Using surveillance data to monitor impact of rotavirus vaccine. Lúcia De Oliveira Regional Advisor on New Vaccines IM/PAHO

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1 Using surveillance data to monitor impact of rotavirus vaccine Lúcia De Oliveira Regional Advisor on New Vaccines IM/PAHO

2 Main Topics Epidemiological surveillance of rotavirus in American Region Impact studies using surveillance data: el Salvador, Nicaragua and Bolivia Conclusions and recommendations

3 Year of universal introduction of the rotavirus, Region of the Americas, Year Rotavirus 2001 NA 2002 NA 2006 BRA, ELS, EUA, MEX, NIC, PAN, VEN 2007 ECU 2008 BOL 2009 COL, HON, PER, Cayman Islands 2010 GUT, GUY, PAR 2012 DOR- Total 16 countries and 1 territory

4 Estimates of rotavirus diarrhea-associated mortality, 10 Latin American and Caribbean countries, Thi s study W HO estimates Country Population < 5 years of age* Diarrhea deaths, < 5 years of age, 2004 (n) Rotavirus (RV) prevalence among diarrheal hospitalisations (%) RV deaths among children <5 years / year Risk by age 5 years RV deaths R isk by age among 5 years children <5 years / year Bolivia 1,231,245 2, ,057 1 in in 1507 Chile 1, 246, in 415,4 72 <1 0 1 in El Salvador 804, in in 3452 Guatemala Guyana Hondura s Paraguay 1,988,338 2, ,225 1 in in , in in ,131 1, in in , in in 4401 St. Vinc ent 11, no determinado <1 0 1 in 1156 Suriname 46, in in 2307 Venezuela 2, 842,078 1, in in 6641 TOTAL 10,035,941 8, , in ,416 1 in 2937 Fuente: de Oliveira LH, Danovaro-Holliday MC1 Andrus JK, de Fillipis AMB, Gentsch J, Matus CR and Widdowson MA, on behalf of the Rotavirus Surveillance Network. Rotavirus Surveillance in Latin America and the Caribbean JID 2009:200 (Suppl 1) S131

5 Seasonality of hospitalizations for rotavirus infection in Latin American and Caribbean countries in the North Hemisphere (A) and South Hemisphere (B), Fuente: de Oliveira LH, Danovaro-Holliday MC1 Andrus JK, de Fillipis AMB, Gentsch J, Matus CR and Widdowson MA, on behalf of the Rotavirus Surveillance Network. Rotavirus Surveillance in Latin America and the Caribbean JID 2009:200 (Suppl 1) S131

6 Effectiveness of the rotavirus diarrhea in El Salvadorian Children El Salvador: low middle income country in Central America Rotavirus monovalent (RV1) vaccine introduced in October 2006 Methods: case-control study carried out from January 2007-June 2009 Objective: to evaluate effectiveness of the RV1 in children < 5 years old using WHO protocol Cases: identified from 7 hospitals surveillance system Controls: 3 controls for each case (individually matched to the case s date of birth +-30 days) Sentinel surveillance established in Jan. 2006: 7 sentinel hospitals in cities across the country (represent 48% of El Salvador s annual admission for diarrhea in <5 yrs. old) Source: De Palma O, Cruz L, Ramos H; Baires A, Villatoro N, Pastor D, Oliveira L, Kerin T, Bowen M, Gentsch J, Esposito D, Parashar U, Tate J, Patel, M. Effectiveness of rotavirus vaccination against childhood diarrhea in El Salvador: case-control study. BMJ, June 2010: page 1-7.

7 Effectiveness of the rotavirus diarrhea in El Salvadorian Children Effectiveness with 2 doses against diarrhea hospitalizations: 76% (CI: 64%-84%) Effectiveness in children >12 months: 59% (CI: 27%-77%) Effectiveness in children between 6-12 months: 83% (CI:68%-91%) One dose of the vaccine: 51% (CI:26%-67%) Source: De Palma O, Cruz L, Ramos H; Baires A, Villatoro N, Pastor D, Oliveira L, Kerin T, Bowen M, Gentsch J, Esposito D, Parashar U, Tate J, Patel, M. Effectiveness of rotavirus vaccination against childhood diarrhea in El Salvador: case-control study. BMJ, June 2010: page 1-7.

8 Rotavirus vaccine impact study: 7 sentinel hospitals Between Jan and June 2009: 8151 (33.1%) children <5 years old were positive due to RV 98% of the cases were identified during January to June Sentinel hospital surveillance, children under 5 yrs old, January to June, : year % RV + % rv coverage at national level NA (lack of vaccine) Source: De Palma O, Cruz L, Ramos H; Baires A, Villatoro N, Pastor D, Oliveira L, Kerin T, Bowen M, Gentsch J, Esposito D, Parashar U, Tate J, Patel, M. Effectiveness of rotavirus vaccination against childhood diarrhea in El Salvador: case-control study. BMJ, June 2010: page 1-7.

9 RV impact of the vaccine on hospitalized diarrhea, El Salvador. Source: De Palma O, Cruz L, Ramos H; Baires A, Villatoro N, Pastor D, Oliveira L, Kerin T, Bowen M, Gentsch J, Esposito D, Parashar U, Tate J, Patel, M. Effectiveness of rotavirus vaccination against childhood diarrhea in El Salvador: case-control study. BMJ, June 2010: page 1-7.

10 Rotavirus pentavalent vaccine effectiveness study in Nicaragua (June 2007 to June 2008) Nicaragua: low middle income country in Central America (GAVI country) Rotavirus pentavalent (RV5) vaccine introduced in October 2006 Methods: case-control study carried out from June 2007-June 2008 (phase 1) Objective: to evaluate the association between RV5 vaccination and rotavirus hospitalized diarrhea Cases: identified from 4 hospitals through active surveillance ( the sentinel surveillance system started at same time) Controls: hospital and neighborhood individually matched to thecase s date of birth +-30 days Source: Patel, M. Pedreira, C, De Oliveira, L. Association between pentavalent rotavirus vaccine and severe rotavirus diarrhea among children in Nicaragua. JAMA, Jun 3, 2009 Vol. 301, No. 21, p

11 Rotavirus pentavalent vaccine effectiveness study in Nicaragua (June 2007 to June 2008) Effectiveness of all diarrhea that require hospitalization or RHIV= 46% (IC95% = 18% -64%) Effectiveness for severe diarrhea = 58% (IC95% = 30% -74%) Effectiveness for very severe diarrhea = 77%( IC 95% = 39% 92%) Source: Patel, M. Pedreira,C, De Oliveira, L. Association between pentavalent rotavirus vaccine and severe rotavirus diarrhea among children in Nicaragua. JAMA, Juneo 3, 2009 Vol. 301, No. 21, p

12 Effectiveness of the rotavirus diarrhea in Bolivian Children Bolivia: low middle income country in South America (GAVI country) Rotavirus monovalent (RV1) vaccine introduced in August 2008 Methods: case-control study carried out from March 2010-July 2011 Objective: to evaluate effectiveness of the RV1 in children < 5 years old Cases: identified from 6 hospitals surveillance system (sentinel surveillance established in 2006 in cities across the country) Controls: 3 controls for each case (individually matched to the case s date of birth +-30 days) UNPUBLISHED

13 Number of hospitalization for diarrhea among children < 5 yrs. of age and percentage of rotavirus positive samples, 6 sentinel surveillance hospitals, Bolivia, Number/Percen tage Hospitalization due to all causes Hospitalization due to diarrhea Eligible for rotavirus surveillance Enrolled in rotavirus surveillance Rotavirus positive % of rotavirus positive : 2008: vaccine introduction in August

14 Number of diarrhea due to all causes and rotavirus diarrhea, monthly distribution, sentinel hospitals, Bolivia. Number of diarrhea cases NUMERO DE CASOS DE EDAs ROTAVIRUS OTRAS Other CAUSAS causes CASOS cases Months MESES

15 Disease Severity *Vesikari score is a 20-point clinical severity scoring system N = 348 Overnight hospitalization 348 (100%) Vesikari >= (94%) UNPUBLISHED 15

16 Effectiveness by Severity * Vesikari score is a 20-point clinical severity scoring system Num. doses of vaccine Vaccine effectiveness (Vesikari >= 11) 1 dose 45% (CI: 13-65) 2-dose 75% (CI: 61-87) UNPUBLISHED 16

17 Conclusions and Recommendations Strengthen epidemiological surveillance through regional and global networks; evaluate the impact, monitor the prevalence of circulating strains, identify changes in the epidemiological profile Strengthen laboratory networks for new vaccines and the coordination between epidemiology and laboratory Report quality data systematically: regional profile, differences and similarities between countries, develop a software * WER, N 23 5 June 2009 (SAGE May 2009)

18 Conclusions and Recommendations Integrate the surveillance of rotavirus and bacterial pneumonia/meningitis Promote special studies: determine effectiveness, safety, protection with incomplete schedules, risk factors that can affect effectiveness Share new vaccines introduction and surveillance experiences. This will help other countries identify weaknesses and strengths as they implement in their countries

19 Thank you!

Monitoring For Rotavirus Serotypes In The Americas. Jon Gentsch

Monitoring For Rotavirus Serotypes In The Americas Jon Gentsch Centers for Disease Control and Prevention, Atlanta, USA * The findings and conclusions in this presentation are those of the authors and