccine Seasonality of Rotavirus in U.S.
Nov Dec Jan Feb Mar Apr May
* 2000-2006 data
(before vaccine
introduction)
Marked Change in Seasonality in 2008 (Post-Vaccine)
Peak month of rotavirus activity
Curns, et al. PIDJ 2010.
Active Rotavirus Surveillance
• Surveillance in 3 US counties
• Enrollment of inpatients, emergency room patients, and outpatients with AGE
• Fecal specimens obtained and tested for rotavirus
8
211 194
147
168
101 104 107 101
9
44
4
27
0
50
100
150
200
250
2006 2007 2008 2009 2010 2011
Hosp
ital
izat
ions
All-cause AGE Rotavirus
All Cause Acute Gastroenteritis (AGE) and Rotavirus AGE Hospitalizations, NVSN 2006-2011
Proportion of AGE hospitalizations positive for rotavirus by EIA by year, NVSN, 2006-2011
51% 52%
6%
26%
4%
26%
0%
10%
20%
30%
40%
50%
60%
2006 2007 2008 2009 2010 2011
Per
cent
of
AG
E h
osp
ital
izat
ion
s ro
tav
iru
s +
Age Rotavirus vaccine
coverage in 2008
(≥1 dose)
< 1 year 56%
1 to < 2 years 44%
2 to < 3 years <1%
Age-Specific Rotavirus Hospitalization Rate Reduction and Vaccine Coverage, NVSN, 2008
Payne et al. CID 2011.
Age Rotavirus vaccine
coverage in 2008
(≥1 dose)
Decline in rotavirus
hospitalization rate
(2008 vs. 2006)
< 1 year 56% 66%
1 to < 2 years 44% 95%
2 to < 3 years <1% 85%
Age-Specific Rotavirus Hospitalization Rate Reduction and Vaccine Coverage, NVSN, 2008
Herd immunity?
Payne et al. CID 2011.
Possible Herd Immunity in Older Children and Young Adults -- Monthly Rate Ratio of GE discharges, 2008 vs. 2000-2006
Month Month
Lopman et al. JID 2011
14
Case-Control Studies of RotaTeq Effectiveness against Severe Rotavirus Disease
Study 1 (Boom, 2010)
Study 2 (Staat, 2011)
Study 3 (Cortese, 2011)
3 doses 89%
(70, 96)
87% (71, 94)
90% (84, 94)
2 doses 82%
(15, 96)
88% (66, 96)
90% (75, 96)
1 dose 65%
(-11, 89)
74% (37, 90)
66% (16, 86)
Longitudinal Variation of Rotavirus G Types in the United States, 1996-2011
15
0
100
200
300
400
500
600
700
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
G1 G2 G3 G4 G9 G12
Vaccine implementation
Gautam R, Mijatovic-Rustempasic S, Quaye O, Tam KI, Bowen M, Gentsch J, et al.
88 77 87 84 86 0
10
20
30
40
50
60
70
80
90
100
G1 G2 G3 G9 G12
Va
ccin
e E
ffec
tiv
enes
s (%
)
RotaTeq Effectiveness Against Severe Rotavirus Gastroenteritis, by Strain, NVSN, 2006-2009
Staat et al Pediatrics 2011
Detection of Rotavirus Vaccine Strains in Children with Gastroenteritis
Season RotaTeq Rotarix
2007-08 1 (retrospective) 0
2008-09 7 0
2009-10 5 1
2010-11 6 0 Gautam R, Mijatovic-Rustempasic S, Quaye O, Tam KI, Bowen M, Gentsch J, et al.
Reassortment in vivo Between RotaTeq Vaccine Strains
P[5]G1 P[5]G2 P[5]G3 P[5]G4 P[8]G6
G1 VP7 gene P[8] VP4 gene
Reassortant strain:
G1P[8] human
9 genes of WC3 parent
Slide courtesy Jon Gentsch
Intussusception Monitoring
• Active surveillance -- VSD
• National passive surveillance -- VAERS
19
JAMA. 2012;307(6):598-604.
VSD Data
Passive Reports of Intussusception after Rotavirus Vaccine Dose 1, VAERS
0
1
2
3
4
5
6
7
8
9
10
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 63 66 69 72 75
Real risk or reporting bias?
Haber et al. Pediatrics 2010
Benefit Versus Risk (If Risk Exists)
Events Rotavirus
disease averted Excess
intussusception Benefit : Risk
ratio
Deaths 14 0.2 70
Hospitalizations 55,000 51 1,100
Emergency visits 150,000 13 12,000
Outpatient clinic visits 273,000 NA NA
Desai et al. PIDJ 2012
Summary Marked declines in rotavirus disease
Appearance of a bi-annual pattern
Herd immunity
Changes in seasonal patterns
High vaccine effectiveness
Against a range of circulating strains
Strain changes after vaccine implementation
Could simply represent natural variation
No documented risk of intussusception
Cannot exclude low risk
Benefits outweigh potential risk
23
New Vaccine Surveillance Network
24