Rotavirus Vaccine Impact and Effectiveness in Armenia and Moldova

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1 Rotavirus Vaccine Impact and Effectiveness in Armenia and Moldova Margaret M. Cortese, MD Centers for Disease Control and Prevention 12 th International Rotavirus Symposium, Melbourne, AUST Sept. 7, 2016 National Center for Immunization & Respiratory Diseases Division of Viral Diseases

2 Surveillance supported by National Center for Immunization & Respiratory Diseases Division of Viral Diseases

3 National RV introductions by geographic region: 81 countries* Americas Argentina Bolivia Brazil Cayman Islands Colombia Dominican Republic Ecuador El Salvador Guatemala Guyana Haiti Honduras Mexico Nicaragua Panama Paraguay Peru United States *As of May 1, 2016 RV = rotavirus vaccine Europe Armenia Austria Belgium Estonia Finland Georgia Germany Latvia Luxembourg Moldova Norway United Kingdom Africa Angola The Gambia Mali Sierra Leone Botswana Ghana Mauritania South Africa Burkina Faso Guinea-Bissau Morocco Sudan Burundi Kenya Mozambique Swaziland Cameroon Liberia Namibia Tanzania Congo, Rep. Libya Niger Togo Djibouti Madagascar Rwanda Zambia Eritrea Malawi Senegal Zimbabwe Ethiopia Middle East Bahrain Saudi Arabia Iraq Tajikistan Israel UAE Jordan Uzbekistan Qatar Yemen Not Gavi-eligible [43] Venezuela Gavi-eligible [38] Western Pacific Australia Fiji Kiribati Marshall Islands Micronesia New Zealand Palau

4 MOLDOVA ARMENIA 4

5 Moldova Armenia Total population 4 million 3.2 million Birth cohort 43,000 40,000 Rotavirus vaccine introduction (Rotarix) Recommended age Dose 1 Dose 2 y 2012 Nov m (to 3.5 m) 4 m (to 7 m) 6 wks (to 15 wks) 12 wks (to 32 wks) In general, physicians may temporarily postpone vaccination, following contraindications 5

6 Photo: Serouj Ourishian Republic of Armenia

7 Armenia Gayane Sahakyan Svetlana Grigoryan Shushan Sargsyan Ara Asoyan Zahuri Gevorgyan Karine Kocharyan Artavazd Vanyan Sergey Khactatryan CONTRIBUTORS WHO Tigran Avagyan Annemarie Wasley Liudmila Mosina Elena Samoilovich Doville Videbaek CDC Benjamin Lopman Umesh Parashar 7

8 Rotavirus Surveillance in Armenia Performed at 2 hospitals in Yerevan, began 2009 Nork Infection Hospital Arabkir Medical Center Follows generic WHO protocol Children aged <5 years admitted because of acute diarrhea 7days duration Rotavirus EIA testing performed at National Virology Laboratory Genotyping performed at WHO Regional Reference Lab in Minsk, Belarus 8

9 Mar May Sep Nov Mar May Sep Nov Mar May Sep Nov Mar May Sep Nov Mar May Sep Nov Mar May Number of hospitalizations Pre Vaccine Sentinel Surveillance: Rotavirus Hospitalizations, Age <1 year 60 Rotavirus Positive

10 Mar May Sep Nov Mar May Sep Nov Mar May Sep Nov Mar May Sep Nov Mar May Sep Nov Mar May Number of hospitalizations Pre and Post Vaccine Sentinel Surveillance: Rotavirus Hospitalizations, Age <1 year 60 Rotavirus Positive

11 Number of hospitalizations Pre and Post Vaccine Sentinel Surveillance: Age <1 year Rotavirus Positive Rotavirus Negative 60 Age <1 year 120 Age <1 year

12 Number of hospitalizations Number of hospitalizations Pre and Post Vaccine Sentinel Surveillance: Rotavirus Positive 60 Age <1 year Age <1 year and 1 year 120 Rotavirus Negative Age <1 year Age 1 year 120 Age 1 year

13 Number of hospitalizations Pre Vaccine Sentinel Surveillance: Rotavirus Hospitalizations, Age <5 years Rotavirus positive y Aug Sep Nov Dec Feb Mar May Jun Calendar month Jun Jun Jun 2013 * 2-month moving average 13

14 Number of hospitalizations Pre and Post (Yr 1) Vaccine Sentinel Surveillance: Rotavirus Hospitalizations, Age <5 years Rotavirus positive y Aug Sep Nov Dec Feb Mar May Jun Calendar month Jun Jun Jun 2013 * 2-month moving average 14

15 Number of hospitalizations Pre and Post (Yr 1, 2) Vaccine Sentinel Surveillance: Rotavirus Hospitalizations, Age <5 years Rotavirus positive y Aug Sep Nov Dec Feb Mar May Jun Jun 2011 Calendar month Jun Jun Jun 2014 * 2-month moving average 15

16 Number of hospitalizations Pre and Post (Yr 1-3) Vaccine Sentinel Surveillance: Rotavirus Hospitalizations, Age <5 years Rotavirus positive y Aug Sep Nov Dec Feb Mar May Jun Calendar month Jun Jun Jun Jun Jun 2015 * 2-month moving average 16

17 Rotavirus-positive and Rotavirus-negative Hospitalizations, Age <5 years Rotavirus-positive Rotavirus-negative * 2-month moving average 17

18 Rotavirus Hospitalizations and Vaccine Coverage, Age <1 year 18

19 Rotavirus Hospitalizations and Vaccine Coverage, Age <1 year 19

20 Rotavirus Hospitalizations and Vaccine Coverage, Age <1 year 20

21 Rotavirus Hospitalizations and Vaccine Coverage, by Age Group 21

22 Rotavirus Hospitalizations and Vaccine Coverage, by Age Group 22

23 RV1 Effectiveness Measurement in Armenia Methods Nested within sentinel surveillance Vaccination record obtained on Yerevan residents o Born after vaccine introduction o Record obtained from polyclinic Determined odds ratio for receipt of 2 doses of RV1 vs. 0 doses in rotavirus cases vs. rotavirus test-negative controls Unconditional logistic regression Controlled for birth month and year, admission quarter and year Assessed available factors for potential confounding o Gender o Gestational age o Birth weight 23

24 RV1 Effectiveness Measurement Results Nork hospital contributed 95% of enrolled children Vaccination record obtained in Rotavirus cases: 91% Test-negative controls: 85% Age at RV1 receipt: median (25 th, 75 th quartile) Dose 1: 7.7 weeks (6.7, 10.0) Dose 2: 15.5 weeks (14.0, 18.7) RV coverage did not change after age 6 months in 95% of infants Concomitant OPV o 97% of first RV doses o 98% of second RV doses 24

25 RV1 Effectiveness Measurement in Armenia 2 doses vs 0 doses All cases Cases % vaccinated Controls % vaccinated VE 95% CI Age 6-23 m 75 (63) 826 (80) Age (56) 461 (80) Age (66) 365 (80)

26 RV1 Effectiveness Measurement in Armenia 2 doses vs 0 doses All cases Cases % vaccinated Controls % vaccinated VE 95% CI Cases with higher severity score Cases % vaccinated VE 95% CI Age 6-23 m 75 (63) 826 (80) (50) Age (56) 461 (80) (42) Age (66) 365 (80) (56)

27 RV1 Effectiveness Measurement in Armenia 2 doses vs 0 doses All cases Cases % vaccinated Controls % vaccinated VE 95% CI Cases with higher severity score Cases % vaccinated VE 95% CI Age 6-23 m 75 (63) 826 (80) (50) Age (56) 461 (80) (42) Age (66) 365 (80) (56) Genotype information on 31% (n=23) 65%=G4P[8] (n=15) 17%=G1P[8] (n=4) each 4%=G2P[8], G3P[8], mixed (n=1) 27

28 Summary Through Sentinel Surveillance at 2 Hospitals in Yerevan, Armenia Substantial impact following RV1 introduction in Nov 2012 o Reduction in rotavirus hospitalizations, compared to pre-vaccine data o Age <1 year: 75% reduction in years 2 and 3 after introduction o Age <5 years: 69% reduction in year 3 o Data suggest indirect benefits o Successful implementation of program with an effective vaccine Vaccine effectiveness estimates of 2 doses of RV1 Including all cases, results similar to countries in Latin America Higher VE point estimates with higher severity score o Near that in higher income countries 28

29 Republic of Moldova

30 CONTRIBUTORS Moldova Stela Gheorghita Ludmila Birca Ala Donos Ion Birca Radu Cojocaru Anatol Melnick WHO Silviu Ciobanu Annemarie Wasley Liudmila Mosina CDC Benjamin Lopman Umesh Parashar 30

31 Rotavirus Surveillance in Moldova Performed at 2 hospitals in Chisinau Municipal Children s Infectious Diseases Hospital Sept 2009 o Mainly children aged 1-5 years Municipal Children s Clinical Hospital No o To also capture infants Follows generic WHO protocol Rotavirus EIA testing performed at National Laboratory 31

32 Pre-Vaccine Sentinel Surveillance: Rotavirus-Positive and Negative Hospitalizations Infectious Diseases Hospital only 32

33 Pre and Post-Vaccine Sentinel Surveillance: Rotavirus-Positive and Negative Hospitalizations Infectious Diseases Hospital only 33

34 Pre-Vaccine Sentinel Surveillance: Rotavirus Hospitalizations by Age Group 34

35 Pre and Post-Vaccine Sentinel Surveillance: Rotavirus Hospitalizations by Age Group 35

36 Pre and Post-Vaccine Sentinel Surveillance Trends Analysis: Methods Interrupted time-series analyses of rotavirus admissions Rate reduction (with 95% CI) compared to pre-vaccine period determined using generalized linear model o Adjusted for calendar month and hospital 36

37 Pre and Post-Vaccine Sentinel Surveillance: Rotavirus Hospitalizations Age Prevaccine 9/2009-7/2012 RV+/Total (% RV+) Year 1 Postvaccine 8/2012-7/2013 RV+/Total (% RV+) Rate reduction, % (95% CI) <1 yr 247/873 (28%) 83/590 (14%) 49% (34-64) 1 yr 725/1524 (48%) 111/327 (33%) 25% (14-35) 2-4 yrs 732/1390 (53%) 116/346 (33%) 32% (22-42) <5 yrs 1704/3787 (45%) 310/1263 (25%) 36% (36-44) 37

38 Pre and Post-Vaccine Sentinel Surveillance: Rotavirus Hospitalizations Age Prevaccine 9/2009-7/2012 RV+/Total (% RV+) Year 1 Postvaccine 8/2012-7/2013 RV+/Total (% RV+) Rate reduction, % (95% CI) <1 yr 247/873 (28%) 83/590 (14%) 49% (34-64) 1 yr 725/1524 (48%) 111/327 (33%) 25% (14-35) 2-4 yrs 732/1390 (53%) 116/346 (33%) 32% (22-42) <5 yrs 1704/3787 (45%) 310/1263 (25%) 36% (36-44) Year 2 Postvaccine 8/2013-7/2014 RV+/Total (% RV+) Rate reduction, % (95% CI) 31/458 (6%) 73% (53-84) 43/350 (13%) 75% (55-86) 84/349 (22%) 55% (30-72) 158/1157 (14%) 67% (48-87) 38

39 Pre and Post-Vaccine Sentinel Surveillance: Rotavirus Hospitalizations and Vaccine Coverage Coverage with 1 RV1 dose among rotavirus test-negative hospitalized children 39

40 RV1 Vaccine Effectiveness in Moldova Methods Nested within sentinel surveillance Vaccination record o If born May 1, 2012 Hospitalized ober 1, 2012 o Record obtained from polyclinic Determined odds ratio for receipt of 1 dose RV1 vs 0 doses in rotavirus cases vs. rotavirus test-negative controls Unconditional logistic regression Controlled for age (categorical) and hospital Secondary and stratified analyses o VE of 1 dose, 2 doses o Age group o Case severity using modified Vesikari score 40

41 RV1 Vaccine Effectiveness Results Vaccination record obtained in 96% of those eligible for VE analysis Generally timely receipt of RV1 41

42 RV1 Vaccine Effectiveness in Moldova by Number of Doses, Age 6 Months Controls, n (% vaccinated) All Cases, n (% vaccinated) Overall, 1 dose 422/819 (52) 20/95 (25) 75 (58-85) 1 dose 51/448 (11) 4/79 (5) 60 (4-85) 2 doses 348/745 (47) 14/89 (16) 79 (62-88) VE 42

43 RV1 Vaccine Effectiveness by Increasing Case Severity Score 43

44 RV1 Vaccine Effectiveness in Moldova Moderate to Severe Cases, age 6 months Controls, n (% vaccinated) All Cases, n (% vaccinated) VE Mod. to Severe Cases (% vaccinated) 1 dose 422/819 (52) 20/95 (25) 75 (58-85) 10/62 (16) 82 (63-91) 1 dose 51/448 (11) 4/79 (5) 60 (4-85) 2/54 (7) 71 (2-92) 2 doses 348/745 (47) 14/89 (16) 79 (62-88) 7/59 (12) 84 (64-93) VE 44

45 RV1 Vaccine Effectiveness in Moldova 1 dose vs. 0 doses, by Age Group Overall, 1 dose Controls, n (% vaccinated) All Cases, n (% vaccinated) VE Mod. to Severe Cases (% vaccinated) 422/819 (52) 20/95 (25) 75 (58-85) 10/62 (16) 82 (63-91) Age 6-11m 274/485 (56) 10/57 (18) 84 (67-92) 3/31 (10) 92 (72-98) Age 12-23m 136/316 (43) 10/36 (28) 46 (-1-75) 7/29 (24) 67 (-3-83) VE 45

46 Summary Sentinel Surveillance in Chisinau, Moldova Following RV1 introduction in y 2012, marked reduction in rotavirus rate In Year 2, coverage estimate of 55% in infants o Rate reduction of 73%, in age <1 yr o Rate reduction of 67%, in age <5 yrs Data suggest indirect benefits Room for increases in vaccine coverage, further disease reduction Vaccine effectiveness estimates of 2 doses of RV1 Including all cases, point estimate higher than in Latin American countries that have higher income levels High VE point estimates with higher severity score o Similar to VE against hospitalizations in middle-to-high income settings 47

47 Thank you for your attention! 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 & Respiratory Diseases Division of Viral Diseases

Dr Michelle Groome MBBCh (Wits) DCH(SA) MScMed (Epi & Biostats) Department of Science and Technology/National Research Foundation: Vaccine

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